BMBL 4TH EDITION PDF
This fourth edition of Biosafety in Microbiological and. Biomedical Laboratories editions of the BMBL, whose guidelines are now accepted as the international. This is not to say that the new BMBL will not require interpretations. This was clarified in the 4th edition by “Filtration and other treatments of. medical Laboratories (BMBL) (HHS et al., ) was pub- lished. Does our facility have to comply with the require- ments of this new edition? • The 4th edition of.
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Page 19 Share Cite. She said out of necessity downdraft tables were being called primary containment, which they are not.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC
Persons who use the lab rarely, such as clinical research coordinators, otherwise believe they can handle biological materials anywhere—having a editiln reassures them that they are using the right lab. Ellis said a discussion of how the HVAC system works would be pretty extensive but he thinks that lab personnel should understand how it works and know why they have to leave the lab when the HVAC system fails, and understand the basics of HVAC system re-start.
He said the number obviously depends on the size of the biosafety cabinet, but two people should be able to work in a six foot cabinet, provided that they adhere to procedural rules etc. Shea said she noticed some conflicting guidance in the BMBL concerning the use of PPE in lieu of primary containment in situations where primary containment is not feasible; there are sections that say this but other sections essentially say that all work will be done in primary containment—could a clarification be made as to which of these practices is considered best practice and could the contradiction be eliminated?
He asked that the editors take a look at this. Final Thoughts After the discussion of the BMBL sections and appendices, Wilson asked the workshop participants to address the following issues that she mentioned at the beginning of the workshop: He added that maybe adding procedures for proper exiting and handwashing and something about future consideration for having hands-free sinks, at least one at the exit area of the BSL-2 lab, would work.
One was about inventories and how it is done. The current format of the summary statements discourages local risk assessment. Ksiazek said the approval of the use of an organism or a protocol is done by the IBC 13 in some institutions; the IBC also reviews notices of use and notices of intent, however, sometimes these are just reviewed by a safety officer or by the PI.
After the introductory remarks from Wilson and Meechan, the chair of the steering committee, Bob Ellis Colorado State Editiion opened the floor for questions from the workshop participants those attending in person and those viewing the live webcast.
Add a section on the importance of hiring credentialed biosafety professionals. It is for building or designing a facility and determining features, it is not about having enhanced practices.
Comments on BMBL Appendix I — Toxins of Biological Origin Ellis said there were only a couple of comments on this appendix; one was about the definition of a biological toxin—is it a chemical or a biologic? Ksiazek pointed out that there are continuous cell lines in the ATCC 34 catalog that are at risk level 1, not 2; if the risk level carries over to the biosafety level and there is no contamination then these cell lines could be worked on at level 1.
Hunt said one other comment they received was that the bacterial agent summary statements include how specific organisms should be handled in the clinical lab versus the research lab but this is not the case with the viral agent summary statements —so information should be added to the viral agent summary statements.
Ellis also mentioned the following comments from the online workshop participants: Meechan said that perhaps they should just talk about eye protection and not focus on contact lenses. Meechan said that hospitals are different from labs, the BMBL cannot advocate for humans to be put in level 4 containment because hospitals are not able to do this. Hunt mentioned the following comments from the online workshop participants: Ksiazek said there was a comment posted on the virtual town hall that mentioned a clinical report published in January this year about four confirmed cases of HIV infections in nonclinical technicians ; he said the agent summary statement should be updated.
Ellis said most BMBL users are now accustomed to how the chapters are arranged; if they are rearranged then users have to get used to a different arrangement. BSL-1 signage is helpful to define when biological materials can be used in a lab, to indicate that a sink is present, and when the lab is really only for nonviable materials and chemicals. Page 14 Share Cite.
Ellis said he agrees that it should remain performance based. Ellis said aside from requests for clarification, there were comments posted on the virtual town hall about the following topics:. Documented support is needed for institutions and engineers to make changes. Hunt said an online workshop participant commented that it is the regulatory agencies that are using the BMBL as the bible and not recognizing subject matter experience and risk assessments.
Harbourt and Bohn said it is an excellent reference but some areas need minor. Wilson said if the BMBL is being used in a way that it was not intended the editors would like to know about it and give it consideration. Accessed June 13, Hunt said four online workshop participants commented that the BMBL should remain performance based ; she also shared the following comments from the online workshop participants: If the intent of the BMBL is not to limit the applicability of its guidance to research labs, then it will help to have a remark to that effect.
Accessed July 14, Ksiazek mentioned an NRC 20 report that said there has to be an environment where people can report incidents without fear of retribution.
She said an online workshop participant asked if any change is being planned in the BMBL with regard to the current effort in polio virus eradication. He asked if the BMBL should be expanded to have additional appendices for a series of greater or narrower fields and added that although this might not be to their best interest, the editors are open to discussing this.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Updating laboratory acquired infections LAI data. Ellis said he agrees with the approach of referencing websites where CFRs 32 and updated regulations are found rather than discussing them further in the BMBL. Keep in mind that the BMBL is used as a basis for guidelines in other countries.
Harbourt said what can be done depends on institutional policy or the procedure itself; there are times when biosafety professionals have limited flexibility as to what containment equipment or devices they can work with. Ellis also mentioned a request to add information on recommended controls for cryostats and microtomes. She said for the next BMBL revision, a more open and transparent process will be employed, with input from users of the BMBL obtained via the virtual town hall meeting and workshop.
The HVAC 23 system. Looking for other ways to read hmbl Before closing the discussion of Section IV comments, Hunt mentioned the following comments from the online workshop participants: To what degree should the BMBL be revised—is a major revision needed or only a minor one?