Regulatory Open Forum

Hello everyone,<o:p></o:p>

My question is with regard to a proposed change in sterility of a reusable stainless steel surgical instrument. Currently it is being offered in the EU and the U.S. nonsterile for reprocessing by the user. We are exploring the possibility of marketing a sterile version, to be reprocessed (cleaned and sterilized) by the user after first use and after every subsequent use.<o:p></o:p>

We have been in contact with several suppliers of packaging and Gamma sterilization services, but the documentation they are willing and/or able to provide for inclusion in our TD/DHF seems to differ.<o:p></o:p>

To our understanding, we would need the following documents:<o:p></o:p>

1.       The contract packager's ISO certificate for contract packaging services for sterile devices<o:p></o:p>

2.       Summary report of cleaning validation<o:p></o:p>

3.       Summary report of packaging validation<o:p></o:p>

4.       Shelf life validation report, including a discussion of the accelerated and real-time aging procedures and testing.<o:p></o:p>

5.       The sterilization establishment's  Performance Qualification report including dosimetric results for our product and packaging and defining the validated parameters.<o:p></o:p>

6.       The packager's microbiological performance (re)qualification of the gamma radiation sterilization process.<o:p></o:p>

7.       For the FDA of course company registration and listing of both the packager and the sterilization provider.<o:p></o:p>

8.       At a later date we would require the sterilization records for each batch, including the purchase order, irradiation certificate and delivery note. <o:p></o:p>

Am I missing anything here?<o:p></o:p>

Also, would item number 6 need to be performed on our product or would the packager's routine testing report for a similar „worst case" product with identical packaging specifications suffice? And is it the packager's responsibility to provide this or should we have it done ourselves?<o:p></o:p>

Thank you for any pointers or suggestions!<o:p></o:p>

Hello Anon,

There are quite a few considerations which need to be made for your example, including the specific type of device, because even reusable surgical instruments can have some differences.  In general, the list of documents you made sounds fine, but there also may be many others which need to be made available or obtained.  Sterilisation validation is a complex process with many aspects involved.  You might want to seek some expert advice to go through the process in detail to ensure all considerations have been made.  Already you are experiencing the complexity of these processes in contacting different suppliers providing differing documentation.  Sorry, for not providing more succinct information, but the information your are requesting is deep and broad which would be more than a forum response.

Hello everyone,<o:p></o:p>

My question is with regard to a proposed change in sterility of a reusable stainless steel surgical instrument. Currently it is being offered in the EU and the U.S. nonsterile for reprocessing by the user. We are exploring the possibility of marketing a sterile version, to be reprocessed (cleaned and sterilized) by the user after first use and after every subsequent use.<o:p></o:p>

We have been in contact with several suppliers of packaging and Gamma sterilization services, but the documentation they are willing and/or able to provide for inclusion in our TD/DHF seems to differ.<o:p></o:p>

To our understanding, we would need the following documents:<o:p></o:p>

1.       The contract packager's ISO certificate for contract packaging services for sterile devices<o:p></o:p>

2.       Summary report of cleaning validation<o:p></o:p>

3.       Summary report of packaging validation<o:p></o:p>

4.       Shelf life validation report, including a discussion of the accelerated and real-time aging procedures and testing.<o:p></o:p>

5.       The sterilization establishment's  Performance Qualification report including dosimetric results for our product and packaging and defining the validated parameters.<o:p></o:p>

6.       The packager's microbiological performance (re)qualification of the gamma radiation sterilization process.<o:p></o:p>

7.       For the FDA of course company registration and listing of both the packager and the sterilization provider.<o:p></o:p>

8.       At a later date we would require the sterilization records for each batch, including the purchase order, irradiation certificate and delivery note. <o:p></o:p>

Am I missing anything here?<o:p></o:p>

Also, would item number 6 need to be performed on our product or would the packager's routine testing report for a similar „worst case" product with identical packaging specifications suffice? And is it the packager's responsibility to provide this or should we have it done ourselves?<o:p></o:p>

Thank you for any pointers or suggestions!<o:p></o:p>

Hello everyone,<o:p></o:p>

My question is with regard to a proposed change in sterility of a reusable stainless steel surgical instrument. Currently it is being offered in the EU and the U.S. nonsterile for reprocessing by the user. We are exploring the possibility of marketing a sterile version, to be reprocessed (cleaned and sterilized) by the user after first use and after every subsequent use.<o:p></o:p>

We have been in contact with several suppliers of packaging and Gamma sterilization services, but the documentation they are willing and/or able to provide for inclusion in our TD/DHF seems to differ.<o:p></o:p>

To our understanding, we would need the following documents:<o:p></o:p>

1.       The contract packager's ISO certificate for contract packaging services for sterile devices<o:p></o:p>

2.       Summary report of cleaning validation<o:p></o:p>

3.       Summary report of packaging validation<o:p></o:p>

4.       Shelf life validation report, including a discussion of the accelerated and real-time aging procedures and testing.<o:p></o:p>

5.       The sterilization establishment's  Performance Qualification report including dosimetric results for our product and packaging and defining the validated parameters.<o:p></o:p>

6.       The packager's microbiological performance (re)qualification of the gamma radiation sterilization process.<o:p></o:p>

7.       For the FDA of course company registration and listing of both the packager and the sterilization provider.<o:p></o:p>

8.       At a later date we would require the sterilization records for each batch, including the purchase order, irradiation certificate and delivery note. <o:p></o:p>

Am I missing anything here?<o:p></o:p>

Also, would item number 6 need to be performed on our product or would the packager's routine testing report for a similar „worst case" product with identical packaging specifications suffice? And is it the packager's responsibility to provide this or should we have it done ourselves?<o:p></o:p>

Thank you for any pointers or suggestions!<o:p></o:p>