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About

Life Support Equipment are medical devices that are used in maintenance of the vital functions of a critically ill or comatose person or a person undergoing surgery. The Joint Comission (TJC) stadards require each hospital create its own list of what it deems to be Life Support, Life Safety, or Life Sustaining devices that include:

The FDA’s Class III devices provides a greater Life Support list of devices.

History

Prior to 2004, TJC had a mandatory PM completion requirement of 95% for all scheduled medical equipment. Concern arose that hospitals could meet this requirement without completing PMs on their more critical equipment, creating what TJC saw as a potential threat to good patient care and the public. As a result, TJC modified its standard EC.6.20 (as of 2009; EC.02.04.03 EP 2, EP3) by dividing medical devices into two separate classifications:

  • Life Support. Devices identified as Life Support were required to meet a higher standard (a 100% PM completion rate)[2]
  • Non-Life Support. Devices identified as Non-Life Support were required to meet local standards (a 90% PM completion rate).

References

  1. FDA. "Medical Device Tracking - Guidance for Industry and Food and Drug Administration Staff: V. Medical Devices Requiring Tracking." 25 Jan 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071756.htm Accessdate: 4/15/2016.
  2. 24x7 magazine. "Coming to Terms with Identifying Life Support Equipment." 10 oct 2009. http://www.24x7mag.com/2009/10/coming-to-terms-with-identifying-life-support-equipment/ Accessdate: 4/15/2016

Links

FDA’s Life-Sustain/Support Device Search Database

Also

Life Safety

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