MJA: Whitby & Looke, "Single use only": obfuscation or the necessary attainment of zero risk?

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"Single use only": obfuscation or the necessary attainment of zero risk?

Stringent reuse of medical devices could save us millions of dollars each year

MJA 1997; 167: 519-520

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	The revolution in plastics technology over the past 40 years has resulted in a wide variety of healthcare items produced as presterilised "single use only" disposables. In spite of the admonitions of many peak and government organisations in Australia and overseas,^1-3 many hospitals are reprocessing single-use medical devices because staff feel this will result in substantial monetary savings.⁴ The labelling as "single use only" of non-critical items used exclusively on external body surfaces (as opposed to critical items used invasively), commented on by Stewart in this issue of the Journal, is an extremely relevant issue in the debate. Here, we argue that the global term "single use" provides a barrier to rational analysis by masking the complexity of the issues and the range of devices. Is a "single use only" item truly disposable, or is it a durable item that has been labelled "single use only" by the manufacturer according to certain criteria? Such criteria may include cost, life expectancy, potential physical or infection hazards after repeated use, minimisation of the manufacturer's legal liability, or even an expression of lack of confidence in the capability of hospitals to reprocess the item satisfactorily.
Manufacturers would probably argue forcefully that all single-use labelling is appropriate	Manufacturers would probably argue forcefully that all single-use labelling is appropriate, including that of non-critical items. Legal advice to many hospitals confirms the need to comply with manufacturers' instructions and thus precludes reprocessing. Nevertheless, infection control prin ciples suggest that, where an item of equipment is used externally against unbroken skin and does not penetrate a sterile site, thorough cleaning between uses is all that is required, and sterility is certainly not essential. Whether the reprocessing of such items is cost-effective may be questioned. However, if reuse of single-use, non-critical medical devices were prohibited by law, then logic demands that restaurants provide "single use only" crockery and cutlery to each patron -- as these items enter body cavities and are regularly contaminated with body fluids, they induce as much, if not more, risk of transmitting infection. Stewart advocates legislation to prohibit inappropriate labelling. As sensible as this suggestion appears, Australia constitutes less than 1% of the world market for single-use products, and overseas manufacturers are unlikely to change their labelling to meet requirements unique to our country. Reprocessing of "single use only" instruments that penetrate sterile body sites is an even more contentious issue. The recent National Health and Medical Research Council (NHMRC) expert report,⁵ which examined reuse of critical items, confirmed the economic rationality of reprocessing some "single use only" items by stating that if such reuse was not permitted in Australia "either appropriate resources (estimated at $100 million per annum) to purchase sufficient single use devices must be provided or a reduction in services be explicitly recognised". However, the NHMRC panel also concluded that "continuation of the current practice of re-use cannot be condoned", and suggested that either Australian health ministers make a decision to disallow reuse of medical devices labelled as "single use only", or allow reuse to continue but that it be subject to more stringent regulations.
	Although State and Commonwealth departments of health do not support reuse,^6-8 the dilemma for many hospitals continues because they implicitly recognise that it is in their interests for services to continue without the imperative to obtain increased funding to purchase further stocks of single-use equipment. Therefore, reprocessing, although against written policy, is tolerated by governments. From the patient's perspective, there is both an expectation and a legal right to be assured that any equipment used is devoid of infection risk, as well as being non-toxic, non-pyrogenic, physicochemically stable and functionally reliable. To what extent does the healthcare consumer require this assurance? The outcome in the recent Sydney case of patient-to-patient transmission of HIV⁹ suggests that the judiciary, presumably reflecting a community view, believes that zero risk should be the accepted standard. By this precedent, any reprocessing of "single use only" items is likely to be unacceptable to the community, in spite of scientific argument to the contrary and the economic implications of such a decision. No one who has seriously considered this issue could deny that a policy on the reprocessing of critical items marked as "single use only" will be difficult to formulate, or that prospective and scientifically rigorous data on their potential transmission hazards are urgently needed. In response to the NHMRC document, the Australian Health Ministers Advisory Council (AHMAC) has commissioned detailed studies into the risk of disease transmission by cardiac electrophysiology catheters and their ability to be satisfactorily reprocessed (Dr H Wellington, Chair, NHMRC working party on re-use of medical devices labelled as single use, personal communication). The alternatives provided by the NHMRC expert panel represent two diametrically opposed solutions to the problem. To continue disposing of all items labelled as "single use only", regardless of their ability to be adequately re-processed, creates unnecessary expense at a time when healthcare dollars are scarce. To agree to the reprocessing of certain items may lead to opposition, particularly from manufacturers. Nevertheless, if, after expert advice, the community and its parliamentary representatives can agree on an acceptable, practical and economically attainable level of risk, then appropriate characterisation of those devices suitable for reprocessing under stringent conditions could save Australia's healthcare system millions of dollars each year. While acknowledging that it is a challenging question, it is one that Australia's health ministers must consider, and one on which they must develop and disseminate a collective view. We hope that the relevant issues will continue to be debated by AHMAC. R Michael Whitby Director, Department of Infectious Diseases Infection Control & Sexual Health, Princess Alexandra Hospital, Brisbane, QLD David F M Looke Senior Specialist, Department of Infectious Diseases Infection Control & Sexual Health, Princess Alexandra Hospital, Brisbane, QLD Federation of Sterilising & Research Advisory Councils of Australia. FSRACA policy statement: re-use of single-use items. Melbourne: FSRACA, 14 Feb 1994. Medical Industry Association of Australia. Statement of Industry Policy: re-use of single-use medical devices. Sydney: MMIA, 6 Aug 1991. United States Food and Drug Administration. Compliance Policy Guide. Re-use of medical disposable devices, 7124.6. Washington, DC: FDA, 24 Sept 1987. Collignon PJ, Graham E, Dreimanis DE. Re-use in sterile sites of single-use medical devices: how common is this in Australia? Med J Aust 1996; 164: 533-536. National Health and Medical Research Council. Report of the NHMRC expert panel on re-use of medical devices labelled as single use. Canberra: AGPS, 1997. Adams A (Chief Medical Adviser, Commonwealth Department of Human Services and Health). Communication: re-use of single-use devices. Canberra: DHSH, 1 Aug 1994. Owen JW (Director-General, New South Wales Health). Reuse of single-use medical devices. Sydney: NSW Health, 1994. (Draft Circular 83/62.) Lynch P (Acting Chief Medical Officer, Victorian Department of Health and Community Services). Re-use of disposable single-use items. Melbourne: DHCS, 29 January 1993. (Circular No. 2/1993.) Chant K, Lowe D, Rubin G, et al. Patient-to-patient transmission of HIV in private surgical consulting rooms [letter]. Lancet 1993; 342: 1548-1549.

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