Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD) (February 10-11, 2005) - Panel Recommendations

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Recommendation 1

Reuse of single use devices (SUD's) shall not be allowed unless it is regulated by Health Canada (HC).

If validated evidence for safe reprocessing is demonstrated and compliance with the validated protocol can be assured then reuse of SUD's may be permitted.

The validated evidence for safe reprocessing shall include both the appropriate level of cleaning, disinfection and sterilization, and documented evidence of maintenance and preservation of device integrity and functionality.

Recommendation 2

To establish a sub-group to develop a list of criteria based on device design features and materials that could be used to decide whether a device should be considered for reprocessing or should be rejected.¹

1. See the attached document developed by the Panel sub-group "Technical Aspects of Reprocessing SUD's"

Recommendation 3

To follow established national standards and guidelines. These shall include the CSA Healthcare Technology series of standards (e.g. Z314.1 ETO, Z314.3 Steam, Z314.8 Decontamination, etc.), HC Infection Control Guidelines, and other consensus guidelines and standards of practice. ISO sterilization series should also be used as a guide.

Recommendation 4

To improve communication to all health care facilities (i.e. long term care, community health units, surgery centres, doctor's offices, etc.) and ensure the distribution network includes communication to frontline healthcare staff across the continuum of care.

Recommendation 5

To recommend HC send an advisory letter to hospitals and all other health care facilities making interim recommendations on reprocessing of SUDs until some form of regulatory control (either Federal or Provincial/Territorial) is established to ensure patient and staff safety.

Technical Aspects of Reprocessing SUDs

Introduction

One of the tasks assigned to Health Canada=s Scientific Advisory Panel on Reprocessing Medical Devices was to prepare a list of criteria, based on device design features and materials, that could be used to decide whether a device should be considered for reprocessing or should be rejected from consideration for reprocessing. This document discusses aspects of device design and materials as a guide to hospitals considering the reprocessing of single-use devices (SUDs).

Although evidence demonstrates that carefully controlled reprocessing of some SUDs is safe, it also is clear that some SUDs cannot be reprocessed safely. Single use medical devices used on patients with CJD should never be reused.

The first step in determining whether to implement a reprocessing program is for health care workers to determine whether a device can be cleaned adequately and whether it can be inspected and tested for its integrity and functionality. If all surfaces of the device cannot be inspected and tested for cleanliness and functionality, and the device does not function as required, the device should not be reused.

If there is concern that any of the product's parts cannot be cleaned properly; that porous materials, such as certain plastics, may absorb contaminants and chemicals; or that the nature of materials in a device are changed, then that product should not be included in the reprocessing program.

Design considerations

A number of design features common in single-use devices can make it difficult or impossible to clean and sterilize the device, and to verify its functionality without specialized processing equipment. Third-party reprocessors may have the necessary equipment and expertise to do this, but health care facilities seldom do. Users should consider carefully whether they can verify the cleanliness, sterility and functionality of devices with the following design characteristics:

• Narrow lumens penetrable by body fluids
• Wires or cables inside sleeves penetrable by body fluids
• Corrugated tubing
• Inner coiled wires (e.g. biopsy forceps)
• Optical fibres
• Dead spaces (holes, channels or cavities not open at both ends)
• Devices made of separate parts that cannot be disassembled, such as articulated parts joined by pivots or hinges
• Threaded parts (e.g. as found in single-use laparoscopy cannulae)
• Press-fitted or riveted parts with surface crevices between them
• delicate parts that cannot withstand ingress of fluids or physical cleaning, such as batteries, LCD screens, and balloon catheters

Material considerations

Before deciding to reprocess a device, the user should determine the materials of which the device is made and should verify that these materials are compatible with the reprocessing methods to be used. Several types of materials that will pose problems are:

• bio-active coatings
• surface lubricants
• insulating coatings (such as on tonsillectomy forceps)
• bovine or porcine materials
• absorbable components or coatings
• latex rubber
• any plastics that become brittle, cracked or crazed after reprocessing

The attached table lists some materials that one third-party reprocessor has found to be compatible with their disinfection and sterilization methods. However, users are cautioned that they should verify the compatibility of all materials before deciding to reprocess them.

Decision Process on Reuse

Before reusing any SUD, health care facilities should conduct a systematic review of all factors that could affect the safety of the reprocessed device. A useful decision matrix has been published by the Canadian Healthcare Association ("The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities", CHA Press, Ottawa, 1996). Some of the major decision factors listed in the matrix are:

• Can the functionality of the device be ensured using equipment and techniques found within the hospital?
• Are test methods available?
• Will degradation of the device affect its functionality?
• testing be performed in the hospital laboratory?
• Can cleanliness, sterility and freedom from pyrogens be verified by tests?
• Does testing confirm freedom from toxic residues of disinfectants and sterilants?
• Can employee competence be verified?
• Are the results of ongoing quality assurance reports acceptable?
• Is it cost-effective to reuse this product?

Attachment 1.

MATERIALS AND DEVICES THAT MAY BE SUITABLE FOR REPROCESSING

PLASTIC	DEVICE
AramidJ fibre	EP (electrophysiology) catheter
Barium Sulfate	EP catheter
Nylon	EP catheter, trocar, sleeve
PET	OPCAB (Off-Pump Coronary Artery Bypass)
Polyacrylonitrile	Aortic punch
Polyamide	Sleeve, EP catheter, AcuNavJ ultrasonic catheter
Polybutadiene	Aortic punch
Polycarbonate	OPCAB, STA, EP catheter, aortic punch, trocar, laparoscope
Polymethylsiloxane	Harmonic scalpel
Polydimethylsiloxane	OPCAB
Polyester	STA, AcuNavJ , EP catheter, CAB, trocar, Kendall CS
Polyester Urethane	EP catheter
Polyether imide	Harmonic scalpel
Polyether urethane	EP catheter, OPCAB
Polyetheramide	OPCAB
Polyethyl cyanoacrilate	EP catheter
Polyethylene	EP catheter, OPCAB
Polyimide	AcuNavJ , OPCAB, phaco tip
Polymethylmethacrylate	OPCAB
Polyoxymethylene	OPCAB
Polystyrene	Aortic punch, trocar
Polytetrafluoroethylene	Tubing, harmonic scalpel, laparoscope
Polyurethane	EP catheter, OPCAB, STA, Huntleigh CS
Polyvinylchloride	OPCAB
Polyvinylidine	Tubing
Rayon	Sleeve
Silicone	OPCAB, trocar
Vespel	EP catheter
Vestamid	EP catheter
Cellulose Acetate	Compression sleeve
Acrylic + polystyrene	Trocar

OTHER MATERIALS	DEVICE
17-4 PH Steel	Harmonic scalpel
2000 Aluminum Alloy	Trocar, EX-FX
300 Stainless Steel Alloy	OPCAB
316 Stainless Steel	OPCAB
400 Stainless Steel Alloy	Trocar
Carbon Fibre	EX-FX
Chromium	AcuNavJ
Copper	Bur, EP catheter, AcuNavJ
Iron	Bur, EP catheter
Nickel	Bur, AcuNavJ , EX-FX
Platinum	STA, EP catheter
Silver	EP catheter
Stainless Steel	Bur, blade, STA, EP catheter, AcuNavJ , OPCAB, trocar, EX-FX, laparoscope
Steel Alloy	Harmonic scalpel, EX-FX
Titanium	Phaco tip
Titanium Alloy	Harmonic scalpel, EX-FX, trocar
Tungsten	STA