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Reforming Federal Oversight Of Medical Devices Won’t Be Easy

A recent Senate report exposed failures by the Food & Drug Administration, device makers and hospitals that contributed to the nationwide spread of antibiotic-resistant infections from gastrointestinal scopes. (Andrew Harnik/The Associated Press)

In response to recent infections and deaths from tainted medical scopes, U.S. lawmakers are wrestling with how to keep other dangerous devices from harming patients.

Members of Congress, federal officials and health-policy experts agree that the Food and Drug Administration’s surveillance system for devices is inadequate and relies too heavily on manufacturers to report problems with their own products.

But fixing the federal warning system to enable more timely identification of risky scopes, implants and surgical tools means overcoming significant challenges in Congress, from partisan divisions to the need for more government funding. Even then, it could take years for a new system to be up and running.

Patient advocates are skeptical of the FDA’s commitment to reform. Federal auditors have criticized the agency’s oversight of devices since the 1990s.

The latest push for changes came from Sen. Patty Murray (D-Wash.), who issued a report Jan. 13 exposing failures by the FDA, device makers and hospitals that contributed to the nationwide spread of antibiotic-resistant infections from a gastrointestinal scope. Senate investigators cited 19 superbug outbreaks in the U.S. that had sickened nearly 200 patients from 2012 to 2015. Two were in Los Angeles, at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center.

The Senate report faulted the FDA for taking 17 months to investigate before issuing its own warning in February 2015. In the meantime, seven more hospitals suffered outbreaks and 68 patients developed dangerous infections.

Murray has called for an entirely new medical device tracking system, akin to the way prescription drugs are monitored. It would draw primarily on insurance claims data to supplement the industry’s injury reports, which are often cursory and filed months late, if at all. President Barack Obama’s nominee for FDA commissioner has endorsed that data-driven approach.

Part of that proposal, putting bar codes on every instrument for the first time, is already being phased in over the next few years. But experts say those unique identifiers will be of little use unless Congress requires hospitals and doctors to include them on insurance claim forms.

Researchers say claims filed with private insurers and Medicare are useful because they give close to real-time data on a large population. By tracking device IDs, like the VIN number on a car, regulators could spot patients across the country coming into an emergency room or developing infections after a procedure.

Those red flags would trigger further investigation and possibly a safety alert — without the need to wait on incident reports from manufacturers or hospitals. The data also would help find patients who have implants that were recalled, or assist hospitals in pulling defective equipment out of service quickly.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate health committee, said the investigation into superbug outbreaks uncovered “disturbing facts” about the FDA’s response. But he and other Republicans appear intent on making sure regulators are using the powers they already hold before embarking on a new government program.

Republican lawmakers have pointed out that the FDA can impose civil and criminal penalties against manufacturers for failing to report injuries or deaths, but it rarely uses those powers.

Budget hawks are likely to resist funding a new medical device monitoring system. It could cost up to $250 million to implement and maintain a new system over the first five years, drawing on government or private-sector funding, according to a Brookings Institution report last year.

Greg Daniel, one of the report’s authors and now deputy director of the Center for Health Policy at Duke University, has been working with the FDA, hospitals and device makers, planning and designing a new tracking system.

“It will take a financial contribution to get this off the ground. It’s expensive and complicated,” Daniel said. “Most people think this is already being done, but we don’t have the fundamental ability to link devices to their outcomes, like on the drug side.”

Representatives of the device industry said they welcome the debate, but they too emphasize that regulators have plenty of authority already. Device makers wield considerable influence with Congress, contributing to lawmakers of both parties.

“The FDA has extensive post-market authorities — including requirements for quality systems, adverse-event reporting, mandatory recalls, corrections and removals — to help ensure the safety and effectiveness of medical technologies once they are on the market,” said JC Scott, senior executive vice president for government affairs at AdvaMed, an industry trade group. He didn’t address the Senate report’s recommendations directly.

After safety problems with certain drugs a decade ago, Congress helped create the Sentinel program to better track medications. The program analyzes claims data on more than 170 million Americans from several large health insurers, dozens of hospitals and disease registries.

Dr. Robert Califf, the FDA’s deputy commissioner and the president’s nominee to lead the agency, said during his confirmation hearing that regulators need a Sentinel-like system for devices, too.

“We have plans to do that, but we are going to have to work with you on how to fund it,” Califf told senators at the Nov. 17 hearing. “Imagine with these duodenoscopes, if there had been such a system, we would have seen the problem very early. We could see it independently of industry and act on it much more rapidly.”

An FDA spokeswoman said the agency is carefully considering the recommendations in the Senate report, and is already taking steps to address some of the issues raised, such as notifying the public sooner about suspected problems before an investigation is finished. By the end of this year, the agency said it hopes to gain access to 25 million electronic patient records containing bar codes on the devices used.

Families affected by the recent superbug outbreaks support such changes but are skeptical about the FDA’s role, given its past missteps.

For months, Glenn Smith of Woodland Hills, Calif., saw his 19-year-old son, Aaron Young, battle a superbug infection. He got it from a contaminated scope at UCLA’s Ronald Reagan Medical Center in 2014.

“Something needs to be done,” the father said, “but I’m wary of the FDA being in charge of anything until it gets its own house in order. They were very slow to react.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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