Hi Al.
If you go to MEDDEV 2.12/1 Rev 8 this defines
Incident and if you refer to Section 5.1.1 there is Criteria A through C for when an Incident is reportable. This defines an Incident that is reportable, but then the question is what is the difference between a Serious Incident, Non-Serious Incident (or Dan's wording Not Serious Incident), and a Complaint. My own interpretation is that a customer complaint is all inclusive meaning this is a notification by a customer of defect, quality, reliability, usability, etc. This means that all Serious Incidents and all Non-Serious Incidents are complaints. For me a Serious Incident is an event that is reportable. A Non-Serious Incident is an event that while it has occurred has been determined by the organisation to
not be reportable.
Some people I have chatted with view a Non-Serious Incident as a malfunction that has
not contributed to a death or serious injury, however, if it were to recur, may contribute to some serious deterioration of health. As an example, a Serious Incident is a device having failed caused surgical intervention of the patient to occur or even death. This is still considered a compliant. A Non-Serious Incident is a malfunction of a device, say a power loss occurring outside of any connection or use with a patient. Still considered an Incident, but a Non-Serious Incident because the failure did not contribute to any death or serious deterioration of health. This is still considered a complaint. The organisation has determined the malfunction to have occurred, but is not reportable. Or it may be reportable but again has not cause any patient injury or harm. Then a complaint would be a device failed with risk of any harm or injury to a patient.
The EU MDR 2017/745 does define Adverse Event, Incident, and Serious Incident. There also could be interpretation that a Non-Serious Incident is anything NOT a Serious Incident whether it is reportable or not. So if an incident has been determined not to be Serious Incident then it is Not a Serious Incident or maybe to some just a "complaint" and recorded as such. I would be interested to hear others thoughts on these terms, because while I have my own interpretation I know this is different from other people's thoughts.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Jul-2019 20:40
From: Dan O'Leary
Subject: MDR Trending non-serious incidents
There is no explicit definition, it is by exhaustion.
The set of incidents is partitioned into two mutually exclusive and exhaustive sub-sets: serious incidents and not serious incidents. (I call them non-serious incidents, but I have a colleague who takes delights in correcting me.)
See my attached diagram.
Look at ISO 14971:2007 Table D.3. I infer that, using the MDR definition, a serious incident is catastrophic, critical, or serious. A non-serious incident (I'll get yelled at) is minor or negligible.
Also, be cautious of Article 88. In addition to non-serious incidents you will analyze incidents "that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits".
Starting with just the first part, ISO 14971:2007 requires the identification of residual risks. I consider side-effects as a type of residual risk. I recommend that, in the Excel worksheet implementation, you create a separate column to identify side-effects. These are a subset of residual risks. I can't think of a better place to identify them. Then, classify each side-effect based on the EU-MDR type. A quick word search reveals:
expected side-effect
expected undesirable side-effect
identified side-effect
previously unknown side-effect
side-effect
undesirable side-effect
undesirable side-effects and risks relating to overdose
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 01-Jul-2019 11:50
From: Al Van Houdt
Subject: MDR Trending non-serious incidents
For MDR, is there a definition or do you have a definition of a non-serious incident and perhaps some good examples?
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Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
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