Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Reg Experts,

I have a question regarding biocompatibility assessment for custom made procedure packs for general surgical procedures. The medical devices/components within the pack are selected by the customer and hence there can be several different types of packs, the customer has the choice of choosing between 300+ different components, ranging from drapes, manifolds, pressure monitoring tubing, needles, syringes, etc. Each pack can contain more than 50+ components.

The individual medical devices/components are sourced from OEM suppliers. About 50% of the components are purchased as finished goods in sterile form while others include non sterile components, and the remaining include devices that are supplied as bulk non sterile (but the the OEM manufacturer may have sterile equivalents of these devices). The components are then packaged and sterilized via EO sterilization.

I would like to ask for guidance on how to complete biocompatibility assessment for the procedure packs. We have obtained declarations from the OEMs indicating they have completed biocompatibility assessment relating to the toxicity end points depending on the nature and duration of contact for each of the devices/components (those that are sourced in finished form can be either sterile or non sterile, and also those that are sourced as bulk non sterile). But this will not be sufficient to complete the assessment as they are then packaged and subjected to EO sterilization?

As the legal manufacturer we do conduct EO residual testing however, this is only on selected components that are considered to be the worst case.

Please can you provide some suggestions on how to assess biocompatibility for all of the components that come in direct/indirect contact? Can we use the declarations from the OEMs as part of the risk assessment? If so, should all the components be subjected to EO residual testing to justify this approach?

Your advice on this matter is greatly appreciated.

Thanks.

Annon.

This message was posted by a user wishing to remain anonymous

Dear All,

Re-posting to see if someone might be able to help with this question?

Thanks.
Annon.
Original Message:
Sent: 02-Aug-2019 06:19
From: Anonymous Member
Subject: Biocompatibility Testing for Procedure Packs

This message was posted by a user wishing to remain anonymous

Dear Reg Experts,

I have a question regarding biocompatibility assessment for custom made procedure packs for general surgical procedures. The medical devices/components within the pack are selected by the customer and hence there can be several different types of packs, the customer has the choice of choosing between 300+ different components, ranging from drapes, manifolds, pressure monitoring tubing, needles, syringes, etc. Each pack can contain more than 50+ components.

The individual medical devices/components are sourced from OEM suppliers. About 50% of the components are purchased as finished goods in sterile form while others include non sterile components, and the remaining include devices that are supplied as bulk non sterile (but the the OEM manufacturer may have sterile equivalents of these devices). The components are then packaged and sterilized via EO sterilization.

I would like to ask for guidance on how to complete biocompatibility assessment for the procedure packs. We have obtained declarations from the OEMs indicating they have completed biocompatibility assessment relating to the toxicity end points depending on the nature and duration of contact for each of the devices/components (those that are sourced in finished form can be either sterile or non sterile, and also those that are sourced as bulk non sterile). But this will not be sufficient to complete the assessment as they are then packaged and subjected to EO sterilization?

As the legal manufacturer we do conduct EO residual testing however, this is only on selected components that are considered to be the worst case.

Please can you provide some suggestions on how to assess biocompatibility for all of the components that come in direct/indirect contact? Can we use the declarations from the OEMs as part of the risk assessment? If so, should all the components be subjected to EO residual testing to justify this approach?

Your advice on this matter is greatly appreciated.

Thanks.

Annon.

Dear Anon,
Your best bet is to look at ISO 10993-1:2018.  This update focuses on using a risk-based assessment of all known biocompatibility information and justifying what and why you are doing testing.  Based on the limited information you described, you may have a case for writing a justification for why no further biocompatibility testing is needed.  Keep in mind the standard requires any biocompatibility assessment to include a plan and a report written by "knowledgeable experts".   While my company is full of experts on our product, we have been contracting with outside sources to provide the expertise in materials, toxicity, etc. as well as to perform the necessary database and literature searches that are required to support the complete justification. 
I hope this helps.
Good luck!
Sara

------------------------------
Sara Coon
Director, Regulatory Affairs
MN United States
------------------------------

Original Message:
Sent: 02-Aug-2019 06:19
From: Anonymous Member
Subject: Biocompatibility Testing for Procedure Packs

This message was posted by a user wishing to remain anonymous

Dear Reg Experts,

I have a question regarding biocompatibility assessment for custom made procedure packs for general surgical procedures. The medical devices/components within the pack are selected by the customer and hence there can be several different types of packs, the customer has the choice of choosing between 300+ different components, ranging from drapes, manifolds, pressure monitoring tubing, needles, syringes, etc. Each pack can contain more than 50+ components.

The individual medical devices/components are sourced from OEM suppliers. About 50% of the components are purchased as finished goods in sterile form while others include non sterile components, and the remaining include devices that are supplied as bulk non sterile (but the the OEM manufacturer may have sterile equivalents of these devices). The components are then packaged and sterilized via EO sterilization.

I would like to ask for guidance on how to complete biocompatibility assessment for the procedure packs. We have obtained declarations from the OEMs indicating they have completed biocompatibility assessment relating to the toxicity end points depending on the nature and duration of contact for each of the devices/components (those that are sourced in finished form can be either sterile or non sterile, and also those that are sourced as bulk non sterile). But this will not be sufficient to complete the assessment as they are then packaged and subjected to EO sterilization?

As the legal manufacturer we do conduct EO residual testing however, this is only on selected components that are considered to be the worst case.

Please can you provide some suggestions on how to assess biocompatibility for all of the components that come in direct/indirect contact? Can we use the declarations from the OEMs as part of the risk assessment? If so, should all the components be subjected to EO residual testing to justify this approach?

Your advice on this matter is greatly appreciated.

Thanks.

Annon.