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For any problem, even the messiest ones, a simple solution might be the best one, says Kristina Cybularz, manager of Alerts Tracker at Pennsylvania-based ECRI Institute. “Small changes can cause a big impact,” Cybularz said during her presentation on recall management in remarks made on the final day of the AAMI 2015 Annual Conference and Expo held in Denver.
Focusing on one thing to change at a time can equal big results in a recall program.
There are plenty of areas of improvement to choose from, Cybularz said. Alerts Tracker, which Cybularz manages, is a web-based, automated alerts management system that electronically distributes safety information about medical devices to healthcare organization staff.
Alerts management challenges include the large amount of alerts being sent out, high-impact alerts, or ones that affect many areas, the ability to obtain and review alerts, collaboration, leadership and sponsorship, and documentation and reporting.
“Alerts can get lost in the mail and be difficult to match to inventory,” Cybularz said. “It just adds to the complexity of the issue.”
She offered a set of best practices for organizations that want to streamline and improve their recall management process.
“Sound processes and policies need to be in place to ensure that everyone knows what they should be doing,” she said. Staff members need to know who to inform about alerts that they receive directly from manufacturers, and the policy should specify a program coordinator and the team that’s involved in the management process.
“Whenever possible, incorporate into your purchasing agreement who your program coordinator is. That way, they are then responsible to send (a recall alert) directly to the program coordinator.”
Once the alert is delivered to the right person, consider how it is evaluated against the inventory data.
“In our experience, centralized purchasing usually means a more complete and accurate database resulting in more accurate searches on products you actually have,” Cybularz said. “In healthcare organizations where centralized purchasing and acceptance testing is universal, the burden of alerts management becomes less on the other clinical department staff because the supply chain and clinical engineering can more readily identify the recalled products.”
When obtaining and sharing alerts information, Cybularz recommended establishing and promoting an internal notification process and re-evaluating policies and procedures. This needs to involve the appropriate stakeholders, including management.
“Staff involvement is critical,” Cybularz said. “Too often, management doesn’t get involved until there’s a problem. There needs to be awareness that this is a team effort.”
There are several ways to promote participation in a recalls management program. Cybularz offered these tips:
Recruit safety champions from each key department.
Define roles, responsibilities, and processes.
Provide productivity and collaboration tools.
Recognize effective champions.
Address poor performers.
Plan for staffing changes.
Provide feedback to sponsors, participants, and partners.
When a team comes together to focus on one aspect of an organization’s recall management, big changes can happen piece by piece.
“You can set measurable but reasonable goals,” Cybularz said.