Safety Risk Management for Medical Devices 1st Edition

Bijan Elahi has worked in the medical device industry for over 25 years and published a best seller, landmark book, Safety Risk Management for Medical Devices by Elsevier Publishing under the label of Academic Press. I’ve read the book twice and found it to be a critical addition to my library. It is beneficial to expanding my knowledge of medical device risk management, which is receiving a lot of attention as an update to ISO14971 is circulating.The author has chosen a hypothetical Automatic External Defibrillator (AED) named Vivio to illustrate risk management of medical devices. AEDs are widely used around the world and serve as an excellent, easily understood technology to apply and learn the principles of risk management.If you are new to the medical device industry, there is no better book for you to read at this early stage in your career. It provides a historical perspective to help you understand where the industry was and where it is headed in terms of management of safety risk for medical devices. If you need to know the basics and wonder “Why do risk management?” this book, starting in Chapter 2, is for you. You will never forget the humor of Figure 2.1. Quickly read the next ten chapters and you will be ready to actively participate in your first risk management meeting. If you need to know how to build a risk management file, Chapter 11 was written for you. It outlines a list of potential items that could be included and emphasizes the importance of a risk plan that should be created at the beginning of the process and updated continuously.If you are a seasoned professional, grounded in the basics already, you will enjoy discussions about (i) benefit to risk, (ii) state of the art and (iii) the three categories of failed use, e.g., abnormal use, misuse, and reasonably foreseeable misuse.The chapter on software risk management is timely with case studies and a figure that provides a decision tree process for the determination of the safety risk class of the software system. Got SOUP? If your medical device contains Software Of Unknown Provenance (or unknown pedigree) commonly referred to as SOUP, you will enjoy Chapter 15. No need to reinvent developing software for those devices using SOUP, but the discussion points to the importance of its influence on the safety of a system. If you are heavily involved with clinical trials, Chapter 26 is a concise discussion on how to assess and map device risk, especially understanding severity class and how risk management needs to be documented (see Table 26.2).The book ends with chapters on axioms (self-evident truths), special topics, critical thinking and, my favorite, advice and wisdom. If you need templates, check out Annex B.This is a very practical book that starts out with a statement I found comforting.“Manufacturers are not expected to be error-free, flawless, or perfect. They are expected to use sound processes and good judgment to reduce the probability of harm to people.” If you believe that, the content and tools that are provided will support the perspective of safety risk management for medical devices. It is a 5-star book that has received my highest recommendation.David R Rutledge, Pharm.D., FCCP, FAHAMedical Device ConsultantPresident & CEOGlobal Strategic Solutions, LLC

Reading and untangling ISO standards is time consuming and daunting. Elahi untangles Risk Management in a comprehensive and thorough manner. He provides clear and precise definitions, interprets unclear sections of the standards, provides templates and step by step directions on how to perform analysis of complex medical devices. He also warns were people tend to get tripped up and lays down ground rules to keep the analysis from getting out of control and keeping progress moving forward. I found the book invaluable.

Sorry, I wanted to buy a paper version

Elsevier Academic Press has recently published a new safety book titled “Safety Risk Management for Medical Devices” written by Bijan Elahi. This book explains how to conduct a risk management program that will show conformance to the FDA safety standards established for medical devices. It describes a safety process as well as some of the tools utilized in the process. Since medical devices are life saving devices they are somewhat safety-critical, requiring a rigorous process to ensure they are safe for public use.This book revolves around ISO Standard 14971, “Medical devices -- Application of risk management to medical devices”. This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the life-cycle of a medical device.Understanding and applying safety standards is a daunting process, particularly if one is not already familiar with the generic System Safety Engineering risk management process. The author presents risk management in a comprehensive and thorough fashion. He provides definitions, interprets unclear sections of the standards, provides templates, and step by step directions on how to perform risk management analysis of complex medical devices. The author also provides special tips to warn about confusing areas and how to avoid problems associated with these areas.The author presents a methodology he has developed called the “BXM” method for conducting a thorough risk management process. This is a complete process that essentially follows the basic tenets of the System Safety Engineering process, thereby following the design-for safety philosophy. He also provides a detailed demonstration of the risk management information discussed in the book through the application of his BXM method on an example system.A sample of some of the topics covered in this book include:• Understanding risk• Requirements of the risk management process• Risk management standards (for medical devices)• Relationship between ISO 14971 and other standards• The BXM method• Risk analysis techniques• Software risk management• Risk estimation• Risk controls• Risk management process management metrics• The BXM method applied to an example (hypothetical) medical deviceIn the chapter on risk analysis techniques the author provides an introduction on how to perform Fault Tree Analysis, Failure Modes and Effects Analysis, Preliminary Hazard Analysis, and Mind Map Analysis. Since these techniques are not trivial the reader might need more detailed information from other sources in order to perform the analysis technique on a large complex system or product.If you work in the medical device field, either in design or safety, this book is a definite required read.

This book is a keeper. If you work in the development or sustaining of medical devices, get this book. Don't think too much about, just get the book! Bijan provides a concise overview of medical device risk management and what are it's A, B, C's. He explains key information to look for in standards like ISO 14971, IEC 60601-1, ISO 14155, IEC 62366. The book provides the theory and also a case example to go with it.

Due to Kindle editions, the figures, block diagrams and flow charts are not readable. The book also lacks any practical examples.

I've recently discovered this book and have been really impressed by what an incredibly useful resource it is,  both because of the  clear theoretical descriptions of different aspects of risk management and also the time taken to create a detailed case study which really brings each of the tools into sharp focus. As someone who has spent a number of years working in or with med dev startups I've repeatedly seen the huge amount of time (and trial and error) needed to take what's written in the standards and regulations and derive a practical and logically consistent risk management methodology.  This book provides a comprehensive manual that will both save time and raise the quality of risk management across the board, but particularly in organisations new to medical device development.

I wish this book had been available when I first started working on Medical devices. It is both a learning book and a reference which uses a hypothetical product to show the process and the output documents that must be produced.

Really helped me to understand better the concept of risk management. I really recommend this book to all MedTech people.