Respiratory Protection

Julie Cahn, DNP, RN, CNOR, RN-BC, ACNS-BC, CNS-BC

AORN Senior Perioperative Practice Specialist

Polling Question #1

Polling Question #1

Respiratory Protection Devices

1. Filtering Facepiece Respirators1. Includes N95s

2. Powered Air-Purifying Respirators (PAPRs)

3. Elastomeric 1. Full Facepiece Respirators

2. Half Facepiece Respirators

https://www.cdc.gov/niosh/npptl/pdfs/RespProtectionTypes-508.pdf

NIOSH Respirator Ratings

N Series

Not Resistant to Oil

N95 – Filters at least 95% of

airborne particles

N99 – Filters at least 99% of

airborne particles

N100 – Filters 99.97% of airborne

particles

R Series

Somewhat Resistant to Oil

R95 – Filters at least 95% of

airborne particles

R99 – Filters at least 99% of

airborne particles

R100 – Filters 99.97% of airborne

particles

P Series

Strongly/Resistant to Oil

P95 – Filters at least 95% of

airborne particles

P99 – Filters at least 99% of

airborne particles

P100 – Filters 99.97% of airborne

particles

Filtering

Facepiece Respirators

Surgical N95 Respirator

Key Points to Respirator Use

Capture Particles

Fit SnuglyWorn Correctly

Annual Respirator Fit Testing

• Fit can change over time

• If it doesn’t fit it doesn’t work

• Prioritize testing if• Weight loss of >20 lbs

• Significant weight gain

• Extensive Dental Work

• Scarring

• Cosmetic Surgery

Facial Hair

https://www.cdc.gov/niosh/npptl/pdfs/FacialHairWmask11282017-508.pdf

https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas

Comparing Surgical Mask & N95 Protection

SARS-CoV-2 Virus~0.05-0.2

Benson S, Novak D, and Ogg M. Proper Use of Surgical N95 Respirators and Surgical Masks in the OR. AORN J. 2013;97(4):458-470.Reprinted with permission from the AORN Journal. Copyright © [2013], AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

SurgicalN95 Respirator

Benson S, Novak D, and Ogg M. Proper Use of Surgical N95 Respirators and Surgical Masks in the OR. AORN J. 2013;97(4):458-470.Reprinted with permission from the AORN Journal. Copyright © [2013], AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

AORN Recommendations• NIOSH-approved

• Fit-tested

• Surgical N95 respirator or higher-level respirator

AORN Guideline for Transmission-Based Precautions

Additional AORN Recommendations

• Surgical Smoke Safety• In procedures that generate smoke

and involve HPV• During higher-risk aerosol-generating

procedures

• Medication Safety• When handling medication that may

generate airborne powder or aerosols• When preparing for and

administering chemotherapeutic agents during hyperthermic intraperitoneal chemotherapy (HIPEC) procedures.

• A Safe Environment of Care• Respiratory plan may outline when

respirators are required for specific chemicals and when adequate ventilation cannot be provided

• When the level of formalin in an area is greater than 100 ppm

• Environmental Cleaning• When entering a room of a patient

with an airborne transmissible disease before a complete air exchange occurs.

• When cleaning procedures are expected to generate infectious aerosols

Recommendations from the Guideline for Transmission-based Precautions and the Guideline for Sterile Technique addressed separately.

Powered Air-Purifying Respirators

Polling

Question #2

Question #2

PAPRs

https://www.osha.gov/Publications/3352-APF-respirators.pdf

PAPR Placement

Only wear a PAPR under a sterile surgical

gown when the manufacturer specifies it can be worn this

way.

Perioperative PAPR use Risks and Benefits

Respiratory Protection

Sterile Gown & Sterile Field Contamination

AORN Guidance

• Interdisciplinary team evaluation of perioperative PAPR use when sterile fields are present

• If PAPR use is allowed, a standard plan for protecting the sterile field from contamination should be in place

• Portion of the sterile field to be covered

• Direction of blower exhaust

• Type of PAPR allowed (eg, loose-fitting, full-face piece, hood style)AORN Guideline for Sterile Technique

Sterile Field Covering

Two “Cuffed” Drape Method

Applying AORN Recommendations in Real Life

Changing Evidence

• Reference:

• Howard R, Lathrop G, Powell N. Sterile field contamination from powered air-purifying respirators (PAPRs) versus contamination from surgical masks. Am J Infect Control. 2020; 42(2):153-156.

Surgical Helmet Systems

• Hoods, Togas

• Does not provide respiratory protection

• Protective against splashes, splatters, and sprays

• Follow manufacturer’s instructions for use

• Donning• Determining if a mask is necessary

• Turn on fan once fully donned

• Head cover is unsterile once donned

Surgical Helmet System

CAPRs vs PAPRs

CAPR PAPR

Elastomeric Respirators

Polling

Question #3

Question #3

Elastomeric Respirators

https://www.cdc.gov/niosh/npptl/pdfs/FY17_N95infographicWhatAreAPR-508.pdf

Resources & References

Resources• NIOSH Infographics Page

• https://www.cdc.gov/niosh/npptl/RespiratorInfographics.html

• NIOSH• Health Hazard Evaluations (HHE)

• 42 Code of Federal Regulations Part 85

• https://www.cdc.gov/niosh/hhe/default.html

• Discovery and understanding of health hazards present in the workplace

• Recommendations for elimination or prevention related to the hazard

• Free

• Review of completed HHE reports• Surgical smoke

• Noise exposure

• Latex allergens and water incursions

• Waste anesthetic gases

• Nitrous oxide leakage

Resources - AORN

• AORN Nursing Consult Line• For AORN Members• Tuesdays & Wednesdays• 0900-1300 Mountain Time• 800-755-2676

• AORN OR Nurse Link (ORNL)• For AORN Members• 24/7 access• ASK AORN• COVID-19

• AORN Guideline Essentials• For AORN Members• https://www.aorn.org/essentials

• AORN eGuidelines+• Paid Subscription• Get guideline updates in real time• https://aornguidelines.org/

Resources - AORN

• The Science Behind N95 Decontamination

• https://www.aorn.org/events/hot-topics

• Reporting problems with devices under an EUA

• MedWatch

• https://www.accessdata.fda.gov/scripts/medwatch/

Resources – AORN COVID-19

• COVID-19 FAQs• https://www.aorn.org/guidelines/

aorn-support/covid19-faqs

• COVID-19 Tool Kit• https://www.aorn.org/about-

aorn/aorn-newsroom/covid-19-coronavirus

• Perioperative Care of the COVID-19 Patient

• Located in eGuidelines+

References

• Guideline for Transmission-Based Precautions. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2020.

• Guideline for Sterile Technique. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2020.

• Guideline for Surgical Smoke Safety. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2020.

• Guideline for Medication Safety. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2020.

• Guideline for a Safe Environment of Care. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2020.

• Guideline for Environmental Cleaning. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2020.

References

• Benson S, Novak D, and Ogg M. Proper Use of Surgical N95 Respirators and Surgical Masks in the OR. AORN J.

2013;97(4):458-470.

• Howard R, Lathrop G, Powell N. Sterile field contamination from powered air-purifying respirators (PAPRs)

versus contamination from surgical masks. Am J Infect Control. 2020; 42(2):153-156.

• Rengasamy,S.,W.P.King, B.C.Eimer and R.E. Shaffer.(2008). Filtration performance of NIOSH-approved N95

and P100 filtering facepiece respirators against 4 to 30 nanometer-size nanoparticles. Journal of Occupational

and Environmental Hygiene. 5(9):556-564.

• Vourtzoumis P et al. Operating during COVID-19: Is there a risk of viral transmission from surgical smoke

during surgery? Can J Surg. 2020;63(3):E299-E301.

• Zakka K et al. Electrocautery, diathermy, and surgical energy devices: Are surgical teams at risk during the

COVID-19 pandemic? Annals of Surgery. 2020. Published Ahead of Print

References

• https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html

• https://www.cdc.gov/coronavirus/2019-ncov/hcp/elastomeric-respirators-strategy/index.html

• https://blogs.cdc.gov/niosh-science-blog/2009/10/14/n95/

• https://blogs.cdc.gov/niosh-science-blog/2009/10/14/n95/urgicaln95.html

• https://www.cdc.gov/niosh/regulations.html

• https://www.cdc.gov/niosh/hhe/default.html

• https://www.cdc.gov/niosh/npptl/RespiratorInfographics.html

• https://www.cdc.gov/niosh/docs/2018-176/pdfs/2018-176.pdf

• https://www.cdc.gov/niosh/npptl/pdfs/Fit-test-10.508_FNL-508.pdf

• https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html

• https://www.cdc.gov/niosh/npptl/pdfs/RespProtectionTypes-508.pdf

• https://www.cdc.gov/niosh/npptl/pdfs/FacialHairWmask11282017-508.pdf

References

• https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/default.html

• https://www.cdc.gov/niosh/npptl/pdfs/N95RespirClassesInfographic-508.pdf

• https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource3s

• https://www.cdc.gov/niosh/npptl/pdfs/KeyFactorsRequiedResp01042018-508.pdf

• https://www.cdc.gov/niosh/npptl/pdfs/FY17_N95infographicWhatAreAPR-508.pdf

• https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html

• https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource3healthcare.html#m

• https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource3healthcare.html#m

• see Are PAPRs approved for use in a sterile OR field?

References

• https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas

• fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19

• https://www.osha.gov/Publications/3352-APF-respirators.pdf

• https://www.osha.gov/Publications/3352-APF-respirators.pdf

• US Department of Labor, Occupational Safety and Health Administration, Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute of Occupational Safety and Health. Hospital Respiratory Protection Program Toolkit: Resources for Respirator Program Administrators. May 2015. Occupational Safety and Health Administration. https://www.osha.gov/Publications/OSHA3767.pdf. Accessed September 21, 2016.

• https://www.thomasnet.com/articles/plant-facility-equipment/papr-vs-capr-respirators/

• https://www.mopec.com/product/maxair-capr-series-the-no-hose-papr-powered-air-purifying-respirator/

• https://multimedia.3m.com/mws/media/1822363O/u-s-osha-position-on-fit-testing-during-covid-19-technical-bulletin.pdf

Thank You!

NEXT GENERATION RESPIRATORY PROTECTION

Jon Imms

Global Technical & Product Director

CleanSpace Technology Pty Ltd

THE COMPLETE SOLUTION

Sustainability: An economical and environmentally friendly

sustainable solution

Reliability: Leading certified technology designed by

biomedical engineers and manufactured in Australia in ISO9001

facility specifically for the healthcare

Protection: Highest level of protection against airborne

contaminants; HEPA filtration

Deployable: Scalable training in use and care; ongoing

customer support anywhere in the world

Continuous Improvement: our customers become part of a

community of hospitals that share information.

THE TECHNOLOGY

▪ NIOSH APPROVED

▪ Neck mounted compact design

▪ Lightweight and small

▪ Pressure sensors and algorithm continuously

pressurise the mask though the breath

▪ Rapid pressure control sampling, monitoring and

adapting 100Hz – high protection overcomes mask

leaks

▪ Quiet, long wear, efficient motor; 26,000 rpm.

Achieves high pressures and high airflows

▪ Lithium polymer smart battery technology: Light,

long run time and fast re-charge

PROPRIETARY AIRSENSIT™ TECHNOLOGY

TRADITIONAL RESPIRATOR OFFERINGS

DISPOSABLES

✓ Light & simple

✓ Low protection

✓ Moisture/CO2/heat problems

✓ Breathing resistance

✓ Uncomfortable and low compliance

✓ High disposable costs

✓ Reliant on stockpile and supply chains

✓ Easy to counterfeit

✓ High Protection

✓ Reduces heat stress

✓ Reusable

✓ Heavy and bulky

✓ Many parts and complex

✓ Time to clean and disinfect

✓ Poor PPE compatibility

✓ High costs

TRADITIONAL PAPRS

✓ High protection

✓ Reduces heat stress

✓ Reusable

✓ No hoses or belts

✓ Light, small & easy to use

✓ Mobile & portable

✓ Fast disinfection time

✓ Lower cost

CLEANSPACE HALO

PAPR

PROTECTING FRONTLINE HEALTHCARE WORKERS GLOBALLY

CleanSpace HALO - a powered air purifying respirator (PAPR) being successfully deployed to healthcare

workers in more than 40 countries.

Australia: Westmead (Syd) RPAH (Syd), Epworth (Vic),

Frankston (Vic), Nepean, St Vincent’s (Vic & Syd), Ramsay

Health, Royal Flying Doctors

USA: Houston Methodist (Tx), Maryland University (MD), Sutter

Health (CA), Kaiser Permanente, VA Hospitals.

Japan: Tohoku Univ Hosp, Fukushima Medical Univ, Tokyo

Medical Hosp, Ota General, St Marianna, Saiseikai Yokohama

Tobu, Kanagawa Prefecture, Nagoya Univ Hosp, Osaka Univ

Hosp, Kansai Medical Univ, JCHO Osaka

Singapore: Singapore General, Sengkang General, Teng

Tok Seng, National Centre for Infectious Disease, Novena

Private, SingHealth

Malaysia: Malaysia Health Authority (77 hospitals)

Indonesia: St Borromeus Hospital (West Java) Medistra

Hospital (Jakarta)

Philippines: Major COVID-19 hospitals including Philippines

General Hospital .

PROTECTING FRONTLINE HCWs ACROSS THE USA

CleanSpace HALO has been deployed

in healthcare systems across the US

ensuring that American healthcare

workers treating COVID-19 patients

have the highest level of protection.

CleanSpace is proud to be protecting the

heroes on the frontline of the pandemic

SAFE, COMFORTABLE, DEPLOYABLE

“YOU CAN

SEE THAT I’M

SMILING”

Dr nuri spog

HIGH PROTECTION AND ASSURED SAFETY

▪ Powered airflow and pressurised mask (no mask leak)

▪ Approved: NIOSH, CE Mark (TM3) )OSHA APF 50 & 1000)

▪ HEPA (99.97% filtration efficiency or above)

▪ Operating time up to 10hrs

▪ Rapidly cleaned. Compatible with standard disinfection/sterilisation

IMPROVED COMFORT, COMPLIANCE AND PRODUCTIVITY

▪ Light (370g/1lb), few parts and simple to use

▪ Mobility - No belts or hoses

▪ Fast to don (under ten seconds)

▪ Soft, clear silicon mask for clear communication

COST EFFECTIVE AND DEPLOYABLE AT VOLUME

▪ Reusable and modular.

▪ Eliminates reliance on supply chain and stockpiling

▪ Multi-language web-based Deployment and Training Programs

▪ Proven use in 600 hospitals globally

EXPERIENCED HOSPITAL IMPLEMENTATION

▪ Global training team utilising comprehensive training

platform

▪ Technical and Cleaning IFUs (instructions for users)

▪ Actively educating and share experiences/best practice

from over one thousand hospitals globally

▪ Customer care and technical support

▪ Three year warranty

“minimal parts..no

cables, hoses or

helmets”

Rachel allsopp

CleanSpace HALO is a reusable system that once deployed

can be relied upon by hundreds of healthcare workers for

many years.

Easy to clean, disinfect, recharge and reuse – CleanSpace

HALO offers healthcare providers assurance for their PPE

investment.

Like SARS, COVID19 has exposed life threatening

vulnerabilities in global supply chains for disposable masks.

Governments have been caught paying large sums for

counterfeit masks or receiving no products at all.

CleanSpace (Australian made) is a reusable program that

can be reliable upon for routine use and scalable during

pandemic preparedness.

RELIANCE ON DISPOSABLE MASKS LEAVES FRONTLINE HCW EXPOSED

New Product - Steri-Plus

CleanSpace now has world’s first PAPR with an approval filtered exhalation value for operating theatres, patient

care settings or sterile/clean room requirements.

Steri-Plus was designed to meet the urgent needs of hospital infection control teams and surgeons.

Developed specifically for sterile environments (sterile field, operating theatre, clean rooms) or where filtering of

the wearer’s exhaled air is required to protect others.

Suitable for routine or high frequency use (such as a pandemic).

Features✓ For use with all existing CleanSpace half masks

✓ Filtration efficiency tested to 96% for particles 0.3 micron and above

✓ Easy to fit

✓ Reusable case. Easy to clean

✓ Approvals NIOSH, CE Mark, ASNZS1716 and TGA Class 1

▪ Sydney based ASX listed company. Founded

(2009) by a team of biomedical engineers from

medical device industry

▪ Respiratory protection specialists with product

leading technology

▪ Design and manufacture patented

technology to significantly improve user

protection, comfort and cost

▪ International approvals – NIOSH/CDC, CE

Mark, TGA Class 1, Singapore Medical Device

Class 1, IP Rated 66

▪ Manufacturing ISO9001 facility in Sydney

Australia and exporting to 40 countries

▪ Used throughout USA

AUSTRALIAN TECHNOLOGY TRUSTED GLOBALLY

Jon Imms| Global Technical & Product Director

Email: Jon.Imms@cleanspacetechnology.com

Website:

https://cleanspacetechnology.com/healthusa/