The Medical Devices Introductory Course 2020

Have residual risks been incorrectly reduced?

Device

Failure Mode

Effect

Initial Rating

Risk Control

Updated Rating

PRO

PRO

RPN

RPN

SEV

SEV

Infusion Pump

Incorrect infusion rate

Death

4

3

12

Instructions on safe and correct use

4

1

4

Instructions on how to use a device properly and safely can reduce the probability .

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

Who decides if risk is acceptable? Persons performing risk management tasks shall be competent on the basis of education, training, skills and experience appropriate to the tasks assigned to them. Where appropriate, these persons shall have knowledge of and experience with the particular medical device (or similar medical devices) and its use, the technologies involved or the risk management techniques employed. Appropriate records shall be maintained (ISO 14971:2019 Clause 4.3)

MedDev 2.7.1 requires the NB to ensure manufacturer has involved appropriate clinical expertise in the compilation of the risk analysis to ensure risks and benefits associated with real clinical use are adequately defined .

The Organisation for Professionals in Regulatory Affairs