Medical device makers opposed to the sterilization and reuse of their products by hospitals and other facilities won a round last month when federal regulators weighed in on the issue.
But the matter of reusing devices made to be used just once, and the larger issue of sterilization, remain sticking points.
“It is a critically important issue to all aspects of the industry,” said William Goolsbee, president and chief executive of Horizon Medical Inc., a Santa Ana contract manufacturer of single-use medical devices.
In early August, the Food and Drug Administration said it plans to regulate the reuse of medical devices just like it does medical device makers themselves. That means hospitals and the companies they contract with for cleaning and sterilizing devices have to adhere to the same standards as medical device makers.
For the directive to have any effect, Goolsbee and other device makers insist there has to be careful scrutiny to make sure that product quality and patient safety aren’t compromised.
Reusing single-use medical devices dates back to the 1970s but has become more visible in recent years as hospitals have sought to cut costs. As a result, millions of medical devices such as surgical saw blades, biopsy forceps and catheters are being recycled for use multiple times, known as “reprocessing” in the industry.
Hospital “costs are high and they’re losing money,” said an executive at an area medical device maker who asked not to be named. “Reprocessing is a lot cheaper, but they forget to count the hidden costs.”
The larger issue of sterilization played out at Garden Grove Hospital and Medical Center this summer after the facility was cited by state regulators for violations relating to its surgical tool sterilizing equipment. (see accompanying story). The Tenet Healthcare Corp.-owned facility eventually spent $160,000 to buy four new flash sterilizing machines to replace some that malfunctioned.
“If hospitals and other medical facilities are either incapable of or unwilling to follow correct disinfection or sterilization procedures, they shouldn’t be involved in reuse,” said Dave Anast, publisher of the Biomedical Market Newsletter in Costa Mesa.
While device makers contend reuse is common, officials at some of Orange County’s larger hospitals said they discourage the practice. UCI Medical Center, for one, doesn’t reuse single-use devices, said Dr. Eugene Spiritus, senior medical director of the teaching hospital in Orange.
Spiritus, who’s been at UCI Medical Center for three years, said University of California system officials decided against reuse prior to his arrival.
“It was decided that the risk was too great to be reusing single-use instruments,” Spiritus said. “It’s not so much a marketing issue as it’s a patient-safety issue. If something happens to a patient, the potential risk is too great.”
Guidelines for St. Joseph Health System,operator of St. Joseph Hospital in Orange, St. Jude Medical Center in Fullerton and Mission Hospital Regional Medical Center in Mission Viejo,are clear on the reuse issue, according to Rich Spinello, the Orange-based provider’s vice president of risk management.
“The reuse of medical devices that are manufactured, labeled or marketed for single-use should not occur in St. Joseph Health System facilities,” he said. “If an entity decides to deviate, we look at it on a product-by-product basis.”
Invasive single-use medical devices such as cardiac catheters and balloon catheters are never reused in system facilities, he said.
“We are absolutely, adamantly against that,” Spinello said.
Hoag Memorial Hospital in Newport Beach also does not reuse single-use medical devices, said Jo Ann Adkins, the facility’s administrative director of perioperative services.
The U.S. Centers for Disease Control and the Joint Commission on Accreditation of Healthcare Organizations now recommend that hospitals do not resterilize or reuse single-use devices, added Rosalie De Santis, Hoag’s infection control program manager.
The FDA directive is putting a new onus on device-reuse contractors, which hospitals turn to for the reprocessing of devices.
“The safety record of our members is excellent. Our companies would be out of business if they were not safe,” said Pamela Furman, executive director of the Association of Medical Device Reprocessors, a Washington, D.C.-based trade group.
Alliance Medical Corp., a Phoenix-based hospital device reuse contractor, said in a news release that its facilities have passed FDA quality inspections and have not been cited for any violations. Alliance is an Association of Medical Device Reprocessors member.
“We have no problem with FDA oversight,” Furman said. “It is critical to ensure the safety of reprocessing.”
But Furman contends the FDA’s look into reuse was triggered by device makers’ fears of losing sales of single-use medical devices.
“The original manufacturers saw this as an economic threat,” she said.
Josephine Torrente, president of the Association of Disposable Device Manufacturers, said her group’s concern about reuse is not economic.
“These companies have built up a reputation,” she said.
If a reprocessed device fails, a doctor is likely to blame the original manufacturer, not the reprocesser, Torrente said. Her Washington-based group includes several heavyweight device makers such as Boston Scientific Corp., Johnson & Johnson and Mallinckrodt Corp.
Torrente said she is “hesitantly optimistic” about the new regulations. But she said that she was concerned because the FDA hasn’t made clear what standards it will hold third-party reprocessers to.
As for reprocessers, the FDA’s new regulations will create more paperwork, said Don Selvey, director of regulatory affairs and quality assurance for Alliance Medical. He said his company now has to fill out applications for five general categories of devices that can be reprocessed, including laparascopic instruments, electrophysiology catheters and orthopedic devices like saw blades and drills.
Alliance Medical does some business with Orange County hospitals, although Selvey declined to name specific facilities. n
