WORKER PROTECTION AGAINST M. TUBERCULOSIS IN PATIENT CARE, DIAGNOSIS AND PATHOLOGY

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1 WORKER PROTECTION AGAINST M. TUBERCULOSIS IN PATIENT CARE, DIAGNOSIS AND PATHOLOGY Juergen Mertsching, Franz C. Bange, Florian Länger, Matthias Stoll, Hannover Medical School, Germany

2 Hannover Medical School (MHH) Number of employees: 7200 Number of students: 3100

3 WORKER PROTECTION AGAINST M. TUBERCULOSIS IN PATIENT CARE, DIAGNOSIS AND PATHOLOGY Juergen Mertsching,, Franz C. Bange,, Florian Länger,, Matthias Stoll, Hannover Medical School, Germany Framework of Risk Assessment Risk Assessment - in Patient Care - in Diagnosis Laboratories - in Departments of Pathology European Workers Protection Directive Is this needed in the clinic??

4 Framework for Risk Assessment of Different Workplaces 1. Transmission Concept of droplet nuclei: droplets < 5 µm reach the alveoles (Biological Safety, ed. D.F. Fleming, 2000) Incidence Rate Germany: per ((Global Tuberculosis Control.. WHO Report 2002) 10 per are infected 10 % of them develop the disease Autopsy - undiagnosed tuberculosis Adrino (1981): 1.3 % Ebert (1983): 3.1 % Martinez (1991): 1.8 %

5 Framework for Risk Assessment of Different Workplaces 1. Transmission Concept of droplet nuclei: : droplets < 5 µm reach the alveoles (Biological Safety, ed. D.F. Fleming, 2000) 2. Incidence rate Germany: per (Global Tuberculosis Control. WHO Report 2002) 10 per are infected 10 % of them develop the disease Autopsy - undiagnosed tuberculosis Adrino (1981): 1.3 % Ebert (1983): 3.1 % Martinez (1991): 1.8 %

6 Framework for Risk Assessment of Different Workplaces 1. Transmission Concept of droplet nucleus: : droplets < 5 µm reach the alveoles (Biological Safety, ed. D.F. Fleming, 2000) 2. Incidence rate Germany: per ((Global Tuberculosis Control.. WHO Report 2002) 10 per are infected 10 % of them develop the disease 3. Autopsy - undiagnosed tuberculosis Adrino (1981): 1.3 % Ebert (1983): 3.1 % Martinez (1991): 1.8%

7 BSL-3 3 Research Laboratory for Propagating M. tuberculosis Wild Type and Genetically Modified TB Bacteria

8 Isolation Ward - Building Task: Isolation of patients with infectious diseases

9 Isolation Ward - Entrance

10 Isolation Unit Personal Protection

11 Isolation Ward Technical Measures single room anteroom negative pressure control light for negative pressure at the entrance control tableau at the nurse s desk for vital functions of patients

12 Isolation Ward - Waste Management Waste must be stored and transported in such a way that transport staff are not at risk. One-Way Traffic

13 Worker Protection Isolation Unit Critical Steps Delate diagnosis of TB Protection of staff from aerosol transmission Safety Measures Patients suspected of having TB receive antibiotics treatment Respirator Patient may leave the isolation unit after antibiotics treatment (sputum negative) Removal of contaminated material Safe waste disposal Patient has to wear a mouth-nose mask Container with disinfectant One-Way Traffic The isolation unit for patients with an open TB is a BSL-3 workplace.

14 TB-Diagnosis Laboratory

15 TB-Diagnosis Laboratory Negative Pressure Double Gloves Centrifuges with - Sealed Rotor Heads - Centrifuge Safety Tubes

16 TB-Diagnosis Laboratory Solid Agar Cultures Automated Liquid Culture System

17 Lightcycler for Detection of M. tuberculosis Fluorescence Response Energy Transfer (FRET) J. Lachnik (2002), J. Clin. Microbiol., 40, The PCR is done in a BSL-1 research laboratory.

18 Worker Protection TB-Diagnosis Laboratory Critical Steps Processing of patient material, pipetting Generation of aerosols through heat-fixation of material onto microscope slides Removal of patient material out of the biosafety cabinet Centrifugation Transport of waste to the autoclave Safety Measures Only within the biosafety cabinet, working with two pairs of gloves Air-drying of samples within the biosafety cabinet before heatfixation In sealed tubes In tape-sealed Petri dishes Using sealed rotor heads and centrifuge safety cups In sealed bags and bins The TB-Diagnosis Laboratory is a BSL-3 workplace.

19 Dept.. of Pathology

20 Pathology Frozen Sections of Native Tissue Cryo sections are made under BSL 2 working conditions.

21 Pathology Formalin-fixed Tissue Down Draught Ventilation Table Handling of fixed tissue at a BSL-2 workplace.

22 Risk Assessment Autopsy Possible Routes of Infection: 1. Mucocutaneous contact with infected body fluids 2. Injuries with sharps or needles 3. Transmission of aerosols Neat and Clean Working Personal Protection Equipment

23 Risk Assessment Autopsy Personal Protection Equipment: Cap Eye Protection Face Mask Surgical Shirt and Trousers Waterproof Boots Full-length Gown Waterproof Apron Gloves Kevlar gloves

24 Worker Protection Autopsy Room Critical Steps Mucocutaneous contact with infected body fluids Injuries with sharps or needles Generation of aerosols: - Eventration of the cranium - Preparation of spine - Cutting of the ribcage Safety Measures Personal Protection Equipment Immediate cleaning of all fluids from the work surface Safe sharps practices - All cutting instruments are checked for sharpness - No passing from hand to hand Power saws with extraction by suction For autopsy BSL-3 practices in a BSL-2 facility are recommended.

25 Workers Protection Directive

26 Workers Protection Directive Is there need for the European Workers Protection Directive in a clinic where traditionally many rules are already in place to combat infection of patients, workers and visitors?

27 Workers Protection Directive Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, 18 th September, 2000 Objective: Protection of workers against risks from exposure to any biological agents Employers obligations Determination and assessment of risks Replacement of harmful biological agents, if possible Containment measures Personal protective equipment Informing the competent authority Informing and training staff Asperagillus flavus 1000x magnification

28 Workers Protection Directive is not the one and only Some more regulations in force at Hannover Medical School: Workers Protection Directive ( Biostoffverordnung ) Protection Against Infections Act ( Infektionsschutzgesetz ) Genetic Engineering Act ( Gentechnikgesetz ) Safety at Work Act (Betriebssicherheitsgesetz) Statutory Regulations of Working Hours (Arbeitszeitgesetz) Medical Products and Drugs Act (Medizinproduktegesetz)

29 Workers Protection Directive is not the one and only Some more regulations in force at Hannover Medical School: Workers Protection Directive ( Biostoffverordnung ) Protection Against Infections Act ( Infektionsschutzgesetz )) Genetic Engineering Act ( Gentechnikgesetz )) Safety at Work Act (Betriebssicherheitsgesetz) Statutory Regulations of Working Hours (Arbeitszeitgesetz) Medical Products and Drugs Act ((Medizinproduktegesetz Medizinproduktegesetz))

30 Take-home Message The Workers Protection Directive has a high juristical value for all European countries. The Directive leads to a balance of safety and economic interests within Europe. Risk Assessment and safety instructions must be carried out and are to be signed by all employees.

31 Hannover Medical School Franz-C. Bange, Inst. for Medical Microbiology Matthias Stoll, Isolation Ward Florian Länger, Dept. of Pathology Thomas Rothämel, Dept. of Legal Medicine Christine Bader, Occupational Health Stefan Gerstel, Office for Biosafety Juergen Mertsching, Biosafety Officer

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