To the Editor
In response to the letter in the APSF Newsletter Winter 1997-1998 issue written by Clair S. Weenig, M.D., I have the following comments.
It is understandable that from the perspective of an academic and private practitioner of anesthesia, the writer assumes and states that many disposable and single use devices can be recycled.
It is evident, however, that the writer is seeing only the tip of the iceberg from one vantage point. Dr. Weenig, obviously, has no experience with and understanding of the regulatory world of medical devices and the business economics relating to them. In addition to my extensive clinical and academic experience, I have been involved with the R & D, manufacture, and sale of medical products (mostly disposable devices) for the past 25 years. Dr. Weenig seems unaware of the costly, long development times required for these items before they can be brought to market. The pathway that a medical device must take is long, complicated, and arduous, with FDA 510K authorizations (which can take years in some instances to obtain), mandatory GMP enforced by FDA periodic inspections and more recently the advent of implementing, at substantial cost, ISO 9001 production standards. In addition, there are now EN 46001 requirements for medical devices and individual product CE Marks essential for foreign sales.
Dr. Weenig should understand that all of these stringent regulations have been imposed in order to obtain performance reliability for each device in the interests of patient safety. Also, it is important to realize that expensive sterilization validation procedures are part of this process to ensure product performance reliability and patient safety. Most medical devices have been invented by doctors or with significant doctor input to address problems and needs requiring new or better equipment. They are not off-the-wall profit motivated contrivances.
From a business standpoint, manufacturers invest considerable sums of money in R & D, in GMP, etc. and in manufacturing equipment that can’t be amortized for many years.
Contrary to the belief that “single use-do not reuse” labeling of devices is done in order to enhance sales volume and profit, many of the commonly used disposable products, such as face masks, breathing circuits, bacterial filters, endotracheal tubes, oral and nasal airways and stylets are sold under the most competitive circumstances resulting often in little or no profit because these products functionally have become commodities. Sometimes they are sold as loss leaders resulting in negative cash flow to the medical manufacturer for those specific products.
Dr. Weenig may not have been on the medical scene before the age of disposables arrived. I was. From personal experience, after coming from an aerospace medicine research background into anesthesia, I was abhorred at the state of the art before the era of disposables. As a resident at UCLA, I was handed stylets which were nothing more than cut pieces of multiple strand wire off electrical wire spools. You can imagine how inefficiently these served as ET tube guides and what damage often occurred because of the open raw ends of the wire.
Suggestions for recycling disposables are specious at best and too over-simplified. Suggestions that devices, such as airways and stethoscopes, which are in internal contact with the patient, can be safely resterilized by cleaning and sterilizing between use is, by experience, subject to the risk of transmission of infection by inadequate processing and can also cause loss of product integrity, changes in composition resulting in poor performance, burns to the patient from residual sterilizing chemicals and, in some instances, breakage of the device with consequent patient injury.
The danger of attempting to resterilize and reuse a disposable product is underscored by the recent reports of two TB epidemics occurring from inadequately sterilized Reusable bronchoscopes. The AMA News article reporting these incidents demonstrated concern that even a standard reusable item, which has been resterilized according to protocols existing for several decades, still may have inherent dangers to the patient.
Dr. Weenig appears to minimize the time-cost studies showing that it is less expensive to use disposables than to resterilize them. This cavalier approach to sterilization in that it can be accomplished by personnel “when other work requirements are low” implies that when these people are too busy with other chores, unsterilized products might be reused. Lastly, it is important to understand the staggering magnitude of attempting to implement and monitor adequate resterilization protocols for disposables. The cost for this effort alone would be overwhelming and demonstrates the impracticality for the reuse of disposables.
Gerald S. Linder, M.D.,F.A.C.A.
President and CEO
POLAMEDCO, Inc.
Associate Clinical Professor of Anesthesia
UCLA School of Medicine
Los Angeles, CA