Medical Device Recalls: What Patients Need to Know?
A patient comes in with some worrying symptoms, which you decide can be solved with a pacemaker. The patient accepts your decision, and the operation goes ahead smoothly. But just a few days later, the patient returns -- and things have become much worse. Little did you know, the pacemaker was defective. On top of that, judging by the patient’s history, a pacemaker may not have been the best option either. Could this have been avoided?
The medical device recall industry: the damage
Millions have suffered injuries and over 80,000 have died because of cases like this. Recalls have a $6 billion impact on the healthcare systems, from litigation payouts, to the costs of managing the recall process. The tragedy is that it is largely preventable.
Poor quality, counterfeit and expired medical products and devices hurt front-line doctors, nurses and patients. Many sophisticated implants that are meant to prolong life can cause infection or even death in patients.
How can healthcare providers, and patients, reduce the risk of medical recalls?
At present, the onus is on healthcare providers -- to check the devices and products, to speak to patients, to ensure stock is kept up to date. But what if patients were able to look out for themselves?
To change the impact recalls have, we need our patients to be as aware as we are. We can be patient advocates, but to be effective, some of the advocacy needs to come from the patients themselves..
Did you know these facts about recalls?
Medical device recalls from manufacturers are a growing problem. The FDA shows 48 medical device recalls in 2019. That compares negatively to just 32 medical device recalls in each of the previous two years.
Counterfeit medical devices are a global problem, not limited to developing countries. The World Health Organization estimates that 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
Every implant has an expiry date. That includes everything from pacemakers to titanium knee replacements and silicone breast.
Quality is job 1? When it comes to medical devices design, maybe not. Device design was the most common cause of FDA-determined recalls in recent years.
One of the biggest reasons for recalls is that in 99 percent of cases, medical devices never have to provide clinical data in the first place (The FDA requires the “least burdensome route” to approval). The recall often comes after faulty devices have already hurt patient outcomes.
The more informed patients are, the better outcomes we can all hope for. While healthcare staff, doctors and nurses, are experts in their fields, the patient will always be the most invested in their own wellbeing -- which is why an extra nudge and check on their part should always be welcomed and encouraged.
