Page 33 - Safety Risk Management for Medical Devices

12 Safety Risk Management for Medical Devices

potential risks due to the identified Hazards. Hazard analysis precedes risk analysis and
identifies the Hazards. Risk analysis estimates the risks of Harms that could ensue
from the identified Hazards.

3.1.1.1 Reasonably foreseeable misuse
It is a requirement of ISO 14971 [3,7] for the manufacturer to identify and document
the intended use, and reasonably foreseeable misuses of the medical device. But the
concept of reasonably foreseeable misuse creates confusion and debate due to its ambi-
guity. First, what is reasonable? In whose judgement? Second, what does foreseeable
mean? Should every wild and creative idea be considered as reasonably foreseeable?
[1] offers this definition for reasonably foreseeable misuse: “use of a product or system
in a way not intended by the supplier, but which can result from readily predictable human
behavior”. But this definition still leaves the ambiguity of the word ‘readily’.
Misuse is defined as incorrect or improper use of the medical device by the
Standard [3,7]. But how do you distinguish use-failure from misuse?
Below, some guidance is offered to help the analyst distinguish what is a reasonably
foreseeable misuse. First, we distinguish misuse from use failure. Use failure is a failure of
the user to perform a user-action on the medical device. This type of event is covered in
the UMFMEA and its risks are accounted for, in the RACT. The following six tests are
offered as a means to determine if something is a reasonably foreseeable misuse.

1. Deliberate
There is a deliberate decision by the user to use the device in the manner they
want.
2. Well-intentioned
The User intends to do well by the patient, i.e., no harm is intended.
3. Beneficial
The User believes a benefit can be derived for the patient from the misuse.
4. Feasible
The misuse is feasible, i.e., it is technically, financially, and skill-wise within the
capability of the user to do the misuse.
5. Safe
The user can safely use the device in the manner that they wish to use the device.
6. Ethical
The user is acting ethically. They have disclosed the truth about the misuse and
have the consent of the patient and the hospital. (This is not relevant when a
patient is using the device on him/herself.)
If a foreseen misuse meets the above six tests, then it can be construed as a
reasonably foreseeable misuse. Off-label use is a typical kind of misuse. Malice is
excluded from the analysis. That is, if the user intends to harm a patient, such action
is not included in the risk management of the medical device.