Changes in Medwatch Reporting Requirements

B

Bunny

#1
Can anyone shed some light on what types of medical device complaints need to be reported? Years ago we used to only report adverse incidents that was caused or contributed by our medical device. Now that I am working for a different company, this company's policy is to report any incident that could possibly cause or contribute to an adverse event. They said that the FDA has become much more strict yet cannot show me a regulation that states this. Here are a couple of examples of incidents that I would not think are reportable and they do.

1. A sterilizer has a leak and water gets on the floor. The amount of water on the floor extends past the footprint of the machine. Even though no one slipped and fell, this would be reported.

2. A display monitor looses the image due to a power failure, unplugged cord, or another reason. Even though a secondary monitor continues to display the image, this would be considered reportable.

I would appreciate any advice on this topic.
 
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L

lfrost

#2
Bunny,

On the FDA Website, there is a summary of who and what needs to be reported to the FDA and the time frames for each incident. By your examples, both would not need to be reported as they are only malfunctions of the device. See the summary here http://www.fda.gov/MedicalDevices/D...quirements/ReportingAdverseEvents/default.htm

Using the summary tables contained in this summary, you can determine that what you describe would not need to be reported to the FDA as the incidents did not contribute to an adverse event nor death.

Hope this helps..
 
B

Bunny

#3
Thank you, I am aware of that and pointed that out. But, they say that that was changed but not documented. So, I am asking what does the FDA expect? Do they expect to follow the written guidance or did they really tighten the definition and expect of to know? Is my new company correct?
 
L

lfrost

#4
Thank you, I am aware of that and pointed that out. But, they say that that was changed but not documented. So, I am asking what does the FDA expect? Do they expect to follow the written guidance or did they really tighten the definition and expect of to know? Is my new company correct?
Bunny,

There really isn't a change in thinking. Manufacturers do not have to report malfunctions of devices if the malfunction did not contribute to or cause an adverse event, serious injury or death. FDA defines serious injury as when professional medical assistance is needed. So, in your two examples, because there was no adverse event, there is no need to report the malfunctions. If you would like further information, 21CFR803.50 is the part of the Code of Federal Regulations which govern medical device manufacturers as to what is to be reported. In that subpart, it states that the only time a malfunction needs to be reported is if the malfunction contributes to or causes a death or serious injury. Because your examples do not state that no one was injured, or died, due to the malfunction, then you do not need to report the event as it is not a medical device report (MDR).

:topic:
I would most likely explain that it would also be better not to make such a report to a public database as it would state that there is a possibility that a problem might exist with your device and cause a design change. I would suggest that instead of making a report, I would state that there should be a design review to ensure that the design of the device did not cause the malfunction to occur. I would feel better if a device design could be changed to reduce the risk, than submit a report that stated that we should have made a design change to let the public know that a design change, or some other change, could have prevented the malfunction from occurring again.

Just some off topic thoughts....
 
L

Laura Halper

#5
Sorry for this delayed response to Bunny's question. I only just saw this thread.

I believe that the earlier responses were incomplete and may be a little misleading. Even if the device malfunction did not cause or contribute to a death or serious injury, the FDA requires that the malfunction be reported if the malfunction "would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur" (21CFR 803.50(2)).

The regulation as written has an inherent assumption that if a malfunction has occurred, it could occur again (unless, of course, some corrective action was taken that eliminated the cause for the malfunction.) And I have seen a shift in FDA's expectations in this area. It used to be that if a malfunction did not recur for at least 2 years, the manufacturer could consider that the malfunction would not recur. But recently I saw a statement from FDA (unfortunately I don't have the citation handy) where they no longer accept this informal "two-year rule". This shift may be what Bunny's company has seen as FDA becoming more strict.

I have seen Warning Letters for not reporting malfunctions that did not result in death or serious injury, but that could result in death or serious injury if they recurred.

Hope this helps.
 
B

Bunny

#6
Thank you Laura. I have since heard from a well respected regulatory consultant that that indeed is the current shift I was asking about. Maybe one day the regulations will be revised to be more clear as to the current thinking of the FDA.
 
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