By Chris Schreiber
January 24, 2000
Photo: Corbis/William Jacoby

Patients who undergo surgical procedures requiring equipment like heart catheters or biopsy needles may have even more to be concerned about than the procedures themselves. That’s because many surgical devices labeled “single use only” by the manufacturers are routinely being reprocessed and reused by hospitals in an attempt to save money and stave off the continued pinch of managed care.

Dubious beginnings

A hot topic of late, the practice of reuse actually emerged in the late 1970s when hospitals correctly deduced it was cheaper to sterilize and reuse single-use devices (SUDs) rather than purchase new devices for each procedure. When devices became too complex to sterilize on-site, an entire third party reprocessing industry was born.

After years of tacit approval by the Food and Drug Administration (FDA), reprocessing has only recently begun to draw the attention of federal officials and congressional leaders and the ire of SUD manufacturers themselves. Opponents of reprocessing are now pushing for regulations to make it more difficult to reuse any SUD—or to ban the practice altogether.

“The issue is about money, and I won’t tell you we are not economically interested,” said Steve Northrup, executive director of the Medical Device Manufacturers Association, which represents SUD manufacturers. “Hospitals are trying to make do under tighter economic conditions, and that’s indirectly a push from managed care. But there are some places you can cut corners and this isn’t one of them. Reprocessing provides no benefit to any individual patient.”

But many hospitals and reprocessing companies argue that properly reprocessed devices do no harm to patients. And technically, their argument is irrefutable. There is no data to prove that patients are at greater risk when treated with a reprocessed device. And there has never been a comprehensive study tracking the infection rates and post-procedure complications of patients who were treated with reprocessed devices, said Michele Pearson, MD, medical epidemiologist at the national Centers for Disease Control and Prevention.

Northrup sees this lack of data as an indictment of the reuse process. Though hospitals charge the same amount for a procedure done with either a new or reprocessed device, patients aren’t told with which they will be treated. If a problem arises with a procedure performed with a reprocessed SUD, hospitals make no correlation because a relationship between the problem and the device would increase the hospitals’ liability, Northrup said.

But many reprocessing companies feel that it’s too risky to reprocess some devices. It is common for reprocessors to decline to service certain equipment, like the balloon angioplasty catheter. “It’s not worth reprocessing an instrument if it’s going to hurt someone,” said Mac McKibben, president and owner of SISS Inc., an Oregon reprocessing company.

Federal intervention

Such reprocessing decisions are presently unregulated, which is why the FDA entered the fray last month. The agency began soliciting opinions from healthcare experts, device manufacturers, and the reprocessing industry in an attempt to determine whether federal regulations should be created to handle the reprocessing and reuse of SUDs.

“We need the FDA to step in and sort out which devices should or should not be reused,” said Rick Wade, senior vice president of the American Hospital Association. “We think it would be appropriate for the FDA to say to the manufacturers that when you submit a device to [the FDA], you justify its single-use label, and it would be helpful if the FDA also said how many reuses are acceptable.”

FDA spokesperson Sharon Snider said the agency will continue to take opinions on the issue the rest of the month and expects to publish new guidelines by June. Despite the seeming incongruity of regulating the reuse of SUDs, the FDA is expected categorize them as high-, medium-, or low-risk devices. Each classification would require a varying level of scrutiny to verify the sterility and functionality of the device.

The possibility of new regulations has polarized the competing sides, though both welcome third party monitoring of one another. The main complaint from both hospitals and reprocessors is that device manufacturers can’t be trusted with labeling since adding a single-use label always stands to add to their bottom line. “There are economic incentives for manufacturers to label their product single use,” said Bill Stover, CEO of Paragon Reprocessing Services Inc. in Little Rock, Ark., one of the country’s leading reprocessors.

McKibben said the number of SUDs has increased dramatically in the last 20 years and includes many items that were once accepted as multiple-use devices. Northrup conceded that the number of SUDs has risen sharply, but he argued the increase was justified because modern materials like plastic are more difficult to sterilize. The problem is compounded by medical advancements as well because many SUDs are used in complex procedures, he said.

The rise in new types of SUDs and the high price of equipment—McKibben said some items can be marked up as much as 3,000 percent—leave hospitals little choice but to seek more affordable alternatives. “If the manufacturers had been more fair with their pricing, perhaps there wouldn’t be a reprocessor industry,” McKibben said.

Consumer issues

Stover’s concern is that what should be a scientific issue has become a public issue clouded by emotion. Fear could guide a consumer’s decision, especially when the idea of being treated with reprocessed equipment is confused with stories like that of the California phlebotomist who allegedly reused single-use needles and IV lines on dozens of patients.

“There is a perceptive problem that new is always better. New is assumed to be sterile,” said Arthur Levin, director of the Center for Medical Consumers, a nonprofit consumer advocacy group in New York City. “But new doesn’t guarantee sterile. There is no empirical evidence to suggest one side or the other is correct, and you can’t rely on the two major players here, because they have too much economic self-interest in promulgating one side or the other. Most of us don’t have a lot of faith in the amount of oversight in either of these processes. My concern is that whichever way you go, you are relying on people doing the right thing. You just have to hope they do the right thing.”