Risky Reuse of Medical Equipment Is on Rise

Millions of medical devices that come in contact with blood or other body fluids and are supposed to be discarded after one use are instead being reprocessed and reused, putting other patients at risk without their knowledge, some experts fear.

The U.S. Food and Drug Administration is poised to crack down on the largely unregulated practice, which is escalating because managed care reimbursements are not sufficient to cover the costs of new devices. About 1 million disposable devices are reprocessed every year in the United States.

Reports stored in government files document malfunctions related to reprocessed disposable devices, such as cases of cardiac catheters with tips that have broken off inside a patient’s heart. Other incidents include infections caused by presumably non-sterile devices, as well as adverse patient reactions to bacterial toxins left after devices are cleaned.

The situation is most critical at hospitals, which often lack guidelines on how to reprocess a device. About one-third of all hospitals use reprocessed disposable devices, according to a recent survey.

“It’s a pretty grim scene, as far as I’m concerned, with what’s going on in the hospitals,” said Anne Cofiell at a recent meeting co-sponsored by the FDA and the Assn. for the Advancement of Medical Instrumentation. Cofiell represents workers at hospital sterilization facilities.

“I can tell you, just in general, there’s lots of reuse going on with no protocols, no standards, no nothing,” added Patty Stein of Advanced Sterilization Products.

The FDA historically has not considered reprocessing illegal, openly exercising regulatory discretion with those who reprocess single-use medical devices. That includes hospital in-house reprocessing facilities, as well as a rapidly growing group of “third-party” reprocessors.

At present, the agency does not require reprocessors to demonstrate that a device is safe after it has been reprocessed.

But that might not last long. In a recent letter to the Assn. of Medical Device Reprocessors, the FDA stated that “third-party reprocessing of devices labeled for single use is unlawful” unless reprocessors provide documentation that a device is safe.

Manufacturers also are urging the agency to take a stand on the issue of reprocessing. In May, the Medical Device Manufacturers Assn. requested a ban on use of reprocessed single-use devices. And recently Sen. Richard Durbin (D-Ill.), who is proposing legislation to force stricter regulations on reprocessors, asked the U.S. General Accounting Office to investigate the practice of reprocessing.

Caught in the middle of the controversy is the patient. Doctors are not required to inform patients that a reprocessed single-use device will be used on them. Also, the patient is usually billed the same amount, regardless of whether a device was new or reused.

“It is only a matter of time until the public becomes aware in large measure of the reuse situation,” said Lynn Sehulster of the U.S. Centers for Disease Control and Prevention at the conference in May. “Will they tolerate this practice? This remains to be seen, but for now, reuse is largely unadvertised.”

The situation sets manufacturers, who want to sell as many new devices as possible, against the rapidly growing industry of third-party reprocessors, who cater to hospitals striving to save health care dollars.

According to the manufacturers, reusable devices are made of durable materials, shaped so they are easy to clean, and tested for multiple use. In contrast, says the association, single-use devices are engineered for only one use.

“These devices are intricate, they have sharp points or tightly coiled wires, and they’re often made of materials not used to withstanding mechanical or biochemical aspects of reprocessing,” said Philip Grossman, a Miami gastroenterologist who is a consultant for manufacturers.

Widely reprocessed devices include electrophysiology catheters--long wires guided through a blood vessel into the heart that are used for measuring the organ’s electrical activity. Also on the list are angioplasty balloons--thin inflatable devices that unclog arteries--and biopsy needles, used to take small tissue samples.

Rising Costs Drive the Practice

Even as the controversy unfolds, economic pressures are forcing hospitals to consider reuse of disposable devices more than ever.

For example, the cost of two new cardiac catheters during a typical electrophysiology procedure can amount to about $2,000, said Mark Salomon of Vanguard Corp., one of the biggest third-party reprocessors. This is about 60% to 80% of the reimbursement for the entire procedure, including personnel and surgical costs.

Third-party reprocessors can save the hospital from 30% to 50% of the cost of the devices.

If reprocessing were to be restricted, health care costs for hospitals would escalate, many argue. According to the American Hospital Assn., restrictions on reprocessing could “seriously affect both the quantity and the quality of health care we offer our patients.”

Roger Richter, a spokesman for the California Healthcare Assn., said he doubts that a ban on reprocessing will lead to higher reimbursements for procedures.

Reprocessors agree that not all single-use devices are reusable. In fact, Salomon said that out of the thousands of single-use devices, his company reprocesses only 15 types.

Salomon said Vanguard will reprocess only those devices that can be successfully cleaned and sterilized. Reprocessing, when done well, does not pose a threat to patients’ health, reprocessors say.

But FDA files on adverse outcomes from reused disposable devices in the last few years would seem to argue the contrary. Some involve malfunctioning devices, such as three cases of electrophysiology catheters that broke during surgery.

In one case, the tip of the catheter remains lodged in the patient’s atrium. In another, the 4-inch-long tip traveled from the patient’s heart to his stomach, leading to additional surgery in which doctors opened the man’s stomach in an attempt to remove the tip. The device’s manufacturers say they are unaware of any cases in which such a catheter broke during its first use.

Also, cardiac catheters became contaminated with high levels of bacterial toxins in a Colorado hospital.

“One death occurred from this particular outbreak, and these were definitely reprocessed catheters,” said Trish Perl, an infection control practitioner at Baltimore’s Johns Hopkins Hospital.

But as emotionally charged as those incidents are, FDA officials stress that they are isolated, considering that tens of millions of devices have been reprocessed over the years. And even then, they say, it is hard to prove that a device malfunctioned or spread an infection because it had been reprocessed.

In fact, the FDA has many reports of new devices failing during their first use. And a number of tuberculosis and hepatitis C outbreaks have been linked to devices that were approved to be reused.

“The problem all along, and the reason why we have not exercised any regulatory discretion, is because we have not had really good data with which to project that a certain amount of harm was occurring to the public,” said Larry Spears, director of the division of enforcement at the FDA’s center for devices and radiological health.

The lack of adverse reports is not hard to envision in a system where tracking of reprocessed devices is poor, manufacturers say. Product failures are often registered as a problem with the device itself, without mentioning that the device was reprocessed.

Health professionals know that using a reprocessed single-use device can bring liability, a clear disincentive to report an adverse outcome.

And there is no proper follow-up on patients on whom reprocessed devices have been used. Many participants at the recent conference agreed there is no good tracking, by either hospitals or doctors, of which patients have been operated on with reused devices.

“So we don’t really know what’s happening to all of these patients. Sometimes complications that can occur look like the complications [that] occur from other things,” Grossman said at the conference.

Few Safety Studies Have Been Undertaken

Independent, peer-reviewed studies of reused disposable devices are scarce. The few studies that have been done, experts agree, are not substantial enough to conclude that reprocessing disposable devices is either safe or unsafe.

Other analyses abound that tend to incriminate or absolve the practice of reprocessing--but these are mostly sponsored by manufacturers or reprocessors, and the results tend to support the sponsor’s point of view.

Manufacturers say all they ask of the FDA is a level playing field. Health care in the United States is based on the premise that devices and drugs need to be proven safe before they even go to the market. If it is not known whether reprocessing is safe, manufacturers argue, those devices should not be allowed near patients until their safety is proven beyond doubt.

Right now, if a manufacturer wants to change the label of a device from “single use” to “reusable,” the FDA requires it to submit documentation, called pre-market notification, showing that the change in use is safe.

But the FDA does not require third-party reprocessors to submit similar documentation, even though reprocessing essentially changes the classification of a device from single-use to reusable.

In fact, manufacturers argue that many third-party reprocessors are not even registered with the FDA. Of an estimated 23 such companies, only seven are registered with the agency.

The FDA is considering several options. One is to force reprocessors to submit documentation that reprocessed devices are safe. The agency also could request manufacturers to prove that labeling a device as “single use” really means that it can’t withstand reprocessing.

“Absolutely, some simpler-looking devices labeled as single-use can maybe be reused. But the burden will be on the person [who wants to find out],” said Josephine Torrente, president of the Assn. of Disposable Device Manufacturers.

In fact, some of the instruments being reprocessed, Vanguard’s Salomon said, used to be marketed by manufacturers as reusable before the labels were changed to “single-use.”

Others claim that in the past, manufacturers knew that hospitals were reprocessing their single-use devices, and it did not seem to be causing much concern.

“So it appears to many of us that as long as it was just hospitals reprocessing any device, that was not a problem. But as soon as the reprocessors stepped on the playing field and took too much of the piece of the pie, then there was cause for a concerted alarm,” said Kay Watson, who manages sterilization for the Texas Heart Institute.

FDA officials said the agency hopes to have an official position on reprocessing of single-use devices by October.

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Most Frequently Reused

Disposable Medical Devices

1. Anesthesia breathing circuits

2. Electrosurgical devices

3. Respiratory therapy breathing circuits

4. Biopsy needles

5. Electrophysiology catheters

6. Hemodialyzers

7. Cardiac catheters

8. Angioplasty balloons

Source: Emergency Care Research Institution