Medical device recalls and issues have been doubling over the past few years. In fact, since 2003, the United States Food and Drug Administration (FDA) has stated that there have been steep increases in the number of recalls. The FDA attributes these increases to the enhanced interaction that people have with drug and medical device manufacturers, as well as safety initiatives that were expanded over the past few years by the FDA to stop defective devices quickly.
What Has Been Recalled?
Some of the recalls seen as of late include:
- Cardiovascular devices
- Transvaginal mesh
- Metal on metal hip replacements
- Linear accelerators
- CT scans
Software Issues Are A Common Reason for Device Recalls and Malfunctions
The most common reason for the device recalls over the past few years has been attributed to software issues and failures. These made up for 15 percent of the device recalls issued in 2010 and 2012.
With more medical devices focuses on software over the past few years, these percentages are no surprise to the FDA and other regulators.
Other common recall issues were attributed to material or component issues, packaging problems, labeling issues, and process control problems.
The most common type of device recalled due to software failure was radiological devices. Other software devices recalled include chemistry products, general hospital equipment, and cardiovascular devices.
Domestic Devices More Likely to Face Recalls
When FDA researchers examined the bulk of the device recalls over the past few years, they noted a trend that indicates domestic devices are more likely to be recalled than foreign devices. In fact, 80 percent of those recalls were made in the United States.
The FDA attributes this rise to reporting required by United States-based companies, combined with the under-reporting most likely occurring through foreign manufacturers. Also, domestic companies have a higher risk for being investigated and scrutinized by the FDA. However, foreign device recalls are equally on the rise. Some countries where foreign manufacturers are subject to FDA regulation include Australia, Canada, and those manufactured in Brazil.
Quality Assurance is Obviously the Biggest Issue
The most obvious issue is that quality assurance needs to be improved in these domestic companies. Some are allowing products to enter the market with as little testing as possible, which then results in device malfunctions later, and large recalls that impact patients.
Software should be implemented in the quality assurance and compliance programs through the FDA, since more devices will rely on software and other technology. Also, medical devices today are highly complex compared to those made just a few years ago; therefore, the FDA needs to step up their investigatory processes and potentially increase the number of regular inspections done on these technological advancements to ensure that they are safe.
Manufacturers must implement more verification testing, design change management processes, and design control protocols to ensure their software-based products are safe.
Speak with a Medical Malpractice Attorney if You Were Injured by a Defective Medical Device
If you or a loved one was injured due to a faulty medical device, whether it was recalled or not, you may be entitled to compensation. Contact the attorneys at Carey, Danis & Lowe Attorneys at Law today toll-free at 877-678-3400 or request your consultation appointment online.
