Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

Hi , 

Once the device has been released for use and a deficiency ( if the deficiency falls within the definition of a complaint) has been discovered whether by the manufacturer or customers,  it would be filed as a complaint.  it doesn't matter who discovers the deficiency. Look up the definition of "complaint" in 21 CFR 820 to see what qualifies as complaint.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

Completely agree. This is a complaint. If it were handled differently for customer (vs. internal report), that would be noncompliant to the regulation. I think often companies might do this in an attempt to not want complaints (goal to reduce complaints). This is why you have to be careful about how you set up objectives (unintended consequence on behavior). 

For ISO 13485, this is why the title of the section (and input to management review) removed the word "customer" from the complaint handling requirements and now the input to management review is information from 'complaint handling' and section 8.2.2 does not have a reference to customer.

Good luck in your work!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 25-Jun-2019 16:08
From: Karen Zhou
Subject: Complaint handling process

Hi ,

Once the device has been released for use and a deficiency ( if the deficiency falls within the definition of a complaint) has been discovered whether by the manufacturer or customers,  it would be filed as a complaint.  it doesn't matter who discovers the deficiency. Look up the definition of "complaint" in 21 CFR 820 to see what qualifies as complaint.

------------------------------
Karen Zhou

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

This message was posted by a user wishing to remain anonymous

What about a misuse during clinical investigation? It has also happened.
Original Message:
Sent: 26-Jun-2019 09:19
From: Mark Swanson
Subject: Complaint handling process

Completely agree. This is a complaint. If it were handled differently for customer (vs. internal report), that would be noncompliant to the regulation. I think often companies might do this in an attempt to not want complaints (goal to reduce complaints). This is why you have to be careful about how you set up objectives (unintended consequence on behavior).

For ISO 13485, this is why the title of the section (and input to management review) removed the word "customer" from the complaint handling requirements and now the input to management review is information from 'complaint handling' and section 8.2.2 does not have a reference to customer.

Good luck in your work!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 25-Jun-2019 16:08
From: Karen Zhou
Subject: Complaint handling process

Hi ,

Once the device has been released for use and a deficiency ( if the deficiency falls within the definition of a complaint) has been discovered whether by the manufacturer or customers,  it would be filed as a complaint.  it doesn't matter who discovers the deficiency. Look up the definition of "complaint" in 21 CFR 820 to see what qualifies as complaint.

------------------------------
Karen Zhou

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

This message was posted by a user wishing to remain anonymous

What about a use error noticed in clinical study? It happened too, but since it does not harm the patient, or caused injuries, the clinical team don't think it's a complaint.
Original Message:
Sent: 26-Jun-2019 09:19
From: Mark Swanson
Subject: Complaint handling process

Completely agree. This is a complaint. If it were handled differently for customer (vs. internal report), that would be noncompliant to the regulation. I think often companies might do this in an attempt to not want complaints (goal to reduce complaints). This is why you have to be careful about how you set up objectives (unintended consequence on behavior).

For ISO 13485, this is why the title of the section (and input to management review) removed the word "customer" from the complaint handling requirements and now the input to management review is information from 'complaint handling' and section 8.2.2 does not have a reference to customer.

Good luck in your work!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 25-Jun-2019 16:08
From: Karen Zhou
Subject: Complaint handling process

Hi ,

Once the device has been released for use and a deficiency ( if the deficiency falls within the definition of a complaint) has been discovered whether by the manufacturer or customers,  it would be filed as a complaint.  it doesn't matter who discovers the deficiency. Look up the definition of "complaint" in 21 CFR 820 to see what qualifies as complaint.

------------------------------
Karen Zhou

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

I think for a clinical investigation, in Canada for example,  it is under an investigational testing authorization which mandates that the manufacturer follow the complaint management process and problem reporting requirements where an adverse event meets reportability criteria. It is treated like any other licensed device in terms of post-marketing processes like complaint management.  A complaint is associated with some quality deficiency of the device but doesn't have to arise from an injury.  I think you may be thinking of medical device reporting where reportability will depend on the degree of injury and other considerations.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 26-Jun-2019 16:32
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

What about a use error noticed in clinical study? It happened too, but since it does not harm the patient, or caused injuries, the clinical team don't think it's a complaint.
Original Message:
Sent: 26-Jun-2019 09:19
From: Mark Swanson
Subject: Complaint handling process

Completely agree. This is a complaint. If it were handled differently for customer (vs. internal report), that would be noncompliant to the regulation. I think often companies might do this in an attempt to not want complaints (goal to reduce complaints). This is why you have to be careful about how you set up objectives (unintended consequence on behavior).

For ISO 13485, this is why the title of the section (and input to management review) removed the word "customer" from the complaint handling requirements and now the input to management review is information from 'complaint handling' and section 8.2.2 does not have a reference to customer.

Good luck in your work!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 25-Jun-2019 16:08
From: Karen Zhou
Subject: Complaint handling process

Hi ,

Once the device has been released for use and a deficiency ( if the deficiency falls within the definition of a complaint) has been discovered whether by the manufacturer or customers,  it would be filed as a complaint.  it doesn't matter who discovers the deficiency. Look up the definition of "complaint" in 21 CFR 820 to see what qualifies as complaint.

------------------------------
Karen Zhou

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

Both the complaint definition in QSR and in ISO 13485:2016 include the concept that the device must have been released for definition. Neither have a restriction on the person filing the complaint. It can come from employee, a contractor, or an employee of a contractor. In my complaint management course I have a case in which a reliability engineer analyzes the service data under 820.200 and uncovers a reliability problem with a certain part. Her report satisfies the definition of a complaint and I tell people it needs to be in the complaint system. This usually creates an interesting discussion because the customer does call to lodge a complaint, but to request service (corrective maintenance).

In summary, base the complaint determination on the definition, The person reporting the complaint is not a factor.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

Interestingly, no one has pointed out that the definitions of 'complaint' differ between the QSR and ISO 13485:2016, but only in one small respect that is relevant to this question from Anon. This is that the ISO definition includes the word "usability". So in my opinion, looking strictly at the definitions, under ISO, the situation described initially by Anon would be a 'complaint', whereas under the QSR, it would not meet the definition of 'complaint' unless the usability issue noticed had a potentially adverse effect on "safety, effectiveness, or performance".

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 26-Jun-2019 19:06
From: Dan O'Leary
Subject: Complaint handling process

Both the complaint definition in QSR and in ISO 13485:2016 include the concept that the device must have been released for definition. Neither have a restriction on the person filing the complaint. It can come from employee, a contractor, or an employee of a contractor. In my complaint management course I have a case in which a reliability engineer analyzes the service data under 820.200 and uncovers a reliability problem with a certain part. Her report satisfies the definition of a complaint and I tell people it needs to be in the complaint system. This usually creates an interesting discussion because the customer does call to lodge a complaint, but to request service (corrective maintenance).

In summary, base the complaint determination on the definition, The person reporting the complaint is not a factor.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.

Hello Anonymous,

You raised two questions relating to clinical investigations, one concerning misuse during a clinical investigation and the other when use error does not harm the patient or caused injuries and therefore the clinical team does not believe it's a complaint. The clinical team is correct. Under the internationally recognized standard for medical device clinical investigations, ISO 14155:2011, what you are describing should be treated as a device deficiency, unless the device is being studied in the post-market period and has been released for distribution (US Quality System Regulation) or released from the organization's control (ISO 13485:2016). That is, if the device being studied is not yet on the market (here I am limiting this circumstance to the US and Europe), device deficiencies identified during a clinical investigation are not complaints.

Clause 3.15 of ISO 14155:2011 defines "device deficiency" as "inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. NOTE Device deficiencies include malfunctions, use errors, and inadequate labelling."

Clause 6.4.2 of ISO 14155:2011 states: "All device deficiencies related to the identity, quality, durability, reliability, safety or performance of an investigational medical device shall be documented throughout the clinical investigation and appropriately managed by the sponsor." The rest of the clause addresses device deficiencies that require reporting.

According to ISO 14155:2011, which is a European harmonized standard and an FDA recognized standard, when use errors occur during a clinical investigation, they need to be documented and managed by the sponsor in a manner that is appropriate to the use error, which of course, could be due to the design of the device, its labeling, need for user to be trained, etc.

The European Medical Device Regulation (EU 2017/745) has adapted the definition of "device deficiency" from ISO 14155 in Article 2(59) to be "…any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer."

The US Investigational Device Exemption (21 CFR Part 812) regulation states only that records concerning adverse device effects (whether anticipated or unanticipated) and complaints must be maintained. There is no further comment about "complaints," which as stated above, are alleged deficiencies of a device after it is released for distribution.

I hope this helps!

------------------------------
Maria E Donawa, M.D.
President, Donawa Lifescience Consulting Srl
Rome, Italy
medonawa@donawa.com
+39 06 578 2665
------------------------------

Original Message:
Sent: 25-Jun-2019 16:01
From: Anonymous Member
Subject: Complaint handling process

This message was posted by a user wishing to remain anonymous

Hi all,

Say a device has been released for customer to use, our engineer notice a user error while observing the customer using the device, and reported back to the company. Does that count as complaint? Should it be handled differently as it's not a complaint coming directly from the customer.

Thanks.