Improved Medical Device Safety: New Reporting and Cleaning Rules
This act introduces new rules for medical device manufacturers to ensure greater safety and cleanliness. Citizens can expect that medical devices used will be more thoroughly inspected and better maintained, increasing their safety during treatment.
Key points
Manufacturers must report changes in medical device design and cleaning instructions before devices are marketed.
Manufacturers must report important safety communications about devices, even if sent to foreign healthcare providers.
New rapid assessment tests are introduced to ensure reusable devices are properly cleaned, preventing infections.
Introduced
Citizen Poll