A five-year study carried out by Stericycle Expert Solutions shows alarming trends when it comes to why medical devices are recalled. Researchers found that 25.7 percent of them in the final quarter of 2017 had software flaws that prevented them from functioning as intended. This wasn’t a new trend. This had been the leading reason for recalls for seven quarters.
The lead researcher on the study says the reason that so many medical device manufacturers have been plagued with software failures is that they’ve often prematurely released their products on the market. He notes that many of these companies find themselves is a rush to put their latest innovative technology on display, so they don’t enough time to work out the kinks that their technology may have until after it’s already out there.
As for the second most common reason that medical devices are recalled, researchers found that it has to do with sterility.
One of the largest recalls resulting from sterility issues in recent years was in 2013. In that instance, at least 102 million devices were recalled after an investigation showed that they were not handled according to proper sterility protocol. The second largest recall for this reason happened just last year. As many as 54 million devices were impacted.
The research also revealed that Class I recalls, ones that pose the highest risk of serious injury or death to patients, have been steadily increasing during the last three years. During 2017 alone, at least two million defective medical devices were recalled by their manufacturers.
If a recalled product has led to a decline in your health, then a Houston defective medical devices attorney can advise you of your right to file a lawsuit to recover medical expenses and damages for pain and suffering.
Source: Medical Design & Outsourcing, “Software is a top cause of medical device recalls: Here’s what you can do,” Heather Thompson, accessed June 08, 2018