FDA weighs rules for surgical instrument repair

Joel Kurth
The Detroit News
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Hospitals in Michigan and nationwide increasingly are saving money by operating on patients with refurbished and repaired surgical instruments, but safety fears could prompt the government to intervene.

Darlene Delonis, Certified Biomedical Equipment Technician, she is seen using a radiometer, (on table), to measure to intensity of light for the Led Phototherapy machine.****Beaumont Hospital department that refurbishes and repairs surgical instruments, other medical equipment. Surgical tool makers are pushing for a rule because they say repair shops should live by same rigorous regulations that affect them.Royal Oak, Mi, October 24, 2016, (ClarenceTabb Jr./Detroit News)

Unregulated by either the state or federal government, medical device maintenance has quietly grown into a $50 billion industry. Vans staffed by repair technicians circle hospitals waiting for equipment to break. Tools and pumps are rebuilt, sometimes with different parts, to extend their lifespans.

It’s a situation even some repairers liken to the Wild West. There are no laws requiring licenses of repair shops. Unlike auto garages, their technicians aren’t legally required to be certified. And no government agency monitors the competence of shops or imposes penalties if their work causes mishaps.

Now, as anecdotes circulate about injuries caused by faulty equipment, the U.S. Food and Drug Administration is exploring regulations to the industry that repairs everything from imaging systems and X-rays to ventilators and endoscopes, thin tubes equipped with tiny cameras for minimally invasive surgery.

“First and foremost, this is an issue about patient safety, so it’s important that the FDA gets it right,” said Colin J. Ford, senior director of state and federal government relations at the Michigan State Medical Society, which has not taken a position on any regulations.

The FDA took testimony on the issue last month in Maryland. Any regulations would be a year or more away and the debate comes amid heightened concern about healthcare costs and the safety of medical devices.

Federal regulators threatened the Detroit Medical Center with a loss of federal funding this fall over longstanding problems sterilizing surgical instruments, while infection outbreaks tied to filthy tools in recent years have hit hospitals in Seattle, Los Angeles and Houston.

All major hospitals in southeast Michigan use outside contractors to fix equipment. They and patient advocacy groups contend the practice saves money, reduces waste and is safe. Third-party shops charge 30 percent to 50 percent less than manufacturers to repair equipment and thousands of dollars less for replacing it, according to FDA documents.

“A robust marketplace drives out poor performers,” said David Anbari, vice president of Mobile Instrument Service Repair Inc., an Ohio company, told an FDA panel.

Biomedical technician Alan Ziolkowski works on an infusion pump at Beaumont Hospital, which, like many other such facilities, has an in-house department to fix such equipment.

Surgical horror stories

Medical device manufacturers point to horror stories about rebuilt equipment that broke during surgery, increasing the risk of infection, septic shock or other complications.

More than 100 pages of mishap incident reports were presented to the FDA by Karl Storz, one of the world’s largest makers of endoscopes.

In one case, kidney stone removal surgery went awry when the beak of an rebuilt endoscope dislodged in a 68-year-old man and the doctor couldn’t retrieve the broken piece. In another, two hours were added to a surgery to fix an enlarged prostate when the sheath of a repaired scope broke off in a 69-year-old man’s urethra.

Baxter, an Illinois-based device manufacturer, contends that four of its pumps dispensed too much medicine in the past three years because they weren’t correctly repaired.

In those cases — as with the broken instruments — doctors intervened before patients were injured. The reports redacted many details about the incidents, including their locations and names of patients and doctors.

“There’s strong concern these (repaired) devices are operating safely and effectively,” said Tara Federici, vice president of technology and regulatory affairs of AdvaMed, a Washington, D.C.-based trade group that represents manufacturers. “These devices are far more complex than they were 20 years ago.”

Don’t legislate by ‘anecdote’

Manufacturers have not identified any deaths or serious injuries caused by rebuilt equipment. That’s because the threat is vastly overstated, contended Mark E. Bruley, who studied the issue for the ECRI Institute of Pennsylvania, a nonprofit dedicated to patient safety.

Unlike repair shops, manufacturers are heavily regulated by the FDA. By law, they must report all injuries and deaths involving surgical instruments or medical devices to the FDA.

Bruley has studied 2.1 million incident reports in the past 10 years. Less than 0.005 percent of those incidents involved repaired equipment. Most of those 96 cases involved durable medical goods such as shower trolleys or chair lifts used to transport patients.

“Why regulate a problem that doesn’t exist?” asked Bruley, who conducted the study and is vice president, accident and forensic investigations, for the institute.

“You should not legislate by anecdote.”

New equipment can break during surgery because of misuse or other factors, he argued, and there’s no greater risk of mishaps with repaired or refurbished equipment. It’s a view echoed by most healthcare advocacy groups — including the nonprofit Joint Commission that accredits hospitals — which oppose new regulations.

Manufacturers said they can’t quantify the problem because the FDA doesn’t keep records about it. Hospitals must file reports to the FDA if patient deaths involve malfunctioning devices, but there’s no requirement to say if that equipment was rebuilt or re-purposed.

“The absence of information doesn’t mean there’s no harm being done,” said Federici of AdvaMed, the industry group.

Range of repair shops

This is the second time the FDA has considered regulations. In 1997, the agency sought public comment on the issue but did nothing.

Manufacturers had a virtual monopoly on servicing equipment until the 1960s. As devices became smaller and more specialized, the aftermarket and maintenance industry exploded, according to the Association for the Advancement of Medical Instrumentation, a Virginia-based nonprofit.

Manufacturers also offer service contracts to repair their equipment and regulations would reduce competition. No one keeps track of how many repair shops exist, but they range from multi-state operations to those with fewer than 10 employees such as Endoscope Repair Specialist Inc. in Hastings, whose website says “there is NO SUCH THING as an obsolete scope.”

Jim Schneiter, a Chicago-based instrument designer, said endoscopes degrade over time and need to be replaced.

“There are things that are relatively straightforward — sharpening scissors — that could be done by a third-party refurbishing firm that shouldn’t have to go back to the original manufacturer,” Schneiter said.

“Endoscopes are the other extreme. They’re very complex, delicate, expensive instruments. I can understand manufacturers not wanting other people to fix them.”

One Detroit Medical Center doctor disagreed, saying he often uses refurbished flexible scopes without problem. There’s no issue as long as they are rebuilt by reputable firms, said the doctor, who asked not to be identified because he is not authorized to speak for the DMC.

Endoscope Repair Services officials declined comment.

So did two other Michigan companies with stakes in the outcome of the debate — Kalamazoo-based Stryker Corp., which is one of the largest medical device manufacturers in the world, with $9 billion in sales; and Prezio Health of Madison Heights, an emerging national player in the device repair industry with clients including the University of Michigan Health System.

Hospitals tout safeguards

Officials for Michigan hospitals say they employ numerous safeguards when repairing and re-purposing equipment.

“We have extensive experience with third-party service and repair and have experienced significant cost savings as a result,” said Brian Taylor, spokesman for Ascension Michigan, which owns St. John Providence in Detroit, Crittendon Hospital in Rochester, Genesys Health System in Grand Blanc and three other Michigan hospitals.

“This has been possible without compromising patient safety and quality of care. We urge the FDA to exercise great care as it considers these issues.”

At Henry Ford, staffers “routinely inspect surgical instruments for safety,” limit repairs to a “small number of tools and discard those that can’t be repaired, said spokesman David Olejarz, who added that federal oversight would “ensure the highest standards of quality and safety.”

Like many other hospitals, Beaumont has its own in-house department to fix equipment such as blood pressure machines, vital sign monitors and infusion pumps. High-tech equipment such as MRI machines or Da Vinci robots are not serviced by employees, hospital officials said.

“Manufacturer repairs are more costly and take longer because we either have to wait for a manufacturer service technician to arrive on site, or we need to send equipment out for repair,” Mark Geary, a Beaumont spokesman, wrote in an email to The News.

“In-house repairs allow us to bring the equipment back online sooner, which benefits our patients and our staff.”

The University of Michigan Health System called refurbished instruments “cost-effective and environmentally conscious” but didn’t elaborate in detail about its practices.

Spectrum Health, which owns 10 hospitals on the west side of the state, said it buys news equipment, uses contractors for simple or moderate repairs and evaluates those needing more extensive work on a case-by-case basis.

The Detroit Medical Center declined comment.


Twitter: @joeltkurth

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