From: Hastings, Richard C (richard.hastings@astrazeneca.com)
Date: Fri Feb 21 2003 - 17:02:50 EST
Paul, I totally agree with Keith on this issue. When I first came to my current position, part of my duties was to sort lentivirus-infected human T cell lines. Although the lentiviruses we used were replication incompetent, I sorted with a mask, face shield, double gloves and in a bunny suit. It was not fun. We purchased an aerosol containment system from our sorter manufacturer. My engineer encouraged me not to have this option installed because he believed it would be more of a hindrance to normal sorter operation and would provide little protection. To this day it sits in its box. Our manufacturer now wants to take this containment system back and replace it with a next generation system. The manufacturer must convince me that the new system will work. I think a large research, jet in air sorter should have aerosol containment ability right out of the crate. What do the manufacturers think we are sorting? Gum drops. Rich -----Original Message----- From: Keith Bahjat [mailto:me@keithbahjat.com] Sent: Thursday, February 20, 2003 5:37 PM To: cyto-inbox Subject: Re: Sorting live human lymphocytes Paul, Low risk group? Perhaps you should refer him to the OSHA bloodborne pathogens document, that is very clear when it states, "Blood and Body Fluid Precautions will be applied to all patients as described in OSHA Bloodborne Pathogens Standard, not just those with diagnosed blood-borne disease such as hepatitis or AIDS". It's always been my opinion (not to mention a government mandate) that we MUST run our research labs just as you'd run a clinical lab with regards to exposure control plans. That means if investigators want to sort human samples, they must find the funds to purchase the appropriate hardware to protect the operator at all times. This of course raises the question, "Does sorting hardware exist to safely handle human samples?" I think the answer is "probably". Is it as good as it could be? Probably not. How to get better hardware seems straight forward: 1) Do not sort human samples of any kind, or mouse samples involved in studies with potential human pathogens (viral vectors, etc.) without complete protection for the operator and surrounding environment. 2) DO NOT purchase a new sorter that does not have complete sample containment, from uptake to sort and waste collection. This means adequate hardware controls to prevent exposure, and vendor-performed validation of these devices at the time of manufacture as well as during preventative maintenance inspections. It's ludicrous to spend your money on a system that does not meet the current occupational safety guidelines for a medical instrument. This would not be tolerated from a maker of hematology instrumentation, so why should it be acceptable for a flow cytometer? And should we be testing these things ourselves? When was the last time you heard of someone performing a "phage assay" on their hematology or chemistry analyzer to prove biocontainment?? The quickest way to get the vendors to focus development on this issue is to stop buying instruments until it's resolved. So I would flat-out tell this faculty member no. You can put the OSHA Bloodborne Pathogens Standard is his hands to explain why, and prepare for him an itemized budget of the costs involved to be in compliance. kb Keith Bahjat, Ph.D. Scientist, Cancer Vaccines Cerus Corporation Concord, California keith_bahjat@cerus.com ----- Original Message ----- From: "J.Paul Robinson" <jpr@flowcyt.cyto.purdue.edu> To: cyto-inbox Sent: Wednesday, February 19, 2003 6:04 PM Subject: Sorting live human lymphocytes > > Colleagues: > > I would like to get input into the following issue - this has been discussed > before, but I would like to put this topic into the summary page and I also > need some advice. > > There is a faculty member here who is insisting on sorting live human > lymphocytes from untested patients. His argument is that these are from > children or teenagers and therefore a low-risk group. He obtains the mateirals > from a clinic and claims that he has no time to test the samples. > > He is unbelievably insistent (my techs say he is rude and obnoxious) and is > very upset that I have told him that I need some time to research this issue to > see what we should do. Even after I stopped a sort from taking place > instructing my technicans not to sort the cells, he tried to convince them to > sort after I left for a meeting!! > > He claims that he has done dozens of similar live human sorts at several > major institutions (I am checking so I won't list the institutions here!) > > He claims that "many of the major papers in the immunology literature sort live > human lymphocytes, so why can't you do that here? Other institutions do it all > the time...." > > Has anyone actually tracked the number of such sorts? > > So my questions are the following: > > 1. What is your institution/lab policy on sorting live human materials? > 2. Does your institution list this policy on a web site > 3. How many of these sorts do you do? > 4. Do any of you have obnoxious faculty that treat your techs like dirt? If not, > we have one you can have! > > I will be happy to sumarize the discussion and post it to the new summary > page at > http://www.cyto.purdue.edu/hmarchiv/cytomail.htm > "view Summaries" link > > Regards > Paul Robinson > Purdue > > J.Paul Robinson, PhD PH:(765)4940757 > Professor of Immunopharmacology > Professor of Biomedical Engineering > Purdue University FAX:(765)4940517 > EMAIL:jpr@flowcyt.cyto.purdue.edu > WEB: http://www.cyto.purdue.edu >
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