Reprocessing single-use devices—regulatory roles

AORN Journal,  July, 2002  by Debra Dunn

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With the advent of FDA regulations, hospitals now are being forced to choose one of the following options:

* assume a host of new administrative and financial burdens if they wish to begin or continue reprocessing in-house,

* outsource to a third-party reprocessor and monitor for compliance with FDA regulations, or

* abandon SUD reprocessing programs altogether.

In each instance, hospital costs to reprocess will rise. (86)

   Hospitals are expected to retreat completely and rapidly from the
   instrument reprocessing business in the wake of the FDA's move to issue
   final guidelines that force hospitals to jump through high hoops if they do
   any onsite reprocessing. (87)

Although reprocessing costs for hospitals will increase with the new regulations, reprocessing still is an important consideration because of the ultimate cost savings in comparison to purchasing a new product from the OEM. This increase in expenses, however, could force some health care facilities to stop performing certain high-cost disposable instrumentation procedures altogether. The other side of this picture is the danger that reprocessing and reuse could be driven underground and continue in secret as some facilities try to maintain the cost benefits without complying with the new regulations. (88)

After a third-party reprocessor has been chosen, other decisions that should be made by the hospital include

* choosing which SUDs to reprocess,

* finding separate storage space containers for clean and contaminated goods to be shipped to the reprocessor,

* developing a tracking system to document which reprocessing phase the item is in for inventory control purposes,

* deciding where reprocessed items will be placed when returned to the hospital, and

* choosing the appropriate patient billing system for reprocessed items.

HEALTH CARE LEGAL LIABILITY

It is likely that hospitals' liability for reuse of SUDs will be analyzed under the principles of negligence in a court of law. Negligence results if hospitals fail to take reasonable measures to guard against foreseeable risks. Under negligence principles, health care facilities that participate in reprocessing are responsible for ensuring that a reasonable standard of care is adhered to in the reuse of a device. (89) To establish negligence, the plaintiff (ie, injured party) must demonstrate that the

* defendant (ie, hospital, physician, third-party reprocessor) owed the plaintiff a duty of care;

* defendant breached the duty of care;

* plaintiff was injured; and

* breach of duty caused the injury.

The primary difference between negligence and strict liability claims is that with negligence, the plaintiff must establish the defendant's failure to meet a reasonable standard of care (ie, fault based) while strict liability claims require no proof of fault (ie, focus on product performance). (90) Health care facilities and physicians generally have been held liable only for negligence in the past. This is because both are in the business of providing medical services, not selling medical instruments. Many US courts have held that strict liability in tort cannot be imposed on hospitals for goods that may be used incidentally or are supplied during the course of medical care and treatment. (91)