Reusable devices trigger alarms over health risk

Millions of disposable medical devices — such as heart catheters — that are commonly used in ICUs are finding their way back into hospitals a second time and being legally reused on patients, according to the U.S. Food and Drug Administration (FDA).

If your hospital is regularly purchasing quantities of reusable medical devices, critical care experts are advising managers to be sure to obtain the hospital’s policy regarding the safe use and legal parameters of reusing these products.

In most cases, medical device manufacturers and companies that repackage used devices are reconstituting the equipment and supplies in a procedure called "reprocessing," and selling the products back to hospitals at a discount.

"Essentially, what these reprocessors are doing is recycling medical waste, and it’s alarming," says Philip Grossman, MD, a Miami gastroenterologist who is waging a virtual one-man campaign against the practice.

Affected by this largely unregulated industry are millions of disposable medical devices, including parts of or entire biopsy forceps, pulse oximeters, cardiac catheters, tubing materials, and endoscopy supplies. Many of the devices are being purchased by hospitals at between 20% and 50% of their original price, according to reports.

Critical care units are among the most vulnerable targets for safety concerns due to the heavy, frequent use of devices, such as heart catheters, and the critical nature of most patients. (See related article, above.)

Almost always, clinicians are unaware they are potentially endangering the lives of patients by using a reprocessed device that was originally designed for single use, Grossman says.

And although there have not yet been reports of deaths directly linked to a recycled device, random samplings conducted by federal officials earlier this year (including the FDA) at three undisclosed hospitals found trace amounts of contamination, including evidence of human waste associated with a range of products.

In many cases, evidence of contamination has been the culprit; but in other instances, sample catheters have been found to be misshapen or in a condition that could lead to malfunctioning during use, says Grossman, who has been studying the government’s findings.

"These devices are intricate," he recently stated in an interview. "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."

In addition, "hospitals aren’t telling patients about this," Grossman adds, which he says raises additional questions of legality and informed consent.

Exposing patients and clinicians to those risks is both unethical and possibly illegal, he says. As many as half of U.S. hospitals may be affected.

An FDA official stopped short of asserting that the widespread reuse of devices intended for single use posed a patient health risk, and could not say how many hospitals are buying those products. However, FDA spokeswoman Sharon Snider acknowledged the agency is concerned about patient safety and other aspects of the issue, which got widespread attention from a Los Angeles Times article published earlier this year.

While the use of reprocessed devices is legal under present FDA regulations, the agency is concerned about whether both providers and reprocessors are properly adhering to infection control procedures when reprocessed devices are being used, she says. "We’re concerned, because these devices complicate existing safety standards. If they are being used more than once, they raise questions about proper cleaning and disinfectant requirements [by vendors]."

The FDA is presently re-evaluating its medical device standards and, as Critical Care Management went to press, was about to issue an announcement regarding a "new policy direction."

The agency has been criticized in the media for allegedly "turning a blind eye" to the problem because it doesn’t require reprocessors to demonstrate or document a device’s safety after it has been reprocessed.

There also has been no independent follow-up research on the effects of reprocessed devices on patient outcomes and clinical complications during medical treatment, Grossman adds.

According to the Times report, device manufacturers have stated that they are required to notify the FDA if a single-use product is being reprocessed for reuse.

But they are under no obligation under existing regulations to submit documentation indicating that a single-use device has become reusable, the Times report indicated.

Providers urged to study reuse protocols

The Association of Medical Device Reprocessors, the industry’s trade group based in Washington, DC, confirmed the information.

Meanwhile, Thomas S. Ahrens, RN, CCRN, a critical care nurse and medical technology expert, says he has not heard that ICUs are being threatened by health risks stemming from the reuse of single-use devices.

However, Ahrens, a clinical nurse specialist at Barnes Jewish Hospital in St. Louis, advised ICU managers to contact their facility’s infection control departments to determine whether the hospital has a policy regarding the use of reprocessed equipment. They should also follow the policy as a way to protect themselves in the event of a health-related risk.

Most hospital infection control departments follow guidelines for the reuse of single-use devices. The Association for Professionals in Infection Control and Epidemiology (APIC), a Washington, DC-based membership organization, has standing protocols that apply to clinicians. (For information about obtaining the APIC protocols, see editor’s note at end of article.)

The protocols are quite specific and cover the care and handling of devices after their initial use, as well as transporting, cleaning, inspection, and performance testing.

However, the APIC protocols are designed to address internal hospital reuse standards, and don’t necessarily reflect when hospitals purchase devices already reprocessed by an outside entity.

Nevertheless, the protocols offer effective guidelines for clinicians, says Sandra Reiner, RN, an infection control coordinator at Northwestern Memorial Hospital in Chicago. (The box on p. 126 offers suggested considerations for developing a hospital reuse protocol.)

Regarding the reprocessing controversy, Reiner indicated that the issue isn’t quite black or white, and no blanket statements can be drawn from the mere fact that a device has been reprocessed for use.

"The debate turns on what exactly you’re using," Reiner says. "These devices don’t usually pose a health threat across the board."

Many products are in fact reusable, but are packaged by manufacturers with warnings that they are to be single-use only "in order to sell more products," she says.

By using appropriate sterilization and handling procedures, providers can safely reuse many products on patients. And many manufacturers label their products as recycled on the packaging, which alerts providers that they are using a reprocessed product, Reiner adds.

Reiner advised nurses to identify which specific devices are being used that have been reprocessed and work with their infection control officers on safety concern before taking further steps.

She also called for more research into reprocessed equipment to avoid alarming providers, and getting fact-based information to support safety claims. "We don’t yet know enough about these products to make blanket statements about them," she cautioned.

[Editor’s note: To obtain a copy of the APIC guidelines for the reuse of single-use medical devices, contact: APIC, 1275 K St. N.W., Suite 1000, Washington, DC 20005-4006. Telephone: (202) 789-1890. Fax: (202) 789-1899. E-mail: APICinfo@apic.org.]