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Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, your company and they are highly skilled in the specific procedures your device will be used for. After your own experts have make their final edits to your draft IFU, you now need a “fresh set of eyes.” The best approach is to validate the effectiveness of your IFU with potential users that don’t know you or your company. If your product requires animal performance testing or human clinical studies, you could use these studies to validate your IFU. However, I recommend conducting a simulated use study prior to conducting animal or human studies. Conducting a simulated use study prior to animal and human studies can prevent deviations from your documented protocols that were caused by inadequate review of the IFUs.
After your IFU is validated, and you obtain regulatory approval for your product, you may still need to make updates to your IFUs as new risks are identified. In order to decide whether you need to update your IFUs you need to gather post-market surveillance data.
Post-market surveillance is not just asking customers if they are satisfied. You need to continue to monitoring adverse event databases, your own complaint database and any service records to determine if there are any new risks and to verify that the risks you identified were accurately estimated with regard to severity and probability of occurrence of harm. In fact, clinical studies and PMS are the only way you can gather data regarding probability of occurrence of harm. When you design your post-market surveillance questions, make sure you include questions specifically targeting the residual risks you identify in your IFU. You should also ask, “What indications do you use this device for. Specifically, please identify the intended diagnosis, treatment and patient populations.” This wording is more effective than asking if a physician is using your product “off label.”
If you want to learn more about using a risk-based approach to developing IFUs, validating IFUs and performing post-market surveillance to monitor the effectiveness of your IFU, then visit my blog posting from earlier today (http://www.medicaldeviceacademy.com/blog) or the following webinar page to register for our webinar on Friday, April 21:
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Edwin Bills, ASQ Fellow, RAC IFU Validation is a part of Human Factors (Usability) Validation and as Robert has stated, needs to be validated by those not part of the development of the device. FDA guidance and the Usability Standard IEC 62366-1 provide guidance on validation and IFU is a part of that process.
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