FDA NEWS: Device Data Collection by Hospitals, Opioid Action Plan Update, Abuse-Deterrent Opioids, Depression Treatment – Drug and Device Digest

Hospital staff use a variety of medical devices, help identify new safety problems with devices,  use technologies in real-world setting of clinical practice

FDA improving work with hospitals to modernize and streamline data collection about medical devices – with focus on SAFETY

(1) Medical device reporting from hospitals

• Must report device-related serious injuries/ device-related deaths to both FDA and the manufacture
• However, this is passive surveillance

(2) MedSun (the Medical Product Safety Network) with hospitals

• Understand and report on device use in the real-world environmen
• But limited added value, unnecessary costs and resources
• Not enforced universal reporting requirements

High-profile device safety issues occurring in hospitals in 2015

• Inspections at 17 hospitals- related to spread of uterine cancer from use of morcellators or  contaminated duodenoscopes

Lessons learned from inspections

• Didn’t submit required reports for deaths or serious injuries
• Didn’t not have adequate procedures for reporting device-related death or serious injury events to FDA/manufacturers
• Need better way to work with hospitals to get the real-world information

Next Steps to effectively work with hospitals

• Participate in the National Evaluation System for health Technology NEST
• Asses current reporting requirements
• Use effective modern tools for surveillance
• Public workshop to solicit input and advice on improving hospital-based surveillance systems
• Work with the Association of American Medical Colleges and the American Hospital Association

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