Volume 12, No. 2 • Summer 1997

Expert Urges Safety Criteria

Arnold J. Berry, M.D.

Expert Weighs Factors on Reuse of Disposables, Urges Safety Criteria and New Studies

To the Editor

The safety of patients, the foremost concern of physicians, is being challenged by the current emphasis on “production pressure” (go faster and do more with less) and desires to minimize medical costs for equipment and drugs. The Associated Press article referred to by Mr. Leagre [See letter on Page 10.] notes that concerns have been raised by the Food and Drug Administration regarding mechanical failures or infection transmitted by reuse “single patient use” medical devices. Based on reports of adverse patient outcomes from reuse of disposable equipment, the FDA is considering whether it should intervene in this area.

Two to three decades ago, when the cost of labor to clean, process, and reuse nondisposable medical equipment was deemed to be too high and the technology to produce complex devices had been developed, there was a shift to single-use disposable items. This eliminated on-site processing charges and insured patients’ safety by having devices sterilized by the manufacturer. With rising costs for storage and disposal of biohazardous materials and for production of complex medical devices, there has been a strong temptation to try to reduce costs by reusing or reprocessing devices intended by the manufacturer for single-patient use. (There is a distinction between reuse [the product was previously used on a patient], reprocessed [the packaging has been entered but the device was not used on a patient], and resterilization [the device’s package remains intact but it is resterilized].) However, these cost-saving efforts have introduced new problems. After cleaning and resterilization of a used single-use item, the physical integrity of the device may be compromised or complete elimination of infectious pathogens by the disinfection process may be prevented by its design. Device failure or transmission of an infection can be a risk. Therefore, practitioners or institutions that choose to reuse single-use products have implicitly assumed the liability if an adverse patient outcome results.

To insure patient safety, when an institution chooses to reuse or reprocess single-patient use devices, written procedures, based on scientific clinical trials should be in place and enforced. Criteria for determining the number of times each device may be reused must be developed, and the manufacturer (if cooperative with such a request) should be contacted to ascertain appropriate methods for processing and sterilizing the particular device to insure compatibility with materials and components. There must be a system in place to track the number of times that each individual item has been reused so that the predetermined limit is not exceeded. Additionally, quality assurance programs must document that there are no adverse patient outcomes from the reuse program.

With the inherent complexity and costs associated with setting up a program to reuse “disposable” items, it seems as if we are left with two choices: to use “single-patient use” devices as they were intended or, as Mr. Leagre suggests, to begin to work with manufacturers to develop products that can be safely reprocessed and sterilized for multiple patient uses. This is a topic which needs reexamination in view of the changing economics of health delivery systems. With the cooperation and input of clinicians, researchers, and manufacturers, the Anesthesia Patient Safety Foundation appears to be one organization in a position to consider these most timely issues.

Arnold J. Berry, M.D. Professor of Anesthesiology Emory University School of Medicine Atlanta, GA