System Safety for the 21st Century, 2nd Edition

CHAPTER 26Medical Devices and Equipment

INTRODUCTION

This chapter highlights system safety related to medical devices to include the most basic tools such as tongue depressors and wound dressing to the most complex and potentially dangerous x‐ray diagnostic and treatment systems. The chapter about medical devices is first in this section because it represents the most logical transition of system safety principles to the medical field from the “hardware” beginnings of system safety in the aerospace industry.

PURPOSE

The purpose of the chapter is two‐fold: (1) Provide information to the system safety practitioner about medical devices, their importance to the medical profession, and their safety life cycle. (2) For the medical practitioner and medical device developer, it goes beyond the details about system safety in earlier portions of the book; this chapter gives an introduction to a potentially enhanced safe development of medical devices. Also and important is a listing of the majority of medical device requirements for quick reference for the reader.

SYSTEM SAFETY REVIEW

Again as defined in the glossary at the end of this book, system safety is the application of engineering and management principles, criteria, and techniques to optimize all aspects of safety within the constraints of operational effectiveness, time, and cost throughout all phases of the system life cycle.

According to the International System Safety Society, the essence of system safety is ensuring ...