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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Harbourt said the current BMBL allows lab workers to accomplish their goals using different methodologies and making it prescriptive would take away their flexibility. Delarosa said it has mbbl be a living document.
Ksiazek also editionn up another issue related to arboviruses: He said the IBC is a mandated committee that reviews essentially all biosafety protocols that involve recombinant agents or materials and in some institutions the IBC reviews other biosafety protocols, but the BMBL does not fully address or mandate a formal mechanism for having documents reviewed by the IBC.
He noted that there is one really long and valuable comment that he thinks should be looked at by the editors; he suggested that the editors work with the person who submitted this comment to ensure accuracy throughout this appendix. 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.
Salerno also said that diagnostic and medical labs have relatively sophisticated quality management systems, which they are required to have, that embrace this approach. He also said it would be helpful to have some information about types of exhaust ventilation units and a discussion of when the use of downdraft tables has merit.
It would be great to have some reference to what eye protection should be worn in a clinical diagnostic lab versus bench work versus biosafety work. Ksiazek said there was a comment about whether BSL-2 waste can be removed by simple surface decontamination and moving it to an area where it is autoclaved or in some instances, having it removed by a commercial medical waste company. Hunt clarified that the steering committee is not giving recommendations; its members are just making comments as BMBL users.
However, she said she also believes in having certified biosafety professionals. Ellis said there will be a standalone agricultural BMBL document in the future as mentioned by Joe Kozlovac earlier ; Appendix D will stay as it is, with updates, until the standalone document is released. Major themes from the virtual town hall meeting were further discussed in a workshop held on 12 May in Washington, DC.
Debra Hunt Duke University; member of the steering committee said clinical labs have also developed their own standard through the CLSI, 4 which addresses clinical microbiology and gets into specific procedures and safety issues and is revised every now and then. He said this document set some baselines but did not go into the details that are contained in the BMBL; it is a good supplement but the BMBL remains the basis for most of the work that is being done.
Should the BMBL remain performance based or should it be prescriptive? 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.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC
edittion Ellis suggested that instead of a stand-alone chapter, this could just be added to the introduction. There is no requirement but when it is needed, engineers take the minimal approach rather than having a differential that accomplishes the purpose. Hunt said there was a comment from an online workshop participant about including guidance for generic unknown samples clinical and field samples in the BMBL.
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. Citing the incident where a nurse was infected with Ebola as an example the hospital PPE 8 was not adaptedshe asked if there could be something added in the risk assessment section that gives BMBL users a better idea about increasing or decreasing BSL to address certain risks. Salerno commented that those who have been in the biosafety community for a long time interpret the agent summaries differently than someone who is relatively new.
To what degree should the BMBL be revised—is a major revision needed or only a minor 4gh The MSDS are clear and concise, which make them easier to read—but, she asked, are they really useful in terms of providing data needed for risk assessments?
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A biosafety level is a designation based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from various risk groups WHO.
He said it is an essential element of bio-risk management to have credentials that indicate a certain level of expertise. Page 15 Share Cite. Hart said it is not the same and not as authoritative as the BMBL. 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.
Eye protection with or without contact lenses. He said he thought this approach is adequate.
He suggested that the text be edigion more strongly to encourage researchers to be aware of the risks. Ellis said there were several comments posted on the virtual town hall that pertain to this appendix and these will be handed over to the BMBL editors.
He also said if a product will be used off label, studies should be conducted to confirm that it will work in the correct concentration and contact time.
According to Deborah Wilson NIH; one of the editors of the forthcoming BMBL 6th Editionthe BMBL 5th Edition was completed with input from over scientists, biosafety professionals, and subject matter experts—yet, despite the participation of numerous individuals in the previous BMBL revision, there were criticisms that the scientific and biomedical bbmbl were not given the opportunity to provide input.
He thinks there is a way for getting it reviewed where both of them do their parts, he said.