When a recall gets issued for food, toys, consumer electronics or other consumer items, you'll often hear it announced on the nightly news. Sadly, there isn't the same degree of proactiveness among media outlets in getting the word out about medical device recalls. A smartphone app that has recently been released on the market may make it easier for consumers to become aware of device recalls though.
On June 28, the U.S. Food and Drug Administration (FDA) announced the recall of various Medtronic MiniMed insulin pumps. It was discovered that they have the potential to be hacked. The recall includes the Medtronic MiniMed Paradigm and Medtronic MiniMed 508 insulin pumps.
Loud noises and the military go hand in hand. Whether coming from zooming airplanes, the constant crackling of firing weapons, or the persistent humming of large engines powering battleships, the men and women in the armed forces are under siege by the constant bombardment of noise. To protect service members from irreparable hearing loss, military officials require hearing protection around environments that produce deafening noises.
Late last month, the U.S. Food and Drug Administration (FDA) issued a recall of a circular surgical stapler, called Ethicon. The device, which was manufactured by Johnson & Johnson, is considered to be a high-risk Class I recall.
Earlier this month, the U.S. Food and Drug Administration (FDA) issued a warning to patients that have previously been outfitted with Medtronic pacemakers and defibrillators. They noted that their wireless communication systems (WCS) can be hacked into by cybercriminals.
A report published earlier this month by Stericycle Expert Solutions, a U.S. company that manages product recalls, highlighted how problems with software resulted in a significant number of recalls of medical devices during the final three months of 2018. This reason mirrors what has been recorded during previous quarters by the company in their "recall index".
On Nov. 26, 2018, the Food and Drug Administration (FDA) announced that they plan to overhaul the vetting system that has been used to approve medical devices for release on the market for the past few decades. The action comes on the heels of reports showing how many previously approved devices have caused consumer injuries.
Doctors commonly insert inferior vena cava (IVC) filters into the body's largest vein in order to reduce a patient's risk of developing a blood clot after suffering an injury or having a surgery performed on them. They're used as an alternative to prescription blood thinners for those at risk for either deep vein thrombosis (DVT) or a pulmonary embolism (PE).
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.
Alere, a company that manufactures various medical devices including diagnostic machines, settled a $33 million dollar claim with the government over claims it sold hospitals unreliable testing devices. As a result, the hospitals ended up submitting fraudulent claims to Medicaid and Medicare.