Professional Documents
Culture Documents
Iscon Surgicals
Iscon Surgicals
SUBMITTED BY
NAME
KUNAL JOSHI
13MJIXX603
Session
2014-2015
Training Period
Days 45
SUBMITTED TO
Dr. Punita Soni
Head, Department of Management Studies
PREFACE
Practical knowledge means the visualization of the knowledge, which we read in books, for this
we perform experiments and get observations. Practical knowledge is very important in every
field. One must be familiar with the problems related to that field so that he may solve them and
become a successful person.
After achieving the proper goal a Management Trainee enters in his professional life. According
to this life, he has to serve an industry, may be Public or Private sector or self-owned. For the
efficient work in the field he must be well aware of practical knowledge as well as theoretical
knowledge.
To be good management Trainee, one must be aware of the industrial environment and must
know about management, working procedure of the industry; labour problems etc. so he can
tackle them successfully.
ACKNOWLEDGEMENT
I would sincerely like to thank the Management & Staff of ISCON surgical
Ltd. Jodhpur which gave me the opportunity to complete my summer training in
their reputed and esteemed industry.
I would like to convey my sincere regards for Mr.-------------------- for
giving me the opportunity of undergoing the training at ISCON surgical Ltd.
Jodhpur I would express deepest gratitude for Mr. -------------------- , Managing for
giving proper guidance in their department. It would rather be inappropriate if I
dont thank the rest of the ISCON staff without the ground support of whom my
training would have been incomplete.
I would like to thank Honble Prof. Dr. Abhishek soni & all
professors of JODHPUR INSTITUTE OF ENGINEERING AND
TECHNOLOGY, JODHPUR, Who guided me for training.
(KUNAL JOSHI)
S.NO.
01
02
PARTICULARS
03
SWOT ANALYSIS
04
05
CONCLUSION
06
INDEX
PAGE NO.
CHAPTER-IST
INTRODUCTION TO INDIAN SURGICALS INSTRUMENTS
A surgical instrument is a specially designed tool or device for performing specific actions of
carrying out desired effects during a surgery or operation, such as modifying biological tissue, or
to provide access for viewing it. Over time, many different kinds of surgical instruments and
tools have been invented. Some surgical instruments are designed for general use in surgery,
while others are designed for a specific procedure or surgery. Accordingly, the nomenclature of
surgical instruments follows certain patterns, such as a description of the action it performs (for
example, scalpel, hemostat), the name of its inventor(s) (for example, the Kocher forceps) or a
compound scientific name related to the kind of surgery (for example, a tracheotome is a tool
used to perform a tracheotomy).
The expression surgical instrumentation is somewhat interchangeably used with surgical
instruments, but its meaning in medical jargon is really the activity of providing assistance to a
surgeon with the proper handling of surgical instruments during an operation, by a specialized
professional, usually a surgical technologist or sometimes anurse or radiographer.
HISTORY:Surgical instruments have been manufactured since the dawn of pre-history. Rough trephines for
performing round craniotomies were discovered in neolithic sites in many places. It is believed
that they were used by shamans to release evil spirits and alleviate headaches and head traumas
caused by war-inflicted wounds.
In the Antiquity, surgeons and physicians in Greece and Rome developed many ingenious
instruments manufactured from bronze, iron and silver, such as scalpels, lancets, curettes,
tweezers, speculae, trephines, forceps, probes, dilators, tubes, surgical knifes, etc. They are still
very well preserved in several medical museums around the world. Most of these instruments
continued to be used in Medieval times, albeit with a better manufacturing technique.
In the Renaissance and post-Renaissance era, new instruments were again invented and designed,
in order to accompany the increased audacity of surgeons. Amputation sets originated in this
period, due to the increased severity of war-inflicted wounds by shot, grapnel and cannon.
However, it was only with the discovery of anesthesia and surgical asepsis that new surgical
instruments were invented to allow the penetration of the inner sanctum, or the previously
forbidden body cavities, namely the skull, the thorax and the abdomen. A veritable explosion of
new tools occurred with the hundreds of new surgical procedures which were developed in the
19th century and first decades of the 20th century. New materiais, such as stainless steel, chrome,
titanium and vanadium were available for the manufacturing of these instruments. Precision
instruments for microsurgery in neurosurgery, ophthalmology and otology were possible and, in
the second half of the 20th century, energy-based instruments were first developed, such as
electrocauteries, ultrasound and electric scalpels, surgical tools for endoscopic surgery, and
finally, surgical robots.
CHPTER II nd
COMPANY OVERVIEW
"ISCON" - where growth and innovation is the way of life.
ISCON Group was first established in the year 1978 by three Techno-entrepreneurs in the name
of JAIN METAL COMPONENTS PVT. LTD. to manufacture High Precision Machined Metal
Components, Sub-assemblies & Assemblies for varied Engineering Industries. The flagship
company ISCON SURGICALS LTD. was established in the year 1994 to meet the growing
demand
of
Disposable
Medical
Devices.
Keeping the pulse on the clinical needs and considering the growing demand for Medical
Devices, the company subsequently invested not only in the machines but in the complete
manufacturing lines to manufacture products from raw material to finished products, viz.
ISCON SURGICALS LTD. is an ISO 9001:2000, ISO: 13485 & WHO GMP Certified company.
Today the company is manufacturing and exporting wide range of products used for
ANAESTHESIA,
ANGIOGRAPHY,
UROLOGY,
ONCOLOGY,
VETERINARY,
Other Products: -
Mechanical
cutters
Irrigation and injection needles, tips and tubes, for introducing fluid
Scopes and probes, including fiber optic endoscopes and tactile probes
ORGANIZATION STRUCTURE
Organization is the structural framework of duties and responsibilities required of personal in
performing various functions within the company. It is essentially a blue-print for action
resulting in a mechanism for carrying out functions to achieve the goals setup by the company.
An organization structure shows the authority and responsibility relationship between various
position in the organization and also clarifies who reports to whom. It is a set of planned
relationships between groups of related functions and between physical factors and personnel
required for the achievement of organizational goals.
The organization structure is generally shown on organization chart. It represent authority
relationship between various positions in the organization by showing who reports to who me. It
is a set of planned relationships between groups of related junctions and between physical factors
and personnel required for the achievement of organizational goals.
An organization chart is a diagrammatical form which shows important aspects of an
organization including the major functions and their respective relationship. It is a graphic
portrayal of positions in the enterprise and of the formal line of accountability among them. It
provides a bird eye-view of the relationship between different departments or division of an
enterprise as well as the relationship between the executives and the subordinates at various
levels.
An organization cannot work cutting without a detents structure. The first step in designing the
structure of an organization is to insetting and group the activities involved, which is expressed
as departmentation, because of the intimate connection between the felonry over time and cost
accounts it is necessary before consider the letter in details to deal.
Departmentation of ISCON
Instrument Care
Cleaning, disinfecting and sterilising are the three levels of instrument care. Cleaning removes
dirt, debris and biological material from surgical instruments. You can clean surgical instruments
manually or mechanically using water and detergents or an enzymatic cleaner. Thoroughly clean
your instruments, because debris that remains on instruments can interfere with further
disinfection/sterilisation or corrupt research data. Cleaning is the first step toward sterilisation
and sometimes is all that is required.
Disinfection can be broken down into three tiers: low level disinfection (LLD), intermediate
level disinfection (ILD) and high level disinfection (HLD). LLD eliminates all vegetative
bacteria (except tubercle bacilli), lipid viruses, some non-lipid viruses and some fungi in less
than 10 minutes. ILD destroys tubercle bacilli, mycobacteria, lipid enveloped and some non-lipid
enveloped viruses and fungus spores. In addition to killing these microorganisms, HLD can also
kill bacterial spores, though not in a high number. The CDC recommends a 90 minute soak at
25C.
Sterilisation destroys all microbial life. Some chemical sterilants can be used as HLD
disinfectants when used for shorter exposure periods. Dry heat or autoclaving are the preferred
method of sterilising surgical instruments.
Cleaning
The first step in properly cleaning your surgical instruments is to rinse off all blood, bodily fluids
and tissue immediately after use. Dried soils may damage the instrument surface and make
cleaning more difficult. Rinse your instruments in cool water. Hot water can cause proteinous
substances to coagulate. If desired, soak your surgical instruments in cool water with an
enzymatic detergent. The detergent helps to dissolve the proteins and break down oils. Then, the
instruments may be cleaned manually or mechanically in a washer or ultrasonic bath.
Manual Cleaning
If a mechanical cleaning method is unavailable, manual cleaning may be necessary. Likewise, if
instruments are easily damaged, complex (requiring disassembly) or have small lumens, they
may need to be cleaned manually.
When cleaning your instruments manually, wear heavy-duty rubber gloves, a plastic apron, eye
protection and a mask. Use only neutral pH detergents. If your instruments are not rinsed
properly, low pH detergents may break down the protective surface of stainless steel instruments
and cause black staining. Likewise, alkaline detergents may leave surface deposits that cause a
brown stain and interfere with the smooth operation of the instrument. Use soft plastic cleaning
brushes to scrub the instruments. Do not use steel wool, wire brushes or other abrasive materials
that could scratch the finish or dull your instruments. Hold the instruments below the surface of
the water when you scrub them to avoid splattering contaminants. Be sure to brush out all
crevices, teeth and grooves. Rinse each instrument thoroughly under running water. Open and
close hinged instruments like scissors, hemostats and needle holders under running water to
thoroughly rinse detergent from the hinges.
Visually inspect your instruments to ensure they are free of stains and tissue. Check each
instrument for proper function and condition. Scissors blades should be tight and should open
and close smoothly. Forceps and tweezer tips should be properly aligned. Like the scissors, the
hemostats should not be loose. Verify that they lock and unlock easily. Close the needle holders
and hold them up to the light. Light coming through the tip indicates that the jaws are worn.
Knives and cutting blades should be sharp and free of nicks and chips. After a visual inspection,
dry the instruments with a soft cloth. This minimizes the risk of corrosion and the formation of
water spots. Use a spray lubricant in the hinges to improve the function of the instrument.
Mechanical Cleaning
Typically, a washing machine runs through several cycles. A cold water rinse removes debris.
Then, a hot water bath and rinse cycle is followed by a blow dry with hot air. Some washers are
also disinfectors. These units use 100C water in the hot water cycle. Follow the manufacturers
instructions when using a mechanical washer. Be sure to lubricate hinged instruments after the
last rinse cycle and prior to sterilisation.
Ultrasonic cleaning is the most effective cleaning method, because of its cavitation. As the sound
waves vibrate through the cleaning solution, they create microscopic bubbles, which grow as the
pressure in the unit changes. Eventually the bubbles implode. The bursting bubbles effectively
dislodge debris, even in the most difficult to reach places. A neutral pH detergent improves the
effectiveness of the cleaner, because it increases the number of bubbles.
Before you begin, fill the ultrasonic cleaner with deionised water and detergent according to the
manufacturers directions. Run the cleaner for several minutes to allow the temperature to
equilibrate and to remove any gases from the solution.
Separate instruments by metal type and process them in batches. For example, do not mix
chrome plated and stainless steel instruments in the same cleaning cycle. Fully submerge all
instruments. Place hinged instruments into the solution in an open position. Make sure that any
sharp instruments do not touch other instruments. Allow the instruments to process for 510
minutes before removing them from the ultrasonic bath and rinsing thoroughly. As before,
visually inspect each instrument, dry it with a soft cloth and lubricate any hinges.
Disinfection
Both thermal and chemical methods are available for HLD. As a general rule, surgical
instruments are not susceptible to heat, making boiling the preferred method for disinfecting.
Boiling instruments in 100C water for at least one minute kills all microorganisms, except for a
few bacterial spores. Boiling does NOT sterilise equipment.
Bring the boiler to a rolling boil. Submerge open instruments in the boiling water. When the
water returns to the boiling point, turn the heat down to a gentle boil. A rolling boil could damage
instruments as they bounce around in the boiler. After one minute, remove the instruments from
the water using a set of disinfected tongs. Allow the instruments to dry and lubricate the hinges.
Do NOT leave boiled instruments in the water as it cools, because they could be recontaminated. Discard the water when you finish disinfecting your instruments.
To eliminate lime buildup on boiled instruments, use distilled water for boiling or add a small
amount of white vinegar to the boiler before you process your instruments.
Chemical disinfection can be used when instruments will be damaged by heat. Some chemicals
that may be considered include glutaraldehyde 2% for 20 minutes, hydrogen peroxide 6%7.5%
for 2030 minutes, peracetic acid 0.20.35% for 5 minutes and ortho-phthalaldehyde (OPA) for
512 minutes.
Sterilisation
Sterilisation kills all microorganisms and spores. Autoclaving (saturated steam under high
pressure) is the most common method for sterilising surgical instruments, however, dry heat and
chemical sterilants (ethylene gas, hydrogen peroxide gas plasma, etc.) can also be used.
Autoclave
Prior to autoclaving, clean the instruments and lubricate all hinged instruments with a surgical
instrument lubricant. Do not use WD-40 or other industrial lubricants. Always autoclave
instruments in an open position. Locking an instrument prevents the steam from reaching all the
surfaces. The heat also causes the metal to expand, which can crack the hinges of locked
instruments. Never overload the autoclave chamber. Instruments can be placed in sterilisation
trays or wrapped in paper or muslin before autoclaving. This helps to prevent contamination of
the instruments after sterilisation.
Arrange the instruments, sterilisation trays or packs in the autoclave without stacking them. The
steam must circulate freely inside the autoclave. Follow the manufacturers directions for
adjusting the time, temperature and pressure of the autoclave cycle. Process the instruments as
follows:
When the autoclaving cycle is complete and the pressure reaches zero, open the door a
centimeter or two to allow the steam to escape. Run the drying cycle as recommended by the
autoclave manufacturer until all the instruments are dry. It should take about 30 minutes. Using
sterile tongs, remove all the instruments, trays and packages. Allow them to cool to room
temperature before storing.
Unwrapped items must be used immediately or may be stored in covered, dry, sterile trays for up
to a week. Store wrapped packages in a warm, dry, closed cabinet. Instruments remain sterile as
long as the wrap is dry and intact.
Dry Heat
Dry heat may also be used to sterilise surgical instruments. Instruments can be wrapped in
aluminum foil or placed in sterilisation trays before putting them in the oven. Refer to the
manufacturers directions to heat the oven. Instruments can be heated to any of the following to
be considered sterilised:
Allow the instruments to cool to room temperature inside the oven and store them as described
above.
Cold Sterilisation
Soaking surgical instruments in most cold sterilants requires 10 hours to sterilise them. This can
be detrimental to fine instruments. If disinfection is required (and not sterilisation) a 1090
minute soak in a cold sterilant may be all that is required. When using instruments with tungsten
carbide inserts (needle holders, scissors, forceps), avoid using solutions with benzyl ammonium
chloride.
When Do I Sterilise?
Many years ago, Earle H. Spaulding proposed a simple method to determine the level of
sterilisation required for patient protection. It is still a suitable guideline for most applications
today. Spaulding categorised equipment as critical, semi-critical and non-critical.
Critical items must be sterilised, because they pose the greatest risk for infecting a patient. These
include any item that enters or touches sterile tissues, the vascular system or bodily fluids like
blood. This includes surgical instruments, catheters, implantable sensors and other equipment
used inside a patient.
If an item comes into contact with mucous membranes but is not used inside sterile tissues, it is
considered semi-critical. Mucous membranes are not usually susceptible to a small number of
bacterial spores, so a high level disinfection is suitable for semi-critical items. These items
include anaesthesia equipment, some scopes (endoscope) and temperature probes.
Non-critical items do not come into contact with mucous membranes but touch intact skin.
Equipment like blood pressure cuffs, surgical beds and stereotaxic frames are considered noncritical. They must be thoroughly cleaned, but will not require sterilisation. A low level
disinfection may also be used.
With proper care and maintenance, your instruments will last for years to come. Understanding
the difference between cleaning, disinfecting and sterilising can safeguard your research and
protect your investment in surgical instruments, equipment and laboratory animals.
Our Clientele
The Syringes & Needles are presently exported to South Africa, Sudan, Kyrgystan, Russia, etc.
are being exported to U.S.A., Philippines, Thailand, South Korea, Turkey, Egypt, Malaysia,
Canada and many other developed countries under the registered brand name of PRICON.
Quality Assurance
Quality control and specification adherence are the hallmark of Iscon Surgical and we follow
stringent quality control norms and methods at every stage of our process to ensure the smooth
and flawless production. Guidelines and procedures issued by WHO / WHO-GMP are followed
in order to deliver a non-toxic and non-pyrogen range of surgical disposables and equipments to
our valued clients. The products are packaged in durable packaging material to ensure
uncontaminated transportation.
The company is an OEM service provider and holds prestigious membership of PLEXIL.
Our Infrastructure
The company has manufacturing facilities at four different locations in Jodhpur, India, spread
over more than 150,000 sq. ft. land area and have architectural area of about 75, 000 sq. ft. Our
overall setup have been categorized into the following divisions:
Engineering Division
Medical Division
The company's production unit is outfitted with latest technologies and equipments like:
Blasting Machines
Competitive prices
Facilities : 1.
Drinking Water: At all the working places safe hygienic drinking water should be
provided.
2.
Facilities for sitting: In every organization, especially factories, suitable seating
arrangements are to be provided.
3.
First aid appliances: First aid appliances are to be provided and should be readily
assessable so that in case of any minor accident initial medication can be provided to the
needed employee.
4.
Latrines and Urinals: A sufficient number of latrines and urinals are to be provided in
the office and factory premises and are also to be maintained in a neat and clean condition.
5.
6.
Spittoons: In every work place, such as ware houses, store places, in the dock area and
office premises spittoons are to be provided in convenient places and same are to be maintained
in a hygienic condition.
7.
Lighting: Proper and sufficient lights are to be provided for employees so that they can
work safely during the night shifts.
8.
Washing places: Adequate washing places such as bathrooms, wash basins with tap and
tap on the stand pipe are provided in the port area in the vicinity of the work places.
9.
Changing rooms: Adequate changing rooms are to be provided for workers to change
their cloth in the factory area and office premises. Adequate lockers are also provided to the
workers to keep their clothes and belongings.
10.
Rest rooms: Adequate numbers of restrooms are provided to the workers with provisions
of water supply, wash basins, toilets, bathrooms, etc.
CHPTER III rd
SWOT ANALYSIS
A SWOT analysis (alternatively SWOT matrix) is a structured planning method used to
evaluate the strengths, weaknesses, opportunities and threats involved in aproject or in
a business venture. A SWOT analysis can be carried out for a product, place, industry or person.
It involves specifying the objective of the business venture or project and identifying the internal
and external factors that are favorable and unfavorable to achieve that objective. Some authors
credit SWOT to Albert Humphrey, who led a convention at the Stanford Research Institute
(now SRI International) in the 1960s and 1970s using data from Fortune 500 companies.[1]
[2]
However, Humphrey himself does not claim the creation of SWOT, and the origins remain
obscure. The degree to which the internal environment of the firm matches with the external
environment is expressed by the concept of strategic fit.
Threats: elements in the environment that could cause trouble for the business or
project
CHPTER - Vth
CONCLUSION
A surgeon performing a surgical procedure should be able to assume that the instruments used
are safe and reliable particularly if they are new. To ensure the quality of these instruments, the
Health Care Standards Policy Committee directed the British Standards Institution to produce
requirements for the materials, design, dimensions and other features of surgical instruments. As
a result, British Standards (BS), incorporating International Organisation of Standardisation
(ISO) standards, were published.1 Each year, large numbers of new instruments are ordered by
healthcare facilities across the UK, and those ordering them should be able to rely on these
standards. This study reports the results of local quality control by the clinical engineering
department of all new instruments supplied to a single NHS trust.