In a perfect world, a company's quality control procedures would prevent the distribution of products and devices that are defective or otherwise pose a danger to consumer. But as you know, we don't live in a perfect work — and therefore dangerously defective products are an unfortunate reality, even in the medical field.
Studies report that drug and medical device recalls are on the rise in 2018 and there are reasons to believe this tragic trend will continue.
What is a defective product recall?
A recall is when a manufacturer removes a defective product such as a medical device or pharmaceutical drug from the marketplace, or issues a correction because the product poses a risk to the health of patients.
Recalls are usually conducted voluntarily by the manufacturer, but the U.S. Food and Drug Administration (FDA) has authority to issue a mandatory recall order if the manufacturer fails to recall a device or drug that should have been recalled.
The FDA classifies medical device and drug recalls into three groups based on the apparent danger the product poses to a patient:
- Class I: the product has a reasonable chance of causing a serious health problem or death;
- Class II: the product may cause a temporary or reversible health problem, or there is a slight chance the product will cause a serious health problem or death; and
- Class III: the product is not likely to cause a health problem.
How dramatic is the rise in medical device and drug recalls?
According to a report by Stericycle Expert Solutions, drug and medical device recalls have risen sharply in 2018. In the first financial quarter of 2018 (Jan-Mar), recalls rose 126 percent from the previous quarter (Oct-Dec 2017).
The second quarter of 2018 (Apr-Jun) managed to surpass the first quarter by 17 recalls, with the average recall affecting 607,000 units. This resulted in the most medical device recalls in any financial quarter since 2005. Medical device recalls decreased slightly in the third quarter (Jul-Sep 2018), but there were still more recalls in the third quarter than there were in any quarter in 2017.
Perhaps even more alarming is that the number of serious medical device recalls has been trending upward. Class 1 medical device recalls have increased steadily over the past three years. In 2018 alone, Class 1 recalls impacted over two hundred million units.
While medical device recalls often fluctuate from quarter to quarter, there are reasons to believe the recent trend will continue.
On top of medical device recalls, pharmaceutical drug recalls have also risen this year. In the first quarter of 2018, there were 105 drug recalls, with about 332.5 million units of pharmaceutical drugs recalled.
Why have recalls increased?
Software issues have been the top cause of medical device recalls for ten financial quarters in a row. Considering the rapid pace of technological growth, this should come as little or no surprise. Medical device manufacturers (also known as med-tech firms) are constantly pushing the limits of what is possible. Often, this results in significant health gains.
For example, according to a 2018 study published by the Harvard Business School, it's estimated that med-tech innovations have added approximately five years to life expectancy and reduced hospital stays by more than 50 percent since 1995. However, as med-tech companies rush to be the first-to-market with the latest innovations, and as medical devices continue to get smarter and more complex, the opportunity for something to go wrong increases as well.
Perhaps the most illustrative example of this is the recent medical device recall issued by Abbot. In 2017, Abbott voluntarily recalled almost 500,000 pacemakers due to a cyber-security issue. The problem? The pacemakers could be hacked into and the hacker could drain the battery of the implantable device or cause it to administer inappropriate shocks.
Corrections to medical devices suffering from software issues generally come in the form of software updates, which themselves present the potential for new issues – as anyone with an iPhone knows. Juuso Leinonen, a senior project engineer at the Emergency Care Research Institute explained:
“With any update to any device, there's always the potential of something going wrong during the update process. We're talking about life-sustaining devices. Disruption[s] . . . could result in harm.”
When it comes to recalled pharmaceutical drugs, foreign materials and failed specifications have led to a dramatic increase in the number of recalls in the industry according to experts.
What devices were recalled in 2018?
So far in 2018, medical device recalls have ranged from headrest systems to resuscitation devices. Perhaps the most publicized recall concerned intra-aortic balloon pumps (IABP's), which are used on critical patients to increase blood flow immediately after a heart attack. The reason for the recall? The IABP's simply failed when used above certain altitudes.
To find a continuously-updated list of medical device recalls, take a look at the FDA's recall database. As of the day this post was published, there were 27 defective medical device recalls listed in 2018 alone. This number doesn't include defective drugs.
What should you do if you've been hurt by a defective medical device?
Keep in mind that state law places certain limitations on how long you can wait until your claim expires. The legal term for this time limit is the “statute of limitations,” and it can vary depending on the state where you live and the facts of your case. For this reason, it's important that you speak with an attorney as soon as possible if you think you might have a case.