The Food and Drug Administration’s surveillance system, designed to identify harmful medical devices, relies too heavily on manufacturers to report problems with their own devices, and should be revamped in order to protect public health. That’s the opinion of members of Congress, federal officials and health-policy experts. But how to rework the system leaves a great deal of room for much debate.
One issue at the center of the debate involves duodenoscopes, specialized endoscopes that are fed down patients’ throats to diagnose and treat various bile duct and pancreatic conditions. The scopes have been blamed for spreading antibiotic-resistant infections causing outbreaks in 19 hospitals across the country, sickening nearly 200 patients.
The Senate faulted the FDA for taking 17 months to investigate the issue before alerting the public in February 2015. During that time, outbreaks occurred at seven more hospitals, infecting 68 patients.
One proposal involves creating an entirely new tracking system for medical devices that would work similarly to the monitoring system for prescription drugs, which uses insurance claims data along with manufacturers’ adverse event reports. That proposal supports adding bar codes on medical devices, a system that is being phased into practice over the next several years. However, those unique identifiers won’t be helpful unless Congress requires medical professionals to include those bar codes on insurance claim forms.
The system would flag cases where patients required emergency treatment or developed infections after a procedure, and could help officials identify trends that required investigation. The information would also help identify patients who had implants that were recalled or help hospitals in removing equipment found to be defective.
The new FDA commissioner, Dr. Robert M. Califf, says he supports a new surveillance program for medical devices that relies on data. He told senators last November:
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.
But it won’t be cheap to revamp the system. Lawmakers say it could cost as much as $250 million to implement and maintain a new surveillance system over the next five years. However, it’s needed and it’s also the right thing to do.
Source: Washington Post
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