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Use Of
Reusable Medical
Devices -
Recommended Guidelines
in
Endoscopy
Settings
Terminology
Reuse
- The process by which a reusable device that has come into contact with a
patient is cleaned, decontaminated, reconditioned/refurbished, and
disinfected or sterilized prior to subsequent use on the same or another
patient.
Reprocessing
- The process by which a pack, which is opened but unused, is repackaged and
sterilized.
Resterilization
- The further processing of a product (which was sterile and unopened) due
to a passing expiry date or for its inclusion into larger pack.
Non-critical Device
- Any device that comes in contact with intact skin - e.g. blood pressure
cuff.
Semi-critical Device
- Any device, which comes in contact with mucus membrane. - e.g. endoscopes.
Critical Device
- Any device, which comes in contact with sterile areas of the body or the
vascular system. e.g. biopsy forceps and sphinctertomes.
Background
Attention
must be given to the reuse of medical devices. Contaminated and unsafe
medical devices pose a potential source for cross-contamination, infection
and injury to patients and personnel. Strict guidelines are needed to
standardize the process of reusing medical devices. The guidelines are
intended to assist institutions and Endoscopy units in the development of
their specific needs. Providing the best possible care is the ultimate
mission of each healthcare institution and the professionals who staff it.
An integral component of delivering quality care is instrumentation. Most
Endoscopy procedures are performed on an outpatient basis. The volume of
procedures scheduled each day is often high. Whether that schedule can be
met and each patient given high quality care is dependent on device
reliability and safety.
The reuse of
critical and semi-critical devices has become a common practice in many
institutions. The reuse of medical devices is a practice undertaken
primarily for economic reasons as a means to maximize the effective usage of
a particular non
disposable device. It is estimated that 41% of Canadian hospitals reuse
medical devices of some kind. Only the devices labeled reusable can be
reused.
Due to this
concern the CSGNA decided to establish
some guidelines and recommendation for reuse of reusable medical devices.
Recommendations for Reuse
All reusable
medical devices must be placed into three categories:
1. Critical
2. Semi-Critical
3. Non- Critical
The process for reuse,
resterilizing and reprocessing is determined by the category in which the
medical device is classified.
Reprocessing
of reusable endoscopic devices include the following steps:
-
Transport to the reprocessing area
-
Soaking
-
Brush
cleaning
-
Rinsing
-
Ultrasonic cleaning
-
Inspection
-
Drying
-
Lubrication
-
Packaging
-
Sterilization according to Manufacturers Recommendation
-
Transport back to the Endoscopy suite
-
Inspection
-
Prepare
for use
{Refer to CSGNA Infection Control: Recommended
Guidelines in Endoscopy Setting}
Reusable
Device Reprocessing and Validation of Performance
-
Requires thorough policy and procedure program
-
Requires assignment of responsibility to highly qualified individuals
-
Must
ensure integrity of the device.
Issues to
Consider to Meet Performance Standards
-
Strict
adherence to the Manufacturer's Instructions for Reprocessing.
-
Clinically
Proven Device.
-
Inspect
Upon Opening Package.
-
Necessity
to Perform Multi-Step Cleaning Process and High Level
Disinfection/Sterilization Process.
-
Ensure
Adequate Backup Inventory.
-
Establish Protocol for Reprocessing.
-
Establish Protocol for Inspection and Repair.
-
Establish Training and Retraining Protocols for Staff.
-
Establish
Institutional Policy/Standards to determine maximum number of use for the
device.
Preventing
patient infection means that the device must be free of contamination.
Preventing injury means that the device must function according to
specifications without degradation of parts that might become dangerous to
the patient or staff. Perhaps the most significant risk of injury from
product degradation is the fraying of electrical sheaths due to reprocessing
plus normal wear and tear during procedures. This is difficult to monitor
even with close inspection. The potential of injury to the patient may be
significant.
Issues
in
Reuse
-
Risk of infection
a) Thorough
cleaning : Thorough cleaning is the most integral part of reprocessing.
Concern is expressed regarding mechanical parts being difficult to clean,
and that porous material, such as plastic, may absorb contaminants and
chemicals.
b) Sterilization:
Most manufacturers recommend steam sterilization. Gas is excellent in
sterilizing provided the equipment is free from all blood and other organic
materials. The item should be dry because the presence of saline or water
may form a poisonous chemical in the presence of gas. With the elimination
of chlorofluorocarbons
(CFCS), which are required for
most gas sterilizers, institutions are switching to other technologies.
Check manufacturer's label for reprocessing.
c) High
Level Disinfection: High level disinfection may be appropriate for
semi-critical devices, but the effect on functionality must be assessed.
d) Risk
to personnel: Personnel performing the reprocessing of the item are at risk
if being exposed to body fluids and/or cleaning, disinfection or
sterilization products. Personnel must follow the Health and Safety
recommendations outlined in the CSGNA
Infection
Control
Guidelines.
-
Medical Device Integrity
It is
necessary to assess what effect the high level disinfection or sterilization
process will have on the integrity and functionality of the device. The
number of reuses should be based on manufacturer guidelines.
-
Cost-effectiveness
Institutions
should consider the following; cost of labor, supplies and machine use,
storage, quality assurance programs, overhead, possible additional liability
insurance and possible increase in price of an item if fewer are used. There
are also protocol development costs and educational costs to consider.
-
Legal Issues
The
manufacturer's labeled information on care and usage of reusable products
must be adhered to. When infections occur or injuries take place due to an
instrument selected and maintained by the institution, there is a potential
for significant legal liability. Instruments that are continually
reprocessed can increase that risk.
Disposal of
the instrument after its useful life must be performed according to
institutional and governmental regulations.
Liability
may be avoided or reduced if a reasonable standard of care can be
demonstrated, including the adherence to established hospital guidelines on
reuse.
-
Ethical Issues
Must the
patient be informed that the instruments/devices being used for their
procedure is a reusable device? Is this part of an informed consent?
Usually,
specific consent is not obtained from the patient. The risk of the procedure
in general is described to the patient in the same manner whether it is a
new or reusable device.
It has been
suggested that internal procedures must be developed, approved by the Board
of Directors, and that hospital policy must become public policy. The debate
revolves around the social responsibility of stakeholders to society and to
individuals.
Summary
There is a
high volume of endoscopic procedures performed in many institutions. For
both the patient's safety and the financial health of the institution, it is
important that these procedures be performed reliably, safely and
efficiently.
Most of the
devices used in endoscopic procedures are classified as critical or
semi-critical .The threat of potentially life threatening malfunction can
lead to patient/staff injury or needless prolongation of the procedure.
Reusable
devices provide assured first-use performance. After that, a series of steps
must be performed to ensure that they are properly reprocessed and provide
acceptable performance during subsequent procedures.
It is
important that each institution be fully aware of the issues involved in
device selection. Institutions that choose to reuse devices needs to
validate the sterility and integrity of the reprocessed devices, and have in
place detailed protocols to include mechanisms for ongoing evaluation and
quality assurance monitoring.
Disclaimer
These
guidelines are based on current understanding and practice in the field of
gastroenterology. Each institution is responsible for establishing policies
and procedures for that particular Endoscopy setting.
The Canadian Society of Gastroenterology Nurses and
Associates assumes no responsibility for the practices and
recommendations of any member, other practitioner and for the policies and
practices of any Endoscopy unit.
Bibliography
Alfa, M. 1996.
"The Effectiveness of Hospital Sterilization", Infection Control Hospital
Epidemic.
Bronowicki,J.
1997. Patient to patient transmission of the Hepatitis C virus during
Colonoscopy. The New England Journal of Medicine. July (337):237-240.
Canadian
Healthcare Association -The Reuse of Single-Use Medical Devices: Guidelines
for Healthcare Facilities.
Considerations: Endoscopic Device Selection -Performance, Safety and Cost-
Making Informed Decisions_Microvasive Education Center, Boston Scientific
Corporation.
CSA,
Decontamination of Reusable Medical Devices, Z314:8-00 Mach 2000.
ECRI Special
Report: Reuse of Medical Devices: Making Informed Decisions 1996.
Favaro,M.S.
and Bond,W., "Sterilization, Disinfection, and Antisepsis in the Hospital."
Manual of Clinical .
Microbiology(5th Ed.). Washington,DC: American Society for
Microbiology,1990.
Health Care
Corporation of St. John's -Reuse of single-use Items.
International
Association of Healthcare Central Service Material Management-Position
Statement Paper on The Reuse of Medical Devices.
Medical
Devices Canada -Industry Position Paper__The Reuse of Medical Devices.
Ponchon,T.
1997. Transmission of Hepatitis C and Prion Diseases Through Digestive
Endoscopy: Evaluation of Risk and recommended Practice. Endoscopy 29:
199-202.
Recommended
Guidelines for Infection Control in Gastrointestinal Endoscopy Setting. SGNA
Inc., SGNA Monograph Services. 1995.
Reichert M.
Choice to Reuse Disposables Requires Factual Assessment. OR Manager.
1996;12,6:8-9.
SGNA Position
Statement -Reuse of single-use Critical Medical Devices.
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