Covid Free Statements for Implants and sales reps.

[mpfizer]

Hi,

How does one certify that implants used in orthopaedic surgery and sales reps, are covid free .... hospitals have started to ask these questions .....is there a SOP or protocol or any standard to follow ?

Any help would be highly appreciated

Thanks

michelle

 

[RoxaneB]

You use these implants in your sales reps?!?! Sorry, that's how I read that sentence.

Seriously, though, I'm not sure you can say it's C19-free. C19 remains active on different surfaces for varying amounts of times. Technically, you could argue that if it's shipped after the applicable amount of time, then it's free...until someone touches the product or the box as part of the delivery process.

Can you share a request or two coming from the hospital? Word for word? Is it about your implant or about ensuring your people who make the product are properly screened?

 

[mpfizer]

You use these implants in your sales reps?!?! Sorry, that's how I read that sentence.

Seriously, though, I'm not sure you can say it's C19-free. C19 remains active on different surfaces for varying amounts of times. Technically, you could argue that if it's shipped after the applicable amount of time, then it's free...until someone touches the product or the box as part of the delivery process.

Can you share a request or two coming from the hospital? Word for word? Is it about your implant or about ensuring your people who make the product are properly screened?

The request from hospital is as follows

"Please certify that the implants supplied by your company are covid free and the slaes reps. coming into the hospital are also covid free."

 

[John C. Abnet]

"Please certify that the implants supplied by your company are covid free and the slaes reps. coming into the hospital are also covid free."

Good day @mpfizer ;
Some considerations...
1- What does your organization current deploy within your internal processes (i.e. how is your organization currently addressing clause 6.4.2 and 7.5.2 and 7.5.3 and 7.5.5 and 7.5.7 ...assuming some/all are applicable to your organization).?

2- What controls does your organization currently deploy within your supply chain [i.e. sales rep] (if applicable to this discussion) ?

3- Regardless of the customer, what are the risks to your organization and how is your organization responding to those risks?

4- What data do you have with which to make your decisions? (as referred to by @RoxaneB , different surfaces, environmental conditions, etc..etc.., can play a significant role in the "life" of this and other viruses).

Yes, your organization is required to meet requirements of the customer, governing international standards, and applicable governmental and/or statutory rules. Regardless, I would council that your organization consider what IT needs to do to eliminate and mitigate the risks that are presented. This may require your organization to actually go beyond what is stipulated by others.

What ever determination your organization makes, I would recommend that it be made sustainable as part of your management system AND there is reference to the data and/or evidentiary materials that support and defend your organization's position.


Hope this helps.
Be well.

 

[Watchcat]

I would define "COVID-free" and then certify that implants and sales reps meet my definition:

"We certify that we take and record the temperature of each of our sales reps every day. Any sales rep whose temperature exceeds 99.5 degrees is not permitted to visit hospitals." Best scenario would be to find out what procedure the hospitals have for "certifying" that their staff are "covid free," and do that.

"We certify that all our implants are [describe a process that is recognized as effective at killing COVID-19 virus] prior to distribution"

Either they accept that or they don't. I think a claim that anything or anyone is "covid free" is a false claim.

 

[Ajit Basrur]

The request from hospital is as follows

"Please certify that the implants supplied by your company are covid free and the slaes reps. coming into the hospital are also covid free."

I have never heard about the request for Covid-19 free. See attached statement from BD, a major medical device manufacturer and they do not have such a statement.