According to U.S. Food and Drug Administration (FDA) requirements under the Safe Medical Device Act of 1990 (SMDA) and the FDA Modernization Act of 1997 (FDAMA), healthcare facilities must report certain adverse events involving medical devices within 10 work days of "becoming aware" of information that reasonably suggests the device's role in a death or serious injury. FDA defines a work day as a day from Monday through Friday, excluding federal holidays. However, there has been confusion about when the 10-day clock begins to run. Does it run from the time the adverse event occurred? When a physician or nurse became aware of the event? When the risk manager first learned of the event? Or when staff determined that the device contributed to the event?
FDA says that the 10-day clock starts when the facility "becomes aware," meaning "that an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred." Device user facilities are considered to have "become aware" when, according to FDA, "medical personnel . . . who are employed by or otherwise formally affiliated with your facility, obtain information about a reportable event." (FDA "Medical . . . Electronic")
There are two basic times that a healthcare facility could designate as the time the facility "becomes aware" of the incident:
- The time when the facility's reporting manager receives an internal report of the incident, since the reporting manager is the employee responsible for receiving adverse event reports or supervising the people responsible. In this case, day one would begin the day after the reporting manager initially receives information about the event.
- The time when the facility is notified of the results of an investigation of an adverse event involving a device. Opting to incorporate this definition can be useful in cases where there is uncertainty about whether the device led to the death or serious injury being investigated. Adopting this definition would allow the facility to investigate the event and learn to what extent a device contributed; once it is determined that the device played a role in the event, the facility will have "become aware," and the 10-day clock would start.
According to ECRI's Accident and Forensic Investigation Services team, the second definition may be less problematic because risk managers are generally immediately made aware of patient injury or death; as a result, the risk manager may submit a medical device reporting (MDR) form to FDA before it is determined whether a device played a role in the event. Events that are reported to FDA before it is known whether a device contributed to harm perpetuates a Manufacturer and User Facility Device Experience (MAUDE) database rich in reports listing a number of devices present during the event with no evidence that the devices were actually involved in causing harm.
Regardless of which definition the organization chooses, the organization's interpretation of the 10-day clock and of what "becoming aware" means should be incorporated into the organization's written policies and procedures and followed consistently.
For more information, see
Medical Device Reporting in Ambulatory Care.
Reference
U.S. Food and Drug Administration (FDA). Medical device reporting: electronic submission requirements. Federal Register. 2014 Feb 14 [cited 2022 Mar 30].
https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements