Regulatory Open Forum

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

Thanks David. I used to manage the adverse event handling unit at a large company. In every training I can remember, we were told that "intervention" does not necessarily mean "medical intervention given by a physician." Intervention could literally be as simple as applying a topical treatment at home. Let's use an extreme example. Suppose that while using a medical device, I accidentally amputate my finger. I could say, "Meh, just a pinky. I've got nine more fingers" then clean it, wrap it up & be done with it (again, extreme example), while another person may rush to the hospital & go through a surgery, reattachment, recovery & physical therapy. While I don't think anyone would argue that this would be a serious injury, the response of the individual may vary drastically. Therefore, I don't feel that setting criteria for non-serious events based on the type of event/injury itself is effective or appropriate. There are also many reasons people may not see a physician for what they know to be a serious injury (financial reasons, mental capacity, fear of losing job, etc.) which must be considered. In response to your statement, "that is acceptable unless such event can lead to complications/serious issues", I agree, but not being a physician, I do not feel qualified to state whether or not these events could lead to more serious complications or further injury. For example, there are many rashes that are essentially harmless, while others can be life-threatening. Without having the ability to diagnose this, I cannot say that this may not lead to something far more serious, if not for the individual concerned, perhaps to another person that may experience the same/similar event. I hope that makes sense.

As for my 510(k) question, I have already advised them all of the things that you have suggested. My question is strictly regarding reporting/not reporting adverse events involving the unapproved devices. 

Thanks so much for the feedback so far.

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

------------------------------
Lauren Parker
CA
United States
------------------------------

The essence of your question boils down to whether or not the MDR threshold for “serious injury” is met by descriptors such as “burning sensations”, “irritations”, “rashes”, “infections”, etc.  It may be that your coworker is basing his opinion on the third arm of FDA’s “serious injury” threshold, which speaks to injury or illness that necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Regardless, 21 CFR 803.20(c) basically dictates the manner in which “serious injury” decision-making is to happen.  Therefore your team needs to carefully attend to the intent and implications of 803.20(c).

In a nutshell, 803.20(c) states that the “serious injury” decision needs to be anchored by the insights of a person qualified to make a medical judgment.  The FDA says that this means a physician, nurse, risk manager, or biomedical engineer.  Therefore, you showed great wisdom when you noted the importance of being medically-qualified to judge how serious an injury may/may not be.

Firms also need to be aware that the Agency has had a history of heavily weighting the impressions and opinions voiced by device users when those users are themselves people qualified to make a medical judgment.  For example, the original 1984 MDR regulations and preamble included a “per se” rule whereby if a user qualified to make a medical judgment informed the manufacturer that a reportable event occurred, then it in effect constituted a reportable event based solely on the fact that such a user is viewed by FDA to have, “…special education, training, experience, expertise, and knowledge with respect to medical devices…”  Although the “per se” rule was stricken in 1996, I for one remain cognizant of this because my experience has been that this general thought process persists in the minds of FDA inspectors.

So at the end of the day, if a firm receives complaints alleging injuries/illnesses such as “burning sensations”, “irritations”, “rashes”, “infections”, etc., even if apparently minor, then the ultimate designation of “serious injury” (and especially lack of serious injury) needs to be based on input from a person qualified to make a medical judgment, AND who has made his/her judgment in the direct context of the intended use and technology for the particular subject device.  Without such a basis, the manufacturer leaves itself vulnerable to compliance and safety pitfalls because, contrary to FDA’s requirements, such a basis isn’t based on qualified professional, scientific, or medical facts, observations, or opinions.

I’ve observed the integration of qualified medical judgement in practice at multiple firms and clients, large and small, where qualified medical advisory reviewers were included in the review and sign-off of the MDR reportability decision.  While this may seem overly burdensome, MDR reportability assessments are not the place to cut corners, as failure to submit required MDR reports is one of FDA’s Warning Letter triggers.

Hope this helps,

------------------------------
Kevin Randall RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States

Copyright 2016 by ComplianceAcuity, Inc.  All rights reserved.

Original Message:
Sent: 04-19-2016 17:43
From: Lauren Parker
Subject: complaint handling / MDR

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

------------------------------
Lauren Parker
CA
United States
------------------------------

I agree with Kevin, that is how we assess whether we will report or not.  We have a Potentially Reportable Events Committee that assess each event and a Clinician is on this committee to help in the assessment.   

Depending on the type of medical device, a rash or irritation doesn't seem too serious, but someone qualified to make this decision should be making this decision and perhaps Risk Management should be consulted as well. 

Honestly, I am kind of wondering if a lot of companies don't have this type of assessment because when I go through the MAUDE database for post market surveillance I see a lot of things that are reported that seem very minor are would not be considered reportable on our end.  I'm not sure many of them would ever meet FDA's definition of serious injury. It is a waste of time and resources, in my opinion, to report these.

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

------------------------------
Lauren Parker
CA
United States
------------------------------

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

------------------------------
Lauren Parker
CA
United States
------------------------------

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

------------------------------
Lauren Parker
CA
United States
------------------------------

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!

Hi all. I am assisting a company w/ their complaint handling & medical device reporting process. Class II devices. I have run into a couple of roadblocks & would like your opinions.

As I was reviewing their complaint log, I noticed complaints describing burning sensations, irritations, rashes, infections, etc. I feel that these events should be reported, but the employee in charge of the project does not want to report any adverse events unless the customer actually goes to his or her physician because of it. His rationale is that if the condition eventually resolves on its own, or if the customer never went to the doctor because of it, then "it must not have been serious." While I understand his position, I disagree. Perhaps I have just worked for extremely conservative companies in the past, but these types of events would have always been considered reportable events in all of my prior companies. My rationale is that we are not physicians, & are therefore not qualified to make the determination of how serious an injury may/may not be. Further to that, I feel that we should report based on the fact that the same type of event may be more serious depending on the individual should it reoccur. I'd love to hear your opinions.

Another problem that I have discovered is that some of their devices which are currently on the market do not have the required 510(k) clearances. The owner assures me that they are working towards getting them, but as of yet, they are not cleared. So my dilemma is whether to suggest that they file MDRs for complaints involving these uncleared devices or not. Their concern is that doing so may draw attention from FDA before they get   510(k) approvals.  I certainly can understand where they are coming from, but I am equally as concerned, if not more so, about not reporting events concerning these devices. Have any of you faced a similar situation, and if so, what would you suggest? Essentially, which is the "lesser of two evils" so to speak? The owners would like to know which is riskier to the company, etc. 

I appreciate everyone's feedback. Have a great afternoon!