Medical Devices usage is rampant. By 2020 the sales revenue and international trade value for the global medical device (MD) market are expected to reach $543.9 billion and $289.2 billion, respectively. These figures look interesting and promising for the healthcare sector. Unfortunately, the large volume and high profits also raise concerns about the safety and efficacy of these devices. The fact that these devices are FDA approved should provide some comfort, but it is not clear that FDA approval equals patient safety.
As a standard protocol, every medical device passes the regulatory standards set by FDA in one of two ways:
In comparison, the regulation of 510(k) devices does not mandate that the efficacy and safety of the device be proven via clinical trials, unlike PMA requirements. On an average, the 510(k) process takes less than six months for the approvals, which makes the 510(k) process less time consuming and convenient for the manufacturers. On the flip side, a research study by Marcus in 2016, showed only 45% of the devices which were included in the clinical studies received approval. In comparison, 79% of devices submitted via 510(k) were approved. The statistics studied in 2015, showed that 3,006 devices were approved through 510(k) compared to only 43 that used the PMA process. According to a trusted source, as of March 2017, more than 15,000 medical devices were approved through 510(k) process.
Every person with a medical condition is hoping for a quick and easy recovery, but the challenge of safety and reliability does not always match up with that desire. In fact, with the increasing number of devices that are being quickly approved through the 510(k) process, there is a concern that this may result in an more device failures and recalls. Of the 113 devices recalled between 2005 and 2009, more than 70% were approved through the 510(k) process, and about 7% of these devices were exempted from FDA regulation.
One more interesting study done in 2016, by Day CS for FDA-Approved Orthopaedic Devices, reveals that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices. In another recent study in 2017, involving numerous medical devices relating to women’s health (like transvaginal mesh, the power morcellato, and intrauterine devices) found 83 unique recalls affecting more than 88,000 medical devices. 43 percent of these devices were cleared through the 510(k) process.
Recalls are initiated either by the manufacturer or the FDA. Consumer issues are first registered with the FDA. Recalled devices are either determined to be defective or found to cause injury to patients. Many consumer products such as IVC Filter, Mirena IUD, Essure IUD; likewise Surgical equipments for instance Bair Hugger Surgical Warming Blanket, Stockert 3T Heater-Cooler Systems, and Morcellators are all currently in litigation. MDL 2570, MDL 2434, MDL 2652 , and many more cases allege that injuries were caused by such 510(k) approved devices and plaintiffs are still awaiting justice.
Quick short-cut approvals, easy access to devices, lack of safety data, and an increasing number of recalls, all undermine consumers’ trust while victims and their families await justice.
This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email us at email@example.com or call +1-844-NIT-TEAM (648-8326).