11 Nov 2016
The FDA has released final guidance addressing reporting and
record-keeping requirements for medical device manufacturers in the
event of device-related adverse events and malfunctions.
“The goal is to detect and correct problems in a timely manner,” the FDA wrote in the final guidance document,
which supersedes the draft published in 2013 and the guidance from
1997. Manufacturers, along with “medical device user
facilities” like hospitals and outpatient treatment facilities, are
directed to report adverse events and keep detailed records.
Under the Medical Device Reporting (MDR) regulation, found in part 803 of
the Code of Federal Regulations, manufacturers of devices sold in the
United States are required to submit a report to the FDA upon
learning that their device “may have caused or contributed to a death or
serious injury or has malfunctioned and the malfunction of the device
or a similar device that they market would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur.”
“MDR reportable events generally must be submitted to us within 30
calendar days after the day you become aware of the event,” the FDA
continues. “Under some circumstances, a medical device report is
required to be submitted within five work days after the day you become
aware of the need to submit such a report.”
The document notes that in the case of use error, or “a
device-related error or mistake made by the person using the device,”
manufacturers are not always required to submit an MDR report; still,
they should keep a record of the complain in their files. “Such errors often reflect problems with device labeling, the user
interface, or other aspects of device design. Thus, FDA believes that
these events should be reported in the same way as other adverse events
which are caused or contributed to by the device. This is especially
important for devices used in non-healthcare facility settings. If you
determine that an event is solely the result of user error with no other
performance issue, and there has been no device-related death or
serious injury, you are not required to submit an MDR report, but you
should retain the supporting information in your complaint files,”
according to the guidance.
Source: 24X7 Solution for Healthcare Technology Management
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