130. Emergency Use of an Investigational or Unapproved Device
Emergencies may arise where an unapproved device may offer the only possible lifesaving alternative, but an IDE for the device does not exist, an existing IDE does not cover the proposed use, or the clinician is not part of the IDE study.
For a clinician to use an unapproved device to treat a patient, the following conditions must be true:
- The patient is faced with a life-threatening disease or serious condition requiring immediate use.
- No generally accepted alternative for treating the condition is available.
- There is no time to use existing procedures to obtain FDA approval of an IDE.
The clinician must also assess the potential for benefits from the unapproved use of the device, and have substantial reason to believe that benefits will exist.
The clinician must follow as many subject protection procedures as possible including:
- obtaining clearance for the emergency use according to University policy;
- notifying the IRB and obtaining the IRB Chair's concurrence; and
- obtaining authorization from the IDE holder, if an approved IDE for the device exists.
Physicians are responsible for
- obtaining an independent assessment by a physician who is not participating in the investigation; and
- obtaining informed consent from the patient or her or his legally authorized representative or surrogate.
If informed consent cannot be obtained prior to the emergency use, University and affiliate investigators must comply with the FDA requirements and are advised to refer to the IRB policy for FDA exceptions from general consent requirements.
Physician's Responsibilities after Emergency Use of a Device
- If an IDE exists, physicians must notify the IRB and the sponsor.
- If an IDE does not exist, physicians notify the IRB (within five days of use) and FDA of the emergency use and provide
· a written summary of the emergency use,
· description of patient protection measures, and
· information about any scientific results.
Physicians may evaluate the likelihood of a similar need for the device and if similar need is likely, obtain an IDE from FDA for the subsequent use and IRB approval
NOTE: Emergency use of an unapproved device is not research.