Regulatory Open Forum

Dear All,

Good day!

Recently i performed a supplier audit to one of our OEM supplier, with finished goods manufacture, assemble and packaging are done in their facility.

They did three basic biocompatibility testing, cytotoxicity, sensitization and irritation. When i am request to review leachable and extractable testing report as per ISO 10993-16, they said it is not necessary to conduct the test as it is not stated in any regulatory requirements.

Concern raised by our end user on the leachable of tube printing issue where the tube will have contact with laryngeal tissue. May i know in what case i can issue them a non-compliance (NC) for this finding? Is it compulsory for OEM / device manufacturer to perform this test?

Thank you.
-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
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Good Morning Wilson,

You have asked a lot of questions with no one answer being correct. What type of tube are you using? What type of ink is your manufacturer using (food grade)? I will assume that this product of which you speak is a gel lotion that is applied using some type of gauze or some other type of material? In my opinion if you were concerned about any possible leachable, this concerned would have been answered with the cytotoxicity and sensitization studies.

Regards,

John



-------------------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
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Original Message:
Sent: 11-12-2014 20:03
From: Winson Teng
Subject: Leachables and Extractables Testing

Dear All,

Good day!

Recently i performed a supplier audit to one of our OEM supplier, with finished goods manufacture, assemble and packaging are done in their facility.

They did three basic biocompatibility testing, cytotoxicity, sensitization and irritation. When i am request to review leachable and extractable testing report as per ISO 10993-16, they said it is not necessary to conduct the test as it is not stated in any regulatory requirements.

Concern raised by our end user on the leachable of tube printing issue where the tube will have contact with laryngeal tissue. May i know in what case i can issue them a non-compliance (NC) for this finding? Is it compulsory for OEM / device manufacturer to perform this test?

Thank you.
-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear John,

Thank you for your comments. The ink use is medical grade with biocompatibility testing (cytotoxicity & Sensitization) in place. It is printed on the laryngeal mask airway tube for the indication of size, brand and level of depth when it is inserted into the laryngeal. The device is use together with lubricant on application.

For now, we move on without issuing any NC to them despite than a observation. But your advice noted and will discuss with our customer and supplier to reach a common ground on this issue.

Your advice taken with many appreciation!

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Asst Manager
Advance First Aid Research Pte Ltd
Singapore
-------------------------------------------


Original Message:
Sent: 11-13-2014 07:49
From: John Lay
Subject: Leachables and Extractables Testing

Good Morning Wilson,

You have asked a lot of questions with no one answer being correct. What type of tube are you using? What type of ink is your manufacturer using (food grade)? I will assume that this product of which you speak is a gel lotion that is applied using some type of gauze or some other type of material? In my opinion if you were concerned about any possible leachable, this concerned would have been answered with the cytotoxicity and sensitization studies.

Regards,

John



-------------------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:03
From: Winson Teng
Subject: Leachables and Extractables Testing

Dear All,

Good day!

Recently i performed a supplier audit to one of our OEM supplier, with finished goods manufacture, assemble and packaging are done in their facility.

They did three basic biocompatibility testing, cytotoxicity, sensitization and irritation. When i am request to review leachable and extractable testing report as per ISO 10993-16, they said it is not necessary to conduct the test as it is not stated in any regulatory requirements.

Concern raised by our end user on the leachable of tube printing issue where the tube will have contact with laryngeal tissue. May i know in what case i can issue them a non-compliance (NC) for this finding? Is it compulsory for OEM / device manufacturer to perform this test?

Thank you.
-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear Winson, 

I'd like to answer your second question first, from a purely quality standpoint. You can issue a NC if the supplier doesn't conform with your written quality agreement. If you haven't asked them to do it, they aren't obliged to do it. I find that a lot of quality agreements don't adequately cover the detail of expectations in order to clearly say "this specific issue can be a non-conformity" when there is a dispute between the vendor and purchaser. If you received regulatory clearance in the end user's country, with a dossier that didn't contain leachables and extractables, you probably don't need it. 

What would be best,  in my opinion, would be to have a summary report by a materials expert covering the ISO-10993 family, and describing why leachables and extractables testing was not required, provided by a materials expert. Again, whether that's the responsibility of your company or your supplier is a question for your agreement. You may find a need to re-negotiate your quality agreement with your supplier to clarify issues. 

-------------------------------------------
Kathleen Crowder
Fresenius Kabi
Brézins, France
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:03
From: Winson Teng
Subject: Leachables and Extractables Testing

Dear All,

Good day!

Recently i performed a supplier audit to one of our OEM supplier, with finished goods manufacture, assemble and packaging are done in their facility.

They did three basic biocompatibility testing, cytotoxicity, sensitization and irritation. When i am request to review leachable and extractable testing report as per ISO 10993-16, they said it is not necessary to conduct the test as it is not stated in any regulatory requirements.

Concern raised by our end user on the leachable of tube printing issue where the tube will have contact with laryngeal tissue. May i know in what case i can issue them a non-compliance (NC) for this finding? Is it compulsory for OEM / device manufacturer to perform this test?

Thank you.
-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear Kat,

Thank you for your reply. I will take our advise to go with material evaluation first, then decided whether to include the testing of leachable and extractable into supplier quality agreement.

Your comments help a lot!

-------------------------------------------
Winson Teng
Regulatory Affairs Asst Manager
Advance First Aid Research Pte Ltd
Singapore
-------------------------------------------


Original Message:
Sent: 11-17-2014 10:09
From: Kat Crowder
Subject: Leachables and Extractables Testing

Dear Winson, 

I'd like to answer your second question first, from a purely quality standpoint. You can issue a NC if the supplier doesn't conform with your written quality agreement. If you haven't asked them to do it, they aren't obliged to do it. I find that a lot of quality agreements don't adequately cover the detail of expectations in order to clearly say "this specific issue can be a non-conformity" when there is a dispute between the vendor and purchaser. If you received regulatory clearance in the end user's country, with a dossier that didn't contain leachables and extractables, you probably don't need it. 

What would be best,  in my opinion, would be to have a summary report by a materials expert covering the ISO-10993 family, and describing why leachables and extractables testing was not required, provided by a materials expert. Again, whether that's the responsibility of your company or your supplier is a question for your agreement. You may find a need to re-negotiate your quality agreement with your supplier to clarify issues. 

-------------------------------------------
Kathleen Crowder
Fresenius Kabi
Brézins, France
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:03
From: Winson Teng
Subject: Leachables and Extractables Testing

Dear All,

Good day!

Recently i performed a supplier audit to one of our OEM supplier, with finished goods manufacture, assemble and packaging are done in their facility.

They did three basic biocompatibility testing, cytotoxicity, sensitization and irritation. When i am request to review leachable and extractable testing report as per ISO 10993-16, they said it is not necessary to conduct the test as it is not stated in any regulatory requirements.

Concern raised by our end user on the leachable of tube printing issue where the tube will have contact with laryngeal tissue. May i know in what case i can issue them a non-compliance (NC) for this finding? Is it compulsory for OEM / device manufacturer to perform this test?

Thank you.
-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------