ISO 14971 Fundamentals: Reasonably Foreseeable Misuse

Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.

Clause 5.2 of ISO 14971:2019, the International Standard for application of risk management to medical devices, requires manufacturers to document both the intended use and reasonably foreseeable misuse associated with their device.

In general, manufacturers clearly define the intended use of their medical device because it is also required for regulatory purposes. The concept of reasonably foreseeable misuse, on the other hand, is not well understood in industry practice.

Reasonably foreseeable misuse is defined in sub-clause 3.15 as:

Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.

In practice, it is challenging to figure out what is reasonable and what is readily predictable human behavior! Further, what is reasonable and/or readily predictable in one market may not be the same in another market. As a result, managing risk(s) associated with reasonably foreseeable misuse(s) proves to be quite challenging for medical device manufacturers, especially those operating in multiple markets across the world.

A common industry practice is to adopt the requirements of IEC 62366-1, the International Standard for application of usability engineering to medical devices. However, the scope of IEC 62366-1 is limited to assessing and mitigating the risk associated with normal use, which includes only the correct use and use-error. It can be used to identify risks associated with abnormal use, but it does not provide any guidance for assessing and/or mitigating these risks.

Figure A.4 in IEC 62366-1 clearly shows that only the use-error aspect of reasonably foreseeable misuse as defined by ISO 14971 is included in the usability engineering process.

Figure 1: Relationship between ISO 14971 and IEC 62366-1. Source: Figure A.4, IEC 62366-1:2020

As result, there is a significant gap in the current industry practice related to managing risk(s) associated with reasonably foreseeable misuse, especially in circumstances where abnormal use can and does occur frequently.

As an example, consider this recent safety alert for healthcare providers from the US FDA¹ related to off-label use of surgical mesh in breast surgery:

The FDA is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.

The FDA stresses the importance of clinical evaluations to evaluate the safety, effectiveness, and benefit-risk profile of these products when used for breast surgery. There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction.

FDA does not regulate the practice of medicine. When a healthcare provider chooses to use a medical device for a purposes outside the scope of the authorized intended use, they are technically misusing the device in the context of ISO 14971. Note that this misuse may not be due to malicious intent; it is just that they are exercising their professional judgment to use a medical device outside the scope of its intended use.

ISO 14971 expects to manufacture to consider hazards due to both the intended use and misuse(s) of their device. This article clarifies the full scope of reasonably foreseeable misuse using illustrative examples, and offers practical tips for managing the risk associated with such misuse.

Let us take a closer look.