When and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.
What is compassionate use?
- It is the use of an unapproved device in a single patient or small group.
- It is not considered research; if there is a clinical study using the device, the patient would not meet inclusion criteria.
- The patient’s condition must be serious and there must be no other alternative treatment.
What are the physician’s responsibilities?
- The physician would first need to seek approval from the Sponsor and then from the institution’s IRB.
- If the Sponsor or IRB disagrees with the use, the physician can not use the device.
- The physician needs to provide any possible problems and a plan to monitor the patient to the Sponsor.
- Prior to use, the Sponsor needs to submit an IDE supplement to the FDA requesting approval for a protocol deviation.
- If approval is given from the FDA, the patient would need to sign an informed consent document agreeing to the compassionate use of the device.
- After use of the device, the physician would need to report any issues to the IRB and Sponsor.
The IRB also has responsibilities after approving the compassionate use of a device. The IRB needs to retain documentation of IRB and FDA approval. The IRB also needs to review submission of any issues reported by the physician.
Have you worked with a site that used a device in a compassionate situation before? How did you ensure the proper actions were carried out? Please share your experiences with us.
Photo Credit: Leonard John Matthews
