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Scientific Advisory Panel on the Reprocessing of Medical Devices
(SAP-RMD) (2005/02/10-11)
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Record of Proceedings
Panel Members Present: Dianne Trudeau (Chair), Michelle Alfa, Janina Berenyi, Michael Gardam, Susan Hadfield, Linda Jakeman, Sue Lafferty, Colleen Landers, Diane Pinsonneault, Jean Richmond, Rosalind Smith, Cheryl Swan, Mary Vearncombe, Alice Wong, Timothy Zakutney.
Presenters: Kevin Murray, Larry Spears, Pamela Furman, Don Selvey, Allan Hidderley, Jonathan Plumb.
Health Canada (HC) Representatives: Roland Rotter, Philip Neufeld, Theresa Burke, Susan Tainsh, Maureen Burton, Andrew Gaffen, Andre Craan, Jean-Bernard Bitchoka, Dongjiang Song, Martine Vallerand, Hripsime Shahbazian, Monique Chaîné, Eric Ormsby.
DAY 1 PROCEEDINGS
1. Opening Remarks & Welcome
Members of the Panel were welcomed and thanked for their time and effort for agreeing to serve on this Panel. Roundtable introductions of all members of the Panel, the presenters and HC representatives were done.
An overview of the issues of the reprocessing of single use medical devices was given. Members were reminded that the mandate for this panel is in two parts and that the first focus is on the reuse of single use devices, this meeting will be dedicated to that issue. A second meeting will be held to cover the second part of the mandate which will cover the issues regarding reprocessing of reusable devices.
Members were advised that as we proceed with this mandate ad hoc members may be requested if it was deemed necessary to have additional expertise not covered by the core members of this panel.
2. Chair's vision of SAP - RMD
The Chair provided her view of the task that was to be accomplished over the next two days. She stressed the fact that the main focus was to be on reuse of single use devices. She indicated that medical devices used in Canada are considered to be one of three categories, critical, semi-critical and non critical. She suggested that single use devices could be looked at in terms of these categories or otherwise, this would be determined as the meeting progresses.
The agenda was revised to accommodate the presenters participation via videoconference. As a result Item 13 was moved ahead, after Item 5.
3. Terms of Reference
The Terms of Reference were reviewed, and adopted by all members of the Panel.
4. Conflict of Interest
All members completed individual Conflict of Interest forms and no further declarations were made at the time of the meeting.
5. The Canadian Regulatory Environment
Health Canada Perspectives on Reprocessing of Medical Devices - Philip Neufeld
A brief description of the Food and Drugs Act was provided. HC role was described in regulating manufacture and sale of devices. Summary of the questions presented by HC on reprocessing SUDs were presented.
It was noted that results of deliberations at this meeting will be presented at a National Stakeholders meeting that HC is planning for late May.
Presentation is available upon request.
6. Issues Facing Health Care Facilities: What are the current practices of reuse of single use devices in Canada?
Current Practices of Reuse of Single Use Devices in Canada - Jean Richmond
A summary of current practices of reuse in Canada was provided.
It was noted that although the Quebec government initially proposed that the reprocessing of cardiac catheters not be done, one year later it was rescinded because it was felt that reprocessing did not pose a serious problem unless the previous patient was in a high risk category, such as a patient that is diagnosed with Creutzfeldt-Jakob Disease (CJD) and those who are suspected of having CJD.
Presentation was followed by a lively discussion. All members agreed that if a device cannot be cleaned then it couldn't be sterilized. There was a general concern that hospitals do not have the facilities to test reprocessed devices to ensure safety. How do we know that the reprocessed devices are safe to use? If we cannot validate that the device is safe we cannot use it. If reprocessing were to be allowed, both third party reprocessors and hospitals that reprocess would have to be regulated. It was stated that the concern would not just be with hospitals that reprocess, we should look at all healthcare providers that are involved in this practice.
Some concern was raised about current situation within the hospitals regarding education provided to the different departments, from purchasing office that orders the product to reprocessing centres where staff should be fully trained on the cleaning and sterilizing procedures of each product as well as hospital board members who make policy decisions.
Members were concerned that if reprocessing of single use devices is allowed, than tracking and identifying the product would be an issue. As well they needed clarification if we should consider all categories of devices, critical, semi-critical and non-critical or only allow the reprocessing of certain categories.
There was a question regarding single use designation, how was it determined that a device was a single use device. It was explained that it is the manufacturer's decision to market some devices as single use. The regulator cannot insist that a product that may be suited for reprocessing should not be marketed as a single use.
Some members suggested that costing should be considered in this discussion as well since in some cases costs are really substantial if we disallow the reuse of single use devices or insist that reprocessors be regulated. Others felt that cost may actually be less in the long run if we consider such things as how many antibiotics could be avoided if we were cleaning these devices properly, or banning them outright. There was a comment that another point to consider in the cost argument would be that an increase in purchasing volume may actually cause the cost to go down.
Presentation available upon request.
7. Perspectives on Regulating the Reprocessing of Single use Medical Devices
How are other jurisdictions approaching this issue?
Reuse of single-use devices in the UK: Overview of current regulatory requirements for reuse of single use devices - Discussion with Allan Hidderley and Jonathan Plumb (via videoconference)
Dr. Ludgate was unable to attend the discussion.
Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.
Allan Hidderley and Jonathan Plumb presented an overview of the current regulatory requirements in UK regarding the reuse of single use devices. They discussed the Bulletin entitled "Single-use Medical Devices: Implications and Consequences of Reuse" that was published in August 2000 1(a copy of this document was provided to the panel members for their information). This bulletin replaces the earlier bulletin "The Reuse of Medical Devices Supplied for Single-use Only" originally published in 1995. The document was produced by the Medical Devices Agency (MDA) of the Department of Health providing guidelines on the reprocessing of devices. This bulletin is only a guidance and advice, it is not in the EU regulations, however it is adopted within the UK.
Manufacturers who sell devices within Europe must follow the requirements of the Medical Device Directive. These directives make them subject to the risk management process during the products life cycle and labelling is part of this process. The regulatory system, however, is not in a position to challenge the manufacturer's choice of labelling, whether it be single use or otherwise. However they do recognise that some devices labelled single use can indeed be reprocessed. In 2003, a research program was created to look at the whole process of reusing devices, this program was also created to look at any problems that could have been missed with the new recommendations for not reusing single use devices. At this time, the MHRA believes that most hospitals and reprocessors are complying with the guidance. This is partly based on a very low number of adverse event reports for reprocessed devices.
In the UK, reprocessors must follow the Medical Device Directive, which includes the need to validate their reprocessed devices. They must be able to prove that this device is as safe and effective as it was at the first time it was put on the market. However, one loophole in this system is that hospitals or reprocessors that do not put their devices back on the market do not fall within the Medical Device Directives. There currently is a program in the UK that requires that all hospitals reprocessors who do not fall within the Directive, will have to meet these Directive standards by 2007.
With respect to the questions on device identification, the UK has no specific requirement that the manufacturer put an identifying mark on the device itself. This is the case in Canada as well, the only requirement is that on the labelling of the device the manufacturer must identify that the item is for single use only. There was a concern expressed by the members that without a permanent marking it is difficult to differentiate between identical products when they are back for cleaning whether they are reusable or single use only.
It was noted that in the UK device categorization also exists, however, all devices, regardless of their category require cleaning instructions, whereas in Canada, only Class 3 & 4 require that the cleaning instructions validation be provided with the application, the lower classes only need to state their compliance.
Panel members asked regarding patient notification. They advised that currently there is no patient notification requirement when a reprocessed device is being used on them. As well, there are currently no figures to demonstrate any operating room effects that the requirement not to reprocess single use devices may have had.
The chair thanked Allan Hidderley and Jonathan Plumb for their valuable input to panel discussion. End of videoconference with Allan Hidderley and Jonathan Plumb.
1 DB 2000(04) Single-use Medical Devices: Implications and Consequences of Reuse
www.medicoindustrien.dk/Library/Pdf/bulletin.pdf
8. Reuse of single use devices in the US: Overview of current regulatory requirements for reuse of single-use devices.
A brief recap of regulatory guidelines that American third-party reprocessors need to comply with
Past experience and future directions
U.S. Regulation of Reprocessing - Larry Spears
An historical overview of FDA activities regarding reuse of single use devices was provided.. Panel discussion ensued.
There was a question regarding how many times a device may be safely reprocessed. It was explained that in the US the pre-market assessment does not require the manufacturers to provide details of how often they believe a particular single use device (SUD) can be reprocessed. This question is better looked at in the post-market inspections. There, the reprocessors are asked to show validation information on the cleaning / decontamination / sterilization process and how they come to such conclusions as to how often a particular SUD can be reprocessed.
To date no hospitals have submitted to FDA for a 510k - clearance to reprocess SUMD's. The question of litigation has been raised a number of times and it is believed that since the introduction of regulated third-party reprocessors, many hospitals have chosen that route as a manner of reducing costs of litigation.
The Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals is applicable to third party and hospital SUD reprocessors. It was noted that currently the enforcement priorities set forth in this guidance do not apply to:
- Permanently implantable pacemakers. The reuse of permanent pacemakers is addressed in Compliance Policy Guide 7124.12 (issued on October 1, 1980 and revised in March 1995);
- "Opened-but-unused" SUDs,
- Health care facilities that are not hospitals; or
- Hemodialyzers. The reuse of hemodialyzers is addressed in "Guidance for Hemodialyzer Reuse Labeling (final draft issued on Oct. 6, 1995).
There was a question regarding regulating other healthcare centres as well. It was explained that the FDA chose not to regulate the surgi-centres and other such facilities at this time however this matter has not been completely overlooked. The FDA recognises that it is a matter of resources and feels that starting by regulating the reprocessors and hospitals is the first step in a multi-step project. In the interim it is hoped that these surgi-centres will continue to use the voluntary reporting system that is in place with the FDA. Many surgi-centres that are currently functioning, are supported by hospitals and therefore are required to use the same reprocessing system as the supporting hospital. This ensures that these centres are in fact reprocessing their devices correctly.
The presentation is available upon request.
9. Third-Party Reprocessing in the US:
The science applied to and validation processes used for device clearance.
Reprocessing of Medical Devices Labelled for "Single Use" - Pamela Furman (via videoconference) and Don Selvey
An introduction to Association of Medical Device Reprocessors (AMDR) was provided. Currently AMDR includes three companies that provide 95% of the third party reprocessing done in the U.S.
Once again it was mentioned that there have not been many adverse event reports on reprocessed items. It was stated that a number of those reports could also be attributed to new devices as well.
There was a concern that a reprocessor may not have all the current information on a device that they are reprocessing. It was explained that it is the reprocessors responsibility to determine if the manufacturer has made any changes to the product they are reprocessing. Using both a passive method such as verifying the FDA site for any new 510K applications the manufacturer may have made for that particular item, and using a more active method such as material characterization. The FDA responsibility is during the inspection process of the reprocessors, at that time the FDA is responsible for ensuring that the reprocessors have such processes in place to capture any possible changes in the products.
Members had questions surrounding the issue of time required for getting the reprocessed products back. It was confirmed that the US reprocessors currently have to provide, with the cleaning validation, worst-case scenarios for transit times and reprocessing time lines for the devices they reprocess.
There was a question about the biocompatibility of the reused product. It was explained that where biocompatibility is concerned, most reprocessing companies opt to send out their devices for testing to independent labs regulated by the FDA and who follow international standards. This is done in order to ensure independent analysis of data that cannot be manipulated by the reprocessor.
With respect to labelling in the US for reprocessors, the Medical Device User Fee and Modernization Act (MDUFMA) requires that they label all reprocessed devices with a label stating that the product has been reprocessed by the reprocessor and the name of the reprocessor.
Regarding number of times a device could be reprocessed it was stated that it is a one at a time reprocessing cycle. The product is cleared for one more use only.
10. MEDEC's position on reuse of SUDs
Reuse of Single Use Devices Industry Position - Kevin Murray
MEDEC is the national industry association representing medical device and diagnostic companies. A summary of MEDEC's Cause for Concern The Reuse of Single Use Medical Devices A Position Paper2 was presented. The document was provided to the panel members for their information.
Once more it was stated that there is no set criteria for determining if a product will be marketed for single use or multiple use, this is left to the discretion of the manufacturer, however the cleaning, sterilization and performance characteristics are some of the factors that a manufacturer takes into consideration when labelling their product for single use.
There was a question regarding Adverse Event Reporting on reprocessed devices. It was stated that there is under reporting on the market in today's practice, however it cannot be distinctly attributed to either the reprocessors or manufacturers. A better system which would include better reporting from reprocessors and manufacturers and voluntary reporting from physicians and others such as surgi-centres would give a much better indication of the problems we face today. This is something governments are working towards.
Members asked for more information regarding the reference used in the presentation. Kevin Murray will provide information to be distributed to the panel members.
Presentation is available upon request.
2 Cause for Concern The Reuse of Single Use Medical Devices A Position Paper http://www.medec.org/docs/REUSE 2004 - English.pdf
11. Review of the International Regulatory Environment
Overview of the International Regulatory Environment SUDs - Theresa Burke
Summary of various regulatory frameworks regarding reuse and reprocessing of single use devices was presented.
Members requested to know time lines for creating new regulations, should that be the route that HC choose to take. Estimated time lines could be up to 2 years, however HC will move as quickly as possible.
Document is available upon request.
12. Adjournment of day 1
The chair thanked everyone for their participation and contribution. There was a suggestion to provide an introduction to Medical Devices Regulation for the panel members. Don Boyer, Manager, Licensing Services Division, Medical Devices Bureau will be invited to make a short presentation on day 2.
DAY 2 PROCEEDINGS
13. Review of Questions regarding reuse of single use medical devices
The chair opened the meeting by providing a summary of the questions presented by HC.
It was suggested that the panel will address the second question first.
Pamela Furman of (AMDR) joined the meeting via teleconference.
14. HC Questions
1. Should the reuse of single use devices be permitted in Canada?
Canada's Food and Drugs Act and Medical Devices Regulations do not address how a health care facility uses, maintains, or sterilizes medical devices. Furthermore, the Regulations do not address the situation in which a third party re-processes devices belonging to a hospital and returns them to that facility for reuse.
Members agreed that some reuse of these devices may be allowed. Banning hospitals from reprocessing could be controversial; the focus should be on validated reprocessing and whether it can be done. If we can validate the process, then it should be allowed regardless of the reprocessor, whether it is the hospital or another party. Most members were concerned that hospitals will not meet the criteria, however, it was agreed that if hospitals can meet the criteria they should be allowed to do it as well.
There was a suggestion that we should look at cost factor as well when making a decision on reuse. There was a general agreement that some devices could truly be reused, however there are others that should never be reused. Some were concerned about compliance. If the process is regulated, HC has to ensure that reprocessors are in compliance.
Members recommended to look at the criteria listed in the CHA Guideline on The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities as well as the list provided in the OHA document.3
3 Canadian Healthcare Association, The reuse of single use medical devices: Guidelines for healthcare facilities, CHA Press, Ottawa, 1996.
Ontario Hospital Association, Report of OHA's Reuse of Single-Use
Medical Devices Ad-hoc Working Group, Toronto, January 12, 2004.
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.
2. Develop criteria to decide whether an SUD could be considered for reprocessing?
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.
Panel members asked clarification regarding this question. It was explained that HC is seeking advice regarding a basic set of criteria that would be applied to a single use device to decide if it should be considered for reprocessing or not. It could include: design considerations, decontamination issues, sterilization processes, safety and effectiveness testing methods.
Pamela Furman (AMDR) provided comments for consideration. It was noted that this approach of developing a criteria to determine whether an SUD should be considered for reprocessing departs from the FDA's approach. All devices are considered for reprocessing if the reprocessor can demonstrate that it meets the regulatory requirements that the FDA has established, however many devices are not reprocessed because the reprocessors were not able to meet FDA requirements. It is the third party reprocessors that develop the criteria for reprocessing. It should be the reprocessors responsibility to ensure that they have a validation process in place.
It was noted that the FDA web site provides a list of SUDs known to be reprocessed or considered for reprocessing4, however this is not a complete list. Members asked if there is a list of single use devices that are currently marketed in Canada. (Don Boyer to provide feedback regarding this.)
Members raised a concern that when they are dealing with implantable devices, there is often a question of ownership, at which point it causes other issues for consideration such as the sale of the device from the previous owner. Many members were in agreement that implantables should not be reprocessed.
There was a suggestion to address this questions in two stages: first look at all single use devices and define whether they can be considered for reprocessing, than generate a criteria that would allow to reject or consider devices for reprocessing, and if SUD is considered for reprocessing, define a risk category that it falls under.
Some members felt that going through a long list of single use devices would be a daunting task to undertake. Based on the FDA list of reprocessed devices we know which devices were successfully reprocessed. The reason these lists are short is because reprocessors made a decision not to reprocess some of them based on the available processes and validation. The panel should use this information to build on.
Members felt that there is a need for education and proper training of the responsible staff at the hospitals. It was noted that based on education effort the amount of SUDs reprocessing has dropped in Ontario. Hospitals are looking at training needs more carefully now.
Members felt that more work is required to develop criteria. It was noted that many reprocessors have established criteria for reprocessing of different types of devices. It was agreed that a Panel sub-group would be established to develop the details.
4 Reprocessing and Reuse of Single use Devices: Review and Prioritization Scheme
http://www.fda.gov/cdrh/reuse/1156.pdf
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.
Sub-group members are Susan Hadfield, Linda Jakeman, Michelle Alfa, Colleen Landers, Jean Richmond, Timothy Zakutney, Philip Neufeld, and Hripsime Shahbazian.
The sub-group will meet via teleconference 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.
Overview of the Medical Device Licensing Process - Don Boyer
Don Boyer was invited to join the meeting to provide an overview of the device licensing process
A short presentation of Statutory and Regulatory Provisions was provided. Device Classification rules were explained.5
To respond to the question asked earlier in a meeting it was confirmed that devices in Canada are not coded differently for identification of single use or multiple use. Currently there are approximately 18,000 licences covering
600, 000-700, 000 devices, there is no indicator for a single use, therefore it would be a very onerous task to try and get a report of single use devices only.
There was a suggestion that perhaps HC needs to identify single use devices when issuing a licence.
Members had questions regarding device classification. It was explained that medical devices that are attached to an active device will get the same classification as the active device therefore some items which appear to be under the class I classifications are indeed a class II or III because they are attached to an active device which has been classified as a class II or higher.
There was a general concern that manufacturer's directions for cleaning and reprocessing a device (reusable) are not always there. It was explained that manufacturers are not required to provide to HC the validation studies of cleaning and sterilization for Class II medical devices, however they do need to have this information at hand and ready to provide to HC at their request. For devices in Classes III and IV manufacturers are required to provide cleaning instructions as part of the labelling at the time of application.
The members suggested that they would send a list of devices that are difficult to clean to Don's attention.
Members requested to see the criteria that HC uses to classify devices. Some members felt that HC classification seems to be counter-intuitive to the healthcare practitioners. Schedule 1 has the rules however does not have the exact criteria. It was agreed that a short summary of the Classification Rules for Non-In-Vitro Medical Devices will be provided to the members by MDB.
Again the criteria for designation of a single use versus reuse was discussed. AMDR will provide a couple of company letters that touch on this issue.
Presentation is available upon request.
5 Medical Devices Regulations (F-27 -- SOR/98-282)
http://laws.justice.gc.ca/en/F-27/SOR-98-282/text.html
3. If the reuse of single use devices is permitted:
- What type of measures should be implemented to ensure patient safety?
- What validation criteria and tests for cleaning and sterilization should be followed, particularly for devices that are difficult to clean?
- Are there current standards or guidelines that provide useful criteria and recommendations?
The panel members asked further clarification regarding scope of questions (a) and (b). It was agreed that Panel would come back to these questions once the criteria is established.
Regarding the standards or guidelines panel members recommended following the Health Canada Infection Control Guidance and Canadian Standards Association (CSA) standards. It was agreed that Panel members would submit any relevant documents for consideration.
AMDR suggested to look at FDA recognized standards. A list of AAMI standards and guidance documents that are cited by the FDA as being useful in the reprocessing of SUDs are available on the web.6
It was recommended that International Standards association (ISO) documents on medical devices should be looked at as well.
6 AAMI: Resources On Reuse: Related Standards
http://www.aami.org/reuse/standards.html
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.
15. Next steps
The Panel agreed to create a sub-committee to prepare a draft list of criteria for consideration by the Panel.
The sub-group will meet via teleconference 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.
Panel made recommendations to improve communication:
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.
Panel members to provide additional addresses for distribution purposes.
Some members asked if some form of a communiqué, or press release about this meeting would be prepared and sent out to the public. It was explained that as described in the TOR, "Discussion of Panel work with the media or at conferences should only be done when authorization is given by the DG-TPD in consultation with the Chair." It was agreed that if the need arises HC would prepare a press release. HC will prepare a draft record of proceedings and as stated in the TOR, the RoP will be written to capture the advice of the Panel. There will be no attribution. There will be no other official record of the meeting. The RoP will be posted on the web once it is approved by the panel.
It was recommended that an advisory letter should be prepared to inform the users of HC concerns about reprocessing SUDs.
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.
HC will prepare a draft advisory letter. A sub-group was established to assist in this task. Members are Mary Vearncombe, Michelle Alfa, Susan Hadfield, Diane Pinsonneault, Andrew Gaffen and Philip Neufeld.
It was requested that all correspondence should be copied to the chair, Dianne Trudeau, and coordinator, Hripsime Shahbazian.
16. Discuss potential agenda items and set date of next Meeting/Teleconference
A teleconference will be planned for March to discuss the criteria and the draft advisory letter. The next meeting planned for the beginning of May will aim to complete the first portion of the mandate and perhaps start work on the second portion of the mandate. Tentative date has been set for May 2-3, 2005. Members were asked to provide their availability to the coordinator.
Panel Recommendations
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.
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.
