ORLANDO—With approximately 3,000 medical products being recalled each year, organizations must grapple with how to ensure all are neutralized. According to a HIMSS 2008 e-session, “Got Recalls? Manage them, ensure patient safety and reduce risk,” the answer lies in defining and establishing best practices for handling product recalls to manage patient safety and minimize risk.
Managing recalls is a complex issue, especially since recall volume is increasing 32 percent each year. Of recalls, three product categories account for more than 50 percent of all recalls: pharmaceutical products, food and medical supplies, such as catheters.
In 2004, the number of recalls was approximately 1,300, while in 2007, it is estimated to be close to 3,000, the authors wrote. On average, 5 to 15 percent of those 3,000 recalls need to be addressed each year by healthcare organizations, which equals out to about one recall per day. Product categories that need addressing more than 10 percent of the time include biologics, pharmaceutical products, tissue and radiology products.
This growth projection means more diligence is needed, the author wrote, however product recall management is a complex process.
The primary goals of a successful recall management process are to:
- Assess all recalls
- Take appropriate actions quickly and efficiently
- Maintain the context of organizational structure and tools that support and enable appropriate actions
To effectively manage recalls and neutralize the risk associated with them, it is important for an organization to understand the importance of developing effective techniques for acquiring, organizing, distributing, remediating and tracking healthcare product recalls from within.
Once that is accomplished, it is necessary to compare recall management process effect before and after implementing best practices to identify areas of potential improvement and to then understand the benefits of using technology to enable operational efficiency in recall operations.
Best practices can help organizations achieve goals including discovery, structured workflow, accountability and management oversight. By applying best practices, enterprises can realize significant measurable improvements and reduce patient risk.
In summary, to demonstrate an effective recall management process, performance measures, audit trails and other best practices are necessary to position a healthcare organization to manage risk. By establishing a product recall practice with discipline, oversight and a process is assimilated into the fabric of the entire organization to achieve a culture focused on patient safety.