[MCOH-EH] Respirators & testing
Michael A. Sauri, MD, MPH&TM, FACP, FACPM, FACOEM
msauri at ohcmd.com
Sat Mar 21 07:51:10 PDT 2020
Abhijay,
I will try to address your first question by way of some background.
Since the SARS outbreak in 2003, there has been questions about the effectiveness of N-95 respirators during the SARS Epidemic in Hong Kong, China and Canada and relying on fit-tested N95 respirators during an Avian Influenza epidemic. I actually spoke about the issue at the 2007 AOHC and 2007 AIHce Meetings in my talk on Infectious Aerosols.
The issue is:
FDA
FDA certifies material used in respirators. For example A respirator’s Nominal Protection Factor (NPF) is the theoretical protection level based on laboratory measured performance data. That said the Assigned Protection Factor (APF) is the level of respiratory protection that can realistically be achieved in the workplace by 95% of adequately trained and supervised wearers. Consequently, the APF should be used when selecting a respirator.
NIOSH
NIOSH certifies respirators and require that Bacterial Filtration Efficiency be the standard test method for Medical Face Mask material (ASTM F2101-01). The procedure for a NIOSH N95 certification is available at the following website address: http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html . They include four components: 1) filtration efficiency; 2) inhalation resistance; 3) exhalation resistance, and 4) exhalation valve leak (when applicable).
NIOSH Standard: Neutralized NaCl aerosol: a median mass diameter of 0.26µ (0.075± 0.02µ)
Other standards used to screen new respirator material (as per Military Specification MIL-STD 36954C)
Bacterial Filtration Efficiency (BFE) Aerosol of Staphylococcus aureus with a MPS of approximately 3.0µ.
Viral Filtration Efficiency (VFE) phiX174 bacteriophage at 0.027µ (27 nm) in size (one of the smallest known viruses, has no envelope, and has icosahedral morphology)
OSHA
OSHA requires that respirator user must adhere to program requires in OSHA’s Respiratory Protection Standard (29 CFR 1910.134) and used in their approved configuration (Fit Testing) to achieve the assigned Protection Factor (APF) for the particulate respirator (which is multiple of the permissible exposure limit (PEL) for the hazardous agent in question.
OSHA 42 CFR Part 11 Standard certifies the N-95 respirator filtration efficiency using the most penetrating aerosol size (0.30 µ) with either degrading or non-degrading particulates to challenge the respirator at 95, 99, or 99.97% filtration efficiency.
Note: An N-95 respirator is one of nine types of disposable particulate respirators.
Particulate respirators are also known as “air-purifying respirators” because they protect by filtering particles out of the air as you breathe. These respirators protect only against particles—not gases or vapors. Since airborne biological agents such as bacteria or viruses are particles, they can be filtered by particulate respirators.
Respirators in this family are rated for protection against oils.
This rating is important in industry because some industrial oils can degrade the filter performance so it doesn’t filter properly.* Respirators are rated “N,” if they are not resistant to oil, “R” if somewhat resistant to oil, and “P” if strongly resistant (oil proof). Thus, there are nine types of disposable particulate respirators:
N-95, N-99, and N-100
R-95, R-99, and R-100
P-95, P-99, and P-100
Those that filter out at least 99% receive a “99” rating. And those that filter at least 99.97% (essentially 100%) receive a “100” rating.
The N-series will be tested against a mildly degrading aerosol of sodium chloride (NaCl). The R- and P-series filters will be tested against a highly degrading aerosol of dioctylphthalate (DOP)
Those that filter out at least 99% receive a “99” rating. And those that filter at least 99.97% (essentially 100%) receive a “100” rating.
The N-series will be tested against a mildly degrading aerosol of sodium chloride (NaCl). The R- and P-series filters will be tested against a highly degrading aerosol of dioctylphthalate (DOP)
The N95 designation indicates that under the test methods in the laboratory, 95% of particles are captured with a GMD (Geometric Mean Diameter) of 1.6 micron (or 5% will pass through).
Face seal leakage in N95 respirators can be estimated at 1% when properly fit tested. This value corresponds to a fit factor of 100, which is OSHA’s criterion for an acceptable fit.
This is in addition to the large leakage that will result in the practical environment where face fit is not possible and where no training in respiratory protection has been carried out.
A NIOSH certified N-95 rated respirator will filters out at least 95% of airborne particles during a 0.3 micron sized particle challenge.
Note: Other respirators (e.g surgical mask) are allowed to transmit greater than 20% particles through the respirator, but in practice much greater leakage of particles will result due to face fit factors
Consequently, the assigned protection factors (APF) are only effective when the employer
implements a continuing, effective respirator program as required by OSHA (29 CFR 1910.134), including training, fit testing, maintenance, and use requirements. ( NIOSH Pub. No. 2005-100 (Oct 2004)
Finally, the main problem in 2007 was the number of competing standards for respiratory protection which created a challenge in the containment of infectious aerosols as summarized below:
ACGIH TLV’s vs OSHA Limits (Air Quality)
ACGIH TLV's vs NIOSH REL's (Safe Level)
ACGIH vs DOE (Falling efficiency)
CDC Biohazard vs Animal Biosafety (NHP)
Res. Laboratory vs Hospital (BBP)
JCAHO vs OSHA (Tbc)
Note: OSHA Rescinded their own OSHA Guidelines for Tuberculosis in 1995 (based on the realization that the standard would not prevent its most common method of transmission (i.e. undetected reactivation of disease)
OSHA vs EPA (Katrina Relief)
ASHRAE vs FAA (A/C Cabin)
ASHRAE vs CDC (ACH)
ICPA vs OSHA (standard of care issues)
AOHN vs CDC (fit testing)
So, that is why there is finally a MOU (10 years later) between NIOSH, FDA, and OSHA (Memorandum of Understanding Between the Food & Drug Administration/Center for Devices & Radiological Health and the Centers For Disease Control & Prevention/National Institute for Occupational Safety & Health/National Personal Protective Technology Laboratory) https://www.fda.gov/about-fda/domestic-mous/mou-225-18-006
Consequently, you can use either a N-, R-, or P- respirator while caring for COVID-19 patients as long as you have been successfully fit-tested on the respirator.
I hope this is helpful.
Michael
Michael A. Sauri, MD, MPH&TM, FACP,
FACPM, FACOEM, FRSTM&H, CTropMed
Medical Director
Occupational Health Consultants
2301 Research Blvd, Suite #125
Rockville, MD 20850
Tel 301-738-6420
Fax 301-990-3534
www.ohcmd.com <http://www.ohcmd.com>
From: MCOH-EH <mcoh-eh-bounces+msauri=ohcmd.com at mylist.net> On Behalf Of Abhijay Karandikar via MCOH-EH
Sent: Saturday, March 21, 2020 10:21 AM
To: MCOH-EH <mcoh-eh at mylist.net>; dr_abhik at yahoo.com
Cc: Abhijay Karandikar <dr_abhik at yahoo.com>
Subject: Re: [MCOH-EH] Respirators & testing
1. When there is such a shortage of N-95s and the importance of PPE for healthcare workers is clear, is anyone using other respirators in health care:
N-99, N-100 or even the R and P series? Elastomeric reusable respirators?
2. We have been asked by a vendor to consider a "rapid coronavirus test" that will be available from 4/1. It is not FDA approved since there are exceptions on that currently. Anyone has any more information on this?
Abhijay
Abhijay P. Karandikar, MD, MPH, FACOEM
Chief - Section of Occupational Medicine
Sent from my Samsung Galaxy smartphone.
-------- Original message --------
From: "Barnosky,Sandra" <barnosky at uchc.edu <mailto:barnosky at uchc.edu> >
Date: 3/20/20 7:39 AM (GMT-05:00)
To: 'MCOH-EH' <mcoh-eh at mylist.net <mailto:mcoh-eh at mylist.net> >
Subject: Re: [MCOH-EH] Covid-19 restrictions for vulnerable healthcare personnel
We are following CDC and employees can ask to be reassigned based on the following:
For this guidance, we are utilizing the CDC guidance for the definition of severe immunocompromised based on medical conditions and medications, which may be found at:
https://wwwnc.cdc.gov/travel/yellowbook/2020/travelers-with-additional-considerations/immunocompromised-travelers
1.AGE: If you are age 65 or older, you may be considered for re-assignment.
2.PREGNANCY: If you are pregnant, you may ask for an assignment that would limit your exposure to confirmed or suspected COVID-19 patients during higher risk procedures, e.g. aerosol generating procedures.
3.UNDERLYING MEDICAL CONDITIONS: If you have any of the following medical conditions, you may be considered “severely immunocompromised”:
•Active leukemia or lymphoma
•Generalized malignancy
•Aplastic anemia
•Graft-versus-host disease
•Congenital immunodeficiency
•Recent radiation therapy or checkpoint inhibitor treatment •Solid-organ transplant recipients and who are on active immunosuppression •CAR-T cell transplant recipients within 2 years of transplantation or still taking immunosuppressive drugs •Hematopoietic stem cell within 2 years of transplantation or still taking immunosuppressive drugs •Human Immunodeficiency Virus infection and a CD4 count < 200 cells/mm3
4.MEDICATIONS: If you are taking any of the medications listed below, you may be considered “severely immunocompromised.”
If you meet any of the above criteria you may request to be voluntarily re-assigned.
List of Medications that Constitute Severe Immunocompromise •High-dose corticosteroids
o defined as a dose of either >2 mg/kg of body weight or ≥20 mg per day of prednisone or equivalent in people who weigh >10 kg, when administered for ≥2 weeks
•Alkylating agents(such as cyclophosphamide) •Antimetabolites(such as azathioprine, 6-mercaptopurine, methotrexate).
•Transplant-related immunosuppressive drugs(such as cyclosporine, tacrolimus, sirolimus, everolimus, azathioprine, and mycophenolate mofetil) •Cancer chemotherapeutic agents •Tumor necrosis factor (TNF) blockers(e.g. etanercept, adalimumab, certolizumab pegol, golimumab, and infliximab) •Lymphocyte-depleting agents (thymoglobulin or alemtuzumab) •Other biologic agentsthat are immunosuppressive or immunomodulatory including the following:
GENERIC NAME TRADE NAME
Abatacept Orencia
Adalimumab Humira
Alemtuzumab Campath
Anakinra Kineret
Atezolizumab Tecentriq
Avelumab Bavencio
Basiliximab Simulect
Belatacept Nulojix
Bevacizumab Avastin
Certolizumab pegol Cimzia
Cetuximab Erbitux
Dasatinib Sprycel
Dimethyl fumarate Tecfidera
Etanercept Enbrel
Fingolimod Gilenya
Glatiramer acetate Copaxone
Golimumab Simponi
Ibritumomab tiuxetan Zevalin
Ibrutinib Imbruvica
Imatinib mesylate Gleevec, STI 571
GENERIC NAME TRADE NAME
Infliximab Remicade
Interferon alfa Pegasys, PegIntron
Interferon beta-1a Avonex, Rebif
Interferon beta-1b Betaseron
Natalizumab Tsabri
Nivolumab Opdivo
Ofatumumab Arzerra
Panitumumab Vectibix
Pembrolizumab Keytruda
Lenalidomide Revlimid
Rilonacept Arcalyst
Rituximab Rituxan
Sarilumab Kevzara
Secukinumab Cosentyx
Sunitinib malate Sutent
Tocilizumab Actemra
Tofacitinib Xeljanz
Trastuzumab Herceptin
Ustekinumab Stelara
Vedolizumab Entyvio
From: MCOH-EH [mailto:mcoh-eh-bounces+barnosky=up.uchc.edu at mylist.net] On Behalf Of Hodgson, Michael - OSHA via MCOH-EH
Sent: Thursday, March 19, 2020 4:32 PM
To: MCOH-EH <mcoh-eh at mylist.net <mailto:mcoh-eh at mylist.net> >
Cc: Hodgson, Michael - OSHA <Hodgson.Michael at dol.gov <mailto:Hodgson.Michael at dol.gov> >
Subject: Re: [MCOH-EH] Covid-19 restrictions for vulnerable healthcare personnel
*** Attention: This is an external email. Use caution responding, opening attachments or clicking on links. ***
The venerable Dr Teichman appropriately defends a non-discriminatory practice... But here CDC has uttered a new warning. In fact, since language ambiguities made some people interpret their warning that all employees over 65 should stay home and not enter Federal buildings even if they are essential staff. Sigh
>From a 70-year old...
_____
From: MCOH-EH <mcoh-eh-bounces at mylist.net <mailto:mcoh-eh-bounces at mylist.net> > on behalf of Teichman, Ron F <Ron.Teichman at bannerhealth.com <mailto:Ron.Teichman at bannerhealth.com> >
Sent: Wednesday, March 18, 2020 9:05:26 PM
To: MCOH-EH <mcoh-eh at mylist.net <mailto:mcoh-eh at mylist.net> >
Subject: Re: [MCOH-EH] Covid-19 restrictions for vulnerable healthcare personnel
At this point the first question that must be asked is why does an immunocompromised HCW feel they cannot be around someone potentially infected with COVID-19, but has no such concern over potential infections with measles, TB or influenza? If they are immunocompromised they should avoid contact with potentially infectious patients, but should not pick an dchoose which disease they don't want to work around (remind anyone of GRIDS?).
Ron Teichman, M.D., M.P.H., FACOEM, FACP
Division Medical Director
Banner Occupational Health and Wellness
1300 N. 12th Street, Suite 610
Phoenix, AZ 85006
602-747-7294
Ron.teichman at bannerhealth.com <mailto:Ron.teichman at bannerhealth.com>
-----Original Message-----
From: MCOH-EH <mcoh-eh-bounces at mylist.net <mailto:mcoh-eh-bounces at mylist.net> > On Behalf Of Sumeet Batra
Sent: Wednesday, March 18, 2020 5:58 PM
To: mcoh-eh at mylist.net <mailto:mcoh-eh at mylist.net>
Subject: [EXTERNAL] [MCOH-EH] Covid-19 restrictions for vulnerable healthcare personnel
Hello,
I am interested in what my colleagues at other institutions are doing with vulnerable HCP, such as HCP over 60, pregnant, immunocompromised. At this time my institution has not recommended changes in work practices, such as not assigning these workers to known or suspected Covid cases but we are getting a lot of pushback from employees and physicians who feel unsafe. I am wary of the legal/ethical/logistical issues that could arise from creating these restrictions but would be very interested in how others are handling this.
Sumeet Batra, MD, MPH
Medical Director of Occupational Health
Cook Children’s Healthcare System
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