Dive Brief:
- Senator Patty Murray (D-WA) wants a new medical device tracking system similar to how prescription drugs are monitored, using insurance claims data to supplement industry injury reports.
- Murray's proposal includes adding bar codes to all instruments, which is slowly being phased in. These will need to be included on insurance claim forms in order to track infections, which could trigger a safety alert without waiting for a manufacturer's report.
- The new device monitoring system could cost $250 million to implement for the first five years, according to a 2015 Brookings Institute report.
Dive Insight:
Most health-policy experts agree the FDA's surveillance system for devices is inadequate and depends too much on manufacturers to report problems.
There's little doubt the FDA's surveillance system for medical devices is in need of reform, especially after Sen. Murray's recent report exposed the agency's failures that lead to nationwide antibiotic-resistant infections from a gastrointestinal scope.
There were 19 superbug outbreaks that sickened 200 patients between 2012 and 2015. In addition, the report pointed out the FDA took 17 months to investigate before issuing a warning last February, but not before seven more hospitals had outbreaks and 68 patients were infected.
Republicans, including Sen. Lamar Alexander (R-TN), chairman of the Senate health committee prefer the FDA use its authority, including imposing civil and criminal penalties, before implementing a new tracking program.
However, Dr. Robert Califf, Obama's nominee to lead the FDA as deputy commissioner, said there are plans to implement the device tracking system during his confirmation hearing on Nov. 17.
In the interim, the FDA said it is considering the Senate's recommendations and is making progress on notifying the public sooner about problems before an investigation. It hopes to have access to 15 million EHRs with device bar codes before the end of this year.