Reprocessing of Reusable and Single-Use Medical Devices

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Contact MDB Enquiries

Therapeutic Products Directorate
Holland Cross, Tower "B"
6^th Floor, 1600 Scott Street
Address Locator # 3106B
OTTAWA, Ontario
K1A 0K9

July 30, 2004

04-113720-921

To: Hospital Administrators
Hospital Risk Managers
Hospital Infection Control Practitioners
Hospital Biomedical Engineering Departments
Provincial Hospital Associations
Canadian Healthcare Association
Provincial Health Ministries
Canadian Medical Protective Association
Canadian Medical Association
Colleges of Physicians and Surgeons
Canadian Dental Association

Subject: Reprocessing of Reusable and Single-Use Medical Devices

This letter presents Health Canada's recommendations to health care facilities on the reprocessing of reusable and single-use medical devices.

Proper Cleaning, Disinfection and Sterilization of Reusable Medical Devices

In late 2003, there were reports in the news media of incidents in which health care facilities had not been following manufacturers' instructions for the proper cleaning, disinfection, or sterilization of reusable medical devices between procedures.

On December 5, 2003, Health Canada published an advisory reminding users of the importance of following manufacturers' instructions for the reprocessing of reusable medical instruments¹.

Health care facilities have also reported cases to Health Canada in which the manufacturer's instructions for cleaning and sterilization are vague or insufficiently detailed.

The Reuse of Single-Use Devices

The recent concern over proper cleaning procedures for reusable devices has also emphasized the hazards of reprocessing and reusing single-use devices - those labelled by their manufacturer as being intended, and licensed by Health Canada, for a single use only. Some Canadian hospitals clean, resterilize and reuse single-use devices (SUDs) ^2,3. Whereas reusable devices are sold with instructions for proper cleaning and sterilization, no such instructions exist for single-use devices. Furthermore, manufacturers often have not provided to Health Canada research data to determine whether the device can be thoroughly cleaned, whether the materials can withstand heat or chemical sterilization, or whether delicate mechanical and electrical components will continue to function after one or more reprocessing cycles.

Risks of Reuse

The health risks of reusing an SUD depend to a great extent on the type of device and the way it interacts with the patient's body. SUDs are often classed as critical, semi-critical, and non-critical, according to a set of criteria known as the Spaulding definitions⁴. Under these definitions, critical SUDs are those that are intended to contact normally sterile tissue or body spaces during use. Semi-critical SUDs are intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. Non-critical SUDs are intended to make topical contact and not penetrate intact skin.

Most non-critical devices, like compression sleeves, can be cleaned and reused with minimal risk. Opened but unused sterile instruments can sometimes be re-sterilized, provided the materials can withstand the sterilization procedure.

However, some invasive SUDs, especially those with long lumens, hinged parts, or crevices between components, are difficult or impossible to clean once body fluids or tissues have entered them.

Reusing SUDs carries with it the obvious risk of cross-patient infection, but also the increased probability that the device could malfunction due to the adverse effects of reprocessing on materials or delicate components.

Guidance Documents

In 1996, Health Canada collaborated with the Canadian Healthcare Association (CHA) to provide guidance to hospitals in making decisions on reuse. The result was a CHA publication partially funded under a contract from Health Canada⁵. This guide has been used in Canadian hospitals and has been distributed in the USA by the Association for the Advancement of Medical Instrumentation (AAMI). The CHA guideline does not take a position for or against reuse, but provides a framework to enable a facility to judge the merits of reuse, and to establish the quality systems necessary to ensure that reprocessed SUDs are safe.

The CHA guideline suggests that a quality system for reprocessing SUDs should include the following components:

1. Reuse committee

   This committee should include members from the facility with responsibility for administration, risk management, epidemiology, infection control, biomedical engineering, central processing, medical departments and accounting. The committee should establish policies, ensure that protocols exist for each reprocessed device, and monitor adherence to approved procedures.

2. Written reprocessing procedures for each type of SUD.

3. Validation of the effectiveness of reprocessing procedures, to ensure both sterility and function of the device.

4. Assurance of quality

   This includes monitoring of control points and quality indicators, regular sampling and inspection of devices, and a periodic review of external factors that could affect the safety or function of reprocessed devices, such as changes in hospital use practices, changes in the supplier of the device, or changes in the design or materials of the device.

Ontario Hospital Association Advisory on Reuse

In January, 2004, the Ontario Hospital Association approved a report written by its Ad hoc Working Group on Reuse of Single-Use Medical Devices⁶, and issued a Position Statement on reuse⁷ which included the following recommendations:

• Hospitals should not reprocess critical and semi-critical SUDs

• Health Canada should develop regulations for safe sterilization practices in hospitals for reusable and single-use devices

• Health Canada should regulate third-party reprocessors

• Until Canadian regulations are established, hospitals should consider using third-party reprocessors licensed by the USFDA.

Health Canada is taking these recommendations under consideration. (See Recommendations and Next Steps).

The International Regulatory Environment

United States

The US FDA has established regulations controlling all reprocessing of SUDs. Hospitals and third-party reprocessors are subject to the same Quality System Requirements as manufacturers. Hospitals that wish to reprocess SUDs must register as a reprocessor with FDA and apply for approval for each type of reprocessed SUD. To date, no hospital has registered as a reprocessor. FDA has begun inspecting hospitals to ensure that there is no reuse without FDA approval.

Under the US regulations, SUDs are classed into three risk groups from Type I (low) to Type III (high). (Note: These classes do not correspond exactly with the Spaulding criteria, or the risk classes for licensing of new devices). Four third-party reprocessors have been licensed, but only for Type I and II SUDS. No licences have yet been issued for Type III SUDs.

Australia

Under regulations introduced in December, 2003, the Australian Therapeutic Goods Administration will not permit the reuse of single-use devices, unless the reprocessing of those devices is done to a standard that ensures the devices are safe and perform as originally intended.

If a health care facility re-manufactures an SUD, that facility will be regulated as a medical device manufacturer and will need to be licensed by the TGA and comply with rigorous Good Manufacturing requirements. Institutions wishing to reprocess SUDs will have until December, 2005, to come into compliance with the new regulations.

The Canadian Regulatory Environment

The delivery of health care and the establishment of policies and standards of practice in patient care have traditionally been the responsibility of Provincial and Territorial health ministries and hospital boards. Consequently, Canada's Food and Drugs Act and Medical Devices Regulations have not addressed the way in which a health care facility uses, maintains, or sterilizes medical devices. Furthermore, the Regulations do not address the situation in which a third party reprocesses devices belonging to a hospital and returns them to that facility for reuse.

However, Health Canada has the mandate to protect Canadians against risks to health and the spreading of disease. Health Canada is therefore reviewing its authority to establish regulations governing the safety of reprocessing SUDs.

Health Canada Recommendations

1. Reusable Medical Devices
   
   
   1. Health care facilities and health care providers should review instructions provided by the manufacturer prior to the purchase of reusable medical devices to ensure that the device can be adequately reprocessed with available equipment.
   2. Health care facilities and health care providers should require that manufacturers include complete instructions for use, disassembly, cleaning, reassembly and sterilization with all reusable devices, and that they provide appropriate training to users where such training is essential to the safe use of the device.
   3. Health care facilities and health care providers should establish procedures and provide training for staff to ensure that reusable devices are, cleaned, and sterilized according to the manufacturer's instructions. These instructions should be filed so that they can be easily retrieved and consulted by users.
   4. Health care facilities and health care providers should validate and regularly review their sterilization procedures and ensure that they are being followed.
   5. Health care facilities and health care providers should report to Health Canada any cases in which the manufacturer does not provide adequate instructions for use, cleaning and sterilization of a reusable device.
2. Single-Use Medical Devices
   
   

   Health Canada is concerned that reusing single-use devices may be hazardous to patients. Health Canada is addressing this issue in consultation with the Provinces, Territories, and stakeholders.

Next Steps

1. Health Canada will consult with Provincial and Territorial Ministries of Health and other jurisdictions to develop a pan-Canadian framework to manage the risks of reuse. Risk management measures could include Provincial and Territorial guidelines, standards and directives, or Federal regulations.
2. Health Canada will establish an advisory working group on reprocessing of reusable and single-use devices.
3. Health Canada will hold national consultations on the reuse of SUDs.

Further information on reprocessing of SUDs may be obtained from the Medical Devices Bureau. Tel: 613-957-7285; Fax: 613-957-7318. Email: mdb_enquiries@hc-sc.ca.

Yours sincerely,

Original signed by Brigitte Zirger for

Robert G. Peterson, MD, PhD, MPH Director General

References

1. Health Canada, Purchase of Licensed Medical Devices for Use in Healthcare Facilities, Dec. 5, 2003.
2. Mahoney, J et al. Reuse of Medical Devices Labeled by the Manufacturer for 'Single Use' Only, contract report to the Advisory Committee on Health Services, May, 2001.
3. Miller MA, Gravel D and Paton S, Reuse of Single-use Medical Devices in Canadian Acute-care Healthcare Facilities Canada, Communicable Disease Report, vol. 27-23, Dec.1, 2001.
4. Spaulding, EH, The Role of Chemical Disinfection in the Prevention of Nonsocomial Infections, PS Brachman and TC Eickof (ed), Proceedings of International Conference on Nonsocomial Infections, 1970, American Hospital Association, Chicago, IL 1971:254-274.
5. Canadian Healthcare Association, The reuse of single use medical devices: Guidelines for healthcare facilities, CHA Press, Ottawa, 1996.
6. Ontario Hospital Association, Report of OHA's Reuse of Single-Use Medical Devices Ad-hoc Working Group, Toronto, January 12, 2004.
7. Ontario Hospital Association, Reuse of Single-Use Medical Devices Executive Summary, Toronto, January 12, 2004.