This document describes the policies the UW-Madison Health Sciences IRB follows for conducting reviews of applications involving Humanitarian Use Devices (HUDs).
This policy applies to the review of HUDs by the Health Sciences IRB.
The Health Sciences IRB follows the FDA definitions of what constitutes a HUD.
Under FDA regulations a HUD is a device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 8,000 individuals in the United States per year.
If a HUD will be evaluated as part of a clinical investigation or research project designed to obtain data to support a Premarket Application (PMA) to the FDA, such evaluation constitutes human subjects research and falls outside the scope of this policy.
IRB review and approval are required before a HUD can be used, except in the case of an emergent situation where a HUD must be deployed to address a life threatening condition and there is not sufficient time to obtain IRB approval.
The initial review must be performed by the convened IRB, but continuing review may be conducted on an expedited basis.
As part of its review, the IRB ensures that the proposed use is within the FDA-approved indication and that the use of the device does not exceed the scope of the FDA's approval.
The IRB can approve the use of a HUD within its FDA approved indications for multiple patients or may approve use of the HUD on a case-by-case basis.
If a HUD will be used at the Madison VA Hospital, approval by the Madison VA Chief of Staff is required. However, VA R&D Committee review and approval is not required for non-research uses of HUDs.
The IRB generally requires the health care provider to obtain informed consent for the use of the HUD from the patient who will receive the device or the patient’s legally authorized representative.
Wisconsin state law, which requires a health care provider to obtain informed consent of a patient for medical diagnosis or treatment, applies to the use of a HUD.
Except when a HUD is being evaluated as part of a research study, because the use of a HUD is considered to constitute treatment rather than research, HIPAA authorization is not required prior to treating a patient with a HUD.
If there are any modifications to the HUD or to anticipated clinical use of the HUD after IRB approval, the health care provider must report and obtain approval of these changes to the IRB promptly by following the IRB policy and procedures for changes to protocols.
A compassionate use of a HUD arises when a health care provider wishes to use a HUD off-label because no other alternative exists for the patient's condition, but the situation is not an emergency.
Before using a HUD on a compassionate use basis, the health care provider must obtain an assessment from an independent (e.g. not referring) physician that the use is appropriate; IRB approval covering such use of a device and the informed consent of the patient or the patient's legally authorized representative.
The health care provider should provide the following information to the holder of the Humanitarian Device Exemptions (HDE), who would then submit that information in an HDE report to FDA approval prior to the use: (1) a description of the patient's condition; (2) the circumstances necessitating treatment with the HUD; (3) a discussion of why alternative therapies are unsatisfactory; and (4) information to address the patient protection measures outlined in 7.1 above.
Any unanticipated adverse device effect must be reported to the sponsor of the device and the IRB within 10 working days of the health care provider first learning of the effect.
The following must be reported by the user facility of a HUD to the device manufacturer within 10 working days after becoming aware of the event:
A HUD has or may have caused or contributed to the serious injury of a patient. If the manufacturer is unknown, the report must be made to the FDA.
A HUD has or may have caused or contributed to the death of a patient. The event must be reported to the FDA in the same timeframe.
Any FDA actions regarding the HUD should be promptly reported to the IRB.
Any withdrawal of IRB approval must be reported to the FDA promptly.