Page 227 - Safety Risk Management for Medical Devices

206 Safety Risk Management for Medical Devices

Table 26.1 Definitions of severity based on ISO 14971 table D.3
Severity class Definition

Catastrophic Death
Critical Permanent impairment or life-threatening injury
Serious Injury or impairment that requires professional medical intervention
Minor Temporary injury or impairment that does not require professional
medical intervention
Negligible Inconvenience or temporary discomfort

A commonly used set of definitions for Harm severities, based on [3,7] table D.3 is
presented in Table 26.1:
ISO 14155 [33] requires that the risks associated with the clinical investigations be
estimated in accordance with ISO 14971 [3,7]. This necessitates the mapping of ter-
minologies among the two standards. It could be surmised that SAE maps to
Catastrophic, Critical, and Serious severities of Harm, and therefore, Minor and
Negligible classes of Harm severity would NOT be SAE.
As it is intended that Clinical Investigations provide feedback to risk management
regarding the risks of the medical device, a higher resolution classification of SAEs is
needed to facilitate proper feedback to Risk Management. The CIP would be a good
place to capture the higher resolution classification of AEs and SAEs during the
Clinical Investigations.

26.4 RISK MANAGEMENT REQUIREMENTS

ISO 14155 [33] requires that prior to the execution of clinical trials, the risks associ-
ated with the use of the investigational device be estimated in accordance with ISO
14971 [3,7].
The participants in a clinical investigation are faced with two types of risk:
• Risks associated with the medical device
• Risks associated with the design and conduct of the clinical study
The risks associated with the medical device are the main subject of this book and
are covered extensively. The risks associated with the conduct of the clinical study
could involve the clinical study design, methods of data collection, data processing,
clinical setting, personnel performance, etc.
Risk management must estimate and balance the combined risks against the poten-
tial benefits to the participants. The same principles that are applied to the manage-
ment of the device risks are applied to the design and conduct of the clinical