186 - Total Recall! Strengthening Hospital Systems and Patient Safety with a Novel Program for Managing Recalled Medical Products

Publication Number: 3179.186

Cassandra Schmidt, Childrens Hospital of Philadelphia, Kintnersville, PA, United States; Shawana Rivers, Childrens Hospital of Philadelphia, Philadelphia, PA, United States; Jeanette Trella, Childrens Hospital of Philadelphia, Philadelphia, PA, United States; Kevin Osterhoudt, Children's Hospital of Philadelphia, Philadelphia, PA, United States

Background: Medication / product recalls require organized safety response. A health system’s recall response can be hindered by lack of a centralized approach. In January 2023, our children’s hospital created a novel, multidisciplinary system-wide Recall Response Program (RRP) to manage recalls across clinical settings. The program goals are to establish centralized coordination, standardized response, and enhanced communication and health equity, and to better document recall activities. Characterization of the RRP activities inform resource allocation, internal education needs, external communication needs, and institutional preparedness.

Objective: To characterize the development of a new RRP and its first 18-months of accomplishments.

Design/Methods: The scope of the RRP includes medical supplies and devices, pharmaceuticals, software vulnerabilities, and nutritional formula products (not toys nor general food recalls). Notice of a recall is submitted via a reporting form; a dedicated RRP email inbox and a “Report A Recall” form standardize reporting. Coordinating with clinical stakeholders, a response tier is designated that classifies the impact to the health-system: Tier A) measurable impact requiring immediate ( < 24 hour) response, B) urgent ( < 48 hours) response, C) suitable for response within 72 hours, and D) low / no impact to the health-system. The public is notified via public-facing webpage and social media platforms; a call center is available to field questions. A Recall Response Library exhibits detailed documentation for all recalls. To characterize the RRP, two independent abstractors summarized blinded, aggregate data from the program from its first 18 months of operation.

Results: During the first 18 months, 178 recalls (~10/month) were managed by the RRP. 12% were triaged as 'Tier B' warranting an urgent response in < 48 hours; the remainder were deemed to allow a scheduled review process. Among recalls, 51% involved medical supplies, 45% medical devices, 3% medications, 1% formula, and 1% other types. Of the 178 recalls, 16 resulted in programmatic patient and family communications, totaling direct outreach to 1,156 individuals. A real-time Recall Response Dashboard communicates program activities throughout the health system.

Conclusion(s): We successfully implemented a coordinated RRP that has improved early recall detection and organizational response, and enhanced communication. Recalls of medical supplies and devices are most common, and 12% of recalls warranted urgent institutional evaluation and safety mitigation. This program may serve as a model for medical product recall response.