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.
|Published (Last):||17 February 2010|
|PDF File Size:||2.99 Mb|
|ePub File Size:||14.39 Mb|
|Price:||Free* [*Free Regsitration Required]|
Ksiazek said if a protocol was developed that diverts from the recommendations it should be reviewed by the institution and should be supported by a documented formal risk assessment. There are allowances editiion handling an unknown sample in a clinical lab until you know what the sample is, he added. Meechan mentioned saying something general about these technologies in the BMBL and not going into details that are too fluid.
Looking for other ways to read this?
Page 8 Share Cite. The comment was about how updates on agent risk level can be hmbl shared with the public, without waiting until the next edition of BMBL is released.
He also said bmmbl a product will be used off label, studies should be conducted to confirm that it will work in the correct concentration and contact time. 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.
Ellis said the BMBL is currently geared more towards providing guidance to PIs 12 and lab directors on how to safely conduct research but biosafety professionals should also be involved in making decisions on procedures. He said he thinks that adding links to ACIP 27 and other bodies that would provide this information would probably be the best way to address this comment. He said it is an essential element of bio-risk management to have credentials that indicate a certain level of expertise.
Hunt said there was a comment from an online workshop participant about nmbl guidance for generic unknown samples clinical and field samples in the BMBL. Bohn bmhl it would be worthwhile to have this discussion especially if it shows that administrative controls, safety practices, use of PPE, and engineering controls help reduce LAIs. Wilson thinks the BMBL editors should look at the recommendation to work on infected animals only in primary containment and refer to the use of local exhaust ventilation devices or slot hoods.
Hunt said an online workshop participant commented that it should definitely be performance based; with the multiplicity of public health and biosafety challenges and research avenues, and the accelerating rate of technological change in response to these challenges, any prescriptive approaches in the BMBL 6th Edition would most likely be obsolete upon publication; even real-time, web-based curation of the new edition would require constant updating of prescriptive procedures.
Adding a little bit more risk assessment information on toxins. 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.
She said the BMBL has to be more of a living document, posted in an electronic format that is easier to use and can be readily updated as science evolves and as public and global health situations change.
Accessed June 14, She said it was meant for use in the academia, industry, and government but it has been used broadly, i. 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. Ellis said this is an excellent comment that was not posted on virtual town hall and that it would be good to address it. Hunt said editors of agent summaries could be encouraged to include updates on LAIs that have been reported in literature.
Sign up for email notifications and we’ll let you know about new publications in your areas of interest when they’re released. 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.
The BMBL is not necessarily the appropriate place for this, but this could be mentioned in the select agent section, he added. To what extent should the BMBL be revised?
It would be helpful if the BMBL stated that a best practice of biosafety is for the institution to put in place policies for everyone to follow when working with biological material. She explained the rationale for being redundant—people do not read the BMBL cover to cover; they only read parts of it or just print out certain sections of the manual.
Wilson said this is an issue that has been discussed before and still has not been resolved. Wilson said the comments about DURC, gain of function, and other attendant technologies will be discussed with the OSP 37 so these topics could be addressed in a way that the information does not become out of date prior to the completion of the next BMBL edition.
Hart said that while the BMBL was originally written more for academia and research, it is used by diagnostic labs and public health labs. Hunt said two comments from the online workshop participants were in support of the MSDS format for the summary statements ; she said one commenter also prefers the MSDS style and wanted decontamination methods to be included, especially for agents that are resistant to disinfection. 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.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC
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. Salerno requested that the editors consider adopting a management systems approach to safety.
Consider if certain aspects should be prescriptive, such as minimum containment or facility design components, others should remain performance based. Ellis said he agrees that it should remain performance based. Wilson explained that the errors could be due to the redundancy in presenting information, which entailed a lot of copying and pasting. Hunt said there was a comment that not all IBCs review assessments. He said the addition of Appendix D to the BMBL 5th Edition was the first time that agricultural biocontainment was addressed in the BMBL; Appendix D will also be in the 6th Edition because the USDA guidance on agricultural biocontainment will not be done by the time this edition comes out the guidance will take 5 to 6 years to finish.
Morland said the ATCC characterization of a material does not equate to how it should be handled and this is why Appendix H is useful to have. She said providing definitions for types of protective eyewear would be somewhat counterproductive since there is already established guidance.
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:.