Management of Risks and Benefits for Medical Devices

Bijan Elahi

doi:10.56094/jss.v52i1.137

Authors

Bijan Elahi Eindhoven University of Technology

DOI:

https://doi.org/10.56094/jss.v52i1.137

Keywords:

ISO 14971, medical devices, hazard theory, risk acceptance, risk/benefit, patient safety

Abstract

Medical device safety is of paramount importance. Application of the international standard ISO 14971 is mandatory for obtaining approval for commercialization of medical devices. One of the requirements of ISO 14971 is demonstration that the residual risk of the medical device is outweighed by the benefits that it offers to the patients. This poses a difficult challenge for the medical device manufacturers, as risk and benefit are not easily comparable. This comparison must be done on each hazard and also on the overall system. Some of the challenges that device manufacturers face are: How do you determine the overall residual risk of the system? And, if you do determine the overall residual risk, how do you know if it is acceptable? How do you compare the residual risk against the benefit of the device? For example, if the benefit is improved quality of life, but at a 0.1 percent increased risk of death, which is greater — the benefit or the risk? This paper offers techniques and methodologies to provide objective evidence that the device design has met the risk benefit requirements of ISO 14971.

Author Biography

Bijan Elahi, Eindhoven University of Technology

Bijan Elahi has worked as a risk manager for Class II and Class III medical devices, both in the U.S. and Europe for more than 22 years. He is currently employed at Medtronic, plc and is also a lecturer at Eindhoven University of Technology in Eindhoven, Netherlands, where he teaches risk management to doctoral students in engineering.