1. Unit Respiratory protection TB Infection Control Training for Managers at National and Subnational Level
Photo courtesy of WHO/Dominic Chavez
John Donnelly. Airborne: a journey into the challenges and solutions to stopping MDR-TB and XDR-TB WHO/HTM/STB/

2. Objectives After this unit, participants will be able:
To describe the differences between a surgical mask and a respirator
To name the types of respirators that protect against TB transmission, and when to use them
To list the elements of a respiratory programme
[Review slide]

3. Outline WHO recommendations Surgical mask vs. particulate respirator
Respirator standards
Respirator programme
Proper use
Fit testing
This unit starts with WHO recommendations for respirators.
We’ll then contrast the surgical mask with the particulate respirator.
We’ll address respirator standards.
We’ll talk about how a respiratory programme is needed whenever respirators are used.
In the exercise that follows, participants will get “hands-on” experience putting on and fit testing respirators.

4. WHO recommendations
When used with administrative and environmental controls, particulate respirators may provide health care workers (HCW) additional protection from TB
Respirators
Must meet or exceed standards
Be properly used
Be part of a training programme
[Review slide]
WHO also recommends when to use respirators, as we’ll see on the next slide.
Citation
WHO. WHO policy on TB infection control in health-care facilities, congregate settings, and households WHO/HTM/TB/

5. WHO recommends particulate respirators for HCWs:
Caring for patients with confirmed or suspected infectious TB (in particular MDR-TB)
Performing aerosol-generating procedures on infectious TB patients
Bronchoscopy, intubation, sputum induction
Use of high speed devices for lung surgery or autopsy
[Review slide]
Citation
WHO. WHO policy on TB infection control in health-care facilities, congregate settings, and households WHO/HTM/TB/

6. Surgical masks
Reduce the spread of microorganisms from the wearer to others, by capturing large wet particles
Do not protect the wearer from inhaling small infectious aerosols.
This person is wearing a surgical mask.
Surgical masks are designed to capture large, wet particles.
During surgery, they prevent contamination of the sterile field by the surgeon’s germs.
They do not protect the wearer from inhaling small infectious aerosols.
Surgical masks have large pores and lack a tight seal around the edges.

7. Particulate respirators
Protect the wearer from inhaling droplet nuclei
Filter out infectious aerosols
Fit closely to the face to prevent leakage around the edges
[Review slide]
Photo courtesy of GB Migliori

8. Photo from “Control de infecciones de tuberculosis en establecimientos de salud- Módulo de capacitación. Ministerio de Salud, Peru,” courtesy of Paul Jensen

9. Surgical masks (yes for patients)
The slide shows infectious MDR-TB patients in an MDR-TB department.
[Ask participants]: Is respiratory protection being used correctly here?
Problems include:
One patient is not wearing a mask.
One patient’s mask is not tied properly.
While working with infectious MDR TB patients, the health care worker is not using a respirator.
Photo courtesy of GB Migliori

10. Surgical masks do not protect staff from TB
Surgical masks do not protect health care workers from TB.
The picture on the left shows a physician wearing a mask in a former Soviet Union country, in a room where TB patients receive directly observed therapy.
If some of the patients are infectious, this mask is not sufficient protection for the health care worker.
The picture in the right side shows an operating room in an African hospital. The masks protect the sterile field, not the health care workers.
If this is an infectious TB patient undergoing lung surgery with high speed devices, the staff are not adequately protected from TB transmission.
Photos courtesy of Paul Jensen (upper left) and GB Migliori (lower right)

11. Particulate respirators used for TB exposure
N95 (USA)
Filter out > 95% of particles
FFP2, FFP3 (Europe)
Filter out > 94-98% of particles
Both the US and Europe have respirator standards in use throughout the world
On the left of the slide, N95 respirators from the US effectively filter out > 95% of the particles 0.3 μm in aerodynamic diameter
The equivalent respirators according to the European standard are FFP2 and FFP3 (on the right).
The FFP2 filters out > 94% of the particles 0.4 μm in aerodynamic diameter; the FFP3 filters out >98%
Adapted from: Control de infecciones de tuberculosis en establecimientos de salud- Módulo de capacitación. Ministerio de Salud, Peru

12. USA standards* Filter efficiency N (not resistant to oil)
TB protection
95%
N95 ✓
99%
N99
99.97%
N100
For providing routine TB care, the N-95 respirators are sufficient.
Their filtration efficiency is 95%.
The N stands for “not resistant to oil.” This is only an issue in industrial settings where oil aerosols can block the filter.
Citation
Centers for Disease Control and Prevention (USA). Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, MMWR 2005:54(No. RR-17). (See also errata published on 25 September 2006)
*National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC)

13. European standards* Total inward leakage Filtering Face Piece
TB protection
<25%
FFP1
Not adequate
<11%
FFP2 ✓
<5%
FFP3
The total inward leakage defines the FFP2, FFP2 and FFP3 levels in the European standard.
FFP2 and FFP3 are like N95, appropriate for TB protection
For more information see
*Comité Européen de Normalisation (CEN)
(European Committee for Standardization)

14. CEN standards Total inward leakage Initial filter penetration
NaCL Paraffin oil
<20%=P NA=P1
< 6%=P2 <2%=P2
< 3%=P3 <1%=P3
Maximum breathing resistance
Loading test
In addition to total inward leakage, CEN standards include initial filter penetration of NaCl and paraffin oil.
Two additional CEN parameters are maximum breathing resistance and loading.
Which is the difference between CDC-NIOSH and CEN standards?
CDC-NIOSH criteria deal with filtration efficiency only, while CEN (European) standards cover, in addition, how many people the respirators fit.
For more information see

15. Air-purifying respirators
Remove specific air contaminants by passing ambient air through the air-purifying filter, cartridge or canister
Here are pictures of air-purifying respirators.
The picture on the left shows a disposable air purifying respirator. The N95s and FFPs we just discussed are disposable air purifying respirators. The face piece itself is the filter.
In the other 2 pictures, cartridges or canisters filter the air. These respirators are not disposable; they are made of a rubber-like material that is washable.
The picture in the middle is a half-facepiece respirator, while the picture on the right covers the full face. Both have exhaust valves.
The wearer may feel ‘cooler’ when wearing a respirator with an exhaust valve. But respirators with exhaust valves should not be used when a sterile field is needed, as in surgery.
Photos courtsey of Paul Jensen

16. Negative pressure respirators
air pressure inside the facepiece is negative during inhalation
contaminated air can avoid the higher-resistance filter and leak in through gaps in the face seal
Face seal leakage is an inherent problem in negative pressure respirators.
Leakage around the face seal limits a respirator’s protective ability
Each time the wearer inhales, negative pressure (relative to the workplace air) is created inside the facepiece
Because of this negative pressure, contaminated air can avoid the higher-resistance filter and leak through any gaps in the face seal
Photos courtesy of Paul Jensen

17. Types of air purifying respirators
Non–powered (negative pressure)
Powered air-purifying respirators (PAPR)
A blower draws air through the filter and blows it into the face piece
Pressure inside face piece reduces face-seal leakage (offers more protection)
Loose fitting PAPRs can be used for people that cannot achieve an adequate seal
We have been talking about non powered air purifying respirators, and that face seal leakage is an inherent problem with negative pressure respirators.
There is another type of air purifying respirator that is powered.
A blower draws air through the filter and blows it into the face piece.
This creates pressure inside face piece which reduces face-seal leakage during inhalation
This means the respirator offers more protection.
In the US, powered air purifying respirators (PAPRs) may be used during high risk procedures, such as bronchoscopy on potentially infectious patients
Loose fitting PAPRs can be used for people that cannot achieve an adequate seal (such as health care workers with facial hair)
Citation
Centers for Disease Control and Prevention (USA). Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, MMWR 2005:54(No. RR-17). (Errata published on 25 September 2006)

18. Respirator programme elements
Person assigned responsibility
Written procedures
Medical evaluation
Training
Selection of respirators
Fit testing
Maintenance
Programme evaluation
Whenever respirators are used, a respirator programme is necessary.
The main elements of the respirator programme are summarized in the slide.
One person should be given the authority and responsibility to manage the programme.
Written procedures should describe when and how respirators are to be used.
Health screening is done to be sure that health care workers are physically capable of performing job duties when wearing a respirator.
Training should include information on the risk of TB transmission and how to prevent it, and the appropriate use of respirators.
Respirators should be selected that meet standards for protection (N95, FFP2 or FFP3).
Several sizes are necessary to fit a range of faces.
We’ll talk about fit-testing next and maintenance later in this unit.
Finally, the respirator programme should be evaluated periodically.

19. Why is fit testing necessary?
Ensure a proper seal between respirator and wearer
Determine appropriate make/model
Determine appropriate size
We conduct fit testing in order to be sure that each person’s respirator fits adequately.
This means checking that there is a proper seal, as face seal leakage compromises the respirator’s ability to protect the wearer.
We do not want people to have a false sense of security when wearing the respirator.
The fit test is required to select the appropriate model and size.

20. When should fit testing be done?
Employees should pass a fit test:
Prior to initial use
Whenever a different respirator facepiece (size, type, model or make) is used
Periodically thereafter
Whenever changes in the worker’s physical condition or job description that could affect respirator fit are noticed or reported
[Review slide]
[Ask participants]:
What is done in the participants’ own hospitals/settings?

21. Sources of facepiece leakage
Around facepiece/skin interface
Through air-purifying element
Through exhalation valve
[Review slide]
Arrows show leakage points if the fit is not correct.
from: Control de infecciones de tuberculosis en establecimientos de salud- Módulo de capacitación. Ministerio de Salud, Peru, courtesy of Paul Jensen

22. Factors contributing to poor fit
Weight loss or gain
Facial scarring
Changes in dental configuration (dentures)
Facial hair
Cosmetic surgery
Excessive makeup
Mood of workers (smiling/ frowning)
Body movements
Which are the factors responsible for poor fitting respirators?
[Review slide]
There is no one size that fits all.
You will always have people who will require a different model.

23. Qualitative fit tests:
Rely on the individual’s response to the test agent to assess the adequacy of respirator fit
Are scored as pass/fail
[Review slide]
Photo from: Control de infecciones de tuberculosis en establecimientos de salud- Módulo de capacitación. Ministerio de Salud, Peru, courtesy of Paul Jensen

24. Test solutions for qualitative fit testing
Four methods recognized and accepted
Isoamyl acetate
Irritant aerosol
Saccharin
BitrexTM (Denatonium benzoate)
• Four methods are presently accepted to perform qualitative fit tests.
• Among them, saccharin and BitrexTM tests are the easiest to perform

25. Fit tests using saccharin or BitrexTM
Can be used for all respirators (i.e. 95-, 99- and 100- series and FFP2 and FFP3)
Uses subject’s sense of taste
Requires the use of small test hood
[Review slide]

26. Saccharin and BitrexTM
Subject demonstrates ability to detect weak solution in the test hood
Subject dons respirator
Strong solution (~100 times) sprayed into hood
Respirator passes if subject does not taste aerosol
Assumed fit factor = 100
If the subject tastes the Bitrex or saccharin while wearing the respirator he/she failed the test.
Otherwise, the test was passed.
This is assume to be equivalent to a fit factor of 100 if a quantitative fit test had been done.
(We’ll talk about quantitative fit tests in a moment.)

27. Qualitative fit test equipment
The 3M Qualitative Fit Test Apparatus is shown, as an example, in the picture.
There are several other options in the market.

28. Quantitative fit tests:
Measure the amount of leakage into the respirator to assess the adequacy of respirator fit
Are scored with a number
[Review slide]

29. Maintenance and storage
Take care of your disposable respirator
Decontamination NO!
Cleaning NO!
Storage Clean & dry place!
Take care when re-using respirator – closely monitor service life
Inspect prior to each use
Dispose of the respirator if you question its performance
What should be done and what should not be done to take care of a disposable respirator?
Never try to clean or decontaminate it!
The respirator should be kept in a clean, dry place.
A disposable respirator may be re-used by the same health worker, as long as it is not wet, damaged, or contaminated with blood or body fluids, and as long as breathing resistance does not increase.
Check the manufacturer’s instructions for the specified service life.
Filtering facepieces must be inspected prior to each use

30. Read the manufacturer’s instructions to don the respirator properly
Staff wearing respirators should carefully read the instructions before using them.
Photo courtesy of Paul Jensen

31. Is this respirator put on properly?
[Ask participants]:
Is this respiratory put on properly?
Problems include:
The filter is not centered. In the side view, you can see some of the wearer’s right nostril.
The lower elastic band is missing.
In many respirators, the elastic is of poor quality, and it stretches or can break after pulling it a couple of times only.
Photo courtesy of Paul Jensen

32. Post warning sign
The slide shows a warning sign posted outside a patient’s room in Brasil.
This is a reminder that health care workers who enter need to wear a respirator.
If the patient needs to be transported, he or she should wear a surgical mask.
From: Control de infecciones de tuberculosis en establecimientos de salud- Módulo de capacitación. Ministerio de Salud, Peru, courtesy of Paul Jensen.

33. Time to clear the air between patients
Here is another example of a warning posted on a room after an infectious TB patient has left.
The time is recorded on the clock, indicating when it is safe to enter without a respirator.
Once the time has passed, a new patient can enter the room.
The time to clear the air is determined on the basis of the room’s air changes per hour we discussed in the unit on ventilation.
Photos courtesy of Paul Jensen

34. Bronchoschopy room
Now lets look at respiratory protection in several settings.
The picture shows a bronchoscopy room in central Europe.
[Ask participants:]
What is wrong with this picture?
[Responses should include]:
Bronchoscopy is a high risk medical procedure, and staff should be wearing respirators.
Only one health care worker is wearing a mask, but it provides no protection from droplet nuclei since it is a surgical mask, not a respirator.
Also, in terms of administrative controls, too many staff are present. No more staff than necessary should be present.
Courtesy of GB Migliori

35. DOT room Does this nurse providing DOT need respiratory protection?
There is insufficient information from the picture on the risk of TB transmission.
Here are factors to consider:
Could infectious TB patients be present, such as
undetected TB cases (e.g. suspects)
newly diagnosed patients during the first days of the intensive phase of treatment being still potentially infectious
patients not responding to treatment, who may have MDR-TB
What is the ventilation in the area?
Photo courtesy of GB Migliori

36. Isolation XDR-TB tent and DOT
This young patient with XDR-TB lived in a isolation tent placed in front of a hospital in Africa.
The nurse provided DOT (including injections) outside of the tent
The patient is not wearing the surgical mask
The patient died in spite of treatment with second line drugs. Should the nurse have worn a respirator?
No, the nurse is interacting with the patient outdoors, where there is ample ventilation.
Courtesy of Mario C. Raviglione

37. Summary
Surgical masks prevent infectious particles from being expelled by the wearer
Respirators protect the health care worker from inhaling infectious particles
When used with administrative and environmental controls, N95, FFP2 or FFP3 respirators provide additional protection when HCWs care for infectious TB patients
Whenever respirators are used, a respirator programme is necessary
[Review slide]