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Are you ready for a recall?

February 04, 2020
From the January/February 2020 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.

Crystal Geibel
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.

Mark Cohen

Recall Management & Compliance - now available at no cost

February 06, 2020 10:36

This article was right on target with one of the greatest problems today that very few seem to know. It might interest those who read it to know that as long as grants currently exist, it is possible to have complete recall alerting, management, tracking, tracing, matching and reporting compliance from the non-profit National Recall Alert Center - www.recallalert.org. Please check it out while the grants paying for their service are still available.

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Kate O'Rourke

Proud to Work with St. Luke's

February 12, 2020 10:19

I love this article! Congratulations to Crystal and all of St. Luke's on a wonderfully successful program. We at ECRI are proud, and privileged to say that we work work with you. Your thoughtful insights and approach to recall management have helped us to make our Alerts Tracker solution better and better. Here's to continued success.

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