Article Text

Coming clean on reuse of endoscopic equipment
  1. R A KOZAREK
  1. Section Head,
  2. Section of Gastroenterology,
  3. Virginia Mason Medical Center,
  4. 1100 Ninth Avenue, PO Box 900 (C3-GAS),
  5. Seattle, WA 98111, USA

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Over the past decade, endoscopic accessories have evolved from reusable to disposable in many parts of the world. The impetus for this has been multifactorial and includes concerns of cross-contamination between patients because of inability to assure proper cleaning and the inevitable equipment deterioration that occurs with reuse.1 A contrasting and more cynical view has been espoused, however, that marketing items as “one-time-use” precludes the need for manufacturers to undertake microbiological studies after reprocessing. Moreover, its implementation has been associated with a dramatic increase in the purchase of accessories such as needle injectors, sphincterotomes, and even biopsy forceps.2Within the United States, several factors came together to reinforce this “use and dispose” mentality. On the one hand are the known personnel costs needed to store and reprocess an instrument. On the other are medicolegal concerns regarding both cross-contamination between patients and use of an accessory that failed to maintain optimal form and function. Couple the former with an insurance system that routinely reimbursed for the use and disposal of such devices and the fact that many such accessories were only available in a disposable version (for example, double- and triple-lumen sphincterotomes), it is little wonder that the endoscopic accessory market has increased 10-fold in the United States over the past decade.

Several problems have occurred with the shift to disposable accessories in the United States which have direct applicability to European endoscopists and to the report published in this issue (see page 304). On the one hand, the manufacture of disposable accessories utilises a disproportionate percentage of the Earth’s increasingly limited resources. On the other, their disposal is regulated by law in most countries and whether they are burned, buried or, paradoxically, recycled, disposal of medical supplies and devices has raised important environmental concerns. Finally, there is the issue of cumulative cost. As insurance programs in the United States evolved into new payment policies that reimbursed at very discounted levels, and as the government Medicare and Medicaid programs reimbursed hospitals for a diagnosis (DRG), not upon the resources used during that hospital stay; institutions became increasingly aware that disposable accessories may not be reimbursed. In other words, an institution could charge whatever it likes but reimbursement was limited contractually at a pre-set fee level.

Our group has evaluated many aspects of the reusable–disposable accessory question.3-7 For instance, we have suggested that the expense associated with “one-time-use” accessories for therapeutic endoscopic retrograde cholangiopancreatography are such that this procedure may ultimately lose money for the hospital contingent upon other expenses expended (personnel and medication costs, admit-recovery charges...).3 Our data have been confirmed recently by other groups.8 We have also looked at items that are available in both a disposable and reusable form and have documented purchase and reprocessing costs in our unit prospectively, demonstrating that biopsy forceps became cost effective after seven uses at the time our study was done.4 Finally, to cut our costs further, we have evaluated the reuse of items marketed as “one-time-use” when there were no comparable accessories marketed for multiple use. This was not done lightly, and for double-channel sphincterotomes included testing of electrical integrity and contaminating 10 sphincterotomes with an atypical mycobacteria followed by manual processing and sterilisation with ethylene oxide gas on 10 occasions.6 These data were, in turn, presented to an institutional Reuse Committee comprised of three surgeons, a gastroenterologist, head of the microbiology laboratory, the chief operating room nurse, an infectious disease nurse, head of central supply, and the hospital attorney.5 Finally, following approval for reuse, a one-year prospective trial was undertaken to assure that there was not an increase in untoward infectious events related to the reuse of these devices.7

This has been an expensive and time consuming process and has recently been foreshortened by a number of entrepreneurial reprocessing companies in the United States. Such companies incorporate testing facilities to assure that “one-time-use” items can be safely reprocessed without loss of form and function.9 Not limited to endoscopic accessories, reprocessed devices run the gamut from laparoscopic trochars to pneumatic stockings for the postoperative patient to cardiology devices such as balloons or electro-ablation catheters. The companies assure sterilisation and adequate functioning and carry a cumulative liability coverage up to 10 million dollars if device dysfunction is associated with patient injury. However, they charge 50% of the original purchase price to reprocess an accessory.

Does the experience in the United States shed any light on how to solve the dilemma of reusing a single-use endoscopic accessory in the United Kingdom following publication of MDA DB 9501 and implementation of the European Medical Devices Directive? The simple answer is to purchase only reusable accessories. This is easier said than done, however, although it seems that some of the manufacturers have heard the laments from colleagues on both sides of the ocean. As such, at least two manufacturers will market reusable double-channel sphinterotomes over the next few months. Whether individual hospital or government regulations in Britain will allow the labour intensive and variably expensive approaches for reuse outlined earlier (Reuse Committee and reprocessing companies) is uncertain. Perhaps the best approach to reuse, however, is to define accurately the cost structure of your endoscopy unit. As such, modern units are likely to stock a variety of accessories based upon initial purchase price, documented ability to reprocess and reprocessing costs, and the number of uses that can be expected for a reusable or “reposable” device. Like all solutions, what works and is cost effective in one setting may prove of marginal or no benefit in another. One thing is certain, however: medical costs cannot continue to climb indefinitely. Cost constraints will then either push competing manufacturers into reducing prices or limit the number of disposable accessories which are ultimately purchased.

See article on page304

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