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1

Medical Supplies, Equipment &


Lab reagent Management
[Commonly Used Medical Supplies, Equipment and Lab reagents in Health care facilities of Ethiopia ]

Debremarkos University, Ethiopia


Chapter I
Medical Supplies and Equipment
Medical supplies and equipment
 Medical supplies means different things to different people, and the
distinction between supplies and equipment is not always clear.
 In this course, we have defined medical supplies and equipment as
follows:
 Supplies: items that need to be replaced on a routine basis,
including:
 disposables, single use items, e.g. disposable syringes and needles;
 expendables (sometimes also called consumables), items that are used within a
short time, e.g. cotton wool, laboratory stains and tape;
 reusable items, e.g. catheters and sterilisable syringes,

 Equipment: capital equipment and durable items that last for several
years,
 e.g. beds, examination tables, sterilizers, microscopes, weighing scales and
bedpans → will be addressed in

Surgical Dressings
Definition:
Surgical dressing is a term applied to a wide range
of materials used for dressing wounds or injured
or diseased tissues.
Functions:
Prevent desiccation (drying) & facilitate wound
healing
Prevent wound maceration by permitting
evaporation or absorption of exudation
 Excessive moisture induce enzyme & damage repairing tissue
 Exudation favors microbial growth – infection!
… Surgical Dressings
Functions (cont’d):
Reduce heat loss
Control microbial growth (by incorporating
antimicrobials)
Provide support
Reduce pain, increase patient comfort, and improve
functional use of wound site
Reduce odor
Improve the appearance of the wound site eg. scar
Reduce overall costs associated with wound
treatment
… Surgical Dressings
Selection of a Wound Dressing bases on:
 The degree of exudation
 Presence of likelihood of infection
 Presence of necrotic tissue
 Anatomical site
 The state of wound repair

Note:- The use of a wound dressing cannot be


considered in isolation, but rather in the context
of an integrated wound-care program.
Functional classification of dressings:
1. Primary dressings
 directly contacts the wound
 it may provide absorptive capacity of secondary dressings
 it may prevent desiccation & infection
2. Secondary dressings
• placed over a primary dressing
• provide further protection, absorptive capacity, compressions
(firmness), or occlusion.
3. Primary /Secondary Wound Dressings
• they do have the property of both primary and secondary
dressings.
N.B.Surgical dressings are required to meet specific
requirements of pharmacopoeias.
Examples:

1. 1o dressings:
Plain Gauze, Impregnated Gauze, & Film Dressing

2. 2o dressings:
Surgical cotton (absorbent), Nonabsorbent Bleached
Cotton, Surgical gauze, bandages, Adhesive tapes

3. 1o and 2o dressings: Hydro-gels & Hydro-colloids


… Surgical Dressings

Another Classification:
Dressings may also be classified as:
1. Fibers e.g. cotton
2. Fabrics e.g. Absorbent Gauze
3. Bandages e.g. Elastic Bandages
4. Self adhesive plasters e.g. ZnO plasters
5. Compound dressings
 Absorbent Cotton (BP)
Pure, white cellulose
Prepared from raw fiber by series of processes
Natural wax, oils & impurities removed from it
Absorbs water readily
Its absorbency may decrease by prolonged storage,
moisture, heat, dust
Use: absorb wound exudates, cleaning, swabbing,
medicating wounds, applying antiseptics
 Absorbent Gauze
It is a soft cotton cloth of plain weave

Number of threads per inch or mesh type used as

specifications
Mesh No. determines absorbency capacity

Softer, more absorbent, more open structure

required to absorb heavy exudates


 Bandage
 Elastic
 Elasticity is due to special weave
 Stretch twice its length even after repeated laundering
 Conforms closely to the skin or joint surfaces
 Lies flat & secure yet allow some mobilization
 Stretches in case of swelling so that circulation not
impaired
 Adhesive Tape
 Composed of: Backing & Mass
 Backing:
o Cellulose
o Foam
o Paper
o Cloth
 Mass:
o Cohesive substance – rubber
o Plasticizer – make the edge tacky
o Fillers – zinc & titanium oxides
o Other components
Surgical Sutures and Ligatures

 Introduction
 Classification of sutures
 Suture size & indications by location
 Surgical needle
 Surgical sutures for National Procurement
 Summary
Introduction
 The technique of closing wounds by means of needle
and thread is several thousand years old
 Physicians have used sutures for at least 4,000 years.
Archaeological records from ancient Egypt show that
Egyptians used linen and animal sinew to close
wounds.
 The oldest known
reports of surgical
suture is in a mummy
from 1100 BC (ancient
Egypt)
… Introduction
A surgical suture: is a medical device used to hold body
tissues together after an injury or surgery.
 It generally consists of a needle with an attached suturing material
(thread).
 There are numerous types of surgical sutures that vary
by the size, nature and length of thread and shape and
length of the needle.
 The choice of surgical sutures depends on the task it is
required for, the handling characteristics and the
surgeon’s preference
Classification of suture materials
The two main classes of suture materials are:
absorbable and non-absorbable.
1. Absorbable:
Those that are absorbed or digested by the body cells and
tissue fluids in which they are embedded during and
after the healing processes. Of two types
a) Natural origin
Surgical gut: Derived from the small intestine of healthy
sheep.
 It is uniformly fine-grained and possesses great tensile
strength and elasticity.
Chromic suture material:
 Undergone various intensities of tanning with the salt of
chromic acid to delay the tissue absorption time.
 Typical examples of chromic suture and absorption times
are:
Type A plain, 10 days,
Type B mild chromic, 20days
Type C medium chromic, 30days
Type D medium chromic, 40days
 Limitation: can be digested by enzymatic action → can
initiate tissue reaction
b) Synthetic
 Absorbable synthetic sutures are made from polyglycolic
acid or other glycolide polymers.
 Dexon® (Polyglycolic acid): Widespread absorbable
suture material of synthetic origin
 Dexon® has low rate of reactivity and infection rate, and
has excellent knot security and tensile strength.
 A drawback of Dexon® is its high friction that binds and
snags when wet.
 Polyglatin [Vicryl®]- synthetic absorbable sutures
2. Non Absorbable
Not absorbed by the body cells or fluids.
a) Natural origin
 Surgical silk: Suture made of raw silk spun by silkworm
• Problem of acute inflammatory reaction that may lead to
encapsulation by fibrous connective tissue
b) Synthetic
 Nylon (ethilon): monofilament nylon is the most commonly used
in surface closures.
Table: Types of Sutures

Absorbable Non-Absorbable
Natural Synthetic Natural Synthetic
Mono- Multi- Mono- Multi-filament Mono- Multi- Mono- Multi-

filament filament filament filament filament filament filament

None  E.g.  E.g  E.g. None E.g.  Silk E.g.  E.g


Catgut Polydio Polyglactin, Polypro Nylon
Chromi xanone Polyglycoli pylene,
um c acid Polyami
de
(Nylon)
Summary: Classification of Sutures
Sutures based on thread structure
Monofilament threads
Synthetic monofilament threads are produced by a
special extrusion process in which molten plastic is
extruded under high pressure through fine spinnerets.
The monofilament structure is used mostly for
thinner threads.
 Surgeons choose which type of suture to use
depending on the operation.
 it has what is called low tissue drag,
 meaning it passes smoothly through tissue.

 It has have minimal tissue reactivity and resists

infection greater when compared to braided


(multifilament) suture materials.
Multifilament threads
Multifilament threads are composed of many fine individual
threads either twisted or braided together.
 Twisted multifilament threads include e.g. silk threads.
Multifilament threads have a rough surface that impairs passage
through tissue but results in considerably better knot holding
security.
 Multifilament threads are generally coated. The coating
smoothes out the irregular surface and thus facilitates passage
through tissue without impairing knot-holding security.
Braided or twisted sutures may have higher tissue drag, but are
easier to knot and have greater knot strength. Braided sutures are
usually coated to improve tissue drag
Characteristics of suture Materials
The ideal suture has the following characteristics:
 Sterile
 All-purpose (composed of material that can be used in any
surgical procedure)
 Causes minimal tissue injury or tissue reaction
 Easy to handle
 Holds securely when knotted (i.e., no fraying or cutting)
 High tensile strength
 Favorable absorption profile
 Resistant to infection
Note: at present, no single material can provide all of these
characteristics.
Suture removal timing
Time frame for removing sutures: Times will vary according to the
location and depth of the wound. However, the average time frame
is 7-10 days after application. The following general rules can be used
in deciding when to remove sutures:
 Scalp: 6-8 days
 Face, Eyelid, Eyebrow, Nose, Lip: 3-5 days
 Ear: 10-14 days
 Chest and abdomen: 8-10 days
 Back: 12-14 days
 Extremities: 12-14 days
 Hand: 10-14 days
Other Medical Supplies
I. Syringes
 Syringes are supplies intended for instillation of liquids
into the body or its cavities, or to withdraw body fluids
from the body cavities such as blood vessels and other
organs and tissues.
 Syringes are commonly classified according to differences
in principle of action into two major categories:
hypodermic/plunger syringes and bulb syringes.
 On the basis of their capacity, syringes may be classified
as small, medium or large.
A. Hypodermic/Plunger Syringes
 A hypodermic syringe is a simple piston pump consisting of a
plunger that fits tightly in a tube.
 The open end of the syringe may be fitted with a hypodermic
needle, a nozzle, or tubing to help direct the flow into and out
of the barrel.
 Syringes are often used to administer injections, apply compounds such
as glue or lubricant, and measure liquids.
Description:
 Disposable Syringes (Sterile) 3 parts, 3ml Luer fitting with
21G Needle.
 
Figure. Hypodermic Syringe

 Capacity and Graduation of Hypodermic Syringes: .


 The hypodermic syringe is usually of 2 to 50 ml
capacity.
Hypodermic syringes …
Usually graduated in units of volume (ml)
Nearly always transparent
Glass syringes may be sterilized in an autoclave
most modern medical syringes are plastic with a rubber
piston because:
 Seals much better between piston and barrel
 Cheap enough to dispose of after being used only once
 Reduce risk of spreading blood-borne diseases (no reuse)
 Re-use Hypodermic syringes …
 Spreads HIV, Hepatitis….
 Safe for insulin injection at home, if used only
by one person.
 Medical syringes are sometimes used without a
needle for:
 Oral administration of liquid medicines to young children or
animals, or
 Oral feeding of milk to small young animals
B. Bulb Syringes
• Bulb syringes frequently are preferred when sterility is not
necessary and plunger-type syringes, because of their force,
would be dangerous to use.
• They are particularly important in the nose and ear, and for
wound and urinary irrigation.
• Bulb syringes customarily are known by name of part of the
body for which they are intended (Nasal, Ophthalmic, Vaginal
and Rectal)

Figure. Bulb Syringes


II. Needles
 Needles are made of stainless steel, hyper chrome steel, carbon steel, chromium, nickeled,
platinum, platinum-iridium, silver, or gold.
 Needle is used with a syringe to inject substances into the body or to extract liquids from
the body, for example drawing blood from a vein.
Needles are mainly characterized by gauge, needle length and bevel.

i. Size (Gauge): refers to the outside diameter of the cannula (needle shaft):
 The gauge is given in number and the larger the number, the smaller the diameter.
 The usual range of gauges in common use range from 13 (largest diameter) to 27
gauge (smallest diameter).
 Subcutaneous injection usually requires a 24-gauge or 25-gauge needle.
 Intramuscular injection requires a needle with gauge between 19 and 22.
 Needles between 18 gauges and 20 gauges are commonly used for compounding
parenteral.
 For injection administration, gauge usually not greater than 16 G (1.65 mm)
ii. Needle length:
 Length of needle shaft (starting from the hub & shaft junction point)
 Usually ranges from 0.25 to 6 inches

iii. Bevel: is a slanting cutting edge which has a tapering


reinforced point/tip. The bevel facilitates penetration and
injection through tissue or rubber closures.

From top to bottom: 26G x 1/2"


(0.45 x 12mm) (brown), 25G x
5/8" (0.5 x 16mm) (orange),
22G x 1 1/4" (0.7 x 30mm)
(black), 21G x 1 1/2" (0.8 x
40mm) (green), 20G x 1 1/2"
(0.9 x 40mm) (yellow), 19G x 1
1/2" (1.1 x 40mm) (white).

Figure. Hypodermic needles on luer connectors

Figure . Hypodermic needles with different bevels


Needles are designed for a variety of purposes:
 Long-bevel needles: used for local anesthesia, aspirating, and
subcutaneous administration.
 Short-bevel needles: used for intravenous
administration,infusions,
 Special short-bevel needles: employed for intradermal and
spinal administration.
 Needles for local anesthesia: 26 to 20 gauge, ½ inch to 6
inches
 Intravenous, blood transfusion needles:19 to 15 gauge, 1¼
inch to 2½ inch
 Biopsy and bone-marrow transfusion needles: 19 to 16
gauge, ½ inch to 3½ inches
 etc
Description:
Spinal needle 22 G 10 cm

Figure . Needles with length of 10 cm for administering spinal anesthesia

• Factors that dictate gauge, length & bevel:–


 Safety/comfort of patient,
 Rate of flow of administered liquid &
 Depth of penetration
III. Intravenous Cannula
 A flexible tube which when inserted into the body is used

either to withdraw fluid or administer medication.


 Cannula normally come with a trocar (a sharp pointed

needle) attached which allows puncture of the body to


get into the intended space.
 Cannulas are characterized by their size, length, and

internal and outer diameters as indicated in table below


 
IV Cannula …

Water Flow
Color Length Internal diameter Outer diameter
Size Rate
(mm) (I.D), mm (O.D), mm
(ml / min)
2.1
14G Orange 45 1.7 305

Gray 1.7
16G 45 1.3 200

White 1.5
17G 45 1.1 142

1.3
18G Green 45 0.9 95

1.1
20G pink 32 0.8 65

0.9
22G blue 25 0.6 36

0.7
24G yellow 19 0.5 23
Figure. Cannula of different sizes

Description:
Intravenous cannula (IV) Set Sterile Polythene with introducer and injection
Valve external diameter 1.3mm Length 45mm 18G.
Tubes and Drains
• They are wide ranges of materials made of clear
plastics, latex, synthetic polymers or medical grade
polyvinyl chloride (PVC).
• Tubes can be inserted into a body cavity, duct or
vessel to allow drainage, injection of fluids or access
by surgical instruments.
• Drains are common features of the post-operative
management of surgical patients.
• Drains may be superficial, that is placed in the wound
or deep intra-peritoneal are used to prevent the
formation of a or to remove an accumulation of fluids
(hematoma ) that may become infected.
• Tubes and Drains are designed for a variety of purposes.
These include
 Endotracheal tube,
 Tracheostomy tube
 Nasogastric tube,
 Oxygen nasal prong,
 Rectal tube,
 Foley catheter,
 Condom catheter,
 Blood bag,
 Colostomy bag,
 Urine bag,
 Suction tube and
 Chest tube,
Also called as Breathing Tube
inserted into a patient’s trachea in order to ensure that
the airway is not closed off and that air is able to reach
the lungs
 connects the respirator to the patient
Used in general anesthesia, intensive care unit (ICU)
and emergency medicine for airway management and
mechanical ventilation
Types: oral or nasal, cuffed or uncuffed, performed,
reinforced tubes, double-lumen tubes and tracheotomy
tubes.
Figure. Endotracheal tube

Description:
Endothracheal tube, sterile CH 3 cuffed
V. Nasogastric tube (NG tube)

 A clear plastic tube that passes through the


patient’s nose and throat and ends in the patient’s
stomach.
 allows for direct “tube feeding” to maintain the
nutritional status of the patient or removal of
stomach acids.
 The main use of NG tube is for feeding and for administering drugs
and other oral agents.

 also used in poisoning situations when a


potentially toxic liquid has been ingested, for
preparation before surgery under anesthesia and
to extract samples of gastric liquid for analysis.
Sizes:
 Adult: 14-18 Fr
 Infant/Child: 10-14 Fr
III. Catheter
is a tube that can be inserted into a body cavity, duct or
vessel to allow drainage, injection of fluids or access by
surgical instruments.
Placement of a catheter into a particular part of the
body may allow:
 Draining urine from the urinary bladder

e.g. Foley catheters


 Drainage of urine from the kidney by per-cutaneous
nephrostomy
 Drainage of fluid collection, e.g. an abdominal
abscess
Foley catheters are used during the following situations:
 On patients who are anesthetized or sedated for surgery or other
medical care
 On comatose patients
 On patients with acute urinary retention
 On patients who are unable due to paralysis Following urethral
surgeries
Catheter types:
 Foley catheters : are flexible (usually latex) tubes that are passed
through the urethra during urinary catheterization and into the
bladder to drain urine.
 Condom catheter: is a sterile male external catheter used for incontinence
patients.
• Oxygen nasal catheter : also known as "Oxygen nasal prong” or “Nasal
cannula” is a supply used to deliver supplemental oxygen or airflow to
a patient or person in need of respiratory help.
• Suction catheter: also known as “Suction tube” is a medical supply
which provides suction by being attached to a suction machine.
• Suction tube is used to suck the sputum and secretion in respiratory tract by
directly inserting into the throat or by the inserted tracheal tube for anesthesia.
• .
B
Figure. Suction catheter
A
Figure. Foley catheters: A) Two-way, B) Three-way

Figure. Nasal oxygen prong


Figure. Condom catheter
IV. Rectal tube

 A rectal tube is made of PVC and used to expel flatus


from the rectum. 
 Rectal tubes and Colon tubes are basically the same
thing the only difference is the length.  Colon tubes
are longer.
 Types: - Rectal tube open end,
- Rectal tube close end
 Size(Fr.) 18, 20, 22, 24, 26, 28, 30, 32
A B

Figure. Rectal tubes: A) Open- end, B) Closed-end


open end → for administration of
enema solutions, drainage and Closed end → to deliver the
enema solution deeper into
irrigation.
the colon
V. Urine Bag
• is used to collect urine and is available in different
sizes.
Features:
 Soft and kink resistant PVC tubing
 Non-return valve
 Bag graduated in ml to indicate the quantity of
urine collected
 Conical inlet connector with cup
 Tube length 90-100 cm
 Available sterile or non-sterile
Size: 100 ml, 1000ml, 2000 ml
2000 ml
 Used for short and long-term urine drainage
 100ml
 Used for urine collection in infants

Figure. Urine bag


Protective's and other supplies
Protective Supplies

Protective supplies are supplies that act as a barrier

between infectious materials and the skin, mouth, nose, or


eyes (mucous membranes).
 These includes face mask, glove, clothing (apron, gown, trouser, shirt,
cape, boots).

When used properly, protective supplies can help prevent

the spread of infection from one person to another. E.g


Ebola , Coronavirus …
I. Gloves
Medical Gloves:
Used during:
 Medical examinations and procedures
 Collection & handling of lab specimens
help prevent contamination between caregivers and
patients
must be discarded after each patient care contact
Examination/Disposable gloves:
 non sterile, packed in bulk, single use only
… Gloves
Exam Glove Surgical Glove
Size Size
Surgical gloves:
XS 5.5
Sterile
S 6.0
Every pair packed separately
6.5
Size: M
7.0
X-small (5)
7.5
Small (6) L
8.0
Medium (7)
XL 8.5
Large (8)
XXL 9.0
X-large (9)
II. Face Mask
Face masks are made of soft, high grade materials
that ensure a non-irritating and fiberglass free
product which guarantees easy breathing and
comfort.
 Face masks are designed to meet protection from
dust particles and bacteria.
III. Apron
An apron is an outer protective garment that
covers primarily the front of the body in order to
protect clothes from wear and tear. It can be made
of cloth or plastic.
IV. Gown
Surgical gowns are garments worn during medical
procedures. Gowns help prevent contamination between
caregivers and patients, and they protect the caregiver's
clothing.
You should consider using a surgical gown to cover your
trunk, arms, legs, and clothing when you may be
splattered by someone else’s body fluids (such as blood,
respiratory secretions, vomit, urine or feces).
V. Eye Goggle
Goggles are forms of protective eyewear that usually
enclose or protect the area surrounding the eye in
order to prevent particulates, blood and other body
fluids, and chemicals from striking the eyes.
They are used during surgery and dental procedures.
Tourniquet
Tourniquet is a supply for
compression of an artery or
vein. It is used in stopping of
the excessive bleeding of a
hemorrhage, prevention of
spread of snake venom after a
snake bite and aiding in
obtaining blood samples or
giving intravenous injections.
Figure Tourniquet
Description:
Tourniquet of double belt
Medical Equipment
What is inside?

1. Introduction to Medical Equipment

2. Functions and Classification of ME

3. Commonly used Medical Equipment in HFs of Ethiopia

4. Procurement and handling of Medical Equipment


Introduction
What is a Medical Device?
  The World Health Organization (WHO) differentiates the
mostly associated terms such as, medical device and
medical equipment. Hence, the following definitions:
 .Medical device: An article, instrument, apparatus or
machine that is used in the prevention, diagnosis or
treatment of illness or disease, or for detecting, measuring,
restoring, correcting or modifying the structure or function
of the body for some health purpose.
 Typically, the purpose of a medical device is not achieved by
pharmacological, immunological or metabolic means.
 Medical equipment: Medical devices requiring calibration,
maintenance, repair, user training, and decommissioning –
activities usually managed by clinical engineers.
• it is used for the specific purposes of diagnosis and
treatment of disease or rehabilitation following disease or
injury; it can be used either alone or in combination with any
accessory, consumable, or other piece of medical equipment.
• It excludes implantable, disposable or single-use medical

devices.
 Therefore, according to the above definitions medical
equipments are subset of medical devices which in turn are
type of health technology in the larger context of health care
technology as described in figure below.

NB: in this course the


concern is on Medical
Equipment

Figure: The Medical Device Universe


Fig: Global statistics on medical device production (2002)
... Introduction
Concept of “Essential Medical Devices”
 The concept of “Essential Medical Devices” is very
much similar to that of Essential Medicines. It
promotes having a limited range of carefully selected
essential medicines that satisfy the priority health care
need of the population.
 This is believed to lead to better health care, better
drug management, and lower costs. In the same
manner, a medical device should be considered
essential only when the following three criteria are
fulfilled:
a) Its use meets the basic needs of health services.
b) Proven to be cost-effective.
c) Evidence-based (i.e. follows well defined specifications
and widely accepted consensus by experts) .
The following factors must be included in the
consideration during selection
 Specific health services needs are met by acquiring equipment.
 All equipment needs should be identified and coasted, including
any training of users and servicing staff, physical facilities and
auxiliary supplies,
 such as water, electricity, air- conditioning,
protection and safety precautions. The equipment
supplied should confirm to local utility factors.
 Spare parts and technical support from the local agent must be
ascertained.
 Supplier must provide both operation and service manuals.
 In evaluating tenders, quotations must be compared and
evaluated, not only in terms of price and delivery time, but also
in terms of availability and quality of back-up support, spare
parts and technical staff.
 Moreover, the need to standardize must be
considered so as to facilitate the ease of use and
maintenance.
• This includes devices that do not achieve their principal
intended action in or on the human body by pharmacological,
immunological, or metabolic means, but may be assisted in their
function by such means.
• In other words, It is intended to affect the structure or any
function of the body of man or other animals, and unlike drugs
it does not achieve its primary intended purposes through
chemical action within or on the body of man or animals and
is not dependent upon being metabolized for the achievement of
any of its primary intended purpose.
Definition in our context
 Based on the above definitions, in this document a medical

device is meant to encompass all items traditionally


categorized as laboratory chemicals and reagents, medical
supplies and consumables and medical equipments. This
is also in line with the definition issued by the Food
Medicine and Health Care Administration and Control
Authority (FMHACA).
 Though FMHACA preferred the term “Medical
Instrument” rather than “Medical Device”, the content of
the definition matches with what is discussed above.
According to FMHACA the following definition is issued
 “...any instrument or supply that may be used on the inner or

outer part of the body for diagnosis or treatment of a disease


in human, and includes various diagnostic, laboratories,
surgery, dental medical instruments and suturing materials,
syringes, needles and other supplies.”
Classification of Medical Devices by risk
 Regulatory controls are intended to safeguard the health and
safety of patients, users and others. The level of controls will
depend on the identified risks associated with devices.
 The classification of risk is determined from: The
manufacturer’s intended purpose for the medical device,
Four risk-based class
CLASS RISK LEVEL DEVICE EXAMPLES
A Low Surgical retractors/tongue depressors
B Low-moderate Hypodermic needle/suction equipment
C Moderate-high Lung ventilator/orthopaedic implants
D High Heart valves/implantable defibrillator
Technical Specification of Medical Devices
Challenges in Technical Specifications of Medical Equipments
 Apart from their management, procurement of these medical
equipments is really a challenging job in many ways:
A. Nomenclature System: The same kind of a particular medical
equipment carries different nomenclature system.
B. Unavailability of Generic Quality Specifications: There is also
no standardization in medical equipment field in terms of quality
standard adopted, documentation etc. There are several
specifications available by which one can procure a particular
medical equipment, some may be specific to some brands.
C. Inadequate Specifications: There are procurement instances
where no or very little (inadequate) specifications are given.
These all lead to delay in procurement and quality problems.
Scanning System, Magnetic Resonance
Imaging, Full-Body
Other common names:
MRI systems; MRI scanners, MR scanners, magnetic
resonance scanners

Intended use: MRI is primarily used to identify diseases


of the central nervous system, brain, and spine and to detect musculoskeletal disorders. It is
also used to view cartilage, tendons, and ligaments.
MRI can also be used to image the eyes and the sinuses.
MRI can be used to help diagnose infectious diseases; to detect metastatic liver disease; to
display heart-wall structure; to stage prostate, bladder, and uterine cancer; to evaluate kidney
transplant viability; and to study marrow diseases

User(s): Radiologists, MRI technicians


Principles of operation: MRI units use strong
electromagnetic fields and radio-frequency radiation to
translate the distribution of hydrogen nuclei in body
tissue into computer-generated images of anatomic
structures.
MRI depends on the magnetic spin properties of certain
atomic nuclei in body tissue and fluids and their
behavior in the applied magnetic field.
These nuclei are normally aligned randomly in tissue
until an external magnetic field is applied and the nuclei
align themselves with that field.
MRI, mid field 0.4 -1.0 Tesla
Description:- MRI System, medium tesla, Open
system
Magnetic Resonance imaging system with high mom
Minimum guaranteed and typical field homogeneity
Open magnet with large patient space and high homogeniety
Standard gradients and channel digital Radio Frequency System.
To be capable of routine Neuro, Body, Spine Orthopedic &
Perpheral Vascular Imaging.
 Minimum guaranteed and typical field homogeneity in ppm.
Magnet shielding
Scanning System, CT
Other common names:
Computed Tomography Scanners; Computed
Tomography Scanning Systems; Computed X-Ray
Tomography Scanners; Computer-Assisted Tomography
Scanners; Computerized Tomography; CT Scanners
Intended use: These scanners are used
for a wide variety of diagnostic procedures,
including spine and head injuries, lesions,
and abdominal and pelvic malignancies;
to examine the cerebral ventricles, the chest
wall, and the large blood vessels; and to
assess musculoskeletal degeneration

User(s): Computed tomography scanning technician


Principles of operation CT scanners use slip-ring
technology, which was introduced in 1989. Slip-ring scanners can perform
helical CT scanning, in which the x-ray tube and detector rotate around the
patient’s body, continuously acquiring data while the patient moves through
the gantry.
 The acquired volume of data can be reconstructed at any point during the
scan.
 All modern CT scanners are multi slice. Inside the gantry, an x-ray tube
projects a fan-shaped x-ray beam through the patient to the detector array.
 As the x-ray tube and detector rotate, x-rays are detected continuously
through the patient.
 The computer mathematically reconstructs data from each full rotation to
produce an image of one slice.
CT Scan versus MRI comparison chart
CT Scan MRI
The effective radiation dose from CT ranges from 2
to 10 mSv, which is about the same as the average
Radiation person receives from background radiation in 3 to 5 None. MRI machines do not
years. Usually, CT is not recommended for
exposure emit ionizing radiation.
pregnant women or children unless absolutely
necessary.
MRI costs range from $1,200 to $4,000
CT Scan costs range from $1,200 to $3,200; they
(with contrast), which is usually more
Cost usually cost less than MRIs (about half the price of
expensive than CT scans and X-rays, and
MRI).
most examining methods.

Time taken Usually completed within 5 minutes. Actual scan


Depending on what the MRI is looking for,
and where it is needing to look, the scan may
for complete time usually less than 30 seconds. Therefore, CT is
be quick (finished in 10-15 minutes) or may
less sensitive to patient movement than MRI.
scan take a long time (2 hours).
No biological hazards have been reported
with the use of MRI. However, some may be
Effects on the Despite being small, CT can pose the risk of
allergic to the contrast dye, which is also
irradiation. Painless, noninvasive.
body inappropriate for those suffering from
kidney or liver disorders.
CT Scan versus MRI comparison chart
CT Scan MRI
Ability to change With capability of MDCT, isotropic MRI machines can produce images in
the imaging plane imaging is possible. After helical scan with any plane. Plus, 3D isotropic imaging
without moving Multiplanar Reformation function, an also can also produce Multiplanar
the patient operator can construct any plane. Reformation.
Suited for bone injuries, Lung and Chest Suited for Soft tissue evaluation, e.g.,
Application imaging, cancer detection. Widely used ligament and tendon injury, spinal
on Emergency Room patients. cord injury, brain tumors, etc.
Details of bony
Provides good details about bony structures Less detailed compared to X-ray
structures
Acronym for Computed (Axial) Tomography Magnetic Resonance Imaging.
A major advantage of CT is that it is able to
Details of soft Provides much more soft tissue detail
image bone, soft tissue and blood vessels
tissues than a CT scan.
all at the same time.
MRI is more versatile than the X-Ray
Scope of CT can outline bone inside the body very
and is used to examine a large variety of
application accurately.
medical conditions.
Principle used for Uses large external field, RF pulse and 3
Uses X-rays for imaging
imaging different gradient fields
CT scan MRI
Principle X-ray attenuation is detected by Body tissues that contain hydrogen
detector & DAS system, followed by atoms (e.g. in water) are made to emit
math. model (back projection model) a radio signal which are detected by
the scanner. Search for "magnetic
to calculate the value of pixelism that
resonance" for physics details.
becomes a image.
Image Good soft tissue differentiation Demonstrates subtle differences
specifics especially with intravenous contrast. between different kinds of soft
Higher imaging resolution and less tissues.
motion artifact due to fast imaging
speed.
History The first commercially viable CT First commercial MRI was
scanner was invented by Sir Godfrey available in 1981, with significant
Hounsfield in Hayes, United increase in MRI resolution and
Kingdom. First patient's brain-scan choice of imaging sequences over
was done on 1 October 1971. time.
CT scan MRI
Intravenous Non-ionic iodinated agents covalently Very rare allergic
Contrast bind the iodine and have fewer side
reaction. Risk of reaction
Agent effects. Allergic reaction is rare but
more common than MRI contrast. Risk
in those who have or
of contrast induced nephropathy have a history of kidney
(especially in renal insufficiency or liver disorders.
(GFR<60), diabetes & dehydration).
Anxiety, especially anxiety caused by
Comfort Seldom creates claustrophobia
claustrophobia, is common, as is tiredness
level for or annoyance over having to stay still on a
patient hard table for a long period of time.

Limitation Patients with metal implants can get CT Patients with Cardiac Pacemakers, tattoos
and metal implants are contraindicated due
for scan. A person who is very large (e.g. to possible injury to patient or image
Scanning over 450 lb) may not fit into the opening distortion (artifact). Patient over 350 lb
may be over table's weight limit. Any
patients of a conventional CT scanner or may be ferromagnetic object may cause
over the weight limit for the moving trauma/burn

table.
Mammography unit
Other common names:
Mammo units; X-ray system, diagnostic, mammographic,
stationary, digital
Intended use : Mammographic radiographic units
use x-rays to produce images of the breast—a
mammogram—that provide information about beast
morphology, normal anatomy, and gross pathology.
Mammography is used primarily to detect and
diagnose breast cancer and to evaluate palpable
masses and no palpable breast lesions.
Principles of operation
Low energy X-rays are produced by the x-ray tube (an evacuated
tube with an anode and a cathode) when a stream of electrons,
accelerated to high velocities by a high-voltage supply from the
generator, collides with the tube’s target anode. The cathode contains
a wire filament that, when heated, provides the electron source. The target anode is struck by the impinging
electrons. X-rays exit the tube through a port window of beryllium. Additional filters are placed in the path o
the x-ray beam to modify the x-ray spectrum.

User(s): Radiology/mammography technican, radiologist


Monitor, Bedside, Electroencephalography
Other common names:
Cerebral function monitors; EEG recorders; electroencephalographs;
monitors, bedside, electroencephalography, spectral
Intended use:
EEG monitors are used for observing and diagnosing a
variety of neurologic conditions, including epilepsy, related
convulsive disorders, and brain death. They can also be used
to evaluate psychiatric disorders and differentiate among
various psychiatric and neurologic conditions. In addition,
electroencephalographic studies with EEG monitors can
assist in localizing tumors or lesions on or near the surface
of the brain
Principles of operation
Low-amplitude (microvolt range) EPs believed to be generated
by large numbers of nerve cells known as pyramidal cells, which are located in the outer layer (cortex)
of the brain, polarize and depolarize in response to various stimuli, creating the EEG waveform. These
fluctuating electrical potentials are detected by electrodes placed on the scalp and are displayed and/or
recorded on the EEG. Each EEG channel amplifies a signal from a pair of electrodes, and these
amplified signals can be printed on a chart recorder and/or displayed on a monitor.

User(s): Neurologists, neurosurgeons, or other physicians, EEG technicians, sleep lab technicians
Electrosurgical Unit
Other common names:
Bovies; Coagulators, Electrosurgical; Diathermy Units, Surgical;
Electrocautery Units; Electrosurgical Generators;
Endometrial Ablation Systems; ESUs; Hyfrecators; Malis
Coagulators; Stimulators, Muscle; Surgical Diathermy Units;
Surgical Units; Wapplers; Apparatus, electrosurgical; Surgical
diathermy generator
Intended use
Devices intended for surgical cutting and for controlling bleeding by causing coagulation
(homeostasis) at the surgical site. Electro surgery is commonly used in dermatological,
gynecological, cardiac, plastic, ocular, spine, ENT, maxillofacial, orthopedic, urological,
neuro- and general surgical procedures as well as certain dental procedures.
Principles of operation
In monopolar electrosurgery, tissue is cut and coagulated by completion of an electrical circuit that
includes a highfrequency oscillator and amplifi ers within the ESU, the patient, the connecting cables,
and the electrodes. In most applications, electric current from the ESU is conducted through the surgical
site with an active cable and electrode. The electrosurgical current exits the patient through a dispersive
electrode (usually placed on the patient at a site remote from the surgical site) and its associated cable
connected to the neutral side of the generator.
User(s): Surgeon
Technical specification of Electrosurgical Unit (Monopolar-bipolar)
• Outputs of cut, coagulate and blend Maximum output 300 W for monopolar cut
Activation :
• Double pedal switch which may be used for the monopolar and bipolar functions .
• Hand-switch handle
• Bipolar electrode with pedal switch or with automatic Start/Stop system ( for
• coagulation only)
Control
• The Unit shall stop automatically in case of internal error which shall be identified on
• Display and with audible alarm
• Memorization : User shall be able to use at least 4 working programs

Safety :
• Neutral plate safety circuit shall control connections and contacts of Neutral Plate with Tissues:
• Defective Contact shall be notified with visual Alarm and immediate reducing of power
• Output circuit : floating - protected against defibrillator interferences . Shall have HF
• leakages less than 150mA through each electrode
• Power Supply : 220VAC, 50Hz
• Cooling: convection without fan
• HF electrosurgical unit shall be used to execute monopolar and bipolar surgery in many fields of
application where high precision and reliability are essential
Forceps shall be provided with a standard European connection
 Straight Forceps - 18 cm. (7")
 Curved Forceps - 18 cm. (7")
 Curved Forceps - 20 cm. (7 3/4")
 Bayonet Forceps - 18 cm. (7")
 Bayonet Forceps - 20 cm. (7 3/4")
 Straight Forceps - 20 cm. (7 3/4")
 Cable, Bipolar
 Adaptor, Bipolar Cable
 User Manual
Standards : EC Marked, US FDA; ISO certification
Aspirator
Other common names:
Suction unit, suction pump, evacuator, vacuum pump

Intended use:
Most surgical procedures require suctioning to remove
blood, gas, tissue, or other foreign materials and irrigating fl
uids that accumulate in the operative field and obstruct the
surgeon’s view. Portable or mobile aspirators can be used if
there is no central vacuum system or if suctioning is
required in areas that do not have vacuum inlets.
Principles of operation
Various pump configurations include rotary-vane, diaphragm, and piston. Each mechanism
alternately increases and decreases the vacuum and/or chamber volume, creating suction.
Air is drawn from the external tubing into the chamber, drawing aspirate into a collection
canister. Most surgical aspirators have an over flow-protection assembly that prevents fluid
from overflowing into the pump and valves.
User(s): Surgeons, assisting surgeons, nurses, respiratory therapists, other medical
staff
Technical specification of Aspirator/ suction pump
 Suction Unit for Major Surgery Procedures . Mains-powered , mobile on 4 antistatic
 Castors, ABS Casing and 2 graduated Canisters of 2,000ml each made of
 Polycarbonate autoclavable at 121°C and disposable suction bags
 Shall require no maintenance nor lubrication
 Oil-free pump, maximum suction of at least 500 mm Hg
 Free flow rate at least 25 l/min
 Main Switch with Pilot Lamp . Fuses
Pedal Action
 Shall be equipped with a protective thermal cut-out relay.
 Shall be equipped with motor-protection cap that totally prevents aspirated liquids or
 secretions from reaching and damaging the vacuum pump
 Suction command with continuous adjustment , Vacuometer
 2X2,000ml Canisters with airproof screwing-cap with independent Overflow devices
 . Fast Connectors and silicone Tubing
 Power Supply : 220VAC.50Hz.
 Ventilation Fan for overheating
 Sound level: Shall be not more than 55 dBA
Accessories
 Silicone Tubing , sterilizable
 Transparent Cannula Holder, Sterilizable
 Anti-Bacterial Filters ( 4 )
 Set of 4 canulaes with Holder : Yankhauer , Soft Universal Yankhauer
 Diameter : 8.0/6.0mm with anti-sticking Lumen and High Suction Lumen
 Universal Soft Canulaes diameter : 6.0/4.0mm
 Frazier Canulaes (Fergusson) diameter :1,5/2.0/3.0/4.0mm
 Jackson Canulaes
Standards
 CE; EC Marked; US FDA; ISO certification
Electrocardiograph, ECG
Other common names:
Computer-assisted electrocardiographs; interpretive
ECG machines; interpretive electrocardiographs;
automated electrocardiographs; EKG machines;
Electrocardiograph multichannel;
Intended use
Electrocardiographs detect the electrical signals associated with cardiac activity
and produce an ECG, a graphic record of the voltage versus time. They are used
to diagnose and assist in treating some types of heart disease and arrhythmias,
determine a patient’s response to drug therapy, and reveal trends or changes in
heart function. Multichannel electrocardiographs record signals from two or
more leads simultaneously and are frequently used in place of single-channel
units. Some electrocardiographs can perform automatic measurement and
interpretation of the ECG as a selectable or optional feature.

User(s): Physicians, nurses, other medical staff


Principles of operation
Electrocardiographs record small voltages of about one mill volt
(mV) that appear on the skin as a result of cardiac activity. The
voltage differences between electrodes are measured; these
differences directly correspond to the heart’s electrical activity.
Each of the 12 standard leads presents a different perspective of
the heart’s electrical activity; producing ECG waveforms in which
the P waves, QRS complex, and T waves vary in amplitude and
polarity. Other lead configurations include those of the Frank
system and Cabrera leads. The Frank configuration measures
voltages from electrodes applied to seven locations—the forehead
or neck, the center spine, the midsternum, the left and right
midaxillary lines, a position halfway between the midsternum and
left midaxillary electrodes, and the left leg.
Technical specification Electrocardiograph
Recording ECG Leads: 12 standard Leads
Recording Channels: 3/1 user selectable
LCD display of ECG; Lead switching: manual and automatic.
Sensitivity, mm/mV: 5, 10, 20.
Calibration signal: automatic and manual.
Diagnostic frequency range 0.67–150 Hz or better
Filters for mains frequency, low frequency, muscle artifact, high frequency Recorder:
Recording method: thermal paper; Recording speed, mm/sec: 25/ 50 user selectable
Channels acquired simultaneously:1/ 3 user selectable
Channels printed simultaneously:1/ 3 user selectable
Other features:
Portable
Mains and internal rechargeable battery operation
Battery operating time, minimum: 90 min.
Power requirements: 220 V, 50 Hz
Accessories:
1. Patient cable
2. 6 chest limb electrodes
3. 4 limb electrodes
4. 4 strap electrodes
6. 1 bottle ECG Gel
7. 2 rolls of paper or Z-Fold
8. Carry bag
Standards
CE; EC Marked; US FDA; ISO certification
Colonoscope
Other common names:
Endoscopes; video endoscopes; Video colonoscope,
flexible;

Intended use
Colonoscopes are used for the removal of foreign
bodies, excision of tumors or colorectal polyps
(polypectomy), and control of hemorrhage. Routine
colonoscopy is important in diagnosing intestinal
cancer, the second leading cause of cancer deaths in
the United States. These endoscopic procedures
reduce the need for invasive surgical diagnostic and
therapeutic procedures.
Principles of operation
Video colonoscopy insertion tubes contains a fiberoptic
light bundle, which transmits light from the light source
to the tip of the endoscope. Each fiberoptic bundle
consists of thousands of individual glass fibers coated
with glass causing internal reflections that allow light
transmission through the fiber even when it is flexed.
The light is used to illuminate the field of view in the
patient’s colon. Video images are detected by the CCD
and are then transmitted to the video processor and then
display monitors or recording devices.

User(s): Gastroenterologist
Technical specification of Colonoscopy (With halogen light source)
Optical System :
Field of view: at least 120°
Depth of field: 5 –÷100 mm.
Distal end : Outer diameter: not more than 13mm.
Bending Section
Range of tip bending: not less than Up 180°, Down 180°, Right 160°, Left 160°
Insertion tube : Outer diameter: not more than 13.3mm
Working length: not less than 1680mm.
Instrument channel; Inner diameter: not less than 3.2mm.
Light Source
Halogen technology shall provide a high light intensity of at least 150W .
Variable light intensity
Fast and easy bulb change during operation : In case of a bulb failure immediate
switch to the second bulb with the reverser shall be possible
Adjustment of brightness and power with buttons and switches on the front panel.
Shall be connectable with conventional telescopes, fiberscope,
Shall be adaptable to all endoscopic procedures
Optionally , an automatic built-in swivel mechanism will bring the spare halogen
bulb into working position.
Technical Data : Halogen , 150 watts , Halogen, 2 pieces
Manual switch , 2 x 150 W ,24 V, Power Supply : 220 VAC 50Hz .
Standards
CE; EC Marked, US FDA; ISO certification
 For more detailed technical specifications one can refer to the
references depicted at the end of this paper including the
Ethiopian List of Medical Instruments with minimum
specification which is drafted by EFMHACA.
Considerations for equipment providers
 One major problem concerning medical equipment in developing countries is
the huge / large variety of models from different manufacturers. This greatly
complicates the use and maintenance of equipment. Different models entail
different operating procedures that can limit the number of users. Unfamiliar
users carry high risks of making mistakes. In-service training is often not well
established in developing countries.
 Different models also require special spare parts and service skills that are
again difficult to acquire. Lack of recurrent operating and maintenance budget
pose another problem. Sometimes one can see donated equipment lying unused
after the initial excitement of high expectations. If not carefully considered,
donated equipment can bring more problems than it benefit the patient.
Potential donors may consider the following points:
 Medical equipment platform …???
Medical Instruments Procurement
Demand /request from MOH, RHB or HFs
Specification
Tendering
Hand over/receive
Storage
Distribution
Installation
Training
After sales service
During procurement Medical Equipment
Sophisticated or complex equipment is concerned, the
‘turnkey’ approach is always adopted (where the supply
of equipment includes installation, commissioning,
initial training for operators, warranty, building
modification, safety, service and maintenance for five
years after warranty)
NB: an expert committee at national level formulates
generic specifications for each item and circulates them
among healthcare institutions in the country. These
specifications are upgraded annually.
Product selection is an important stage in the procurement
process. Products must be selected based on a thorough
needs analysis and adjudication system, taking into account
the level of the health facility and the skills available.
 More sophisticated equipment is generally needed at
higher levels, as the range of diagnostic and treatment
services offered broadens,
Tip Generally speaking, the greater the technical nature and
complexity of an item, the greater the involvement should be of
technical staff in the buying decision.
Economies of Scale
 Procurement of small quantities increases both the initial
and the life-cycle costs of equipment because you cannot
benefit from the savings that bulk-buying offers.
 By combining procurement for several facilities at the
same time, and gaining the resulting standardization, you
can obtain significant advantages.
 These include better prices for bulk orders of equipment,
consumables, and spare parts, shared training costs, and
improved after sales commitment from the supplier.
Guideline for Describing Medical Devices

Example
CT Scan - Whole body, 128slice, with Anesthesia + Defibrillator + ECG +
Patient Monitor + Injector
SN Guideline Example Remark
 
Please refer
 Resuscitator (Preferred Term )
Medical Devices should always be  Ambubag (Commonly used Brand Name) Annex I for
1  Bed – ICU, Adult, Manual ,4section definition of
written in their preferred term  Analyzer - Laboratory, Hematology, Automated, 24 preferred term
parameter, 5 differential
    Please refer
  Table - Ophthalmic, Operating , Electro Annex II for
2
Preferred term should always begin with hydraulic list of
  commonly
a parent name   Analyzer - Laboratory, Hematology, used parent
  Automated, 24 parameter, 5 differential names
 
 

3  
 Preferred term of should have a data  Anesthesia Unit
  Bed – ICU, Adult, Manual ,4section
structure having the following   Set – Cervical, Dilation and Evacuation
sequence :   Table - Ophthalmic, Operating ,
Electrohydraulic
Parent - Class/Category , Type,   Analyzer - Laboratory, Hematology,
Automated, 24 parameter, 5 differential
Application/ Purpose, Operation,   CT Scan - Whole body, 64slice, with
Capacity/Size/Dimension/Color, Anesthesia + Defibrillator + ECG + Patient
Monitor + Injector
Combination  
  Bowl - Lotion, 500ml, with Stand
   

4   Afterthe parent name, there should follow “white


space”, “dash” then “white space”. Following the
Set - Amputation
second “white space” the descriptions, if any, should Anesthesia
be written comma(s) separated followed by “white  Table - Ophthalmic, Operating,
space”. There should NOT be space between a
Electro Hydraulic
comma and the last letter of the word before the
comma.
SN Guideline Example Remark
 
 
When a medical device has other
5  CT Scan - Whole
combination device(s), the list of the body, 64slice, with
combination devices should begin Anesthesia +
with the word “with” and Defibrillator + ECG +
concatenated using “white space”, “+” Patient Monitor +
then “white space” Injector
 
 
6 Medical devices          Set Please refer
nomenclature should always          Bed Annex II for list
         Analyzer
of candidate
begin with parent name          Monitor
         Anesthesia parent names
         Radiography
         Prosthesis
         Orthotics
 
Medical devices nomenclature should always be    
7 followed by child names/ description (if Anesthesia
applicable) that is ordered as Class/Category, Analyzer - Laboratory,
Type, Application/ Purpose, Operation, Hematology, Automated
Capacity/Size/Dimension/Color, Combination
SN Guideline Example Remark
 
 
8 Words in medical devices should  CT Scan - Whole Body,
always begin with capital letters 64slice, with Anesthesia +
Defibrillator + ECG +
except prepositions. Patient Monitor + Injector
 Set - Dilation and
Evacuation, Cervical  
For centrifuges [number of  
9 When units of measure are expressed in
wholes, volume of wholes]
combination of two numbers, avoid space          8x10ml
before and after the ‘x’ signs.  

10 For electrical devices, unit of   Please refer Annex III


         100W and Annex IV for list
measure for electrical parameters
         65kW of SI units and
should be in SI unit symbol or a  
commonly used
combination. abbreviation
   
11 For Chemistry analyzers, Hematology     Analyzer - Laboratory,
analyzers, CT scanners words that follow Hematology, Automated, 24
Parameter, 5 Differential
size/capacity… the like should be     CT Scan - Whole Body, 64
capitalize and there musrt be Slice
    MRI-1.5 Tesla
“whitespace” between the  
dimension/capacity and the number
Annex I Definitions
Preferred terms are all the names available for the purpose of
classification of medical devices. It is a term representing a set of
devices having the same or similar intended uses or commonality
of technology allowing them to be classified in a generic manner
not reflecting specific characteristics such as brand or trade
names.

A generic device group (represented by a preferred term)


comprises a set of devices, which are identified by their device
type and grouped together for the purpose of reporting or data
retrieval. [“GMDN User Guide: version 20*”; accessed from
GMDN website at www.gmdn.info; accessed date June 5 2017]
Parent is a base concept that occurs in more than two
generic device group terms (preferred terms) for the sole
purpose of presenting these in a hierarchical manner.
• Example 1: Bed as base concept (parent)
• Bed
• Bed - ICU
• Bed - ICU, infant
• Example 2: Analyzer as base concept (parent)
• Analyzer
• Analyzer – laboratory
• Analyzer – laboratory, clinical chemistry
• Analyzer – laboratory, clinical chemistry, automated
Annex II List of parent names
A E
Apron Electrocardiography I
Apheresis Units, Blood Donor Electrosurgical Unit Immobilizer
B Elevator Incubator
Balance
Endoscope Infusion Pump
Basin
Bath
Exerciser K
Blood Bank (Eye) (Kidney)
Bottle F L
Bowl Flowmeter Laparoscope
Burs Fluoroscopes Laryngoscope
C Forceps Light
Cabinet Freezer Lithotripter
Cart
Furniture M
Catheters
Centrifuge
G Magnetic Resonance
Chair Gastroscope Imaging Units
Clamp Guide Mammography
Clip H Manikins
Counter Hammer Microscopes
Cytometer dish Monitor 6
D
Dental
Destroyer
O S T
Orthopedic Scale Table
Orthoses Scissors Tag
Oxygen Thermometers
Screens Tourniquets
P
Phototherapy Screen, Anesthesia Traction Units
Screen, Bedside Tray
Prostheses U
Pulse Oximeter Simulator Ureteroscopes
Pumps Spatula V
Pump, Infusion Ventilators
Spectrometers
Pump, Spray W
Q Sphygmomanometers Walker
Quality Assurance Testers Sterilizers Warmer
R Stethoscopes Washer
Wheelchair
Rack Stool X
Radiotherapy
Stretchers X ray
Specification
 Function/purpose
 Operational requirement
 Technical specification : must be clear and comprehensive
 Accessories, consumables , spare parts
 Standards/safety
 Environmental conditions
 Power consumption
 Documentation
 After sales serving – installation, training, availability of spare parts,
maintenance service in near by
* Specify installation requirements in terms of civil works, data network,
electricity, hot and cold water, special treated water, drainage medical gases,
steam, air conditioning etc. required to the Supplier.
Tips!! during procurement of medical equipments
 In addition to the requirements indicated in the table
above, the technical specification should clearly stipulate
that the following points are considered in the offer:
 Country of origin and source (clarification certificate),
date of start manufacturing this model, date of last
upgrading
 New catalogue is attached with the offer, including data
sheet
 Warranty for two years from installation or 30 months
from delivery at least
 Warranty for not less than 10 years for spare parts
 Service and operation manuals original and copy (2 sets
in English) are included
 Certificates (agency approvals): e.g. FDA, … will be
taken into consideration, the offer must include the
certificates for evaluation
 The equipment must pass the acceptance test of MoH
Biomedical Engineering Unit
Handling and storage, distribution

 Proper care must be taken on instruments that are easily


breakable, like thermometers, glass wares, safety
cabinet with hepa filters
 It is highly recommended all participants along the
supply chain must follow the manual along with the
instruments , for handling, storage and distribution.
Figure : Health-care technology management cycle
References
 WHO (2014), WHO technical specification for medical device
 EC (2010), MEDICAL DEVICES: Guidance document Classification
of medical devices
 WHO (2003). Medical device regulation, Global overview and guiding
principle
 WHO (2011). Introduction to Medical Equipment Inventory
Management, WHO medical device technical series.
 FMHACA (June 2013). Ethiopian List of Medical Instrument with
minimum standard
 Various web sites
Laboratory Reagents & related supplies management
Commonly used Laboratory Reagents & related supplies in health care facilities of
Ethiopia
Content / What is inside?
BASIC LABORATORY TESTS AND REAGENTS
 Hematological tests
 Immunological/Serological Tests
 Clinical Chemistry Tests
 Urinalysis
 Parasitological Tests
 Microbiological Tests

HIV AND ART MONITORING LABORATORY TEST REAGENTS AND


SUPPLIES
 Laboratory Services in Comprehensive HIV/AIDS Program (HIV/AIDs pyramid)
 Selection of HIV Test Kits for HIV/AIDS programs, types of HIV Tests
UNIQUE CHARACTERISTICS OF LABOTORY PRODUCTS
Learning Objectives:

 properly/ Select describe appropriate reagents , supplies and equipment for the
laboratory tests. i.e.
 Describe basic hematological laboratory tests and their equipment’s, reagents &
supplies
 Identify basic immunological tests and their equipment’s, reagents& supplies
 Recognize basic chemistry tests and their equipment’s, reagents& supplies
 Identify basic urinalysis tests and their commodities required
 List common parasitological laboratory methods and their commodities
 Describe common microbiological laboratory methods and their commodities
 Understand the unique nature of Lab commodities and handle laboratory
equipment, reagents and supplies properly.
 Conduct inventory of equipment, reagents and supplies regularly.
Basic Laboratory tests and reagents
6.1. Hematological tests
6.2. Serological/Immunological tests
6.3. Clinical chemistry tests
6.4. Urinalysis tests
6.5. Parasitological tests
6.6. Microbiological tests
6.1 Hematological tests and commodities
 Hematology is the study of blood, the blood-forming organs,
and blood diseases. Hematological information assesses the
body’s ability to carry oxygen, provide immunological
surveillance, and prevent hemorrhage.
 Typical hematological tests include complete blood counts,
which measure the number of red blood cells/hemoglobin,
white blood cells, and platelets. Other tests include examination
of blood film for differential WBC count and red cell
morphology. Romanosky stains (gimsa and write stain) are used
for staining of blood film.
6.1.1 Complete blood count (CBC)
 CBC includes – Total white blood cells count (WBC) or Total
Leukocyte Count (TLC), Differential WBC Count (DLC), Red
Blood Cells (RBC) count, Platelets count, Hemoglobin,
Hematocrit, and a Peripheral blood smear examination.
6.1.1.1 Total white blood cell (WBC) count or TLC: it is mostly
helpful in diagnosis of infectious diseases. TLC estimates the
total number of white cells in cubic millimeters of blood.
Equipment, Reagent and Supplies required
 Microscope
 Counting chamber provided with cover slip
 WBC (Thoma) Pipette, Hand Tally counter
 Diluting fluid ( 2% Glacial acetic acid or 1N hydrochloric acid)
 Lancet or Syringe with needle , Ethylene Diamine Tetra Acetic Acid ( EDTA)
as anticoagulant- if venous blood is used
 Tourniquet- if venous blood is to be used
 70% Alcohol and cotton
6.1.1.2 Differential WBC count: in addition to Total WBC Count,
differential WBC count aids in diagnosis of different infectious diseases.
Equipment, Reagent and Supplies required
 Microscope
 Staining jar Staining jar
 Manual differential counter/Cell calculator
 Giemsa or Wright stain solution
 Slides, Immersion oil , Lancet , Syringe with needle
 Slide drying rack , EDTA as anticoagulant Staining jar
 Tourniquet WBC differential
counter
 70% Alcohol and cotton
 Pencil for marking or labeling Drying rack

Blood lancet

Microscope slides
6.1.1.3. Red Blood Cells (RBC) count: A red blood cell
(RBC) count is typically ordered as part of a complete blood
count (CBC) and may be used as part of a health checkup to
screen for a variety of conditions. This test may also be used to
help diagnose and/or monitor any number of diseases that affect
the production or lifespan of the red blood cells.
Equipment, Reagent and Supplies required
 Diluting fluid: The diluting fluids for RBC count should be
isotonic to prevent hemolysis.
 Microscope, Counting chamber provided with cover slip
 RBC (Thoma) Pipette , Hand Tally counter
 Diluting fluids: Formal Citrate or Hayem's fluid
 Syringe with needle or Lancet, EDTA, Tourniquet
6.2. Immunological/Serological Tests
 Immunology is the study of immunity and all of the
phenomena connected with the defense mechanism of the
body.
 Immunological tests can be used in the diagnosis of bacterial,
viral, fungal and parasitic infectious agents.
 Serology is the study of blood serum and its constituents,
particularly their contribution to the protection of the body
against disease. Serological tests are basically used antigen
and antibody reaction.
 Some of the tests are very simple emerging low-cost, low-tech
systems are being introduced into this dynamic field such as
Weil-Felix and Widal tests.
 Others like enumeration of CD4 cells require sophisticated
instrumentation, expensive labile reagents, and a high degree of
training.
 Some of the immunological/serological tests have cold chain
reagents. These areas require very careful analysis of the
appropriateness of any technology proposed
6.2.1 ABO Grouping
 Blood typing is used to determine an individual's blood group and
what type of blood or blood components the person can safely
receive. It is important to ensure that there is compatibility
between a person who requires a transfusion of blood or blood
components and the ABO and Rh type of the unit of blood that will
be transfused
 A potentially fatal transfusion reaction can occur if a unit of
blood containing an ABO antigen to which a person has an
antibody is transfused to that person. For example, people with
blood group O have both anti-A and anti-B antibodies in their
blood.
 If a unit of blood that is group “A”, “B”, or “AB” is transfused to
this person, the antibodies in the person's blood will react with
the red cells, destroying them and causing potentially serious
complications.
 If an Rh-negative individual is transfused with Rh-positive blood,
it is likely that the person will produce antibodies against Rh-
positive blood. Although this does not cause problems for the
person during the current transfusion, a future transfusion with
Rh-positive blood could result in a serious transfusion reaction.
Equipment, Reagent and Supplies required
Ring Slide
ABO Grouping antisera: Anti-A, Anti-B and Anti-D
antiserum
Mixing sticks (applicator stick) , Lancet

Figure: ABO blood group antisera


6.2.2 Syphilis Tests:
 Syphilis tests are used to screen for and/or diagnose infection with
Treponema pallidum, the bacteria that cause syphilis. Several
different types of tests are available. Antibody tests are most
commonly used.
 Antibody tests (serology)—these tests detect antibodies in the blood
and sometimes in the cerebrospinal fluid (CSF). Two general types
are available for syphilis testing, nontreponemal and treponemal
(derived from the name of the bacterium).
A. VDRL (Venereal Disease Research Laboratory) in addition to
blood, this test is primarily performed on CSF to help diagnose
neurosyphilis.
Equipment, Reagent and Supplies required
 Test tube , Test tube rack, Buffer saline Diluents

 Anticoagulant (Optional), Centrifuge , Khan shaker, 1 ml and 5


ml graduated pipette , Stop watch
 VDRL test kit consisting of (VDRL test slide, Hypodermic needle
without bevels )
 VDRL antigen, Positive control serum , Negative control serum
 Syringe with needle or vacutainer tube with needle and holder
 Tourniquet , 70% Alcohol and cotton, Aprons or laboratory coats
 Pen for marking or labeling
6.2.3. Widal Test
 The test is one method that may be used to help make a presumptive diagnosis of enteric
fever, also known as typhoid fever. It is still in use in many developing countries where
enteric fever is endemic and limited resources require the use of rapid, affordable testing
alternatives
 Enteric fever is a life-threatening illness caused by infection with the bacterium
Salmonella enterica serotype Typhi (S. typhi), usually transmitted through food and
drinks contaminated with fecal matter. It is associated with symptoms that include high
fever, headache, abdominal pain, diarrhea, and a rash known as "rose spots." Early
diagnosis and treatment are important because serious complications, including severe
intestinal bleeding or perforation, can develop within a few weeks .
Equipment, Reagent and Supplies required:
 Centrifuge , Widal test kit consisting of S. typhi "O or D" antigen suspension
S. typhi "H" antigen suspensionm, Salmonella control positive, Negative control , Mixing sticks
 Plastic Pasteur pipette/sample dispensing –stirrer, Test tubes, Test tube rack
 Syringe with needle or vacutainer tube with needle and holder, Tourniquet
6.2.4 Weil- Felix test:
An agglutination test for various rickettsial infections
(as typhus and Rocky Mountain spotted fever) using
particular strains of bacteria of the genus Proteus that
have antigens in common with the rickettsiae to be
identified
Equipment, Reagent and Supplies required:
 Centrifuge , Antigen suspension/proteus ox19 , Positive control
 Microscope slide , Light source, Mixing stick, Pasteur pipette with rubber teat
 Test tubes , Test tube rack , Syringe with needle or vacutainer tube with
needle and holder
 Tourniquet , 70% Alcohol and cotton, Aprons or laboratory coats
 Pen for marking or labeling,, Anticoagulant (Optional)

 
6.2.6 Diagnosis of pregnancy

 Human Chorionic Gonadotrophin (HCG) hormone is secreted by the


developing placenta after fertilization of the ovum. The appearance and
rapid rise in concentration detected easily using a direct agglutination
reaction. In normal pregnancies a positive reaction is therefore possible 2-4
days after the first missed menstrual period.
 The routine pregnancy test aims to detect HCG in urine. A quantitative
HCG test may also be ordered to help diagnose gestational trophoblastic
disease or germ cell tumors of the testes or ovary. It may be ordered at
regular intervals to monitor the effectiveness of treatment for these
conditions and to detect tumor recurrence.
a)Agglutination test
Equipment, Reagent and Supplies required:

Pregnancy latex reagent: a suspension of antibody coated latex


particles in a buffer containing 0.1% sodium azide.
Positive control, Negative control, Pipette-stirrers, single use
specimen dropper/stirrers, Agglutination slide, Specimen Container,
70% Alcohol and cotton, Aprons or laboratory coats , Pen for marking
or labeling

b) β- hCG Strip test


Equipment, Reagent and Supplies required:

β- hCG Strip test, Timer, Specimen collection material (Container)


6.3 Clinical Chemistry Tests
The clinical chemistry laboratory measures change in biochemical compounds as an
indicator of health status or disease processes. Because the biochemical changes of
compounds are not uniform in tissue and organs in response to disease, the
measurement of selected biochemical markers can be used to monitor diseases
processes as they occur in specific living cell systems
The clinical chemistry laboratory provides accurate, precise measurements of
selected biochemical markers, accompanied by reference, or comparison, ranges of the
concentration of these biochemical markers in healthy individuals.
Four categories of organic biochemical markers are used for assessment and
diagnosis of disease: carbohydrates, lipids, proteins, and nucleic acids and the
derivatives of these markers. The assessment of inorganic chemicals, such as ions,
minerals, and dissolved gases, provide a measure of homeostasis in the body. In
addition to the measurement of these endogenous substances, the clinical chemistry
laboratory provides measurement of chemicals that are exogenous to the body—both
beneficial chemicals, such as therapeutic drugs, and harmful substances, such as
poisons. Chemistry tests provide an excellent opportunity to use open systems.
Reagents and standards in the form of kits are of high quality but may be expensive.
Spectrophotometry is the mainstay of the automated clinical chemistry
laboratory. Spectrophotometry is based on two principles: (1) substances absorb
light at unique wavelengths and (2) the amount of light absorbed is proportional
to the amount of substance that is present. Absorbance is equal to an absorptivity
constant that is unique to the substance or molecule times the length of the light
path through the substance times the concentration of the substance.
Since spectrophotometry is the process for measuring the amount of light
absorbed by a substance, relating to the concentration of that substance, a
spectrophotometer is an instrument that measures light of specific wavelengths.
Each chemical test within the equipment represents three principles
of instrumentation:
1. The chemical reaction of the substrates, enzymes, and cofactors
2. The methodology of detecting the endpoint of the reaction
3. Automation that synchronizes all aspects of testing
6.3.1 Renal Function test
The kidneys (renal) control the quantity and quality of fluids within the body. They also produce
hormones and vitamins that direct cell activities in many organs; the hormone renin, for example,
helps control blood pressure.
Any diseases that affect the blood vessels, including diabetes, high blood pressure, and
atherosclerosis (hardening of the arteries), can impair the kidneys’ ability to filter blood and
regulate fluids in the body. Disease and infection in other parts of the body can also trigger a
kidney disorder.
 Among the important substances the kidneys help to control are sodium, potassium, chloride,
bicarbonate, pH, calcium, phosphate, magnesium, urea, Creatinine and uric acid.
A) Measurement of Serum or Plasma Urea: Urea is the main end product
of protein metabolism in the body. Urea is excreted by the kidney in urine. A urea level is used to
evaluate how well the kidney is working and to monitor patients with kidneys that are diseased or
that receiving kidney dialysis..
 There are three methods for the determination of blood urea; Urease method using Nessler's
reaction, Urease method using Berthelot reaction and Diacetyl monoxime method.
B) Measurement of Serum or Plasma Creatinine:
It is used to find out whether your kidneys are working normally.
A combination of blood and urine creatinine levels may be used to
calculate a "creatinine clearance". This measures how effectively
your kidneys are filtering small molecules like creatinine out of
your blood
It is an end-point colorimetric test. Creatinine test kit is based on
the Jaffe-Slot alkaline picrate method.
Equipment, Reagent and Supplies required:

Picric acid reagent (R1) , Buffer reagent (R2), Creatinine standard


( 2mg/dl), Distilled water , Photometer , Cuvettes , Micropipette with tips ,
Test tube , Test tube rack, Timer, Centrifuge
Serological pipette , Filter paper
Syringe with needle or vacutainer tube with needle and holder
Tourniquet , 70% Alcohol and cotton, Aprons or laboratory coats
Pen for marking or labeling, Centrifuge
C) Uric acid
The uric acid test is used to find out whether the body might be
breaking down cells too quickly or not removing uric acid quickly
enough. The test also is used to monitor levels of uric acid when a
patient has had chemotherapy or radiation treatments.
Equipment, Reagent and Supplies required:

Phosphotungstic acid , Sodium carbonate, Uric acid standard (5.0mg/dl)


Photometer, Cuvettes, Test tube, Micropipette with tips , Serological
pipette
Distilled water , Timer, Centrifuge
Syringe with needle or vacutainer tube with needle and holder
Tourniquet , 70% Alcohol and cotton, Aprons or laboratory coats
Pen for marking or labeling, Centrifuge, Water bath or incubator
6.3.2. Liver function tests
This laboratory situation gave you the opportunity to learn
about assessment of liver function and liver diseases. Liver
function entails many vital metabolic functions that involve
secretory and excretory processes such as detoxification,
synthesis of proteins, catabolism of carbohydrates, and others.
As mentioned earlier, several laboratory diagnostic tests can
be used to assess liver function, including total and direct
bilirubin, total protein, albumin, and ammonia levels.
Laboratory tests aid in diagnosis and monitoring of hepatic
disorders such as hepatitis, cirrhosis, and neonatal
hyperbilirubinemia. Specific evaluation of liver function using
assays for bilirubin and ammonia and assessing liver damage
using enzymes such as ALT and ALP were discussed.
a) Serum or Plasma Bilirubin:
Bilirubin concentrations in the blood are high in a condition called
jaundice (yellowing of the skin and the whites of the eyes). Further
testing is often needed to help doctors find out the cause of the high
bilirubin. Too much bilirubin may mean that too many red cells are
being destroyed or that the liver cannot remove bilirubin from the
blood fast enough.
In adults or older children, bilirubin is measured to diagnose and
monitor liver diseases such as cirrhosis, hepatitis, or gallstones.
Patients with sickle cell disease or other causes of haelytic anemia may
have episodes where excessive red blood cell destruction takes place,
increasing bilirubin concentrations in the blood.
Equipment, Reagent and Supplies:
• Spectrophotometer, Centrifuge, Timer , Serological pipettes, Cuvettes, Water
bath or incubator
• Sulphanilic acid reagent, Sodium nitrite solution , Diazo reagent, Caffeine
reagent
• Alkaline tartrate reagent, Ascorbic acid solution , Standard blirubin solution
• Distilled water, Low and high controls, Micropipette with tips , Test tubes,
Tourniquet
• Syringe with needle or vacutainer tube with needle and holde
B)Serum or Plasma Protein
Total protein and albumin are routinely included in the panels of tests performed as
part of a physical, such as a Comprehensive Metabolic Panel (CMP), so they are
frequently assessed as a part of an evaluation of a person's overall health status.
Total protein measurements can reflect nutritional status and may be used to screen
for and help diagnose kidney disease or liver disease, for example. Sometimes
conditions are detected with routine testing before symptoms appear. If total protein is
abnormal, further testing must be performed to identify which specific protein is
abnormally low or high so that a specific diagnosis can be made. Some examples of
follow-up tests include protein electrophoresis and quantitative immunoglobulins.
Equipment, Reagent and Supplies:
Spectrophotometer, Timer , Cuvettes , Water bath /incubator, Centrifuge,
Micropipette
Serological pipettes, Biuret reagent (Stock Solution ), Biuret working
solution
Tartrate iodide solution, Standard protein (8 gm/dl) , Test tube
Distilled water, Syringe with needle or vacutainer tube with needle and
holder
Tourniquet , 70% Alcohol and cotton, Aprons or laboratory coats
Pen for marking or labeling, Micropipette tips
C) Serum Glumtamate Oxaloacetate Transaminase
(SGOT/AST):
SGOT is also known as Aspartate aminotransferase (AST). The blood
test for aspartate aminotransferase (AST) is usually used to detect liver
damage. It is often ordered in conjunction with another liver enzyme,
alanine aminotransferase (ALT), or as part of a liver panel to screen for
and/or help diagnose liver disorders. AST and ALT are considered to be
two of the most important tests to detect liver injury, although ALT is more
specific than AST. Sometimes AST is compared directly to ALT and an
AST/ALT ratio is calculated. This ratio may be used to distinguish between
different causes of liver damage.
AST levels are often compared with results of other tests, such as
alkaline phosphatase (ALP), total protein, and bilirubin to help determine
which form of liver disease is present. AST is often measured to monitor
treatment of persons with liver disease and may be ordered either by itself
or along with other tests for this purpose.
SGOT is also known as Aspartate Aminotransferase (AST) is an enzyme
with the amino acid metabolism is found in liver, kidneys, cardiac muscles
and skeletal muscles in large amounts while small amounts can be found in
brain, pancreas and lungs. It is raised in acute liver damage. This test is
Kinetic method.
Equipment, Reagent and Supplies:
•Spectrophotometer, Timer , Water bath /incubator
•Centrifuge , Micropipette, Serological pipettes
•Phosphate buffer ( disodium hydrogen phosphate and
Potassium dihydrogen phosphate)
•AST substrate ( DL- aspartic acid and alpha –
ketoglutarate )
•Pyruvate standard , Color reagent( 2,4
dinitrophenylhydrazine)
•0.4M sodium hydroxide , Sodium hydroxide
•Test tubes, Syringe with needle or vacutainer tube with
needle and holder , Tourniquet , 70% Alcohol and cotton
• Aprons or laboratory coats , Pen for marking or labeling
•Micropipette with tips
6.3.3. Blood glucose measurement
Glucose is a reducing monosaccharide that serves as the principal fuel for
all tissues. Glucose measurement is important for diagnosis of diabetes.
Diabetics must monitor their own blood glucose levels, often several
times a day, to determine how far above or below normal their glucose is
and to determine what oral medications or insulin(s) they may need.
A) Photometric measurement - by glucose oxidase enzymatic method
Equipment, Reagent and Supplies required:
 Spectrophotometer, Micropipette, Centrifuge, Serological pipette
 Water bath / incubator , Cuvette , Timer
 Phosphate buffer ( disodium hydrogen phosphate di hydrate and potassium
dehydrogenase phosphate, Color reagent (4 amino phenazone, Glucose Odxidase ,
POD , Phenol, Tween), Working glucose ( stock glucose solution , Benzoic acid ),
Test tubes, Syringe with needle or vacutainer tube with needle and holder ,
Tourniquet , 70% Alcohol and cotton
 Aprons or laboratory coats , Pen for marking or labeling
B) Rapid blood glucose test
The test can be performed by visual comparison with
standard or using glucometer.

Equipment, Reagent and Supplies required


•Blood glucose test strip , Lancet, Filter paper
•Glucometer , Tourniquet , 70% Alcohol and cotton
• Aprons or laboratory coats, Pen for marking or
labeling
6.3.4 Lipid determination
The lipid profile is used as part of a cardiac risk assessment to
help determine an individual's risk of heart disease and to help
make decisions about what treatment may be best if there is
borderline or high risk. The results of the lipid profile are
considered along with other known risk factors of heart disease to
develop a plan of treatment and follow-up.
The major constituents of plasma lipids are cholesterol and
triglycerides. Cholesterol is an important compound of cell
membrane and precursor of the synthesis of bile salts and steroid
hormones. Cholesterol is synthesized in the liver and transported
in the blood mainly in the form of Low Density Lipoprotein (LDL)
and High Density Lipoprotein (HDL). Serum cholesterol is
measured by enzymatic method.
a) HDL (High Density Lipoprotein) Cholesterol
The test for HDL cholesterol (HDL-C) is used along with
other lipid tests to screen for unhealthy levels of lipids and to
determine your risk of developing heart disease. HDL-C level
may also be monitored by the doctor on a regular basis if
previous test results have shown you to have an increased risk
for heart disease or if you have had a heart attack or if you are
undergoing treatment for high cholesterol levels.

Equipment, Reagent and Supplies required:


Working reagent , Enzyme reagent 1, Enzyme reagent 2
Precipitate reagent ,HDL cholesterol standard - 25ml/dl
Test tube, Photometer , Cuvettes , Incubator
Micropipette with tips , Serological pipette
Timer Tourniquet , 70% Alcohol and cotton, Aprons or
laboratory coats , Pen for marking or labeling, Distilled water
c) LDL (Low Density Lipoprotein) Cholesterol
The test for LDL cholesterol is used to predict your risk of
developing heart disease. Of all the forms of cholesterol in the
blood, the LDL cholesterol is considered the most important form
in determining risk of heart disease. Since treatment decisions are
often based on LDL values, this test may be used to monitor levels
after the start of diet or exercise programs or to determine whether
or not prescribing one of the lipid-lowering drugs would be useful.
Equipment, Reagent and Supplies required:
•Precipitation reagent, Heparin, Sodium citrate , Reagent solution
for cholesterol determination, water , Photometer , Cuvettes ,
Incubator, Micropipette with tips , Serological pipettes
•Timer Tourniquet, 70% Alcohol and cotton, Aprons or laboratory
coats, Pen for marking or labeling, Test tubes, Centrifuge
c) Triglycerides Determination
Triglycerides are long chain fatty acids esterified to glycerol.
Triglycerides are the primary constituents used for long term storage of
energy for many body functions including that of the heart. The primary
source of triglycerides is from diet. It is an end point reaction.
 Blood tests for triglycerides are usually part of a lipid profile used to
identify the risk of developing heart disease. As part of a lipid profile, it
may be used to monitor those who have risk
Equipment, Reagent and Supplies required:

•Enzyme reagent 1, Enzyme reagent 2, Triglyceride standard


( 200mg/dl) , Photometer , Cuvettes , Distilled water,
Micropipette with tips , Serological pipettes, Test tubes
•Timer, Tourniquet, 70% Alcohol and cotton, Aprons or
laboratory coats. Pen for marking or labeling, Centrifuge
6.3.5. Electrolytes
The test is used to identify an electrolyte or acid-base imbalance and to
monitor the effect of treatment on a known imbalance that is affecting
bodily organ function.
If a patient has an acid-base imbalance, the doctor may order blood gas
tests, which measure the pH and oxygen and carbon dioxide levels in an
arterial blood sample, to help evaluate the severity of the imbalance and
monitor its response to treatment.
 Electrolytes determinations are based on flame photometry and
spectrophotometry methods. The recent reagent technologies are based on
spectrophotometry methods. The electrolytes found in the body fluid
include.
Major cations
Sodium ion (Na +), Potassium ion (K+), Magnesium ion (Mg ++), Calcium ion (Ca
++
)
Major anions
Chloride ion (Cl-), Bicarbonate ion( HCO3-), Phosphate ion( P04-),
Sulphate ion (S042-)
6.4. Urinalysis
Urinalysis is used as a screening and/or diagnostic tool because it can detect different
metabolic and kidney disorders. Often, substances such as protein or glucose will begin to
appear in the urine before patients are aware that they may have a problem.
It is used to detect urinary tract infections (UTI) and other disorders of the urinary tract. In
some conditions, urinalysis also provides an easy, economical, and relatively fast test to follow
patient progress, for example, if you want to know whether a condition is getting better or
worse. However, a urinalysis cannot detect all disorders.
Testing of urine requires low technology the reason is test strip technology is used in many
laboratories. The test strips require good laboratory practice to prevent premature expiration.
The routine tests for urine analysis are grouped in three parts; Physical, Chemical and
Microscopic examination.
Equipment, Reagent and Supplies required
Urine test strips (ten parameter), Slide, Cover slide , Centrifuge tube, Centrifuge
Microscope , 70% Alcohol and cotton, Aprons or laboratory coats
c) Sputum Microscopy for Acid Fast Bacilli
(AFB) smears
Equipment, Reagent and Supplies required :
Basic carbol fuchsin
Methanol/Ethanol absolute , Methylene blue
Hydrochloric acid, Immersion oil
Drying rack , Microscope, Applicator stick
Slide box , Microscope slides
Sputum cups, Staining rack
70% Alcohol and cotton
 Aprons or laboratory coats
Pen for marking or labeling
Bunsen burner or Sprite burner
d) Culture and sensitivity test
Culture and sensitivity test is important to isolate microorganism to
the species level and determine antibiotic sensitivity pattern. Culture
and sensitivity test is frequently used to isolate bacteria and fungi on
artificial liquid (broth) or solid (agar) media.
Equipment, Reagent and Supplies required:
Antibiotic sensitivity test disc( See annex 5) , Differentiation
reagents( See annex 5)
Culture tubes , Autoclave , Incubator , Caliper , Petri dish of
different size
Cotton , Safety cabinet( for TB culture)
Balance , Anaerobic jar , Colony counter
Cotton tipped applicator, Distilled water , Flask of different sizes ,
Hot plate
Gauze , 70% Alcohol and cotton , Aprons or laboratory coats , Pen
for marking or labeling
Culture Media: Culture media can be solid
(agar) or liquid (broth). Most culture media
require supplements for isolation of
microorganisms. Isolation and identification
of microorganisms also require
differentiation reagents, strips and disks.
After isolation, antibiotic disks are used to
determine the sensitivity pattern of isolated
organisms.
HIV AND ART MONITORING LABORATORY TEST REAGENTS AND
SUPPLIES
Laboratories are involved with each of these levels (examples
below):
 Prevention: preventing mother-to-child transmission;
HIV testing
 Detection: HIV testing; testing for sexually transmitted
infections (STIs), opportunistic infections (OIs), and
tuberculosis (TB)
 Treatment: testing for STIs, OIs, TB, and level of virus
 Palliative care: testing for STIs, OIs, TB, and level of
virus; monitoring reaction to treatments
 Antiretroviral (ARVs): monitoring response to
antiretroviral therapy (ART) and detecting toxicity;
baseline investigations
Types of HIV Tests
There are two main types of HIV tests:
Antibody tests (ELISA and rapid test)
Virologic tests (Viral culture , detection of viral nucleic acid by polymerase chain
reaction test)
a) Antibody Tests
HIV antibody tests look for antibodies against HIV; they do not detect the virus itself.
The most commonly used antibody tests are Enzyme-Linked-Immuno Sorbent Assay
(ELISA) and Rapid Tests.

b) Rapid HIV Testing


Rapid tests usually produce results within 5 to 30 minutes. Since the test detects
antibodies, the test result of the client may be negative during window period
irrespective of his/her sero-status. These tests are simple and hence can be
performed with minimal training. Test algorithms are used to select appropriate kits
for rapid HIV test. There are two algorithms in Rapid HIV Testing. These are Serial
and Parallel test algorithms. In Ethiopia, Serial Algorithm is used.
Serial (Sequential) Testing Algorithm
In a serial testing algorithm, three tests are used sequentially based
on first and second test result. The first test is screening and the
second and the third tests are, confirmatory and tie breaker,
respectively. World Health Organization recommends serial test
algorithm in most settings because it is more economical, as the
second test is required only when the initial test result is positive.
Serial testing algorithm is approved in Ethiopia and test kits currently
being used are KHB, Stat-Pak and Uni-gold

STAT-PAK
Figure Rapid HIV Test Kits used in Ethiopia Uni-Gold
Characteristics of HIV Rapid Testing Kits used in Ethiopia.
Materials required:

•KHB , Stat-Pak, Uni-gold, Capillary tube , Blood lancet ,

•Disposable
KHBglove, Safety box STAT-PAK Uni-Gold
Contains: Contains: Contains:
Test cassette (50 tests per •Sample delivery loop •Test cassette( 20 tests per pack)
pack ) •20 Test cassette (20 tests per •Separate buffer solution
pack) •Separate pipette or micro-titer
Buffer solution • Buffer solution tube

Use this test as a: Use this test as a: Use this test as a: Tie-
Screening test Confirmatory test breaker test
StorageTemp:2-30 oC Storage Temp: 8-30 oC Storage Temp: 2-27 oC0
Shelf life:12 months Shelf life:12-18 months Shelf life: 15 months
ELISA to detect HIV antibodies
Enzyme Linked Immuno Sorbent assay is used for detection of antibodies to
Human Immunodeficiency Virus (HIV) type 1 and/or type 2 (HIV 1/ HIV 2)
virus in human serum or plasma.
HIV antibody ELISA is used to screen blood donors and for clinical diagnosis
of HIV infection. In developing countries ELISA is limited in few laboratories as
it requires sophisticated equipment’s and extensive training to perform the test.
Equipment, Reagents and Supplies Required:
 Antigen coated plate ( 96wells), Sample diluents , Enzyme Conjugate , Conjugate
diluents , Positive control , Negative control , Wash solution , Multichannel Pipettes
 Chromogen-substrate , 37oC water bath or incubator, 5% sodium hypochlorite solution.
Disposable pipette tips, Absorbent paper, Stop solution (1 vial, 12 ml
 Cardboard sealer, ELISA reader with 450 and 630nm, ELISA washer
UNIQUE CHARACTERISTICS AND CLASSIFICATION
OF LA BOTORY PRODUCTS
a)Large numbers of products are needed.
Depending on the level, laboratory services need between 350 and 3,000
different types of products. Each test performed in a laboratory requires
several types of products. For example, a simple malaria test can require
five products— three chemicals and two consumables. More complex tests
often require more products, including equipment. The lowest-level
laboratory may offer as many as 20 or more tests, whereas higher-level
laboratories may offer 50 or more. Although one test may require many
products, a single product may also be used for more than one type of test.
This complicates the management of laboratory products.
b) Laboratory products come in a variety of
preparations
Laboratory products, particularly reagents, come in a variety of
preparations such as kits, powders, and solutions. The physical presentation
of a product has implications on its storage, distribution and quantification
Many reagents come as dry powders that are measured and reconstituted with distilled
water. Dry powders are measured using a balance or scale and the liquid used for
reconstitution is measured using a graduated beaker. The solution is held and stored in
a reagent bottle. Dry powders generally have a longer shelf-life than liquid reagents
and hence the shelf-life is significantly shorter for the reconstituted reagent.
c) Dry laboratory chemicals and consumable liquids are often
packed in bulk
Some laboratory products, particularly less expensive, often-used consumables such as
disinfectants, isopropyl alcohol, and distilled water, are procured and distributed in
bulk. Some dry powder reagents are also distributed in bulk. Products distributed in
bulk generally are ordered less frequently and require more storage space. In some
cases, higher-level facilities may redistribute in smaller quantities products that they
receive in bulk. Those facilities need to be sure that they have sufficient materials
available for repackaging.
D) Laboratory products have short shelf-life
Most laboratory reagents have a shelf life of approximately 24 months.
However, certain reagents have much shorter shelf lives, ranging to less than
7 months; others have longer shelf lives of up to 36 months. In general, dry
powder reagents, when stored properly, have a longer shelf life than liquid
reagents, and reconstituted reagents have a shorter shelf life than original
liquid reagents.
The length of the shelf-life is an important consideration when developing
the supply pipeline for laboratory products; a short shelf life requires a
shorter pipeline.
Table : An example of laboratory reagents storage information and shelf-life

Storage
Reagents Shelf Life Packaging
Temperature
Blood typing sera 24 months 2°–8°C 5 ml bottle (6
bottles in a
package)
Bacteriological 36 months 21°–30°C 500 g bottle
media
Chemistry reagent 12 months 2°–8°C or 21°– 100 tests per kit
kits 24°C
CD4 antibody ≤12 months 2°–8°C 50 tests per kit
reagent
Stains, dry powder 60 months 21°–30°C 25 g bottle
E) Some laboratory products have special storage
requirements.
Since a wide variety of products are required for laboratory
services, a wide variety of storage requirements exists for
their maintenance. Most laboratory products can be stored
following general storage procedures for health products.
However, there are laboratory products that require special
storage requirements. These include
•Flammables and corrosives, which should be stored
separately from other products
•Reagents that require cool or cold storage
•Products that deteriorate rapidly when exposed to light or
moisture
Classification of Laboratory Products
For the purpose of supply chain management, including designing and managing
laboratory logistics systems, there are various ways to classify laboratory products.
A) Based on their nature
Laboratory products can be classified into three categories: reagents, consumables, and
durables.
Reagents: are chemicals and biological agents that are used in laboratory testing for
detecting or measuring an analyte (the substance being measured or determined).
Reagents vary widely in cost, stability, storage conditions requirements, availability, and
the hazards associated with each one of them. Reagents can be further subcategorized
into liquid and solid.
Consumables: are items that are used once while performing a test and are not reused.
Consumables that are used across all testing services are classified as general laboratory
consumables.
Durables: are items that can be reused for multiple tests. They include items such as
glass wares that can be washed, sterilized, and reused. Durables are sub-classified as
equipment’s and instruments.
Generally, reagents and consumables are products that are routinely reordered. Whereas
durables are ordered on need base and do not require the same level of logistics
management
B) Based on their consumption
Based on their consumption, laboratory products are classified as:
•slow-moving
•Fast-moving.
Slow-moving products are those that will take several months to be
consumed whereas fast-moving items are highly consumed.
C) Based on their Shelf-Life
Laboratory products can also be classified based on their shelf-life.
The shelf life laboratory supplies vary significantly. For example,
products like biological products (controls) have very short shelf life
whereas reagents in the form of powders have relatively longer shelf-
life.
D) Based on their availability
Laboratory products can be classified as full- and Non-full-supply
based on their availability.
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…not the end ... the


beginning !!

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