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Feds Need to Improve Oversight of Medical Devices––But It Won’t Be Easy

New monitoring system could cost up to $250 million

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, according to a report from Kaiser Health News (KHN).

Members of Congress, federal officials, and health-policy experts agree that the FDA’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, KHN says. Federal auditors have criticized the agency’s oversight of devices since the 1990s.

The latest push for changes came from Sen. Patty Murray (D-Washington), who issued a report in January 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.

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 experienced 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.

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.

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.

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.

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.

Source: Kaiser Health News; February 1, 2016.

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