Reusing single-use devices OK in some cases
Reusing single-use devices OK in some cases
Consider potential liabilities
Hospitals routinely resterilize single-use, or disposable, equipment. Most new devices are costly, so it seems to make sense. And even the relatively inexpensive items are used in such quantity that reusing can save serious money.
But resterilizing and reprocessing a product like leftover suturing should not be confused with the reuse of a disposable device after it’s been used in or on the body of a patient. The latter is accurately termed "reuse," and is a controversial topic fraught with product-safety liability and political issues.
FDA standards don’t cover reuse
In today’s cost-cutting environment, you face some tough decisions about how to help your hospital save money and compete for managed care contracts. But some experts warn that the obvious answer to reuse some one-use devices could create ugly liability questions if a product fails. Yet the rules are unclear, and many devices can be reused with the right techniques.
FDA standards exist for the products themselves and their first-time use, but not for their reuse or reprocessing. The loophole is that reprocessing companies don’t take title to the devices; they service them. In addition, the Association for the Advancement of Medical Instrumentation (AAMI) will not issue standards regarding reuse.
Instrument manufacturers actively lobby against any reprocessing regulations. From their point of view, reusing and reprocessing any instruments costs them money, whether the procedures are safe or not.
The stance of the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, is that health care professionals must follow manufacturers’ recommendations. If, for example, a polymer-based trocar costing between $60 and $80 is intended for one use only, it should not be reused. But many manufacturers make no such specific recommendations.
Some reprocessing can involve resterilization and repackaging of a single-use medical device that has been opened, but never was used on a patient. When an unopened suture that is a part of a larger procedure kit is not needed, for example, it can be thrown away, or it can be resterilized and repackaged for later use. Extra suturing may still be in its original foil wrap. In the same way, a skin stapler may be opened in preparation for an OR procedure only to go unused. Cost-effectiveness priorities mandate repackaging items like those.
In true reuse, however, the device is used on one patient, then cleaned, sterilized, and packaged for the intended purpose of use on another. The item has been manufactured specifically for one use only and is not guaranteed for multiple use. Examples of this are a disposable laparoscopic trocar or an electrophysiology catheter.
"Reusing a single-use device after it’s been used in or on the body of a patient is a whole different ball game," says Bonnie Barnard of Infection Prevention & Management Associates in Houston. "But even there, reprocessing can be a safe practice as long as it’s handled properly. Questions have to be asked: How amenable are the devices to sterilization procedures or reuse itself? The functional integrity of the device must be maintained."
An important caveat: If a patient thinks he’s been harmed during a procedure using a reprocessed instrument, his lawsuit will begin with those closest and move away from there. The liability insurance held by the reprocessing company does not absolve the hospital of liability, and will not prevent you from involvement in litigation. It only adds another cog to the wheel.
Coverage provides no guarantee
The fact that the hospital has sent a particular device out for reprocessing is most likely in contradiction to the manufacturer’s claim, and incurs additional liability for the hospital. Solicit the help of your facility’s risk manager.
"There is no absolution or guarantee with any kind of coverage, whether it’s the hospital’s or the reprocessing company’s," says Jane M. Bryant, director of risk and safety management for the Greenville (SC) Hospital System. "In the same way as with new product liability, there’s no guarantee that the physician or the hospital won’t be involved in a product liability case.
"The best a sued party can hope for, whether a physician or hospital, is indemnification," Bryant says. That is, if you lose a suit, the reprocessing company might reimburse you. "But it’s the physician and hospital who land in the headlines, not the reprocessing company," Bryant warns.
Hospital Peer Review asked Marimargaret Reichert, RN, of Reichert Consulting in Olmsted Falls, OH, if reprocessing instruments was an appropriate way to cut costs. She is an expert in the field of central sterile processing. "Yes, there’s opportunity for some cost saving if reprocessing is done right, but the patients’ safety has to be the first priority," says Reichert. "A wide range of expertise and competency exists among reprocessing companies. A company that pays a lot of attention to quality control is going to be more expensive, but having that company reprocess devices is still cheaper than buying new products."
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