Page 256 - Safety Risk Management for Medical Devices

CHAPTER 35

Advice and Wisdom

Abstract
Mastery of the engineering and mathematics of risk management is not sufficient for success.
Certain additional knowledge and experience helps propel the practitioner to success. In the closing
chapter, advice and wisdom from 25 1 years of experience in doing risk management in the
medical device industry are presented as a complement to the knowledge that is presented in
the rest of the chapters.
Keywords: Advice; wisdom

1
In closing, some advice and wisdom gathered over 25 years of medical device indus-
try experience:

• Team dynamics, how well the team members communicate, and whether there
is a prevailing safety culture have an impact on the design and safety of the
product.
• Discovery of a design flaw that could lead to a Hazard, could create an emo-
tional reaction in the design engineers as a personal offense. Be sensitive and
mindful of this possibility and couch your discoveries as opportunities for
design improvement toward the shared goal of preservation of patient/user
safety.
• Team continuity throughout the product lifecycle has an impact on product
safety. It is possible that the original design team implemented certain safety
features that were not well documented. Then during the maintenance part of
the lifecycle, the continuation-engineering team may remove a safety feature
due to lack of understanding of the rationale for the existence of that feature.
• Make the risk management file available to all team members. Access to this
information helps the product development team make better decisions during
the design and development phase.
• Write well! An easy to read and understand Risk Management Report will go
a long way to build confidence and trust in a regulatory reviewer. Your collea-
gues will also appreciate well-written documents that are easy to understand
and review.
• While compliance with ISO 14971 [3,7] offers a reasonable assurance of safety
of the device, it does not mean the device will not cause harm.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00035-0 All rights reserved. 235