Emergency Situations (Medical Devices)
Medical devices play a crucial role in the treatment and diagnosis of illness and disease. They range from common medical supplies (bandages, hospital gowns) to complex implantable devices that help save and sustain life (heart valves). They include tools that aid in the detection of disease (MRIs, in vitro diagnostics) and digital technology that is driving a revolution in health care (medical apps, surgical planning tools, closed loop drug delivery devices).
Emergencies and disasters such as hurricanes, floods, lightning storms, earthquakes, and fires can affect everyone from people who rely on medical devices, to companies that manufacture medical devices, to shipping and delivery operators who get medical devices to our doors.
We encourage everyone to prepare for unexpected events, including emergency situations, by:
- Understanding how medical devices may be adversely affected by loss of power, moisture, or contamination and taking action to ensure safe storage and use during a potential emergency.
- Anticipating disruptions to the supply of medical devices and taking action to ensure continued availability.
Preparedness can save lives and help minimize the impact of challenges caused by emergency situations.
The resources listed below are intended to help medical device users prepare and respond to emergencies.
Tips for consumers, patients, and caregivers
- FDA Offers Tips about Medical Devices and Natural Disasters
- Preparedness Information for Consumers
- Emergency Preparedness and Response
Tips for industry and health care providers
- Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers and Distributors
- Disposal of Contaminated Devices
- Medical Devices Requiring Refrigeration
- Medical Devices that Have Been Exposed to Heat and Humidity
- Tips for Mammography Facilities Following Natural Disasters or Severe Weather Conditions
Preparedness and Response Activities for Medical Devices
Within the Office of Readiness and Response in FDA’s Center for Devices and Radiological Health (CDRH), the Division of All Hazards Preparedness and Response (DAPR) serves as a focal point for advancing national preparedness, response, and coordination for all hazards threats involving FDA regulated medical devices. This includes:
- coordinating with external partners
- managing information sharing
- developing response plans
- supporting innovation and medical countermeasures development
- leveraging regulatory science to enhance emergency readiness
In addition, DAPR also works closely with the Office of Supply Chain Resilience (OSCR), which aims to prevent and mitigate supply chain interruptions and promote the continued availability of safe and effective medical devices.
Relevant CDRH Organizational Links:
If you have questions or want to learn more about medical device emergency preparedness and response, contact DAPR by emailing cdrharc@fda.hhs.gov.