Appendix 1

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Contact: Policy Bureau Enquiries

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Summary of Issues and Recommended Solutions Presented to MEDEC by the SAP-RMD

Item	Description of the issue	Recommended Solution that could be addressed by the manufacturers
1	Frequently manufacturers provide generic instructions for reprocessing reusable medical devices. These instructions may be confusing and/or inadequate for healthcare facilities to comply with.	Device-specific instructions for disassembly, cleaning, disinfection, assembly, functionality testing, and sterilizing (where appropriate). These instructions should be clearly written, legible and include sufficiently detailed schematics.
2	Instructions for cleaning reusable medical devices do not comply with international and national standards.	Information required by CSA/ISO 17664 and CSA Z314.8 for the provision of validated methods for cleaning of the specific device. A minimum of one automated and one manual method should be provided.
3	Instructions for sterilization and disinfection of reusable medical devices do not comply with international and national standards.	Information required by CSA/ISO 17664 and CSA Z314.3 and CSA Z314.8 for the provision of validated methods for sterilization or disinfection of the specific device. Validated sterilization methods should include the type of cycle (e.g. prevac or gravity), as well as the time and temperature. Rationale should be provided if validated cycles are not the standard hospital cycles used in North America. Validated disinfection methods should be ones that are achievable in Canadian healthcare facilities.
4	Lack of cycle monitoring indicators for extended steam sterilization cycles.	Develop, validate and provide sterility assurance products (BIs & CIs) for monitoring extended steam sterilization cycles.
5	The size and mass of some surgical instrument sets is excessive. This may prevent reliable steam sterilization and contributes to staff injury.	The manufacturer should break down large sets and provide validated steam sterilization instructions that meet North American sterilizer manufacturers' requirements for weight and density.
6	Inadequate cleaning and rinsing of the medical devices that leads to adverse patient outcomes (e.g. cross-infection or foreign antigen reactions) due to; - device design that allows ingress of patient secretions to areas within the medical device that are inaccessible to cleaning/rinsing. - Inadequate manufacturers' instructions that do not provide appropriate cleaning and rinsing instructions . [e.g. Toxic anterior segment syndrome; TASS that occurs following intra-ocular surgery.]	Correct device design issues and/or provide appropriate and adequate cleaning/rinsing instructions that are validated for the specific device.
7	Manufacturers recommending non-medical detergents or no detergent for device reprocessing	Provide validated cleaning protocols for the specific medical devices that meet National Standards.
8	Rigid containers that have not been validated and may compromise sterilization due to:- lack of validation for specific instrument sets - design that may perforate wrapping materials - Trays that are molded and hold the instruments in positions that prevent steam penetration.	Provide validation for specific rigid containers that complies with CSA Z314.14.
9	Manufacturers not providing timely communication to users when they change the reprocessing instructions for their devices.	Ensure that when manufacturers update or change reprocessing instructions for medical devices, they inform current users in a systematic, documented fashion.
10	Manufacturers label a device as being for limited reuse but do not provide a unique device identifier or a means for users to track the number of reuses.	Ensure the when a device is labelled as limited reuse, a unique identifier is placed on the device so that users can track it. Specify how many uses the device can withstand. Provide a method to verify the continued functionality of the device.
11	Loaner instrument sets are not being adequately reprocessed prior to use because distributor or manufacturer provides set just prior to patient procedure. Sets do not have tracking system. Manufacturer does not provide preventative maintenance programs to ensure the device components in the set are reliable. Some instrument loaner sets have been circulating for over 10 years without any manufacturer inspections.	Manufacturers and distributors must comply with CSA Z314.22. [Note; this may require increasing the inventory of loaner sets to meet demand.] Ensure that the manufacturer periodically inspects the loaned or leased sets to ensure that preventative maintenance is performed and that there is routine replacement of components so that they are not used beyond their life-expectancy.
12	Lack of adequate device-specific training of reprocessing staff by manufacturer or distributor.	When complex medical devices are introduced to Healthcare facilities, the manufacturer or distributor must provide training to healthcare staff by an individual who is competent to provide correct, validated information.