Menu
Home
Forums
Forums
Quick Links
Search Forums
Recent Posts
job listings
catering
whistleblower info
legal help
advertise on CP
submit press release
Menu
Log in
Sign up
Search titles only
Posted by Member:
Separate names with a comma.
Newer Than:
Search this thread only
Search this forum only
Display results as threads
More...
Useful Searches
Recent Posts
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
NuVasive to carry Osteocel
>
Reply to Thread
Name:
Verification:
Answer the above question:
(
CustomImgCaptcha
By
Surrey Forum
)
Message:
<p>[QUOTE="Anonymous, post: 3024436"]Let's see... Proactively sterilize the allograft tissue to device level standards or maintain aseptic processing and hope for the best. </p><p><br /></p><p>One example...</p><p>Check out the Progenix DBM product. They do e-beam sterilization with the final DBM product. They then take that final product (every lot) and put it in a live athymic rat model and let it be for 28 days. Only if actual bone grows (osteoinductive) do they release the lots - no petri dish reaction here. So any concerns that sterilization makes it no longer osteoinductive are mute. I think that I would take proactive sterilization rather than take my chances with aseptic only. </p><p><br /></p><p>Also...</p><p>You are right, there are not that many recalls associated with tissue harvesting aseptically. But 1 is enough in my book if it relates to the safety of the tissue. MTF had one posted 12/16/1998. They released 45 tissues that were recalled because the donor tested reactive for HIV. Another recall on 10/7/2004 for tissue testing positive for salmonella arizonii. Another recall reported 4/16/2008 had tissues testing positive for Clostridium Perfringens. Do a search for FDA recalls on <a href="http://www.fda.gov" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.fda.gov" rel="nofollow">www.fda.gov</a>.[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 3024436"]Let's see... Proactively sterilize the allograft tissue to device level standards or maintain aseptic processing and hope for the best. One example... Check out the Progenix DBM product. They do e-beam sterilization with the final DBM product. They then take that final product (every lot) and put it in a live athymic rat model and let it be for 28 days. Only if actual bone grows (osteoinductive) do they release the lots - no petri dish reaction here. So any concerns that sterilization makes it no longer osteoinductive are mute. I think that I would take proactive sterilization rather than take my chances with aseptic only. Also... You are right, there are not that many recalls associated with tissue harvesting aseptically. But 1 is enough in my book if it relates to the safety of the tissue. MTF had one posted 12/16/1998. They released 45 tissues that were recalled because the donor tested reactive for HIV. Another recall on 10/7/2004 for tissue testing positive for salmonella arizonii. Another recall reported 4/16/2008 had tissues testing positive for Clostridium Perfringens. Do a search for FDA recalls on [url]www.fda.gov[/url].[/QUOTE]
Your name or email address:
Do you already have an account?
No, create an account now.
Yes, my password is:
Forgot your password?
Stay logged in
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
NuVasive to carry Osteocel
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
NuVasive to carry Osteocel
>