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Introduction

Most of the debate about reuse of single-use devices has focused on expensive disposables such as cardiac catheters. Currently, such instruments are routinely reprocessed in many hospitals because the cost of disposal after each use would necessitate a reduction of services. The single-use status of devices such as angioplasty balloon catheters appears to be warranted, in that they are invasive devices with narrow lumens which may be difficult to clean and inspect. However, a randomised, double-blind, controlled clinical trial,² cohort studies,^3,4 and a risk-benefit assessment⁵ suggest that cardiac catheters can be safely reused if sound protocols for reprocessing are observed. There is not even any anecdotal evidence for the transmission of viral disease from the reuse of cardiac electrode catheters.⁶

Therefore, the evidence supporting the single-use status of apparently high risk cardiac catheters is unconvincing. Given this situation, how should we view the broad array of devices labelled "single use only" where criteria for disposability are tenuous at best, and most often knowingly inappropriate? Consider just a few examples from a long list of devices that I believe are spuriously labelled as "single use only".

Disposable PVC oxygen masks. Used and discarded in considerable quantities every day in postoperative recovery rooms, most of these masks have a working life of about 10 minutes. They are not supplied as a sterile item (nor should they be) but the accompanying directions-for-use insert says "for single use only". In comparison, multiple-use black rubber anaesthetic masks (which are probably thought to do the same job from a microbiologist's perspective) are deemed safe for many uses.

Disposable pressure infuser. This consists of a bladder with an external sleeve and an inflating bulb. A plastic bag of sterile fluid for flushing an artery or other vessel is placed inside the infuser sleeve and the bladder is inflated. The inside of the sealed bag is sterile; the external surface which is in contact with the infuser sleeve does not need to be sterile. The potential for nosocomial infection from this device is probably less than that of a blood pressure cuff, which is washed periodically, or immediately if soiled (a practice which should also apply to pressure infusers).

Disposable nasal oxygen prongs. Even if staff insist on throwing away the nosepiece (which could be cleaned and pasteurised for reuse), why do the two metres of oxygen tubing need to be discarded? The answer is that the product is sold only as a single unit. It is difficult to see how design efficiency could be claimed to drive marketing decisions in this case because the oxygen tubing is of a larger diameter than the nasal prongs -- the two parts are bonded and sold as one.

Single-patient-use oxygen transducers. A non-invasive device which is fitted to a finger or toe, this is a recent addition to the throw-away stable, and expensive at $26 (adult) or $34 (neonatal) each. They were formerly multiple-use devices that were easy to clean in detergent or with an alcohol swab.

Pill cups, kidney trays, suction tubing, sequential calf compression cuffs and arm splints for intravenous lines also have low potential for cross-infection and would be easy to clean, inspect and, if necessary, resterilise.

Perhaps little consideration is given to the mass consumption and disposal of such instruments because they are seen to be low-cost items. Yet this low cost is somewhat artificial, especially on the disposal side. In most hospitals, waste disposal is not costed to individual departments, so there are few incentives to minimise waste. Many of the indirect costs of waste disposal are passed on to the wider community. Incineration of chlorinated plastic releases carbon dioxide, dioxins and acid vapours into the atmosphere. The incremental costs of pollution monitoring and greenhouse warming, as well as the negative health effects and declining aesthetic value of decreased air quality, are not accounted for in the purchase price of biomedical disposables.

Further, if it were a simple matter of supply and demand, clinicians would not be concerned about the opportunity costs of enforced disposal after one use, and health workers would not be worried about the environmental impact of all this unnecessary consumption and disposal of energy and resources. If there was a demand for durable, multiple-use devices, then surely entrepreneurial suppliers would rise to the occasion!

However, the situation is more complex. John Kenneth Galbraith showed how suppliers can manipulate demand to suit their own ends.⁷ His exposure of the supply-and-demand myth is well represented by the culture of disposability which has taken root in modern healthcare over the last three decades, driven by the fear of litigation, so that non-invasive devices labelled "single use only" are treated as such without question. The infection-risk bogey and the spectre of litigation are raised in articles in nursing journals,^8,9 central sterilising journals,¹⁰ pronouncements of the medical disposables industry,¹¹ and in the mass media.^12,13 The latter forum has a far-reaching capacity to muddy the waters; at least one television program linked the reuse of single-use medical devices with the HIV cross-infection of four women in a Sydney surgery, yet there was no suggestion that the surgeon involved deliberately reprocessed single-use devices.¹⁴ The virus was thought to have been transmitted through some unidentified breach of infection control guidelines,¹⁵ which is an entirely different issue.

The process of cleaning, disinfecting and resterilising needs to be brought out into the open so that the current, somewhat surreptitious, practice of reprocessing single-use items can be guided by clear, commonsense protocols, quality controls and reporting of adverse events. However, the process by which biomedical devices come to carry the stamp of "single use only" should also be scrutinised. At present, these three words could be seen to be a licence to print money -- to my knowledge, manufacturers of single-use products do not have to explain why any device deserves to be labelled "disposable". The Industry Commission's 1996 report on the medical and scientific equipment industries¹⁶ reported that manufacturers have a financial incentive to label as "single use only" devices which may be safe to reuse. The Industry Commission suggested that market forces -- competition, threatened competition and the countervailing market power of more circumspect purchasing policies -- should put the brakes on this practice.

With so much public money at issue, if governments decide to enforce single use more accountability should be required from the industry. If the industry has no interest in writing a code of labelling practice, then perhaps use of the words "single use only" should be regulated and licensed.  

Conclusion

• The question of how biomedical devices come to be labelled "single use only";
• How to support the manufacture and marketing of durable, sophisticated devices that are designed for multiple use;
• How to favour best practice cleaning and resterilisation of all biomedical devices, whether labelled "single use only" or intended for multiple use; and
• How to develop economic indicators to account for the hidden costs of disposables -- storage space, waste disposal and pollution.

References

1. 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.
2. Burton J, Tymchak W, Dzavik V, et al. Randomized controlled trial of reuse of PTCA balloon catheters [abstract]. Circulation 1995; 92 Suppl 1: 661.
3. Frank U, Herz L, Daschner FD. Infection risk of cardiac catheterization and arterial angiography with single and multiple use disposable catheters. Clin Cardiol 1988; 11: 785-787.
4. Mak KH, Eisenberg MJ, Plante S. Absence of increased in-hospital complications with reused balloon catheters. Am J Cardiol 1996; 78: 717-719.
5. Conseil d'evaluation des technologies de la sante du Quebec. The reuse of single-use cardiac catheters: safety, economical, ethical and legal issues. Can J Cardiol 1994; 10: 413-421.
6. Ross DL. Re-use of electrode catheters labelled as single use for clinical cardiac electrophysiological studies [editorial]. Aust N Z J Med 1996; 26: 632-635.
7. Galbraith JK. Economics and the public purpose. London: Pelican, 1975: 150-161.
8. Pickersgill F. Disposables: the case against re-use. Nurs Times 1988; 84: 45-48.
9. Langslow A. Legal liability and the re-use of disposables. Aust Nurs J 1994; 2: 22-24.
10. Milligan J. Sterilizing services perspective. Sterilisation Aust 1992; 11: 6-8.
11. Medical Industry Association of Australia. Statement of industry policy on the reuse of single-use medical devices. Sydney: MIAA, 1991.
12. Robinson M. The patient's right to know. The Sydney Morning Herald 1996 Feb 22: 15 .
13. Australian Broadcasting Corporation. 7:30 Report (television program). 1994: 8 Sep.
14. 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.
15. Penny R. HIV exposure in health care [editorial]. Med J Aust 1995; 162: 509.
16. Industry Commission. Report No. 56: medical and scientific equipment industries. Canberra: AGPS, 1996: 89-91.

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