1-800-333-7477 Employee Login Customer Login

EUAs for Medical Devices: 3 Things You Should Know

Emergency Use Authorizations for Medical Devices: 3 Things You Should Know

 

medical devices with monitors

The FDA originally issued Emergency Use Authorizations at the beginning of the COVID crisis in February of 2020 for in vitro diagnostics specifically relating to the detection of COVID. From there the EAU has expanded to encompass a wide range of medical devices, including but not limited to Infusion Pumps, Ventilators, PPE, and Patient Monitoring Devices.1 While EAUs might have served as a crutch to get healthcare facilities through the early days of the pandemic, after a years’ time there are some key things to consider if your facility is still relying on EAUs to protect against liability for the medical equipment you are using.

  1. EAUs can end at any time

Emergency Use Authorizations can end abruptly and without warning. It is up to the facilities using the equipment that are covered by EAUs to stay abreast of the ever-changing information. Leaving healthcare facilities at risk for using equipment that is not up to code and is no longer covered for liability purposes under an EAU if it were to harm a patient or user.2

  1. EAUs cause more work for hospitals

The responsibility for safe and functional equipment falls on the healthcare facility increasing the workload of those that operate the equipment. Now in addition to adapting to new COVID protocols, increased demand within healthcare, facilities are also expected to ensure their equipment is safe and operational without the security of the FDA clearance or routine maintenance checks.3

 

  1. EAUs present safety risks to patients and liability risks to providers

It goes without saying; medical devices that are not being properly maintained can put patients at risk. Healthcare providers are experts in providing care to their patients but not always in the mechanics of the devices they are using. It is very important to keep your medical devices properly maintained by a clinical engineering professional whether in a pandemic or not. Not only should you maintain your medical equipment for liability purposes but most importantly for patient safety.

For a full list of devices currently covered under the FDA’s Emergency Use Authorization and for the most accurate and up-to-date information click here.

 

CE-Tech is an expert in medical device repair, maintenance, and management. Please call us if you need assistance with ensuring your devices are in safe and working order.

 

  1. https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices
  2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#revision
  3. https://www.ecri.org/press/covid-19-emergency-use-authorization-top-hazard-2021