Hi All. Hoping someone can help clarify this for me. I understand the concepts of off-label use of devices, and as a distributor of medical devices, we always advise customers of what the device is indicated for and that we do not advise using the device outside of what that indication is. We have our customer's sign at the time of sale an agreement that states they are aware of the indications for use and if they use it off-label and an event occurs, we are not liable. But what is grey for me is if a device is cleared outside of the USA for let's say use at a depth of 3mm but it is capable of going to depths of 6mm, is it required that we lock the device settings at a max of 3mm before it is imported? Or can this device be imported unlocked (able to go up to 6mm) and we have our customers sign disclosures that the device is indicated only for 3mm and we are not liable for use above that depth?
Off Label Use
- Thread starter margadia
- Start date
thank you! this is so helpful!
@shimonv beat me to it ... what's the risk?
I think that if you are aware of the off label use, you should at least cover it in risk management. It starts to creep into User Needs if it's a common use scenario. I guess I questions are why the design allowed the extra depth, and why clearance to that depth wasn't considered / desired.
I think that if you are aware of the off label use, you should at least cover it in risk management. It starts to creep into User Needs if it's a common use scenario. I guess I questions are why the design allowed the extra depth, and why clearance to that depth wasn't considered / desired.
Aliken
Involved In Discussions
It is usually the manufacturer who decides what the product's intended use is (and gets approval or clearance for such use). Let's say you somehow took upon yourself such manufacturer role. If you know for sure that the product will be used off-label, then your responsibility would be to change related intended use, labeling, or IFU. In other words, if a new intended use is created by professional users and you know about it, then you would be required to provide adequate labeling for such use.
thank you for your feedback!
This may fall under "reasonably foreseeable misuse" and should be covered through risk management. ISO 14971 tells us that risk should be controlled preferably by an inherently safe design. So in your example, if the device was intended to be used at a maximum depth of 3mm, the device would not be capable of going beyond 3mm. If that is not possible, the next option for risk control would be some kind of guard or alert if the device is used outside of its intended use. The example you provided of a sort of lock at 3mm would be an example of that. The third option for risk control is providing information on residual risk to the end user. This would be how you currently seem to be addressing this risk with the disclaimer you hare having your customers sign. This could also be a warning on the device labelling.
Whichever path you opt to choose will need to be justified in your risk files. The level of risk control of course should be in proportion to the risk presented by the misuse. Your post market activities should provide you with data that will tell you how effective your risk control measures are.
An example (as best as I can recall) from FDA's REdI conference a few years back is an active surgical screwdriver that is used to adjust the torque of screws in an implant. The device is designed an intended to be used to torque screws in a surgical setting. However, the manufacturer was receiving complaints of the device failing. The investigation uncovered that many surgeons were also using the handle of the screwdriver as a sort of hammer, which caused the device to not function properly because it was not designed to withstand repeated percussive forces on the handle. Because of the frequency at which the device was being used as a hammer in addition to a screwdriver, this became an reasonably foreseeable misuse and the manufacturer needed to take additional measures to prevent device failure or user harm arising from misuse/off-label use.
Whichever path you opt to choose will need to be justified in your risk files. The level of risk control of course should be in proportion to the risk presented by the misuse. Your post market activities should provide you with data that will tell you how effective your risk control measures are.
An example (as best as I can recall) from FDA's REdI conference a few years back is an active surgical screwdriver that is used to adjust the torque of screws in an implant. The device is designed an intended to be used to torque screws in a surgical setting. However, the manufacturer was receiving complaints of the device failing. The investigation uncovered that many surgeons were also using the handle of the screwdriver as a sort of hammer, which caused the device to not function properly because it was not designed to withstand repeated percussive forces on the handle. Because of the frequency at which the device was being used as a hammer in addition to a screwdriver, this became an reasonably foreseeable misuse and the manufacturer needed to take additional measures to prevent device failure or user harm arising from misuse/off-label use.
Aliken
Involved In Discussions
This is an interesting discussion. I saw a similar discussion in the forum two years ago (Difference between "misuse" and "off-label use").
I'm attaching a useful Team-NB Position paper on this topic.
I'm attaching a useful Team-NB Position paper on this topic.
Truly appreciate your help Aliken! have a great weekend!
Thank you for such a thorough reply! Appreciate the feedback!
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