New Federal Warning System Could Identify Dangerous Medical Devices

Posted on February 15, 2016 by Shapiro Law Group


Medical devices can be extremely useful for diagnosing patients with health conditions, but these tools can also cause significant problems for patients.

For example, duodenoscopes are used in tens of thousands of medical procedures, but are difficult to clean and could expose patients to superbug infections. Almost 200 patients in the U.S. developed infections from procedures involving duodenoscopes from 2012 to 2015. Duodenoscopes are a good example of how medical devices can risk the safety of patients.

Congress wants to develop new policies that would make medical devices safer to use. Lawmakers argue the current Food and Drug Administration (FDA) surveillance system for medical devices puts too much reliance on manufacturers to report design defects or other risks. By the time a medical device is discovered to be dangerous, dozens of patients could have already been affected.

A new surveillance system would use ‘device IDs’ that could allow federal regulators to trace instances of adverse events. These device IDs could be compared to vehicle PIN numbers, which investigators and regulators use to tie defects to specific automobiles. Device IDs would also be used on insurance claim forms, which could help regulators weed out dangerous medical devices with more ease. Instead of waiting for manufacturers to report defective products, the FDA would use insurance form data and device IDs to spot adverse events and remove dangerous medical devices from hospitals.

Dangerous Medical Devices Should Be Removed from Hospitals

It is inexcusable to not have a system in place that can quickly identify dangerous medical devices before patients lose their lives or suffer catastrophic injuries. Having a more effective reporting system and an efficient means to identify dangerous medical devices could potentially save lives.

Shapiro Law Group is a Tampa Bay-based medical malpractice law firm dedicated to helping victims of dangerous medical device manufacturers and negligent healthcare practices.

Tags: PatientCare


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