Manufacturer Urges Standards for Possible “Limited Reuse”

To The Editor

A patient safety subject prompts this letter. King Systems has been in the business of manufacturing single-patient use breathing circuits, face masks, filters, and related products since the early 1980’s. We are also a proud sponsor of APSF and a supporter of the philosophy and policies that promote patient safety.

Some time ago, an article was released by The Associated Press entitled “FDA Warns Against Reused Surgical Gear.” It discussed the growing popularity of the reuse of single-patient use devices in healthcare facilities, particularly hospitals. The story referred to the well-known economic pressures in the healthcare system that are driving this practice and the resultant increased risks of patient injury and product liability. The article concluded by referencing a soon to be released guideline by the independent health research group ECRI. The ECRI report will offer guidelines to healthcare professionals and practitioners on methods for evaluating the financial benefits versus the hazards of reuse. Although King Systems is very optimistic about ECRI’s report, we feel that medical device manufacturers must participate in solving this problem.

This communication is intended not only to express our concern on this subject, but more importantly to recommend the creation of standards for product performance and patient safety related to ‘limited reuse.’ This will be no simple task, but the experience and practical knowledge of healthcare practitioners, hospital administrations, and device manufacturers that can be applied to scientific data and statistical techniques will establish a foundation for the development of future medical products. As a medical device manufacturer, King Systems recognizes the responsibility to design, manufacture, and test our products according to their intended uses. Based on the current trend to reuse medical devices intended for a single use on a single patient on multiple patients, the risks associated with consequent product failure and cross-contamination must be assessed. Although the effort to create quality testing protocols within the hospitals is certainly a positive step,the reprocessing of a medical device clearly identified as single-patient use is fundamentally wrong [emphasis added – Ed.]. Safe and effective products must begin at the design phase; any standards concerning products and practices relevant to this question that can be agreed upon by organizations such as ASA, FDA, CDC, ISO, and others, will only benefit this development process.

For many years, the use of disposable breathing circuits has been a widespread standard practice prompted by the growing awareness of cross- contamination risks between patients and the hidden costs of reprocessing. The resulting concept of single-patient use continues to serve the anesthesia community well by offering a high-quality option that eliminates one potential cause of patient-to-patient contamination. However, economic pressures have dictated that a reassessment is in order. In doing so, however, let’s not ignore the one element that links all of us in this field…the health and safety of our patients. I look forward to input from all potentially interested parties.

Michael A. Leagre, Director Research and Development King Systems Corporation