management of medical

technology
Management of medical technology
 The manufacturer's technical specifications are
submitted to the purchasing department that provide
this information to the appropriate engineering
department.
 Upon arrival at the hospital, all medical and nonmedical
equipment will be inspected by clinical engineering to
verify compliance with hospital standards and
manufacturers' specifications before delivery to the
requesting department.
SCHEDULED MAINTENANCE PROGRAM
 All equipment to be used in critical-care units will be inspected
quarterly by clinical engineering for adherence to safety and
performance standards.
 All equipment to be used in other patient-care areas will be inspected at
least semiannually by clinical engineering for adherence to safety and
performance standards.
 All equipment in nonpatient areas will be inspected at least annually by
clinical engineering for adherence to safety standards.
 Upon completion of an inspection, an inspection label will be affixed to
the equipment showing the date of the inspection and the initials of the
technician who performed the inspection.
 If apiece of equipment is found to be defective :
# The unit supervisor will be notified immediately
# Corrective action initiated.
# Written results of the testing program will be maintained.
# At the conclusion of each inspection period, any action that is taken
will be reported to the person responsible for the operation of the
hospital unit inspected.
EQUIPMENT RESTRICTIONS
 Equipment users will inspect all pieces of equipment before each
use for physical damage and correct operation.
 If a hazard is suspected, clinical engineering personnel should
be notified and corrective action initiated if necessary.
 Three-to-two wire electrical adapters are prohibited, and
extension cords are prohibited except in case of emergency.
 Special-purpose electrical adapters are to be avoided whenever
possible.
 Patient-owned, line-powered devices are prohibited from all
critical-care areas.
 All electrical receptacles will be inspected periodically for
polarity, ground conductor integrity, contact tension, and overall
physical condition. Defective receptacles will be replaced with
hospital-grade devices.
 Clinical engineering will perform testing in critical-care units.
Facilities engineering will perform testing in other patient and
nonpatient areas.
Hazard Alerts and Recalls
 Hazard alerts and recall notices maybe received from these sources:
@ Equipment manufacturers. @ Subscription services or publications
@ Food and Drug Administration enforcement report.
# The term "recall ,“ as used by the FDA , does not necessarily mean that the
defective Products should be taken out of use. The FDA assigns each recall to one of
three classes :
Class I : A reasonable probability exists that use of or exposure to the device will
cause serious injury or death.
Example : A monitoring device does not alarm during ventricular tachycardia or
ventricular fibrillation.
ClassΠ : Use of or exposure to the device may cause temporary health consequences
, or the probability of serious adverse health consequences is remote.
Example : Wheeled stretchers without braking mechanisms were sold to hospitals.
Class III : Use of or exposure to the device is unlikely to cause adverse health
consequences.
ACTIONS ON A RECALLED DEVICE
 Required steps usually include
 Receiving notices,
 Identifying those devices within the hospital ,
 modifying defective devices,
 Notifying appropriate personnel, dealing with the manufacturer
regarding refund or replacement, and documenting all of these
activities .
@ In such deliberations , careful consideration of all relevant
information must occur before a device is removed from service.
# Consider, for example, the consequences of suspending all
defibrillators from service and Having a patient go into ventricular
fibrillation . In certain cases the risk to patients may Actually be
lessened by using the device than by delaying or suspending
treatment
However, Any such decision must be carefully documented and
approved by the appropriate hospital Administration body.
ACTIONS ON A RECALLED DEVICE
 A hospital is clearly negligent if it receives a recall notice
and takes no action on it . The hospital may be liable if an
injury is caused by a recalled device that has not been
corrected.
 There are four types of action that may be required on a
recalled device :
 Permanent removal from service.
 Modification of the device.
 Changes in instructions.
 Warnings to the users.
# All actions must be documented for each recall notice
received. Even if a hospital does not have the recalled device,
the notice should be filed with an indication of this fact.
Classification of medical equipment related failures
 A . Defects related to the design or production of the item.
 B . Random failure or premature wear of components, sub
assemblies , or mechanisms.
 C . Failure to follow directions given in the operator's manual.
 D . Failure of maintenance technicians to exercise appropriate
care during the repair, or inspection.
 E . Intentional tampering , or malicious use.
 F . Abnormal or unpredictable response by the patient.
 G . Failure of the manufacturer to provide full information about
possible use and misuse of the device.
@ The manufacturer would normally be held liable for incidents
involving failures A , B , G , and possibly D if they perform the
maintenance .
@ Liability for failures C , D , and E would Be born by the hospital.
Incident investigation
 An "incident“ is defined as an event in which equipment or Procedure
has caused injury to a patient , staff member , or visitor.
 It makes little difference whether the incident is caused by specific
equipment malfunction, user error, or a combination of the two .
 Even if the hospital itself is clearly not responsible, It must invest
valuable staff time to minimize liability exposure.
** Equipment-related incidents may lead to the following types of patient
Injury
Overdose.
Suffocation or barotrauma.
Embolism (particulate or gas).
Skin lesion (burns).
Electrocution.
Crushing.
Incident investigation
 Effective investigation of a medical device-related incident can be used to
prevent similar occurrences in the future . It is important for the clinical
engineering director to examine three basic interfaces

1. Operator/device interface.
(a) Was the device used appropriately ?
(b) Were control settings appropriate for the diagnostic or therapeutic procedure ?
(c) When was operator training accomplished and documented ?
(d) Were any facility utility problems identified prior to, during , or after the procedure
( e.g. electrical, medical gas ,water ,or heating ,ventilation and air conditioning ,etc.)?

2. Patient/device interface.
(a) How did the device respond when connected to the patient ?
(b)What medications was the patient receiving ? Were there any sensitivities ?

3. Consumable supply/device interface . Consumable supplies include leads,

electrodes, Plastic tubing, filters, reservoirs and breathing circuits.
(a)Were the items designed for use with the affected device?
(b)Were items properly interfaced to the device and the patient?
(c)Were items reusable or intended for one-time use?
Resources
 Management of Medical Technology-Joseph D. Bronzino
 Clinical Engineering Handbook-Ernesto Iadanza-2020
 The clinical engineering handbook ,joseph dyro2003
 Clinical Engineering: Evolution of a Discipline
Joseph D.Bronzino Trinity College/Biomedical Engineering Alliance and
Consortium (BEACON)

Prepared by : Eng. Mohamed Elghedany