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CADTH » Search All Products » Environmental Scanning » Environmental Scans » Issue 8

Issue 8: Reprocessing Single-Use Medical Devices: An Update of the Clinical Evidence and an Environmental Scan of Policies in Canada

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Context and Policy Issues

Numerous types of medical devices are labelled and marketed by manufacturers as being for single-use only to help ensure device functionality and sterility and to prevent cross-infection.1 The reuse of single-use (medical) devices (SUDs) after reprocessing in health care facilities is perceived to have some economic benefits, but there are concerns about patient safety, cost-effectiveness of SUD reprocessing, ethical obligations, and legal liabilities. Reprocessing involves all the steps performed, including cleaning, function testing, disinfection, and sterilization, to make a device that has been used by one patient ready for use by another patient.1,2

In February 2008, the Canadian Agency for Drugs and Technologies in Health (CADTH) published a national survey of Canadian acute-care facilities and a health technology assessment on the reprocessing of SUDs.1 The useable response rate for the survey was 70% (398 of 572). Twenty-eight per cent (111 of 398) of hospitals that responded reprocessed SUDs. Most hospitals that reprocessed did so in-house (85%) instead of using third-party reprocessors; and 40% of them did not have a written SUD policy, with 12% reporting no incident report mechanism for adverse events related to reprocessing or reuse of SUDs at the hospital.2 According to the limited evidence available on SUD reprocessing, the assessment suggested an uncertain health impact of reprocessing. Few studies of mixed quality were identified, and the authors were unable to suggest or rule out harm to patients from reprocessing.1


Health Canada does not regulate the reuse and reprocessing of SUDs. The provincial and territorial governments and health regions are responsible for the policies, procedures, and recommendations for the organization and delivery of health care services, including the use of reprocessed SUDs.2 Policies and practices vary from one jurisdiction to another.

Objectives

The objectives of this report are to provide an update of the clinical evidence and information on the policies and regulations across Canadian jurisdictions about the reuse and reprocessing of SUDs. The following questions will be addressed:

  • What is the evidence, since the last CADTH review, that reprocessed SUDs are safe and effective?
  • What are the policies and recommendations across Canada on the reuse and reprocessing of SUDs?

Methods

An update of the literature search of the clinical evidence was performed and the selection criteria were applied based on the original CADTH report.1 Studies that measured the clinical effectiveness, safety and device functionality, and contamination of new SUDs compared with reprocessed SUDs or SUDs that had been previously opened but not used in human subjects were included. In addition, an environmental scan of SUD policies and regulations in the Canadian provinces and territories was conducted through communication with the appropriate contact person or examination of websites, such as those related to the provincial ministry of health, for each jurisdiction.

Summary of Findings

Clinical Evidence
Two new studies that compared the safety, efficacy, and function of new SUDs with the reuse of reprocessed SUDs were identified.3,4 One study evaluated the efficacy and complications of pin tract infections, loss of fixation, or loosening of components of new versus reprocessed external fixations.3 A second study compared the handling and functionality of new versus reprocessed single-use ultrasound scissors.4 In both studies, the medical devices were reprocessed by a third-party reprocessor, and the patient safety, effectiveness, and functionality were similar between the new and reprocessed SUDs.3,4 The study characteristics and outcomes appear in Appendix 1. As the sample size was 100 devices in each study, it is difficult to determine if true differences in outcomes between new and reprocessed SUDs exist. Also, Gartner et al. provided limited information on how randomization and blinding were conducted and the sterilization procedure used on the ultrasound scissors.4 Taken together with the previous review, the clinical evidence remains insufficient.

Environmental Scan of SUD Policies in Canada
Information on the regulatory context on the reuse and reprocessing of SUDs provided by the regional health authorities and jurisdictions that participated in our environmental scan or for which information was available on the Internet is presented in Appendix 2. Five out of 10 provinces (British Columbia, Alberta, Saskatchewan, New Brunswick, and Nova Scotia) do not permit the reprocessing and reuse of SUDs unless they are reprocessed by a licensed third-party reprocessor. The Eastern Health and Central Health authorities in Newfoundland and Labrador, the Northwest Territories, and the Queen Elizabeth Hospital in Prince Edward Island do not support the reuse or reprocessing of SUDs under any circumstances. In-house SUD reprocessing is not forbidden entirely in Ontario and Quebec, but these provinces have issued position statements or recommendations to health care facilities to encourage policy development and appropriate documentation associated with the reuse and reprocessing of SUDs.

Limitations

There remains a dearth of evidence on the effectiveness and patient safety associated with the reuse and reprocessing of SUDs, and newly available studies are of mixed quality. We did not receive responses from all health ministries given the short time frame of this scan.

Conclusions

There is insufficient evidence to support or rule out harm to patients from the reuse and reprocessing of SUDs. Moreover, the policies and regulations on SUDs vary by jurisdiction. Some jurisdictions do not support the reprocessing of SUDs unless it is performed by a third-party reprocessor, while others do not support the reuse and reprocessing of SUDs under any conditions.

References

  1. Hailey D, Jacobs PD, Ries NM, Polisena J. Reuse of single use medical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital practice. Int J Technol Assess Health Care. 2008;24(4):430-6.
  2. Polisena J, Hailey D, Moulton K, Noorani H, Jacobs P, Normandin S, et al. Reprocessing of single-use medical devices: national survey of Canadian acute-care hospitals [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH); 2008. [cited 2010 May 21]. (Technology report number 104).
    Available from: http://www.cadth.ca/media/pdf/334A_Reprocessing-SUDs%20National-Survey_tr_e.pdf
  3. Sung JK, Levin R, Siegel J, Einhorn TA, Creevy WR, Tornetta P. Reuse of external fixation components: a randomized trial. J Orthop Trauma. 2008 Feb;22(2):126-30.
  4. Gartner D, Munz K, Huckelheim E, Hesse U. Ultrasonic scissors. New vs resterilized instruments. Chirurg. 2008 Feb; 79(2):175-9.
  5. Update on reprocessing and reuse of single-use medical devices [Internet]. Ottawa: Health Canada, Therapeutics Product Directorate; 2007. [cited 2010 Jun 3]. Available from:  http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/lthsud_md_lahimj_im-eng.php
  6. Standards for single-use medical devices [Internet]. Edmonton: Alberta Health and Wellness; 2008 Jan 16. [cited 2010 Jun 3]. Available from: http://www.health.alberta.ca/documents/IPC-Medical-Device-Single-Use-2008.pdf
  7. Provincial Infectious Diseases Advisory Committee. Best practices for cleaning, disinfection and sterilization in all health care settings [Internet]. Toronto: Ontario Ministry of Health and Long-Term Care; 2009. [cited 2010 Jun 3]. Available from: http://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_cds_2.pdf
  8. Agence d'évaluation des technologies et des modes d'intervention en santé (AETMIS) [Internet]. Montréal: AETMIS; 2009. Reuse of single-use medical devices; 2008 Mar 17 [cited 2010 Jun 3]. Available from: http://www.aetmis.gouv.qc.ca/site/250.1131.0.0.1.0.phtml
  9. Summary: reuse of single-use medical devices [Internet]. Montréal: Agence d'évaluation des technologies et des modes d'intervention en santé (AETMIS); 2009. [cited 2010 Jun 3]. Available from: http://www.aetmis.gouv.qc.ca/site/phpwcms_filestorage/79c20f9940270fa69869b2336a70bec1.pdf Extract from the report prepared for AETMIS by Geneviève Martin and Lorraine Caron with the collaboration of Alexandra Obadia.
  10. Hospital and health care facility standards regulations, N.W.T. Reg. 036-2005 [Internet]. Yellowknife (NWT): Territorial Printer, Northwest Territories; 2009. [cited 2010 Jun 3]. Available from: http://www.canlii.org/en/nt/laws/regu/nwt-reg-036-2005/latest/nwt-reg-036-2005.html

Appendices

Cite as: Polisena,J. Reprocessing Single-Use Medical Devices: An Update of the Clinical Evidence and an Environmental Scan of Policies in Canada [Environmental Scan issue 8]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010.

CADTH takes sole responsibility for the final form and content of this environmental scan. The statements and conclusions in this environmental scan are those of CADTH.

Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government.

Disclaimer: The Environmental Scanning Service is an information service for those involved in planning and providing health care in Canada. Environmental Scanning Service responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide information on a topic that CADTH could identify using all reasonable efforts within the time allowed. Environmental Scanning Service responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness, particularly in the case of new and emerging health technologies for which little information can be found but that may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete, and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report.

Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH.

Links: This report may contain links to other information available on the websites of third parties on the Internet.

Canadian Agency for Drugs and Technologies in Health (CADTH)

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