Safe Space
What is Safe Space?
Safe Space is a community of practice aimed at sharing medical device industry experiences and practices to facilitate learning and growth among participating member organizations. The community of practice consists of the Medical Device Innovation Consortium (MDIC), The Food and Drug Administration (FDA), Health and Social Care Providers, and Medical Device Manufacturers.
The Safe Space process:
- Identify a potential medical device-related safety issue
- Define the scope of an investigation of the issue
- Investigate the issue
- Communicate the investigation’s findings
Current Research – the Digital Recall Notification System Pilot:
As of June 2024, Safe Space is executing a Digital Recall pilot to explore digital communication processes between medical device manufacturers and hospital systems to improve current antiquated medical device recall notification processes. This study has benefits to the FDA and the medical device industry at large because timely product recall notifications using digital communication should result in the timely removal of products from supply chain. Electronic notification for acknowledgement of recalls can become the normal notification process – by bringing together stakeholders from the regulator, manufacturer, and provider perspectives, we can address this issue and improve the recall notification process across the medical device ecosystem. The Digital Recall Notification System Pilot is scheduled to be completed by Fall 2024.
Participation in Safe Space:
- Participation is voluntary
- Participants share expertise, time, and insights
- Biweekly, 1-hour meetings
- Annual Safe Space Summit
- There is no monetary cost to participate in Safe Space
To learn more about Safe Space, the ongoing studies, or to find out how you can get involved – fill out the Contact Us form below!
Current Studies:
Recall Notification Study
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