Regulatory Open Forum

A clinical customer is not able to sterilize our reusable device on-site, and would like to use a 3rd party service provider to re-clean, package, and sterilize the device, then ship back to the customer. We are verifying proper validation of processes and labeling of the device. 

Is anyone aware of a symbol that can be used on the return sterile pouch label to indicate that the device is NOT a brand-new device but is a returned re-sterilized device? 

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Diane King RAC
Redwood City, CA
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This is a very interesting question. I don't know of a symbol but can see how it would be useful, and recommend submitting it for consideration to ISO/TC 145 Graphical Symbols. As a member of ISO/TC 198, WG 12 Information for Reprocessing of Resterilizable Instruments, I can bring this up as an item for discussion. In the meantime, if the device is on the US market, you would need verbiage rather than a symbol. I don't believe reprocessors have to indicate it is not a brand new device (at least those that resubmit a 510(k) and see as their own device), but they might be able to provide additional guidance.

I look forward to hearing what others have to say.

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Lena Cordie
Owner, Consultant
Qualitas Professional Services
Watertown MN
United States
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Original Message:
Sent: 02-03-2015 13:49
From: Diane King
Subject: Labeling of re-sterilized device by 3rd party

A clinical customer is not able to sterilize our reusable device on-site, and would like to use a 3rd party service provider to re-clean, package, and sterilize the device, then ship back to the customer. We are verifying proper validation of processes and labeling of the device. 

Is anyone aware of a symbol that can be used on the return sterile pouch label to indicate that the device is NOT a brand-new device but is a returned re-sterilized device? 

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Diane King RAC
Redwood City, CA
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I can't promise there is no symbol (it's hard to prove that something doesn't exist) but there are labeling (and registration/listing and filing) requirements related to medical devices that are sterilized for re-use. Check with CDRH's Division of Industry and Consumer Education.

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Andrea Chamblee RAC, FRAPS
FDA
Silver Spring MD
United States
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Original Message:
Sent: 02-03-2015 13:49
From: Diane King
Subject: Labeling of re-sterilized device by 3rd party

A clinical customer is not able to sterilize our reusable device on-site, and would like to use a 3rd party service provider to re-clean, package, and sterilize the device, then ship back to the customer. We are verifying proper validation of processes and labeling of the device. 

Is anyone aware of a symbol that can be used on the return sterile pouch label to indicate that the device is NOT a brand-new device but is a returned re-sterilized device? 

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Diane King RAC
Redwood City, CA
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Diane,
This one is interesting and caused me to scratch my head a little.  I am assuming that your company is responsible for the re-sterilization and not the clinical site.  I say this that you need to consider (if you have already not) which party is responsible (liable) for the sterility.

My company is a third party sterilization and cleaning facility, and I have not seen any unique labeling for this. So, i will be watching this thread to see other responses.  
My first thought is that the labeling might be similar to what a "Single Use Device Reprocessed Device" would be labeled.  I realize that is not the exact circumstance, but it is a device that is re-sterilized by a third party.

I have included an FDA link that I found on Single Use Devices that might be helpful, might not. Good luck,

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121093.htm

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RUSSELL CRUM MS
Vice President
C.G. Laboratories, Inc.
GRANBURY TX
www.cg-labs.com
United States
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Original Message:
Sent: 02-05-2015 09:18
From: Andrea Chamblee
Subject: Labeling of re-sterilized device by 3rd party

I can't promise there is no symbol (it's hard to prove that something doesn't exist) but there are labeling (and registration/listing and filing) requirements related to medical devices that are sterilized for re-use. Check with CDRH's Division of Industry and Consumer Education.

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Andrea Chamblee RAC, FRAPS
FDA
Silver Spring MD
United States
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Original Message:
Sent: 02-03-2015 13:49
From: Diane King
Subject: Labeling of re-sterilized device by 3rd party

A clinical customer is not able to sterilize our reusable device on-site, and would like to use a 3rd party service provider to re-clean, package, and sterilize the device, then ship back to the customer. We are verifying proper validation of processes and labeling of the device. 

Is anyone aware of a symbol that can be used on the return sterile pouch label to indicate that the device is NOT a brand-new device but is a returned re-sterilized device? 

-------------------------------------------
Diane King RAC
Redwood City, CA
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Hello Diane,

I am not aware of a symbol that can be used but bear in mind that, under FDA oversight, third-party reprocessors must abide by the same standards imposed on original equipment manufacturers.

Companies that engage in reprocessing must register with the FDA and undergo a number of inspections including premarket approval for devices, regulation in the design, and purchasing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices.

Additionally, the FDA requires tracking of reprocessed devices and monitors all reports, including failure reports. Also, the number of times a device can be reprocessed is pre-validated by the FDA during the approval phase.

In summary, by performing validation testing, the third party should be able to meet FDA guidelines that ensure that the reprocessed devices are functionally equivalent to new devices and meets the FDA's rigorous standards for cleanliness and sterility. There seems to be no need for a symbol

You can also find more information in:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm072951.htm#3d

and,

http://www.fda.gov/OHRMS/DOCKETS/98fr/000053gd.pdf

Nazanin Shalchian-Gregoretti, M.D., M.S.





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Nazanin Shalchian Gregoretti MD
Lexington MA
United States
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Original Message:
Sent: 02-03-2015 13:49
From: Diane King
Subject: Labeling of re-sterilized device by 3rd party

A clinical customer is not able to sterilize our reusable device on-site, and would like to use a 3rd party service provider to re-clean, package, and sterilize the device, then ship back to the customer. We are verifying proper validation of processes and labeling of the device. 

Is anyone aware of a symbol that can be used on the return sterile pouch label to indicate that the device is NOT a brand-new device but is a returned re-sterilized device? 

-------------------------------------------
Diane King RAC
Redwood City, CA
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Thank you to everyone who has posted in response to my original question.  I appreciate the thought and consideration!

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Diane King RAC
Redwood City CA
United States
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Original Message:
Sent: 02-06-2015 18:50
From: Nazanin Shalchian Gregoretti
Subject: Labeling of re-sterilized device by 3rd party

Hello Diane,

I am not aware of a symbol that can be used but bear in mind that, under FDA oversight, third-party reprocessors must abide by the same standards imposed on original equipment manufacturers.

Companies that engage in reprocessing must register with the FDA and undergo a number of inspections including premarket approval for devices, regulation in the design, and purchasing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices.

Additionally, the FDA requires tracking of reprocessed devices and monitors all reports, including failure reports. Also, the number of times a device can be reprocessed is pre-validated by the FDA during the approval phase.

In summary, by performing validation testing, the third party should be able to meet FDA guidelines that ensure that the reprocessed devices are functionally equivalent to new devices and meets the FDA's rigorous standards for cleanliness and sterility. There seems to be no need for a symbol

You can also find more information in:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm072951.htm#3d

and,

http://www.fda.gov/OHRMS/DOCKETS/98fr/000053gd.pdf

Nazanin Shalchian-Gregoretti, M.D., M.S.





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Nazanin Shalchian Gregoretti MD
Lexington MA
United States
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Original Message:
Sent: 02-03-2015 13:49
From: Diane King
Subject: Labeling of re-sterilized device by 3rd party

A clinical customer is not able to sterilize our reusable device on-site, and would like to use a 3rd party service provider to re-clean, package, and sterilize the device, then ship back to the customer. We are verifying proper validation of processes and labeling of the device. 

Is anyone aware of a symbol that can be used on the return sterile pouch label to indicate that the device is NOT a brand-new device but is a returned re-sterilized device? 

-------------------------------------------
Diane King RAC
Redwood City, CA
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