Medical Device Reporting In US/ EU/ Canada

#1
Good Morning Everyone.

I work for a small medical device company which markets Class II(US), IIb(EU), III(Can) Orthopedic implants. Recently, we revised our medical device reporting procedure only in focus of US (a decision tree which can help decide to report or not report). We also have instruments Class II(US), Class IIa(EU) that assist in the placement of implants into the patient's body. Obviously, these instruments are not essential to maintable human life.

My question here is do I have to report to FDA if an instrument (not the implant) if it is broken or cracked during the surgery (with the fact that it didn't interrupt the surgery)? So, if this happens in USA, it triggers Canadian Medical device Problem reporting by default if the product is sold in Canada.

Canada defines the medical device reporting more broadly.

A mandatory problem report is required under the Regulations for any incident involving a medical device that is sold in Canada when the incident:
• occurs either within or outside Canada;
• relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use (section 59(1)(a)); and
• has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur (section 59(1)(b)).

What about EU reporting?

i know this is too much to ask. But I would really really appreciate if everyone of your could share you thoughts (supported by regulatory statements).

Also, does someone have a MDR decision tree for EU and Canada?

Thanks,

Eric.
 
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L

Lerotronic

#2
If it didn't happen in EU, Europeans don't want to know about it - consult MEDDEV.

Check reportable malfunction for Instrument breakage, it is up to you to determine the severity of potential patient impact of this malfunction and thus make this event an MDR reportable or not.

If it didn't happen in Canada, and this event did not lead to remedial actions in country where it happen, Canadians don't want to know about it.

Cannot dig into the documentation now to cite it unfortunately.
 
R

RunningMommaCT

#3
My experience in the US is that if the instrument breaks, and there is no delay in surgery, and no pieces left in the patient then it's not MDR reportable. The MDR decision tree weight heavily on did the surgery get extended; additional anethesia; the longer the patient is operated on then the higher risk of infection. Based on my experience and QMS that I have set up I would not report a broken instrument provided my earlier points are true.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
if the instrument breaks, and there is no delay in surgery, and no pieces left in the patient then it's not MDR reportable.
In my opinion this is a little too expansive of an interpretation, considering the following text from 21 CFR 803:

(o) MDR reportable event (or reportable event) means:

(1) ...

(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:

(i) ...

(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
I read it to mean that even if nothing of that sort happened but could likely happen if the failure recurred, the event is reportable. Eg maybe this time around no pieces were left in the patient but it could happen next time and is likely to have severe consequences, etc.
 
R

RunningMommaCT

#5
I think the challenge that all organizations face is how you interpret the regulations. Risk tolerance is different from company to company and clearly person to person (hence our discussion) and that is what makes the world go round:) You could take a conservative approach and report everything.

I follow a common sense approach with my viewpoints on quality and regulatory. I have been under direct inspection by FDA at a 5 person company and at a 50,000+ person company. Any action you take, (reporting or not) you should ask yourself, am I comfortable defending my decision? Does this decision make sense with the information that I have? A complaint may be received that the driver broke during surgery. You get the instrument back, perform the complaint investigation and conclude that the instrument was used beyond its useful service life. No MDR filed. The complaint is closed. 30 days later you receive additional information (possibly from a sales rep who followed up with the surgeon once the complaint was close out) that the surgery was actually extended because the scrub tech needed to get another tray with more instruments from central supply. You learn that the surgery was delayed and you re-open the investigation citing this new information in your complaint. Next, you file the MDR report. This is all logical given how information became available to your organization.

Good luck!
Nothing worthwhile is ever easy:)
 

Ronen E

Problem Solver
Staff member
Moderator
#6
I think the challenge that all organizations face is how you interpret the regulations. Risk tolerance is different from company to company and clearly person to person (hence our discussion) and that is what makes the world go round:) You could take a conservative approach and report everything.

I follow a common sense approach with my viewpoints on quality and regulatory. I have been under direct inspection by FDA at a 5 person company and at a 50,000+ person company. Any action you take, (reporting or not) you should ask yourself, am I comfortable defending my decision? Does this decision make sense with the information that I have? A complaint may be received that the driver broke during surgery. You get the instrument back, perform the complaint investigation and conclude that the instrument was used beyond its useful service life. No MDR filed. The complaint is closed. 30 days later you receive additional information (possibly from a sales rep who followed up with the surgeon once the complaint was close out) that the surgery was actually extended because the scrub tech needed to get another tray with more instruments from central supply. You learn that the surgery was delayed and you re-open the investigation citing this new information in your complaint. Next, you file the MDR report. This is all logical given how information became available to your organization.

Good luck!
Nothing worthwhile is ever easy:)
Good discussion :agree1:

These are all fair arguments, and as long as your experience indicates that they work for you it would make business sense to follow them. However, there's also a wider perspective to consider here.

One of the purposes of the MDR system is to provide the FDA a more holistic view of technological / medical trends that might require their attention, a sort of heads-up on possible problems before they get out of control. The individual manufacturer doesn't normally see that bigger picture. For instance, if a certain type of instrument is malfunctioning at a low rate it might seem to the individual manufacturer like an anecdotal event, an outlier, while in fact such rare events might be happening with similar instruments made by other manufacturers. This might draw the FDA's attention to something that's potentially problematic with the current practice, the current technology or something similar that goes beyond the specifics of one device brand. This could then be scrutinised and either dismissed as sufficiently low-risk (for various reasons), or acted upon as necessary. If each and every manufacturer decided not to report only because a certain event didn't end up badly (a near miss), no heads up would be possible. I think that this is the reason that the clause I cited was included in the regulation in the first place.

I don't argue that everyone should report everything. Rather, I argue for an honest risk evaluation process, and reporting unless one is certain that the event wasn't a potentially serious near-miss but rather a nuisance that's highly likely to end up with no serious patient harm if repeated (using the same device or a similar one).

By the way, if an investigation concludes that the failure was due to exceeding the device's (prescribed) use life, it doesn't - at least in my opinion - seal the case. It just means that there's a usability issue (use error) or a misuse of the device. Again, the questions should be: Why was the device used beyond its intended life? Did device design and/or labeling contribute? Is it likely to recur (using the same or a similar device)? Are the consequences of recurrence likely or unlikely to be serious?

Cheers,
Ronen.
 

Jean_B

Trusted Information Resource
#7
About cross-region reporting, the most general principle seems to be:
report out-of-region incidents (as FSCA),
for products sold in-region
only when a Field Safety Corrective Action (FSCA; EU-terminology) was initiated based on the out-of-region incidents.

Except for products legally marketed in the USA. In that case, no matter the region of occurrence the FDA wants to know.


For the USA, Adverse event reporting has added info in their guidance "Medical Device Reporting for Manufacturers" dated november 2016. It has a similar question, and clear answer:
4.11.3 I’m a foreign manufacturer of a device that has been cleared or approved in the US and is also lawfully marketed in a foreign country. If an adverse event occurs in a foreign country with the device, must the event in the foreign country be reported under the MDR regulation?
Yes, FDA considers an event that occurs in a foreign country reportable under the MDR regulation if it involves a device that has been cleared or approved in the US – or a device similar to a device marketed by the manufacturer that has been cleared or approved in the US – and is also lawfully marketed in a foreign country. Devices may be manufactured to slightly modified specifications to meet standards in different countries. If these changes do not substantially alter the performance of the device, then any device events that are MDR reportable events relating to such modified devices should be reported under the MDR regulation (see section 2.14 of this guidance).



For EU, Incident reporting is currently explained in MedDev 2.12, rev-8.
Its section 5.1 notes:
INCIDENTs which occurred outside the EEA, Switzerland and Turkey do not lead to a FIELD SAFETY CORRECTIVE ACTION relevant to these geographic areas do not need to be reported. Incidents which occurred outside the EEA , Switzerland and Turkey led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION.


For Canada, Mandatory Problem Reporting is noted in SOR 98-282, clause 59.
Section two notes:
(2) The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.
 
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