Both manufacturers and the FDA alike aim to continuously reduce the number of dangerous devices on the market. However, Q2 Of 2022 saw the highest number of recalls in the last 2 years. Below, we’ll cover some of the factors leading up to this two-year high as well as analyze some of the numbers behind these medical device recalls to get a better sense of the situation.
Which Categories Of Medical Device Recalls Were The Largest Contributing Factors?
We have established that medical device recalls hit a two-year peak overall in Q2 of 2022. By diving deeper, however, we can begin to better understand the most significant contributing factors. Once we gain insights from context, we can also begin mitigating the risks that arise from the circumstances.
Breaking Down The Factors
According to Sedgewick’s Recall Index 2022 Second Edition, the topic of safety topped the list of medical recall contributors in Q2 of 2022. They made up 48 of the recalls in that quarter, closely followed by issues concerning software at 47. After that followed mislabeling, parts, and quality concerns.
Overall, Q2 of 2022 had 268 medical recall events which is a marked rise in events of about 34% from the year’s first quarter. This is 10% higher than the quarterly average of the 5 years before it. Is that driven by an additional 1 million adverse event reports received in 2022 over the 2021 figures?
Quality issues specifically affected around 5 million units, but just two medical recalls were responsible for about 4 million of the affected units. Defibrillator pads accounted for over 1.8 million units, and DNA kits for about 2.17 million units. The remaining reasons for units affected were cited as safety, mislabeling, sterility, and devices out of specification.
The proportional severity of recalls in that quarter resembled that of other years with class II recalls making up the majority of medical recalls at 234 recalls. Class I recalls are the most severe type, as the products associated with them are likely to lead to injury if not death. That said, class I recalls were worryingly high (21 class I recalls) that quarter relative to all other quarters in the 15 years preceding it.
COVID-19 Test Kits
One large contributor to 2022’s second-quarter medical device recall uptick is the chaos of the pandemic. We touched on this in a previous article if you would like to see more details about it. However, there were 9 recalls regarding different COVID-19 antigen test kits in that quarter alone. These recalls were made due to products that were not approved/cleared for distribution and sale as well as safety concerns. This may have contributed to why safety concerns were the top reason for medical device recalls that quarter.
How To Get Ahead Of Medical Device Recalls
Thankfully, recalls mean that unsafe medical devices are taken off the market and kept far away from patients they can potentially harm. However, many unsafe medical devices cause harm well before the FDA can issue a recall. This means that waiting for information to come to you is a major liability. Instead, monitoring medical device adverse event reports (MDRs) surrounding medical devices is the best preventative action you can take. Primarily medical devices your organization relies on, but also ones your organization is considering investing in before they buy. MDRs’ complexity make both finding and decoding them easier said than done through traditional data gathering and analysis methods.
Device Events, however, offers a solution. Our company offers easy-to-use software that makes finding relevant MDRs and spotting problem devices more efficient than ever. With us, you can search through millions of MDRs without wasting time trying to decipher the original reports’ technical industry language. Furthermore, you can define parameters to filter out everything except the exact elements you are searching for.
Curious to see how Device Events’ software can drastically shift the line of defense in your favor? Contact us today.