PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. The Reuse of Single-Use Medical Devices by Eduardo Abreu, M.D., MSc. The reuse of devices labeled for “single-use only” has been a controversial subject for decades. The reality is that, despite heavy criticism, the practice of reuse is prevalent in several countries. Unfortunately, in many cases, reuse procedures have been implemented before safety and cost-effectiveness of the reprocessed devices have been demonstrated rigorously. In some of these cases, no cost analysis was ever performed; as a result, the institutions practicing reuse could not even be certain that economic savings were actually being achieved. For five years I worked on a project that evaluated high-cost and/or high-usage single-use devices (SUDs) for reuse. An important characteristic of that project was that we made an effort to be unbiased and to discuss evidence rather than beliefs. But before I continue with the project, let’s first examine some historical aspects of reuse. We can begin with the critical innovations that resulted in improved aseptic conditions in operating rooms during the 1890s. Among these innovations were the introduction of the "scrubbing up" technique by Kummel in 1886 and the use of rubber gloves by Halstead in 1890, and the gauze mask covering the nose and mouth by Mikulicz in 1892. By 1890 the autoclave, invented a decade earlier by Chamberland, became commercially available, and the first complete facility for steam sterilization was installed at City Hospital in Rochester, New York. Thus, hospitals in the United States began the “on-site” reprocessing of most of their medical devices and surgical items. At that time, outside manufacturers provided only those consumable items that were too difficult, expensive or inconvenient to be reprocessed, such as sutures and bandages. These items, called disposables, were purchased pre-sterilized for single-use only. This practice remained unchanged until the plastic revolution in the1950s, when devices and items originally made of glass, metal, rubber and woven cotton began being replaced by their disposable counterparts. Because these new disposables or “single-use devices” (SUDs) were made of heat-sensitive materials, they had to be sterilized by either ethylene oxide (EO) or radiation, technologies at that time not available in most hospitals. As a result SUDs have become a major hospital expense, particularly since the advent of more advanced technology and very costly categories of SUDs (e.g., angioplasty catheters). Thus, for hospitals worldwide, primarily motivated by the necessity for cost-cutting, the reuse of expensive medical devices became a practical option. More recently, an industry of third-party reprocessors has developed as a result of the more involved decontamination and sterilization procedures required by the reprocessing of complex SUDs. Going back to our project, the main objective was to develop a set of rigorous test protocols as part of an overall program to evaluate the suitability of SUDs for reuse. The generation of scientific and financial data, along with legal and ethical considerations, would permit an informed decision to be reached regarding reuse on an individual, case-by-case basis. The main concern was the patient's safety and the procedure's efficacy. The program had two initial sequential phases: the device audit and the laboratory evaluation. During the device audit the types of SUDs most suitable for reuse were selected to be further evaluated. The laboratory evaluation was conducted in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, to evaluate if sterilization could be achieved and how repeated reprocessing might affect the device’s materials, functionality, and biocompatibility. Simulated-use testing methods were developed individually for each type of device investigated, based on its function and conditions of clinical use. Thus, all parameters that could affect the device as a result of clinical use (e.g., soiling, temperature, mechanical stresses, handling, cleaning, etc.) were evaluated. At the same time, a preliminary cost analysis was performed to assess the potential cost savings that could be achieved through reuse. Only two types of SUDs, arterial and venous perfusion cannulae and PTCA catheter completed the laboratory evaluation. In both cases, although possible, reuse was determined not to be economically viable. Besides, success in the implementation of a formal program for reuse of SUDs does not depend solely on the cost advantages and favorable outcomes from a program model, but is also affected by such related issues as regulatory requirements and legal and ethical concerns. For example, and a single lawsuit can undo the cost savings achieved with reuse. A recent safety concern has been the risk of bloodborne transmission of subacute spongiform encephalopathies (SSEs). An outbreak in the late 1980s in Great Britain of bovine spongiform encephalopathy (BSE) aroused an increased interest worldwide in Creutzfeldt-Jakob Disease (CJD). CJD, BSE and other similar forms of SSEs are associated with the same unconventional transmissible agent, the prion, resistant to routine sterilization methods. In conclusion, in our specific case the devices evaluated could be reused safely for a limited number of times only. As a result, reuse would not be cost-effective. So the final decision was not to reuse. It doesn’t mean that in other circumstances (e.g., development of sterilization technology for prions, different types of SUDs, etc.) reuse could not be achieved. However, a decision to implement reuse practices should always be followed by a careful evaluation where the safety of the patient is the main concern, and not be based on beliefs, in favor of or against reuse. ### Eduardo Abreu, M.D., MSc. is a Research Fellow in the Department of Biomedical Engineering, at the Lerner Research Institute. This institute is part of The Cleveland Clinic Foundation in Cleveland, OH in the United States. He is a member of the 2002-2003 Steering Committee for The Science Advisory Board and a member of The Science Advisory Board since September 1997. ### << Previous Next >> [ View All Perspectives ] |
|
