Case Study: Application of a Systematic Quality Improvement Methodology to a Medical Device Safety Alerts Process.

Safety alerts are published by manufacturers of medical devices when unforeseen hazards are identified in the post-market phase of a device's lifecycle. Multiple problems were identified in 2017 with Lower Mainland Biomedical Engineering's process for identifying, assessing and actioning safety alerts. A quality improvement (QI) project utilizing "The Model for Improvement" methodology, was carried out to improve the process. The original process was centralized and relied on a single individual to carry out all alert management responsibilities. A new hybrid process was developed which involves both centralized and decentralized components with responsibilities shared across multiple stakeholders. The QI project resulted in the closure time for assessing and actioning high priority alerts to improve from 200 days in 2017 to 14 days in 2019.