Mastering the practice of medical device quality control and assurance is a fine and challenging art, too. Much like the pursuit of perfect English, it also is an imperfect process. For example, do you recall the most recent medical device recall? You should. There have been plenty of them recently,
according to a recent report.
A quarterly index by Stericycle ExpertRecall (an Indianapolis, Ind.-based firm that helps life-science companies manage recalls), reported that 242 medical device recalls were announced by medical device companies during the second quarter, which affected nearly 123.5 million individual units. There were about 82 million units affected by recalls in the previous quarter. This number also reflects an eight-quarter high, breaking 100 million units for the first time since the third quarter of 2010. Three of the recalls affected more than 10 million units. Second quarter 2012 recalls impacted 50 percent more units compared to the previous quarter and almost eight times as many units as recalls documented in the second quarter of 2011. The medical device category of the report, which also indexes recalls for pharmaceuticals, food, consumer products and children’s products, includes such products as knee replacements, syringes, gels used in ultrasound procedures, dental implants, and products used in heart surgery.
“The fact that more than 120 million medical device units were affected by recalls last quarter cannot be ignored, particularly because it comes during a time when America’s 50 million aging baby boomers are placing increasingly high demand on life-saving medical devices,” said Mike Rozembajgier, vice president of recalls at Stericycle ExpertRecall. “The growing importance of this product category means that companies need to have a comprehensive recall plan in place that can be deployed within the blink of an eye and can effectively protect their customers and brand.
Manufacturers, suppliers, hospitals and retailers must also continue to stay diligent in their efforts to ensure product and consumer safety in an ever-changing environment, particularly in light of recent proposals by the FDA (U.S. Food and Drug Administration) to track medical devices.”
Companies hit by recent recalls include many of the medical device industry’s biggest names.
Covidien has had a few this summer. In June, CareFusion recalled a ventilator due to potential patient risks. The company also announced a voluntary recall of its AirLife infant breathing circuit in May. In July, Abbott Laboratories recalled reagent kits. General Electric Co.’s healthcare division recalled X-ray machines due to faulty wheels and casters. Not to be left out, Johnson & Johnson, in August, recalled a line of hemorrhoidal circular staplers and accessories due to the potential of a misfire.
(Wow, let’s not go there.) Also in August, J&J’s DePuy orthopedic division launched a recall of all unused custom implants, a product line the company discontinued after receiving a warning letter late last year.
But large companies aren’t the only ones feeling device recall woes. Small and midsize companies have gone down the same path.
In the second quarter, 142 companies were affected by at least one recall. Of these companies, nearly one-third faced more than one recall. A total of 7 percent of the number of recalls in the second quarter were Class I (the most severe), up from 4 percent in the first quarter of 2012. However, Class I recalls affected less than 1 percent of the total number of units recalled.
Of the documented recalls, 70 affected customers nationwide, and 161 affected customers in the United States and at least one other country or territory. Ten recalls hit U.S. customers in limited geographic regions. One recall affected only customers outside of the United States, according to Stericycle consultants.
And, of course, recalls happen for all sorts of reasons. For example, according to the FDA, software failures were behind 24 percent of all the medical device recalls in 2011. But no matter where you are located, what the size of your firm is, or what led to the recall, preparation and proper training to respond are not to be overlooked or taken lightly.
“Every FDA-regulated firm needs to be prepared with a vetted standard operating procedure in place for recalls so that it is ready when that unexpected recall develops,” said Willie Bryant, a former FDA senior recall coordinator and now a Stericycle consultant.
Throughout the coming months, MPO will explore how companies can avoid recalls, better respond to them when they happen, and how they can best manage supplier relationships as part of the solution. Be sure to check it out … if you recall.