The Institute of Medicine (IOM) recently completed a yearlong audit of the 510(k) Medical Device Approval Process and reached shocking conclusions.
The 510(K) Approval Process has been around for 35 years and was enacted in 1976 when the FDA was given responsibility for medical devices. This process allows medical devices to enter the market if they are found to be “substantially equivalent” to products already in the market. Essentially, it gives medical device manufactures a means of by passing what would otherwise be a much lengthier and costly approval process. This way medical devices are able to reach the market sooner to the benefit of patients who in some cases, cannot afford to wait. Sooner means roughly a ten month process as opposed to possibly years of a complex testing.
Arguably a lot of patients benefit, however the lax review process does open the door to possible devastating results. For example, the failure the DePuy ASR hip implant which affected over 90,000 recipients of the hip with life altering health problems. There are of course many other examples, and certainly the risk is high for future issues considering the review process accounts for a shocking 90 percent of medical device applications.
The IOM concluded that the 510(k) approval process is “fatally flawed” and argued replacing the entire process with a new framework. To support its conclusions the IOM claims that the process does not adequately protect patients nor does it promote innovation. Furthermore, it found that medical devices are able to enter the market by establishing substantial equivalency to much older devices that predate any complex FDA review. In other words, medical devices can enter the market by being compared to older devices that have never been tested to be safe. Finally, the IOM further stated that there is no sufficient means of monitoring the approved devices after they have entered the market. Thus, the IOM proposes that the current 501(k) approval process needs to be terminated all together. In its place, a new framework should be developed with a more comprehensive review process and a means of monitoring post-market data.
In response however, the FDA dismissed the IOM’s proposals. Rather the FDA is more focused on improving the current process than scrap it all together. One improvement suggested has been the development of a new category for riskier devices which may demand more heighted scrutiny than “substantial equivalence.” Whatever the outcome, the IOM’s radical report sheds light on the fact that countless consumers will remain vulnerable until something is done.
If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.
