WHO Laboratory Biosafety Manual Revision

Transcription

1 WHO Laboratory Biosafety Manual Revision 02 February 2016, CDC Symposium Dr Kazunobu KOJIMA WHO Headquarters, Geneva

2 WHO Laboratory Biosafety Manual Having served for global biosafety community Hereinafter, WHO Manual For more than years, since it was first published in 1983, the Laboratory Biosafety Manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. WHO web site The 3 rd edition translated into >10 UN official and other languages WHO still receives queries for new languages Published in 2004: 10 years have passed in this fast-evolving field Time for revision YO_2004_11/en/ 2

3 Things evolve WHO Manual (1 st edition, 1983) Risk Group: I, II, III and IV Laboratory Classification : Basic, Containment and Maximum Containment BSL yet to be defined Technology Common diagnostic methods e.g. virus isolation, electron microscope PCR PCR first demonstrated in

4 WHO Extended Biosafety Advisory Group (BAG) Meeting, Geneva, November 2014 Stakeholder meeting Review the 5-year plan Redefine organizational roles and functions of WHO Recommendations Revision to the WHO Biosafety Manual is both a necessary and a priority General agreement that a user needs survey would be beneficial to determine how the Manual can best suit their needs 4

5 Review of the WHO Manual Discussion highlights: Fundamental or progressive changes to manual Prescriptive or performance-based requirements Standard or guideline Practical handbook or authoritative reference Need for basic biosafety principles/criteria Acknowledgement that WHO documents are considered the 'bible for users' Need to promote local and green solutions with focus on energy conversation - move away from unsustainable outcomes Acknowledgement that a graduated approach to compliance (whether by tier, step, etc.) can be beneficial Useful to consider appropriate technology that provides equivalent safety with a limited cost 5

6 Our audience varies 6

7 Maintenance free? 7

8 Pragmatism? 8

9 Revision objectives Comprehensive revision Critical appraisal of biosafety practices e.g. pathogen RG and BSL Evidence- and risk-based knowledge gap? Core/minimum requirements + suggestions for additional safety/security provision of decision making instrument/flowchart biosafety proportionate to actual risks to avoid overkill/overdesign Feasible and sustainable resource-limited settings 9

10 Derivatives/Supplementary publication Training tools Monograph subjectspecific booklet, such as: BS in pathology lab Research and production facilities Animal facilities Designing the labs Waste management/waste segregation clear guidance and solutions Emergency procedures Field/outbreak operations Equipment and PPE - selection criteria Disinfection, inactivation Validation Regulatory oversight mechanism Accident/incident investigation, reporting, analysis Risk communication 10

11 WHO Laboratory Biosafety Manual Reviewing/redefining key concepts Microorganism Risk Group Risk Groups 1 to 4 Biosafety level Simple equation: helpful? e.g. Ebola = RG4 = BSL4?? Risk-based approach Evidence-based biosafety Clear needs to define core requirements realistic; better feasibility and sustainability Risk Group 1: Risk Group 2: Risk Group 3: Risk Group 4: No or low individual and community risk Moderate individual risk, low community risk High individual risk, low community risk High individual and community risk 11

12 Demystify the myth? Pathogen Risk Group = Biosafety Level? Biosafety level 3 pathogens? Influenza viruses types A, B and C: classification 2? because of vaccine (types A and B)? Ebola = BSL-4? Clinical diagnostics/routine laboratory tests BSL-2 (with BSC, PPE and precautions) Canada (PHAC) UK (HSE, DoH) US (CDC) 12

13 Advancement in biosafety Technology virus isolation/culture, electron microscope PCR Primary containment BSC, centrifuge (sealed) improved, more reliable Best practices established Strict use of plastic ware elimination of glassware significantly reduces a risk of gross contamination outside BSC 13

14 Risk-based approach Consider decisive factors: risk assessment Pathogen Procedure diagnosis? research? PCR? virus isolation/culture? amount? titer? susceptibility of the community? detectability? tolerance? 14

15 Impact on Operational and Maintenance Issues in a Low Resource Context Negative Pressure/ Directional Airflow Sealable for fumigation High Efficiency Particulate Air (HEPA) filter on extract Heating and Ventilation Air Conditioning (HVAC) HEPA Filter Housings Recirculation Waste decontamination Primary containment equipment biosafety cabinets/isolators Verification/Certification 15

16 What makes the laboratory safe and secure? Facility and engineering control: Hardware infrastructure Operational/procedural/administrative control: Soft human factor, capacity & competency development Clear management responsibility/commitment Staff proficiency Observance to good microbiological practices Safety culture 16

17 Analysis of reported incidents Validation e.g. anthrax Human factor, safety culture e.g. H5N1 influenza virus, Ebola virus Vaccination e.g. vaccinia Engineering control failure: relatively rare? adherence to SOP, safety training, standardised risk assessment 17

18 WHO Manual revision: Summary Comprehensive revision Work plan drafted a three-year project consultation to various stakeholders planned Manual (main text) + monographs Core requirements Risk-based clear decoupling of RG and BSL decision-making instrument Evidence-based Aiming at practical feasibility and sustainability User-oriented suggestions much appreciated 18

19 THANK YOU For more information on WHO biosafety/security: Dr Kazunobu KOJIMA 19