This article is about public health emergencies when a medical device is used to manage or prevent an emergency. These consist of diagnostic testing equipment and materials, personal protective equipment such as gloves or masks and surgical instruments. Extra medical equipment is not an emergency but can be adversely affected by things like power outages, moisture intrusion or contamination. The FDA which is responsible for registration of medical devices in the country requested public feedback on three scenarios involving medical devices and severe weather, such as hurricanes, floods, lightning storms, earthquakes, and fires in a Federal Register notice published on February 21, 2013. The scenarios are
- Scenario A. Commercial device already in use for patient care
- Scenario B. New or unused equipment, parts, or accessories
- Scenario C. Damage to a medical device manufacturing facility
Severe weather conditions and natural catastrophes can interfere with the production, delivery, storage, or use of marketed technologies, raising questions about their effectiveness or safety. The FDA will utilize this data to assist its decision-making on how to best adapt the present regulatory framework to address risks and weaknesses in the manufacturing chain brought on by extreme weather.
Future steps can be identified to help the industry mitigate or tolerate manufacturing chain challenges caused by extreme weather conditions. Federal Register Notice : Severe Weather Impacts on Medical Device Safety and Quality It can be viewed for more information and to make the comments.
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Source : United States FDA Registration and Public Health Emergency
