As published in the Internal Medicine Journal of the American Medical Association (JAMA), Yale University researchers have uncovered a dangerous trend related to medical device safety evaluations. The study found that older patients, women, and minorities were underrepresented in clinical trials. Although this may seem a minor oversight on the part of those who evaluate the safety of medical devices, it is not.
Problems With the Medical Device Safety Evaluations
The study found multiple problems with the medical device safety evaluations conducted by manufacturers seeking approval by the U.S. Food and Drug Administration. The timing of this study could not be more important. The 115th Congress has two related bills pending in the House and Senate related to the issue. Titled the FDA Reauthorization Act of 2017, HR 2430 and S 934 address medical devices in Title VII.
Currently, Congress is not going to require the FDA pass new rules on evaluations. In the study by Yale, it was found that only 17 percent of the studies accounted for the gender of the participant, only nine percent for age, and four percent for race. This can pose serious problems because as most research shows not every patient responds the same to a medical device; gender, age, and race can play a role.
By ignoring these factors, medical product manufacturers are setting up patients for serious side effects. This study also shows that leaving the issue of properly evaluating medical devices for defects up to the manufacturers will lead to cut corners. Congress, with the FDA Reauthorization Act is leaving that door open.
Another problem the Yale researchers found was that the data reported could not be properly assessed. The team could not determine whether manufacturers’ reported findings were evaluated based on direct analysis or statistical data. This means that the findings reported to the FDA under current and proposed rules lack clinical significance.
Finally, the researchers discovered that, despite rules requiring regular analyses of medical device safety, the evaluations occurred on an infrequent basis.
Although the United States Congress is in the process of rewriting the rules under which medical device manufacturers report to the FDA, the proposed legislation is severely lacking. The proposed FDA rules will allow medical device makers to continue evaluations as they have in the past. The purpose of the Yale study was to learn whether the current processes used to evaluate the safety of medical devices is adequate based on current medical understanding. The team found they were not.
Philadelphia Medical Product Liability Lawyers at Brookman, Rosenberg, Brown & Sandler Represent Individuals Harmed by Medical Devices
This has the potential to impact millions of patients each year. One implant may be perfectly safe for men and dangerous to women. Another may be excellent for one race and deadly to another. Just because a device is safe for younger patients does not make it safe for seniors. The makers of medical devices are clearly falling short of protecting their customers and doing so with the approval of the FDA.
The Philadelphia medical product liability lawyers at Brookman, Rosenberg, Brown & Sandler represent those who have been harmed by defective devices. If you or someone you love has been harmed by a faulty medical device, arrange a free consultation by contacting us online or by calling either 800-369-0899 or 215-569-4000. We serve clients in Pennsylvania and New Jersey, especially Delaware County, Chester County, and Philadelphia County.