The major ISO for risk management is ISO 14971, which is enforced onto medical device companies as a means of preventing or mitigating the hazards associated with the devices. As mentioned in lecture, risk management occurs within multiple areas of a project, which also applies to ISO 14791. These areas mainly apply to safety aspects regarding the design of the medical device itself, such as inherent safety, protective safety, and information safety. Inherent safety aims at making a device as user-friendly as possible so that any mishaps made by the user will not result in any dire consequences. These include features such as making on/off switches easier to see, color-coding connectors so they cannot be mistaken with one another, and overall making all displays that are viewed by the user more noticeable.

Protective safety under ISO 14971 requires the application of safety features that focus on the physical design of the device itself. These features include safety locks, electrical shielding, or software-hardware interlocks that prevent software glitches from falsely activating the hardware that makes up the device. These features also include warning visuals such as when a device has low battery, indicating that it should be charged immediately, especially if the device is used to sustain life. Lastly, information safety states that a device’s hazards must be elaborated in the user manual such as caution statements that highlight the risk the user takes upon operating the device (i.e. a glucose reader reminding the user to sanitize the tip prior to injection).

Are there ISOs or other forms of risk management that are able to take human error into account when handling a medical device? Would a simple warning label suffice if the device was an external pacemaker or defibrillator? We learned in lecture that acceptance towards a medical device during risk management means to just chance its risks/hazards to the public upon release. Are there any examples of medical devices whose company suffered severe consequences from taking the acceptance approach?

Reference:
“Applying Human Factors and Usability Engineering to Medical Devices” (Feb. 2016) FDA website.