FDA allows some reprocessing of single-use medical devices

Although a medical device is labeled single-use only, it might have been used before.

The ad written by Kaplan’s attorney, Dominic Gentile, in the wake of a joint investigation by the Food and Drug Administration and the Nevada State Board of Medical Examiners, said that FDA guidelines "state that single-use devices can be reused after reprocessing."

The FDA allows some single-use devices to qualify for reprocessing for reuse. About 100 types of re­processed single-use devices, which often can be bought at half the price of new devices, are marketed in the United States, according to a 2008 Government Accountability Office study.

About 5 percent of single-use devices found in the health care arena, where administrators try to save on costs and stem a rising tide of medical waste, are re­processed, say business leaders in the medical device reprocessing industry.

The GAO study found no evidence that reprocessed single-use devices create an elevated health risk for patients. But it goes on to say that there isn’t sufficient research "to draw definitive conclusions about the safety of reprocessed (single-use devices) compared to similar original devices."

INFECTION CONTROL

The reprocessing must be done at a facility approved by the government, FDA spokeswoman Amanda Sena said.

There, devices are disassembled, cleaned, sterilized and reassembled to FDA quality standards, making what had been labeled as single-use safely usable again for another single-use. Reprocessing officials say their standards are as high as a plant that makes new devices.

Plastic endocavity needle guides, such as those Kaplan used in performing prostate biopsies, are not on the list that the FDA has approved for reprocessing, said Daniel J. Vukelich, president of the Association of Medical Device Re­processors.

Nor, according to the FDA database, is Kaplan on an authorized list to do any reprocessing of single-use medical devices. The FDA says it would hold doctors who reprocess single-use instruments to the same standards and documentation as a plant that reprocesses.

Authorities said the Las Vegas urologist stopped reusing the single-use needle guides only when they became "too bloody."

Nevada State Epidemiologist Dr. Ihsan Azzam said he finds Kaplan’s case both compelling and sad and prays the 101 patients of Kaplan who have been notified to get tested for HIV and hepatitis are found to be disease-free. But Azzam also said the issue of reuse of single-use devices brought forward in the Kaplan ad greatly disturbs and troubles him.

Azzam, who oversees an agency with a mission that includes initiating disease-control activities and investigating disease outbreaks, said he fears that the continued practice by hospitals of buying reprocessed single-use medical devices — the nation’s hospitals make up almost the entire buying and selling market of such devices — could mean breaches of infection control reminiscent of what was discovered three years ago at area clinics owned by Dr. Dipak Desai.

More than 100 people are thought to have contracted hepatitis after investigators traced an outbreak of the virus to the reuse of syringes and single-dose vials of anesthetic at Desai’s clinics.

"I hate to contradict the FDA," said Azzam, "but I just don’t understand why we take a chance with infection. Even if you’re 99.999 percent sure, why take the risk? I know it’s done to save money, but the money you save isn’t justified if you make people sick. I wish the practice would end. When manufacturers say a device is only for single use, that direction should be followed."

According to the federal Centers for Disease Control and Prevention, about 100,000 people die each year from hospital-acquired infections.

HOSPITAL USE

Nearly all hospitals open to civilians in the Las Vegas Valley — other than University Medical Center, where officials aren’t convinced of the safety of the practice — buy reprocessed single-use medical devices. But they don’t like to talk about it.

Consider: Michael Marcum, regional representative of Ascent, the nation’s largest reprocessor of single-use devices, calls Sunrise Health Hospital Group "one of our best customers." HCA, the huge hospital chain of which Sunrise is a part, is listed as a "partner" on the Ascent website.

Dan Davidson, the spokesman for Sunrise, MountainView and Southern Hills hospitals, wouldn’t comment beyond a statement: "We follow FDA guidelines with regard to single-use items. We dispose of single-use items immediately and appropriately."

The Valley Health System and North Vista Hospitals also had statements that said they were following FDA guidelines.

Jennifer McDonnell, a St. Rose Dominican Hospitals spokeswoman who said her chain followed federal guidelines, added that her chain buys only a few reprocessed items, including catheters and orthopedic saws.

Kim Voss, an associate administrator of surgical services at UMC, said the hospital sells "things like stockings" to a reprocessor, but "we don’t buy things because of our concerns over infection. And it’s not on our radar for the near future."

The Department of Veterans Affairs has had a long-standing policy of VA hospitals not using reprocessed instruments because of safety concerns. VA officials declined to comment for this story.

About half of the nation’s hospitals reprocess single-use devices, industry officials say.

SAFETY VS. ECONOMICS

Manufacturers of single-use devices argue that in the interest of safety their equipment should not be reprocessed.

Tara Federici, vice president of technology and regular affairs for AdvaMed, the manufacturers’ trade association, said: "Single-use devices are designed and manufactured for just a single use in a single patient and are intended to be disposed of permanently after use."

She added that the devices have characteristics that make them "extremely difficult to effectively clean and re-sterilize." Inaccessible areas on the devices, she said, create barriers to cleaning and allow for the collection of organic matter, such as blood and feces, and respiratory secretions on devices.

"Single-use devices are not designed to withstand the harsh conditions encountered during reprocessing such as exposure to solvents and extreme temperatures," she said. "Reprocessing of a previously used single-use device may seriously compromise its safety and effectiveness and even destroy some single-use devices. Studies performed have shown various defects caused by reprocessing that have rendered some single-use devices unusable because materials became brittle, tacky, deformed and/or cracked."

Vukelich, the spokesman for the reprocessors trade association, argued that manufacturers are more worried about profit than safety. He noted that the single-use label rests with the manufacturer, which may choose not to conduct the studies needed to demonstrate that the device is reusable.

"They don’t want their market share to go down," he said.

Industry officials say more than $30 billion of single-use medical devices are sold annually to American hospitals and surgery centers, of which more than $150 million are recycled. Vukelich said even more devices could be safely reprocessed.

Vukelich points to independent studies by the FDA and GAO that found that there is no causative link between reported injuries or deaths and re­processed single-use devices.

"FDA continues to monitor the performances of these devices and to assess and refine our ability to regulate these devices appropriately," he said, adding that he thinks reprocessed devices can be safer than new devices in some cases because each reprocessed item must be inspected before reuse, while original manufacturers test devices only in batches.

Vukelich said to remember that when a single-use item is reprocessed, "it is only for one more use."

"After every single use, it must go through the entire reprocessing system again," he said.

REPROCESSING HISTORY

Reprocessing of select single-use devices is supported by several prestigious health care groups, including the American Hospital Association.

"The AHA supports hospital use of devices reprocessed according to the FDA’s rigorous standards regarding safety and effectiveness," said Elizabeth Lietz, a spokeswoman for the organization. "Using these devices can reduce health care costs without sacrificing the most important goal of all: providing safe, high quality care to our patients and communities."

In 2000, Dr. David Feigal, then the director of the Center for Devices and Radiological Health at the FDA, testified before Congress that "economic pressures create incentives for reuse" of single-use devices.

According to his testimony, the practice of reusing medical devices "labeled, or otherwise intended" for only one use began in the late 1970s.

Before that time, he said, most medical devices were considered to be re­usable, given that they were fabricated from glass, rubber or metal and could be easily disinfected.

Because of the new threat of HIV and the development of new plastics, hospitals began to see products labeled single-use only.

"The practice of reprocessing single-use devices expanded when an increasing number of hospitals decided that reuse was a cost-savings measure and when they become concerned about the amount of medical waste," he said.

Hospitals themselves, he said, started reprocessing complex products. But "reprocessing of these devices required more complicated decontamination sterilization procedures," he said, and an industry of third-party reprocessors "evolved."

According to the FDA, devices reprocessed include surgical saw blades, drills, scissors, catheters, tubes and forceps.

Though Bill Welch, head of the Nevada Hospital Association, said he was sure that none of the reprocessed devices was plastic, FDA officials said many of them are.

Since 2002, the FDA has stepped up efforts to regulate the industry, and reprocessing plants now must meet stricter specifications for functionality and cleanliness.

PATIENTS UNAWARE

Patients contacted by the Review-Journal said they were never told that their procedures might be done with reprocessed medical devices.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said patients should be told that they could receive a reprocessed device.

He said a patient who goes into the hospital for a heart procedure might like to know that catheters and wires labeled single-use only for his operation could have spent time in someone else’s blood vessels and heart.

"I think reasonable people would want to know that," he said. "They may even be willing to pay more for a new device."

Welch, head of the state hospital association, said he thought data showed that patients were not charged for a new device when they got a reprocessed one. He said an assistant would find the information for the Review-Journal, but it was never shared.

Gretchen Papez, a spokeswoman for the Valley Health System, said she could "not discuss financials." Mike Tymczyn of North Vista Hospital said such "proprietary" information could not be shared.

ONE DOCTOR’S TALE

A respected Las Vegas surgeon, who requested anonymity for fear his practice could be hurt, said he sometimes has been troubled by using reprocessed single-use instruments.

"About a year ago I was handed a pair of bloody disposable scissors at Summerlin Hospital during a gall­bladder surgery," he said.

"I was shocked because I thought they had mistakenly handed me used scissors that were supposed to be new. When the hospital explained to me that they were reprocessed instruments, I was relieved but I handed them back and asked for new scissors anyway. I then asked them never to hand me used reconditioned single-use instruments without notifying me first. I have since used these instruments, but I always look at them carefully first. Do I prefer new instruments? Yes, of course I do. Do I fault the hospital for trying to save money and reprocessing used instruments? No."

The surgeon thinks Kaplan, whose lawyer said he used disinfectant between his biopsy procedures, is being singled out and treated unfairly.

"It is commonly accepted practice to reuse instruments to save money," he said.

"Many times I have been handed soiled instruments in the middle of a procedure," he said. "If I am handed a pair of scissors with blood or tissue on it I simply hand it to the nurse because it makes me uncomfortable. But it is not a break in sterile protocol that warrants an incident report or anything else. I know intellectually that the dirty instrument is in fact sterile and is of no risk to the patient. It’s just one of the gross things that doctors have to get past."

To state epidemiologist Azzam, however, there is simply no reason a doctor should have to get used to starting a procedure using dirty instruments that are said to have been sterilized.

"What’s in it for the patient?" he said. "I don’t understand."

Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908.