![]() Though it was initially submitted for PMA approval, it was approved through the 510(k) process. The da Vinci Surgery system is a medical device designed to allow physicians to perform surgery from a remote console. In "The Bleeding Edge," an example of the lack of training for new devices was illustrated with the da Vinci Surgery system. Physicians receive little to no education about many new products, but they’re often prompted to begin using "new" and "innovative" devices. Physicians Don’t Receive Enough Educationĭoctors have a lot on their plate, and they may view the safety of products entering the market as the FDA's responsibility. The adverse event database may only include the tip of the iceberg. There are potentially a lot more unreported adverse events, according to the film. Though its mandatory for manufacturers, importers and device user facilities to report problems, reporting from health care professionals, patients and consumers is voluntary. "There is a system for reporting complications, but there’s tremendous underreporting because it’s a voluntary system," Kessler said. But the agency's Manufacturer and User Facility Device Experience (MAUDE) system, which houses adverse events for medical devices, is based on self-reporting. When there's a problem with a medical device, companies are required to report it to the FDA. They stated that their reported experiences with the permanent birth control device had been altered in the trial results, making the device appear safer than it is.Īnother issue is the reporting of medical device adverse events. ![]() The film illustrates this with the case of Essure by interviewing women who were a part of the clinical trial. In the film, it's suggested that manufacturers have an influence on the outcome or perception of the trials. However, 70 percent of biomedical research is funded by the manufacturer. With a PMA, medical devices are regarded as a new product and clinical testing is required. “It became the rule, so that the vast majority of devices today regrettably are regulated under this framework.” “That provision, which was meant as an exception, in essence, is a loophole,” Kessler said. But it can still be used as a basis to allow another device to enter the market. When a 510(k) process is used, the predicate device may have failed. Substantial equivalence indicates the devices don't need clinical testing. The vast majority of devices are approved through the 510(k) process, meaning they're regarded as substantially equivalent to other devices. “When it comes to medical devices, we built a system that doesn’t work,” Kessler said in "The Bleeding Edge." Medical devices are approved through two processes: a post-market approval (PMA) or a 510(k) clearance.ĭavid Kessler, the former FDA commissioner from 1990-1997, is a former agency staff member speaking out to highlight the issues in the regulatory process. Food and Drug Administration, with a dedicated division specifically intended to regulate the safety of medical devices. In 1976, the Medical Device Regulation Act, also known as Medical Device Amendments, ushered in the modern method of medical device regulation. The Bleeding Edge outlines the current system and shows how the outdated process doesn’t work well for medical device regulation. Medical Devices Are Poorly Tested and Regulated Here are MedTruth's major takeaways from "The Bleeding Edge" documentary: 1.
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