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.

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.

“The St. Luke’s Health System Internal Audit team investigated the need for a systemwide recall program,” said Geibel. “Variable response practices were found throughout the health system that weren’t serving our patients’ need, nor systematically providing the documentation we needed for Joint Commission’s Element of Performance EC.02.01.01 EP 11 requirement that we respond to all types of items, identify responsible parties, and document actions taken. This documentation is also important for FDA audits and responding to supplier audits.”

Lambert says when they realized they needed an automated, centralized program for managing recalls, they took several steps to make it happen. “We hired a competent analyst, investigated industry best practices, created the recall program model, communicated with system leadership, chose a recall software program, onboarded end-users to the recall program, defined roles in a RACI matrix, created a reporting dashboard, and produced a system recall policy,” he said.

“Once we had the software, people, governance, and standards in place we focused on the five levers for employee engagement: competent manager, contextual goals, objective metrics, resources, and autonomy,” Geibel added. “Centralization is important for standardization, including communication, response standards, and escalation, so the information can be accessed for an audit. It’s also important that the information from recalls is automatically shared with local employees who can take action. We use an already developed software program to coordinate the publication, assignment, and storage of alerts and their responses. We also partner with our software provider to help them continue developing the software program we will need.”

Gaining full support and involvement from leadership was also imperative to the program’s success. St. Luke’s chief quality officer and program sponsor Dr. Bart Hill is fully engaged and invested in the initiative, as is the organization’s chief executive officer Dr. David Pate. “For a health system of over 14,000 employees it is impressive he not only knows our program and our standards but has also had goals for us,” said Geibel.

Lambert and Geibel point to purchase order spending and standardization of product acquisition as key focus areas for enhancing recall readiness. “Without full integration of purchase history, health systems must address product recalls that may not impact their facilities,” Geibel explained. “Once we have full purchase history integration, we can focus on how we can assign recalls by the location that purchased the item, potentially reducing the workload by more than 85 percent.

“When we present and hear that health systems aren’t measuring the percentage of recall responses received within specific parameters it highlights the great opportunity healthcare has for improving its recall resolution timeframe,” continued Geibel. “As supply chain professionals it’s very easy to see how the opportunity in healthcare recalls is highlighting a greater need for full product integration – how we buy, how we assimilate our purchases, how we track orders, and how we document what, where and when an item is used.”

Geibel concludes that as healthcare systems adapt to changing reimbursement models and new patient-care initiatives, recall management programs should evolve as well. “This opportunity in healthcare will be further highlighted with increased telehealth visits, population aging, and the proactive, effective treatments that are meeting patients where they are located and are being encouraged with population health models and value-based payments,” she said. “The results of our work will be highlighted as the public demand for quality transparency matures and payment for quality programs progress.”