How do you feel about a product when you hear that it’s FDA-approved?
Usually, pretty good.
You feel comfortable using the product, and that it’s safe.
Unfortunately, the actual harm that has come to thousands of people who have trusted FDA-approved medical devices is making many lose confidence in this supposed seal of approval.
It’s unfortunate that as time goes by and technology gets better, the rate of failure of medical devices continues to go up.
One possible reason for this, according to analysts, is that the FDA is rushing approvals through without taking the time to properly test the devices.
Here are a few statistics about medical device recalls from recent years that surprised us:
More medical devices are recalled because of software issues
The number of medical device recalls caused by a software problem increased from 243 in 2015 to 301 in 2018
Again, you’d think that due to ongoing advancements in technology, they’d be able to work out the kinks and get better results, not worse.
So why have software issues have shot to the top of the list of reasons for recalls?
According to Stephen Grimes, principal consultant and managing partner for Strategic Healthcare Technology Associates, LLC:
“As an increasing number of medical devices become software-based, it poses a significant challenge to the entire industry because of the correlation between software and cyber vulnerabilities, as well as the inherent difficulty in testing software for all possible failure modes.”
Medical device recalls, as a whole, are rising
The first quarter of 2018 saw a 126 percent increase in medical device recalls.
This jump in recalls of 126 percent is quite alarming.
In all, 208 million units were recalled.
A report issued by Stericycle Expert Solutions reveals that there were 343 separate recalls.
Breaking the numbers down further shows that an average of 607,000 units per recalled device were affected.
Unsurprisingly, software issues were the main reason for the recalls.
Of the 343 recalls, 78 were recalled due to software issues. The next highest recall reason was mislabeling issues, causing 73 recalls.
Recalls for the remainder of 2018 weren’t as high as the first, but still high in their own right.
Here are the total number of recalled units per quarter in 2018:
- Quarter 1: 208.5 million
- Quarter 2: 42.4 million
- Quarter 3: 29.4 million
- Quarter 4: 161 million
If you or a loved one have questions about a medical device or have been affected by a faulty medical device, know that you’re not alone. Contact the knowledgeable and experienced Tennessee medical device lawyers at Gilreath & Associates to get answers to your questions, get help navigating through the process, and obtain the compensation you deserve.