The key concept is the consequence to the patient if the software fails in some way.
The level of concern is determined based on all of the following:
(1) both before and after hazard mitigations
(2) as worst case scenario
(3) based on reasonable and foreseeable conditions
(4) if connected over a network, device performance if communications fail
Levels of concern:
(1) major
(2) moderate
(3) minor
Criteria for a major concern - one or more of the following:
(1) Blood Establishment Computer Software
(2) use in combination with a drug or biologic
(3) use with a device that has a major level of concern
(4) potential for death or serious injury prior to hazard mitigation
(5) potential for erroneous diagnosis or delay in appropriate care as a result of malfunction or latent design flaw, resulting in serious patient injury
Examples of uses with the potential for death or serious injury:
(1) control of device providing life support
(2) control delivery of potentially harmful energy
(3) control delivery of a drug or biologic that is potentially harmful
(4) provide diagnostic information that directly drives a therapeutic decision which could be potentially harmful
(5) monitoring of vital signs that alerts the provider to life-threatening situations which require a medical intervention
Criteria for moderate concern - one or more of the following:
(1) use with a device that has a moderate level of concern
(2) potential for nonserious injury to the patient or to the user of the device prior to hazard mitigation
(3) potential for erroneous diagnosis or delay in appropriate care as a result of malfunction or latent design flaw, resulting in nonserious patient injury
Criteria for minor concern - NOT major or moderate concern.
