From the January/February issue of HealthCare Business News magazine
By Valerie Dimond
Drug and medical device recalls continue to roll in at record-high numbers with little sign of letting up.
In fact, medical device recalls increased more than 21 percent to 243 in the third quarter this year, according to Stericycle's most recent Recall Index. The report also revealed that recalled units increased by a staggering 1010.8 percent to 219.2 million — the greatest number of units pulled in a single quarter since 2005, although one of the recalls was responsible for 83 percent of all recalled units. Software issues remain the leading cause of recalls followed by quality issues, device failures, and problems related to sterility, parts, and specs.
Pharmaceutical recalls are also a continuing problem, with deviations from the FDA’s Current Good Manufacturing Practice (CGMP) regulations accounting for 25 percent of all recalls and 93.1 percent of all recalled units. The issue is expected to create ongoing supply chain challenges because “as long as drug makers rely on the current complex web of global suppliers and production facilities, we will continue to see quality concerns,” report the Index authors.
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Implementing an effective recall management program is essential to preventing patient injury, long-term health complications and death caused by defective products. This means it’s up to healthcare systems to remain super-vigilant about when recalls occur and respond immediately, yet some still struggle with the knowledge and/or appropriate resources and tools necessary for developing an effective strategy.
St. Luke's Health System in Boise, Idaho, used to be one of those systems. But today they have a robust program in place that has allowed them to reduce unresolved alerts by 95 percent, cut resolution time from one month to three days, and increase the percentage of recalls completed within three days from 55 percent to 98 percent. Plus, over the last year, 100 percent of all critical recalls (e.g., defibrillator failures, surgical items breaking inside patients) have been resolved within 24 hours across the entire St Luke’s Health System.
These improvements began after a serious incident related to recalled infant formula prompted Paul Lambert, system director for supply chain operations, recall analyst Crystal Geibel, and others at St. Luke’s to conduct a comprehensive review of their recall management program, identify the cracks, and seal them up with solid solutions.