Complaint Training - FDA - How to recognize complaints and what actions to take

Chrisx

Involved In Discussions
#1
It is my understanding that FDA expects all employees at a medical device company to receive basic training on how to recognize complaints and what actions to take. Has anyone seen this expectation documented anywhere (e.g. FDA guidance, QSIT, inspection guides, CDRH Learn, etc.)?

Thanks!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
It is my understanding that FDA expects all employees at a medical device company to receive basic training on how to recognize complaints and what actions to take. Has anyone seen this expectation documented anywhere (e.g. FDA guidance, QSIT, inspection guides, CDRH Learn, etc.)?

Thanks!
The late QSR manual had the following paragraph in chapter 15 - Complaints:

Complaints from any source shall be equally addressed by and be processed according to the company complaint policy and procedure. The company should make certain that market, sales, engineering, manufacturing, regulatory, installation, and service personnel are trained to properly identify and report complaints. These employees shall be made aware of this requirement according to section 820.25(b).
(Emphasis added)
 
#3
Refer to FDA Regulations Part 803 Medical Device Reporting. You can also search “Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities“ on google to view the FDA page on complaints and reporting requirement, how to report, what forms to use, and within what time frame reporting needs to be done. FDA expects that companies have well-defined criteria for reporting which should be based on FDA requirements. Ideally, you should have a complaint handling/reporting Standard Operating Procedure (SOP) on which all your employees should be trained, and records of their training should be maintained. In case this SOP is updated employees must be retrained. This will ensure consistent understanding and implementation of requirements pertaining to complaints throughout the company.
 

JeantheBigone

Quite Involved in Discussions
#4
I don't remember where I saw it or all details, but I do remember the intent of having all employees have basic training.

If someone calls the company to complain, and dials a wrong number or gets transferred to a phone that does not belong to someone who has full training and authority to evaluate the complaint, that does not absolve the manufacturer of responsibility for ultimately evaluating the complaint and pro-actively following up if the contact is lost (say if they don't successfully transfer the call to the right department).

At a minimum each employee should know to record contact information for the caller and basics of the complaint so that it can be followed up on.
 
#5
There is an FDA guidance document Medical Device Reporting for Manufacturers. There are also pieces of information in the QSR as others have indicated. The FDA doesn't have explicit guidlines that I'm aware of that require all employees to be trained at a basic level. Most companies will do this because as soon as someone has "become aware" of an event, the company is required to handle the complaint and determine if an MDR is required.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
If someone calls the company to complain, and dials a wrong number or gets transferred to a phone that does not belong to someone who has full training and authority to evaluate the complaint, that does not absolve the manufacturer of responsibility for ultimately evaluating the complaint and pro-actively following up if the contact is lost (say if they don't successfully transfer the call to the right department).

At a minimum each employee should know to record contact information for the caller and basics of the complaint so that it can be followed up on.
Where is this taken from? I can accept this as an "ideal world" description, but I wouldn't describe it as a requirement or even a reasonable expectation. If a phone call, for example, accidentally lands in the warehouse and the warehouse/shift manager is unavailable I wouldn't expect pick&pack staff to receive or record anything. Would be nice if they did, but...

In my opinion there is some (minimal) responsibility on the complainant to pass the complaint through, such as making sure they speak to someone minimally qualified or that their contact details are recorded with a request to come back to them.

Ask yourself, if you called into your vehicle's workshop to enquire about some mechanical problem, and the cleaner picked up the phone, what would you do?...
 

Ronen E

Problem Solver
Staff member
Moderator
#7
There is an FDA guidance document Medical Device Reporting for Manufacturers. There are also pieces of information in the QSR as others have indicated. The FDA doesn't have explicit guidlines that I'm aware of that require all employees to be trained at a basic level. Most companies will do this because as soon as someone has "become aware" of an event, the company is required to handle the complaint and determine if an MDR is required.
The question is, if the cleaner picks up the phone and someone on the other end mumbles something with an intent to submit a complaint, does that make the company "aware of the complaint"?

(Please don't pick to "cleaner", it's just a code name for an employee completely and obviously unqualified).
 

JeantheBigone

Quite Involved in Discussions
#8
Where is this taken from? I can accept this as an "ideal world" description, but I wouldn't describe it as a requirement or even a reasonable expectation. If a phone call, for example, accidentally lands in the warehouse and the warehouse/shift manager is unavailable I wouldn't expect pick&pack staff to receive or record anything. Would be nice if they did, but...

In my opinion there is some (minimal) responsibility on the complainant to pass the complaint through, such as making sure they speak to someone minimally qualified or that their contact details are recorded with a request to come back to them.

Ask yourself, if you called into your vehicle's workshop to enquire about some mechanical problem, and the cleaner picked up the phone, what would you do?...
The difference between calling in about your vehicle and calling in about a medical device malfunction is that if my vehicle is malfunctioning, that presumably doesn't affect my ability to think straight :rolleyes: but a medical device malfunction conceivably could.

I don't remember exactly where I heard the detailed hypothetical scenario about the janitor picking up the phone at 3 AM and hearing someone at the other end mumble something about a device malfunction other than it being a training seminar or possibly a monthly meeting. What I do remember is the explanation to the effect that if a patient relies on the device to maintain their health, a malfunction may put them in a compromised mental state, so the manufacturer may have to meet them far more than haflway. I know, I know, they'd be more likely to call their doctor first, or even 911 if something were seriously wrong. But it is conceivable that someone in a fog could dial a wrong number or be transferred to a wrong number (think of those "Please listen carefully, as our menu options have changed" :mg: systems).

I think that the broad interpretation comes from the Guidance Document which says:

"2.3 When do I "become aware" that an MDR reportable event has occurred?
[FONT=Times New Roman,Times New Roman][FONT=Times New Roman,Times New Roman]As a manufacturer, you are considered to have "become aware" of an event whenever [21 CFR 803.3]:
• Any of your employees becomes aware of information that reasonably suggests that an event is required to be reported in a 30-day report or in a 5-day report that we have requested from you; or
...
[/FONT]
[/FONT]"

From the regs

from 21 CFR 803.3 (b)"(2) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because we had requested reports in accordance with 803.53(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. "

CFR - Code of Federal Regulations Title 21

Now "any of your employees" is pretty broad, right? :cool:
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Now "any of your employees" is pretty broad, right? :cool:
Unfortunately that doesn't put it to bed.
The real question is when can you determine with certainty that someone has "become aware" (same sentence in the regs) of something.
Surprisingly 2 different employees with different qualifications / roles can have quite different levels of awareness to the exact same input.

If you insist, the lowest common denominator I would train ALL employees to, regarding accepting company phone calls, would be: "If you receive a call that apparently isn't meant for you or you're confused about what the person on the other side says or who they are, reply: "This is <company name>. I'm sorry, I think I received your call by mistake. Please disconnect and try again, thank you."" I think (can't prove) that statistically this approach would yield better results than the one encouraging any employee to take down contact details and then make sure that they are passed to the right person within the company. Too many weak links in the latter, including implied acceptance of "becoming aware" while the ball is still in midair.
 
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