Scientific Advisory Panel on the Reprocessing of Medical Devices
SAP-RMD-sub-group Teleconference (2005/03/30)

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Record of Proceedings

Panel Sub-Group Members Present: Dianne Trudeau (Chair),Susan Hadfield,, Colleen Landers, Jean Richmond, Timothy Zakutney.

Health Canada (HC) Representatives: Philip Neufeld, Hripsime Shahbazian, Marilyn Davis

Michelle Alfa and Linda Jakeman were unable to participate.

Panel sub-group met via teleconference to develop a list of criteria requested in Question 2.

Hripsime Shahbazian welcomed the panel members and thanked them for agreeing to participate on this sub-group of SAP-RMD. She noted that a "Suggested List of Criteria" was circulated prior this meeting to facilitate discussion process. Members confirmed receipt of the document. Dianne Trudeau was invited to lead the discussion.

The chair asked the members to focus on the task of the day:

To develop a list of criteria requested in Question 2.

A. Technical Aspects of Reprocessing Single Use Devices (SUDs)

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.

A general discussion ensued regarding criteria for reprocessing. Members agreed that design as well as materials used are important when considering reprocessing of SUDs. Visual inspection of a device is required for detecting brittle, cracked, visually misshaped or damaged, visually soiled items.

Some of the SUDs are made of plastics that are not suitable for reprocessing. Some design features can rule out reprocessing such as devices containing batteries, LCD screens, bovine materials, latex rubbers, balloon catheters, devices with hinges, sliding devices.

Members agreed that hospital microbiology labs often do not have proper facilities to test devices after reprocessing. Bigger establishments may have more advanced facilities, but time and staff are also issues. In order to do reprocessing hospitals should have validated procedures, that are currently lacking.

Members agreed that list of criteria will be helpful to hospitals. Criteria needs to be general not specific. It can be used as a guide by hospitals when considering reprocessing of SUDs. The third party reprocessing companies have developed special equipment and processes to enable reprocessing of more complex items that are not available to hospitals.

Discussion focussed on 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.

Design considerations (physical, total system, and user design)

The device must be designed and manufactured in such a way as to permit cleaning of all contaminated surfaces. Some design features that are known to affect the ability to reprocess the device include:

• Narrow lumens penetrable by body fluids
  • Members asked if diameter to length ratio is important.
  • Members were informed that third party reprocessors have special equipment and processes to reprocess devices with narrow lumens, and according to them length is not a limiting factor.

• Coils, springs,
  • Members stated that any device components that have coiled spring design are difficult to clean.
  • e.g. single use biopsy forceps for colonoscopy

• Corrugated tubing
  • Corrugated tubing can trap body fluids

• Wires, cables inside sleeves
  • Wires, cables inside sleeves penetrable by body fluids

• Dead-air spaces
  • These are cavities closed at one end that could trap fluids and cannot be "flushed out"
  • e.g. First generation laparoscopy equipment, these didn't have flush ports, etc.

• Articulated parts joined by pivots or hinges that cannot be disassembled without breaking them
  • Members noted that some of these devices need to be taken apart to clean them.
  • Permanent pivots, hinges or screws on single use items cannot be removed for cleaning, cannot be taken apart without breaking the apparatus therefore cannot be properly cleaned.
  • e.g. Scissors, cannot disassemble it therefore cannot clean it
  • It was noted that third party reprocessors can clean these devices without taking them apart, they do not undo rivets or heads.

• Threaded parts
  • Members questioned if threaded parts are meant to come apart.
  • There was an agreement that in some cases cleaning threads is an impossible task
  • e.g. Single use laparoscopy cannula, almost impossible to get into plastic groves

• Press-fitted or riveted parts with surface crevices between them
  • It was stated that riveted parts make it difficult to reprocess a device.
  • e.g. Single use forceps, scissors, laparoscopy equipment

• Delicate parts that cannot withstand physical cleaning
  • Members listed optical fibers, batteries, LCD screens, balloons, implants, joints, plates, screws, etc.
  • e.g. open but not used, contaminated single use implants.

• Devices that have separate parts that cannot be disassembled
  • e.g.carpal tunnel instrument

Material considerations

Most SUDs have been constructed of some type of plastic (e.g. polymer). There are 20 classes of polymeric materials used in the construction of medical devices, and plastics differ in the way they respond to cleaning and sterilization practices. Generally, all plastics are heat sensitive. These items, therefore, cannot withstand the high temperature of steam sterilization, but some are capable of maintaining their form and function with low temperature sterilization technology such as ethylene oxide.

• Protective coatings or films
  • special coatings, electrical insulation
  • insulated coatings, e.g. insulated forceps
  • bovine or porcine coating
  • resin coating

• Lubricants
  • Lubricants that may be removed during processing
  • e.g. arthroscopic blades or burrs, laparoscopy instruments

• Any materials that may become brittle, cracked or crazed
  • latex rubber,
  • HC will provide a list of plastics that according to some third party reprocessors are OK to reprocess.

Several steps in reprocessing program were discussed:

It was agreed that before any reprocessing program would be considered it must be financially viable. It was recommended to advise the health care professionals of the importance of cost-estimate analysis based on complete reprocessing program.

Members stressed the need for tracking. They would need to:

• Know how many times same product was reused, this could be separate criteria, may be marked with indelible ink or bar coded
• Predetermine number of times each device should be used
• Keep track of which patient it is being used on, especially when CJD is of concern

Method of tracking must be permanent. It was noted that some third party reprocessors use stick-on labels to put on patient charts for tracking purposes.

Members discussed the importance of testing for functionality / integrity. Any reprocessing program has to have the means to test for functionality. Compatibility needs to be looked at as well.

Members questioned whether reprocessing steps should be addressed in detail or not. It was agreed that the sub-group has fulfilled its mandate by addressing design and material considerations. It was recommended that based on general criteria if one decides to reprocess than they need to carefully consider steps involved in a reprocessing cycle.

Members recommended to refer to the Canadian Healthcare Association document (The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities, CHA Press, Ottawa, 1996) for a list of general reprocessing activities.

Members agreed that this should remain a general guide only; each hospital is responsible for initiating a reprocessing function that works in their own setting with their own equipment and circumstances.

It was decided to keep the criteria short and have a general statement about the factors to be considered. Criteria will include design and material characteristics. General paragraph will address process and functionality validation. It was suggested to reference a flow-chart of a decision making process. Members recommended to reference the chart provided in CHA document (Figure 1: Decision Matrix)¹.

Hripsime Shahbazian will coordinate the preparation of the report, all information should be sent to her attention to include in the report. Once the draft report is ready it will be circulated to sub-group members for review and approval. Approved document will be circulated to the panel members for their comments. Final criteria will be added to the panel recommendations on reprocessing of SUDs.

Meeting adjourned.
Revised: April 19, 2005

¹ Canadian Healthcare Association, The reuse of single use medical devices: Guidelines for healthcare facilities, CHA Press, Ottawa, 1996.