The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
Although the agency has yet to receive any reports of defective products or adverse events related to devices incorporating Japanese components, the notice expresses concern that possibly deteriorating manufacturing conditions in areas most affected by the tsunami, earthquake and nuclear plant meltdown could compromise safety and effectiveness of devices for export to the US market.
Specific CDRH and CBER concerns include radioactive contamination of device components, especially those derived from animal materials; contaminated water supplies causing device defects; less reliable availability of electrical power disrupting manufacturing processes; compromised sterilization procedures needed for some devices; compromised reliability of product performance, particularly for components such as electrical connectors, microprocessors and sensors; and damaged manufacturing facilities causing supply shortages of components and finished devices.
The notice urges device manufacturers and distributors to take added precautions—increased sampling and more rigorous testing of components and raw materials, for example—in order to ensure safety and effectiveness of their devices in accordance with 21 CFR Part 820.
Additional precautions are also recommended for certification of electronic products and components, including:
- Assessment of incoming devices and supplies to ensure conformity to specifications and quality requirements
- Monitoring of purchasing and acceptance procedures such as inspections and sampling to ensure device and component integrity
- Inspection of device power supplies for water damage
- Running quality control checks to verify product safety
- More thorough assessment of animal-derived products and components such as raw heparin
A complete list of CDRH and CBER recommendations is available on the notice.
If a manufacturer or distributor requires an alternate supplier following these precautionary steps, a Premarket Approval Application Supplement, 21 CFR 814.39 or a new 510(k) for changes to existing devices may be needed. Firms should review 21 CFR Part 807 Subpart B to determine whether they will require alternate suppliers to register and list.
The FDA’s notice comes as European and Australian regulators have also stepped up scrutiny of medical device components and products imported from Japan.
