Regulatory Open Forum

The investigational device adverse event reporting criteria of subsection 81(k)(v) of Health Canada's Medical Devices Regulations (SOR/98-282) have traditionally been based on the same criteria as prescribed for manufacturer mandatory problem reporting criteria (now called "incident reporting" criteria) by section 59.  Although the most recent amendment via SOR/2020-262 replaced subsection 81(k)(v)'s traditional section 59 cross-reference with a direct statement of the reporting criteria, those basic criteria have not changed, and are still the same as the section 59 criteria.  Specifically, those are to report incidents where both of the following are true:

B. the incident 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 were the incident to recur.

 

 

The interpretation that I integrate into written procedures for Canadian incident reporting is that "failure of the device" or a "deterioration in its effectiveness" mean the failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer's instructions.  I've gleaned this indirectly from Health Canada's guidance for incident reporting and the definition therein for "malfunction or deterioration".  I know of no other guidance from Health Canada about this (I welcome others' insights on their experiences) but can say that my procedures have been successfully audited by Health Canada with no objectionable findings lodged.

 

I would plainly advise that if the device in any way doesn't perform as expected or claimed, then the "failure of the device" or a "deterioration in its effectiveness" aspect of co-criterion (A) has been met.  I wouldn't try to apply risk-based filtering to co-criterion (A), as the heart of the risk-based aspect is embedded in co-criterion (B).

 

Regarding the roles and responsibilities for incident reporting from manufacturers as compared to clinical investigators, remember that manufacturers' section 59 incident reporting obligations are without regard to whether the subject device already has marketing authorization or is instead only a premarket investigational device; indeed, the manufacture must report using its article 59 reporting system either way.  Therefore, be sure that the scope of the manufacturer's written procedure for manufacturer incident reporting is written accordingly so as not to exclude manufacturer reporting related to investigational devices.  Those procedures should also include or refer to procedures assuring that the manufacturer will regarding investigational devices secure a "written undertaking" [section 81(k)] from the clinical investigator(s) assuring that the investigator(s) will fulfill their respective subsection 81(k)(v) reporting obligations.

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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 24-Aug-2021 14:53
From: Sandra Veenstra
Subject: question for regulatory open forum (anonymous)

TOPIC: Subsection 81(k)(v)(A) of the Canadian Medical Device Regulation

Wondering how Canadian manufacturers for medical devices used in investigational testing have interpreted and implemented subsection 81(k)(v)(A) of the Canadian Medical Device Regulation, copied below for reference:

(v) in the event of an incident involving the device and that meets the following conditions, report the incident and the circumstances surrounding it to the Minister and to the manufacturer or importer of the device within 72 hours after the qualified investigator becomes aware of the incident:

(A) the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use.

 

Is there further guidance on scope of "incident related to.....inadequacy in its directions for use"?  Should a risk-based approach be applied, or all incidents reported?  Also, how do manufacturers incorporate this information into their own reporting requirements to Health Canada under their device license?  Is this an input into mandatory reporting procedures or do manufacturers have a separate process to respond to reported incidents from investigational testing?  

Sandra Veenstra

Director- Quality Assurance and Regulatory Affairs

Picomole Inc.

Our commitment to quality saves lives.

191 Halifax Street, Moncton, NB

(506)855-2400 ext. 234 (office)

(709)699-4972 (mobile)

www.picomole.com

Hello Sandra,

If I could further add about the specific line item, some of the text of Canadian Regulations they are lifting from or using some of the good approach from the European regulations and other regulations.  I have read through the updates a few times and generally see how Health Canada takes good intent incorporating into their regulations so the way I read is linking the directions for use to aspects such as risk assessment, mis-use, and/or abnormal use which stem out of ISO 14971.  I would not say it is a risk-based approach, more the relationship to risk management (and usability) for the finished device.  This appears to be a clarification/expansion that not only is an incident related to failure of the device, but could also be related to the user not using the device properly.

As a example, if there was a warning in a powered (active) device which was not provided in the instructions for use (information supplied to the user) and a patient injury occurred or could possibly occur, then this could be an incident report even if the device itself did not fail.  The hazardous situation was not caused by failure of the device itself, but the device failed because the user did not use it properly.  But more the most important point being:  manufacturers will often not report incidents because they attribute to "user error" and many regulatory agencies do not view this excuse or exception any more.  If the device failed because of user error, it most likely is attributed to inadequacy of the instructions.  In my view, this really does not change anything from what was done 1 year ago or 5 years ago - it is more manufacturers need to ensure this is incorporated into their risk management and the linkage is made between post market and risk management (as we have seen in the EU regulations).  And this so called "user error" is looked more closely by companies as a method to not report.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Aug-2021 16:39
From: Kevin Randall
Subject: question for regulatory open forum (anonymous)

The investigational device adverse event reporting criteria of subsection 81(k)(v) of Health Canada's Medical Devices Regulations (SOR/98-282) have traditionally been based on the same criteria as prescribed for manufacturer mandatory problem reporting criteria (now called "incident reporting" criteria) by section 59.  Although the most recent amendment via SOR/2020-262 replaced subsection 81(k)(v)'s traditional section 59 cross-reference with a direct statement of the reporting criteria, those basic criteria have not changed, and are still the same as the section 59 criteria.  Specifically, those are to report incidents where both of the following are true:

 

A. the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and

B. the incident 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 were the incident to recur.

 

 

The interpretation that I integrate into written procedures for Canadian incident reporting is that "failure of the device" or a "deterioration in its effectiveness" mean the failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer's instructions.  I've gleaned this indirectly from Health Canada's guidance for incident reporting and the definition therein for "malfunction or deterioration".  I know of no other guidance from Health Canada about this (I welcome others' insights on their experiences) but can say that my procedures have been successfully audited by Health Canada with no objectionable findings lodged.

 

I would plainly advise that if the device in any way doesn't perform as expected or claimed, then the "failure of the device" or a "deterioration in its effectiveness" aspect of co-criterion (A) has been met.  I wouldn't try to apply risk-based filtering to co-criterion (A), as the heart of the risk-based aspect is embedded in co-criterion (B).

 

Regarding the roles and responsibilities for incident reporting from manufacturers as compared to clinical investigators, remember that manufacturers' section 59 incident reporting obligations are without regard to whether the subject device already has marketing authorization or is instead only a premarket investigational device; indeed, the manufacture must report using its article 59 reporting system either way.  Therefore, be sure that the scope of the manufacturer's written procedure for manufacturer incident reporting is written accordingly so as not to exclude manufacturer reporting related to investigational devices.  Those procedures should also include or refer to procedures assuring that the manufacturer will regarding investigational devices secure a "written undertaking" [section 81(k)] from the clinical investigator(s) assuring that the investigator(s) will fulfill their respective subsection 81(k)(v) reporting obligations.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 24-Aug-2021 14:53
From: Sandra Veenstra
Subject: question for regulatory open forum (anonymous)

TOPIC: Subsection 81(k)(v)(A) of the Canadian Medical Device Regulation

Wondering how Canadian manufacturers for medical devices used in investigational testing have interpreted and implemented subsection 81(k)(v)(A) of the Canadian Medical Device Regulation, copied below for reference:

(v) in the event of an incident involving the device and that meets the following conditions, report the incident and the circumstances surrounding it to the Minister and to the manufacturer or importer of the device within 72 hours after the qualified investigator becomes aware of the incident:

(A) the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use.

 

Is there further guidance on scope of "incident related to.....inadequacy in its directions for use"?  Should a risk-based approach be applied, or all incidents reported?  Also, how do manufacturers incorporate this information into their own reporting requirements to Health Canada under their device license?  Is this an input into mandatory reporting procedures or do manufacturers have a separate process to respond to reported incidents from investigational testing?  

Sandra Veenstra

Director- Quality Assurance and Regulatory Affairs

Picomole Inc.

Our commitment to quality saves lives.

191 Halifax Street, Moncton, NB

(506)855-2400 ext. 234 (office)

(709)699-4972 (mobile)

www.picomole.com