Page 208 - Safety Risk Management for Medical Devices

CHAPTER 23

Benefit Risk Analysis

Abstract
ISO 14971 requires the manufacturers to establish that the benefits of the medical device outweigh
its risks. To determine whether benefits of a medical device outweigh its risks, we must be able to
answer two questions: 1) What are the potential benefits? and 2) What are the potential risks?
Because the risks and benefits are typically not of the same units, it is often not possible to objec-
tively balance the benefits against the risks.
Keywords: Benefit/risk ratio; benefit risk analysis

Medical therapies are not static. Even if we do a benefit risk analysis (BRA) now and
show that the benefits of a device outweigh its risks, the same conclusion may not
hold true later. Because as time goes on, new therapies are developed, culture and
habits change, and benefit and risk perceptions evolve. For example, 60 years ago
smoking was not only tolerated, there were even advertisement touting its health ben-
efits. A simple internet search on vintage advertisements on the health benefits of
smoking would show several cringe-worthy samples. Slogans such as “More doctors
smoke Camels than any other cigarette,” or “As your dentist, I would recommend
Viceroys” may seem ridiculous today. But 60 years ago, they seemed perfectly
reasonable.
Even political changes could affect health policy, reimbursements, and therefore
alter people’s aversion to risk.
BRA is a requirement of ISO 14971 for balancing the benefits of a device against
the risks that it presents. To determine whether benefits of a medical device outweigh
its risks, we must be able to answer two questions:
1. What are the potential benefits?
2. What are the potential risks?

Because the risks and benefits are typically not of the same units, it is often not
possible to objectively balance the benefits against the risks. In other words, it is like
comparing apples with oranges. Ultimately, a subjective decision must be made to
answer the question:

Is the patient willing to accept the potential risk of the device for the potential benefit that it
offers?

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00023-4 All rights reserved. 187