Hospice

Device

The incident is reportable if you become aware of information that reasonably suggests that a device has or may have caused or contributed to the death or serious injury of a patient. This includes instances when the medical device may have merely been a factor in the death or serious injury, including, but not limited to instances of:

• Failure,
• Malfunction,
• Improper or inadequate design,
• Manufacture,
• Labeling, or
• User error.

This requirement applies to "device user facilities" (as defined in 21 CFR § 803.30) which include entities that operate to primarily provide nursing or hospice services. If you are a hospice program that operates at another facility on a contractual basis, the facility may have the reporting obligation. Entities that do not qualify as "device user facilities" may still report voluntarily.

In this context, "serious injury" is an injury or illness that:

1. Is life-threatening,
2. Results in permanent impairment of a body function or permanent damage to a body structure, or
3. Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Note that the FDA’s definition of medical device is fairly broad. For more information about FDA regulations on adverse events reporting please visit FDA Mandatory Reporting Requirements.

Reference: 21 CFR §§ 803.3, 803.30.