Unlike the makers of pharmaceutical drugs, those who manufacture medical devices apparently receive little oversight. Some critics report that the few rules the FDA issues to device manufacturers are often ignored with impunity. In fact, the U.S. Food and Drug Administration has re-assessed its own policies for evaluating medical devices. Unless changes are made, some fear that patients in Ohio and elsewhere may be at risk when those devices are used as part of their medical treatment.
Within 30 days of learning that a medical device may have caused an injury, pharmaceutical companies are required to report those injuries to the FDA. However, at least one company withheld over 1,000 reports related to a certain device used in back surgeries. The FDA apparently did nothing to discipline the company for its delinquent and often incomplete reports. In fact, the FDA says such practices are efficient and beneficial to public welfare. Nevertheless, thousands of patients who were injured by the device are now filing lawsuits.
Some safety advocates are highly critical of the FDA’s history of approving medical devices with little to no research. Until recently, the agency defended this practice. Now, a new website invites patients, as well as doctors, to report any injuries that may be related to medical devices. This development comes on the heels of an FDA investigation of more than a dozen hospitals that failed to report adverse incidents involving medical devices.
Health and safety watchdogs remain skeptical of the new policies the Food and Drug Administration has launched. They feel the agency is more concerned about protecting the devices than protecting patients. It remains to be seen whether the agency will follow through with consequences when medical devices lead to the injuries or deaths of patients. Meanwhile, those in Ohio who are adversely affected by faulty medical devices have recourse to the legal system by contacting a dedicated lawyer for help in pursuing potential damages.
Source: consumeraffairs.com, “After years of criticism, FDA tries to step up oversight of medical devices“, Amy Martyn, Oct. 27, 2016