Social Media Feedback process for Medical Devices

dr1vn

Involved In Discussions
#1
Looking for some ideas here... I'm trying to develop a process for responding to social media posts and other customer feedback related to our medical device. Because of the instantaneous aspect of social media, the timeliness of responses is super important. We have resources devoted to responding to posts using templated responses. The templated responses go through an informal review which I would like to formalize and be sure Regulatory and Marketing pre-approve the templated responses. Pre-approving the templated responses allow us to respond much quicker and still satisfy the "review and approval" portion of 13485. I don't know if there are any issues with this type of approach though.

My other concern, from a QA point of view, is how do you manage such a list of templated-responses? The traditional approach is to create a document that has templated responses and keep adding to it as new issues arise. So, the document would increase in revision quite frequently... But are there other approaches that you have found work for control of templated responses for customer feedback?
 
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dr1vn

Involved In Discussions
#3
Ideas? Are you considering these as inputs to your complaint process?
Most definitely!. If the feedback is a complaint, then it goes into our complaint process. Our complaint process uses a complaint handling unit so it's a bit slower. But, when the complaint is on social media where time is of the essence then we need a response ready to go. So, both the complaint process and the social media response process are linked and having reviewed and approved (and controlled) responses lined up and ready to go is an important preventive action for us.
 

yodon

Staff member
Super Moderator
#4
But, when the complaint is on social media where time is of the essence then we need a response ready to go.
Is this for a Public Relations reason?

13485 doesn't require a response to the complainant (or for whomever provided feedback). (The FDA requires that complaint files include any replies to the complainant.) So I guess it's up to you how you handle canned responses.

Um, canned responses, though, can't be preventive actions (in the context of 13485).
 

dr1vn

Involved In Discussions
#5
Is this for a Public Relations reason?

13485 doesn't require a response to the complainant (or for whomever provided feedback). (The FDA requires that complaint files include any replies to the complainant.) So I guess it's up to you how you handle canned responses.

Um, canned responses, though, can't be preventive actions (in the context of 13485).
Yes, this is a public relations issue, but I still want to be sure that the resource making the canned response is using a canned response that has gone through a review to be sure no other risks are being introduced in their response to the user (hence having RA review).

I'm interested in hearing why a canned response cannot be a prevention in the context of 13485. Say for example, a user tweets that they've been cleaning your product with bleach. You have a canned response to say, "please only use pre-approved cleaning products as noted in the user guide". Getting that response out in a timely manner before that post went viral is very important and would prevent further misuses, right?
 

yodon

Staff member
Super Moderator
#6
I'd wager that not all your customers would be reading the social media outlet of choice so effectiveness of such an action would be difficult to assess for the entire user population. And how would you know if even the original poster re-visited the site?

Complaints are also also supposed to feed into your risk management process. I presume your user's manual / IFU has proper cleaning procedures (and I realize that's just one example). So if they aren't paying attention to the UM, they may not pay attention to a social media post.
 

pziemlewicz

Involved In Discussions
#7
My other concern, from a QA point of view, is how do you manage such a list of templated-responses?
A controlled document with the responses: it could be a work instruction under your Customer Feedback or Post-Market Surveillance procedure. If you think about this like a pareto, there should really only be a handful of issues and one specific reply for each.

If you look at popular/common devices from the bigger manufacturers in MAUDE, you can see reply templates done well.
 
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