Reuse of single-use medical devices: NHMRC deliberations
Whether reuse is banned or condoned practices must change
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The reuse of medical devices labelled "single use only" is widespread in Australian hospitals, as it is in hospitals throughout the developed world. The practice generates both strong support and strong opposition among different sectors of the health care community, and there has been vigorous public debate about it in Australia.1,2
There are numerous reports of adverse outcomes associated with reuse of single-use medical devices. These are not restricted to infection, but include physical trauma, device breakage and toxic reactions.3-5 However, there are few systematic data examining reuse of medical devices or outcomes of this reuse in Australia, and the report by Collignon et al. in this issue of the Journal (page 533) is a welcome addition.
Some professional groups1,2and, more recently, the public6 have raised serious concerns about the safety and efficacy of reuse. The National Health and Medical Research Council (NHMRC) established an expert panel in August 1994 to examine the policies, practices and standards which apply to reuse in Australia, and to make recommendations on future management of reuse.7 Recognising the lack of systematic data, the panel commissioned a survey to document the practices and standards for reuse of medical devices within 11 large public and private hospitals across Australia.
The survey showed that, while reuse had decreased in recent years, hospital policies for reuse were often inconsistent with practices; standards for cleaning and sterilisation before reuse were unsatisfactory; quality assurance procedures for these processes were inadequate; and patients were not fully informed of hospital policies and practices for reuse. In almost all cases, the hospitals cited budgetary pressures as the reason for reuse.
A major part of the NHMRC study was a physical and microbiological assessment, never undertaken before, of a selection of commonly reused devices. Observed deficiencies included physical damage, evidence of contamination and, in one case, bacterial growth (i.e., many of the processed devices were unsuitable for reuse). The results of this assessment made a significant contribution to the panel's further deliberations and recommendations.
The NHMRC expert panel considered a range of options and concluded that the current practice cannot be condoned. Two basic principles underpinned the panel's decisions. Firstly, the dichotomy between policy and practice must be addressed; and, secondly, decisions must always be made on the basis of the most cost-effective allocation of scarce resources. The issue ultimately rests with the responsible health ministers. If they decide that the practice of reuse cannot be endorsed, the following consequences must be recognised and acceptedATBody1stpr:* Funding will need to be increased to allow for purchase of new devices, or a reduction in services will result.
* Some form of regulation will be required to ensure compliance (this will apply also if reuse is endorsed).
Other principles relate to reuse if it is condoned.
* Any decision to reuse must be based on an assessment of the costs and benefits of reuse. If there is no significant economic benefit, reuse should not be contemplated. Economic assessment needs to be rigorous and to include adequate provision for quality assurance monitoring.
* Processing for reuse needs to be of a standard which ensures the cleanliness, sterility and structural integrity of the devices. This requires that institutions processing devices for reuse must apply stringent quality assurance procedures to ensure their safety and integrity. The standards required must approach those of the Therapeutic Goods Administration's Code of Good Manufacturing Practice. Regulatory frameworks may be needed to ensure that these standards are met.
* Institutions and practitioners who reuse devices must carry the responsibility for ensuring the quality and safety of those devices.
* Patients' right to information about an institution's policy for reuse must be addressed. This may prove crucial if reuse is ever an issue in a personal litigation case.
These principles for devices labelled "single use only" apply equally to devices designated for reuse. Indeed, data before the NHMRC expert panel suggested that shortcomings in cleaning and sterilising processes apply generally.
The panel's draft report and recommendations8 are being revised in the light of public submissions, and the final report is expected to be released later this year.
In Canada there has also been a lively debate on reuse of single-use medical devices,8 and for some time there have been strong proponents for reuse.9 The NHMRC panel's conclusions, however, parallel a recent policy statement by the Canadian Healthcare Association.10
Christopher W Brook
Chair, NHMRC Expert Panel on the Re-use of Medical Devices Labelled as Single Use
Director, Public Health, Department of Health and Community Services, Melbourne, VIC
- Australian Nurses Federation. Multiple use of single use items -- the Nurses responsibility. Abstracts. Heidelberg Repatriation Hospital, July 1994. Melbourne: ANF, 1994: 15p.
- Medical Industry Association of Australia. Reuse of single-use medical devices. Conference proceedings. University of New South Wales, August 1991. Sydney: MIAA, 1991: 57p.
- Jacobsen JA, Schwartz CE, Marshall HW, et al. Fevers, chills and hypotension following cardiac catheterization with single and multiple use disposable catheters. Cathet Cardiovasc Diagn 1983; 9: 39-46.
- Kundsin RB, Walter CW. Detection of endotoxin on sterile catheters used for cardiac catheterization. Clin Microbiol 1980; 11: 209-212.
- Case report. MMWR Morb Mortal Wkly Rep 1982; 31: 290-291.
- Australian Broadcasting Corporation. Television program. 7.30 Report. 1994: 8 Sep.
- National Health and Medical Research Council. Expert Panel Report on the Re-use of Medical Devices Labelled as Single Use. Draft report. Canberra: NHMRC, 26 Oct 1995.
- Reuse of disposable medical devices. Proceedings of the Fourth Canadian Co-ordinating Office for Health Technology Assessment. Regional Symposium; 1994 Oct; Montreal, Canada. Montreal: CCOHTA, 1994: 47p.
- The reuse of single-use catheters. Report submitted to: Ministre de la Sant et des Services Socieux du Quebec par le Conseil d'valuation des Technologies de la Sant. July 1993. Montreal: CETS: 1993: 65p.
- Canadian Healthcare Association. The reuse of single-use medical devices. Guidelines for healthcare facilities. Ottawa: CHA Press, 1996. o
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