Personal Protective Equipment (PPE) for Ebola Virus Disease (EVD)

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1 Personal Protective Equipment (PPE) for Ebola Virus Disease (EVD) WARNING: The recommendations contained herein are based solely on the information available to Scott Safety at the time of publication. You are encouraged, on a regular basis, to read and review all relevant guidance provided by the Center for Disease Control, the World Health Organization, and the European Centre for Disease Prevention and Control. Reusable PPE should be used and cleaned according to manufacturer instructions and current healthcare policies. Situational update As of October 20, 2014, the CDC have prepared updated guidance for infection control and PPE usage while managing patients suspected of being infected with Ebola Virus Disease. This updated guidance includes detailed instructions on the donning and doffing sequence. This guidance is specifically for US Healthcare Workers. The updated guidance can be found at the links below Separate guidance for single use filtering facepiece respirators (N95s) and powered air purifying respirators (PAPRs) have been prepared. There are significant differences between the two and care must be taken to review these differences before implementing new protocols. Due to the hazards of handling contaminated items, the CDC is recommending the use of disposable PPE where possible but is providing instructions for the handling of reusable PPE components such as respirator headtops, facepieces, and blowers. Of most importance it should be noted that the updated guidance stresses the need for training, practice, competence, and observation of healthcare workers in correct donning and doffing of PPE selected by the facility. In the newly tightened guidance, the CDC stresses the primary principle of no skin exposure while wearing PPE. Therefore, the CDC no longer recommends the use of goggles for those directly caring for suspected EVD patients. Goggles do not provide the same level of skin protection coverage as single use full face shields without the integration of other PPE. Although the CDC recommendations are for US healthcare workers, other healthcare workers and those in contact with suspected EVD patients and/or contaminated items should follow local recommendations appropriate to the task they are performing. Background The 2014 Ebola epidemic currently affecting multiple countries in West Africa is the largest in history. Affected countries are attempting to control the outbreak while non-affected countries are making preparations for handling suspected infected individuals. Global and national agencies are strengthening human resources in the most intensely infected areas to help respond to and control Ebola. 1-UNI

2 Infections among healthcare workers have been tragically high and the World Health Organization (WHO), along with the US Centers for Disease Control (CDC), is developing training materials and a training course for healthcare workers going to West Africa in response to the 2014 Ebola Outbreak. The use of PPE has been recommended by numerous agencies as part of a larger comprehensive infection control response when caring for persons with known or suspected Ebola. The situation is changing rapidly and therefore you should consult the most current information regarding EVD response from your local health authority. PPE Guidance Guidance has been developed by the US CDC and WHO, considering the high rate of morbidity and mortality among infected patients, the lack of approved vaccine and therapeutics and the risk of human to human transmission. Ebola is believed to be spread by direct contact with an infected person s blood or bodily fluids. Transmission may also occur from contaminated objects, surfaces, or infected animals. Transmission by air has not been documented, but there exists risk of transmission by inhalation of contaminated aerosols in areas of poor environmental control or during aerosol generating procedures (AGP). With this in mind PPE for ALL healthcare personnel must be considered. This extends to all persons, paid and unpaid, working in a healthcare setting who have the potential for exposure to patients and/or infectious materials. Not only should physicians, nurses, etc. be evaluated for exposure risk but also those not directly involved in patient care, such as dietary, house-keeping and security, whom may be potentially exposed to infectious agents. As a reminder, PPE are just one part of standard infection control precautions. The WHO recommends the following when dealing with patients: Hand hygiene Appropriate PPE based on risk assessment at the point of care Respiratory hygiene Prevention of injuries from needles and other sharp instruments Safe waste disposal Cleaning and disinfection of the environment Safe handling of contaminated linens Cleaning and disinfection of patient-care equipment Recommended PPE for all situations involving suspected and known cases of EVD include: Gloves Gown (fluid resistant or impermeable) Eye protection Facemask For situations involving high levels of contaminated blood or body fluids and/or aerosol generating procedures the following additional PPE may be used: 2-UNI

3 Double gloving Disposable shoe covers Leg coverings Respiratory protection While wearing PPE, the wearer should avoid touching or adjusting PPE, change gloves between patients, remove gloves if they become torn or damaged, and perform hand hygiene before putting on new gloves. It is critical that proper procedures for the order of putting on and taking off PPE be followed. Both the WHO and US CDC have developed specific guidance. Manufacturer specific guidance should be followed where applicable for individual items to ensure that the device works as intended. Re-usable PPE should be cleaned and disinfected according to manufacturer instructions and healthcare policies. The choice of disinfectant should be based on healthcare policies and compatibility of the disinfectant confirmed with the PPE manufacturer. Those whom collect and handle soiled re-usable PPE should be trained individuals using PPE themselves. Considerations when selecting PPE Respiratory protection For bioaerosols such as Ebola Virus, particulate respirators are recommended to reduce exposure. Per WHO and US CDC guidance, at minimum a FFP2 / N95 / P2 respirator as approved by local certification standards (EN149, NIOSH 42 CFR pt 84, AS1716) may be used. These are typically filtering facepiece respirators that are disposable after limited use, with extended use allowed in specific circumstances. Disposable respirators often have use limitations, such as no more than 8 hours or single shift only. Manufacturer s instructions should be consulted when considering reuse of disposable respirators. Reusable elastomeric half masks and full facemasks, along with a powered air purifying respirator (PAPR) with particulate filter, may also be used. Respirator classifications vary by local standard and clarification should be sought from the manufacturer to verify the classification of the chosen respirator aligns with the WHO and US CDC guidance. In Europe, per EN143, a P2 or P3 filter may be used. For European powered air purifying respirators (PAPR), per EN12941/2, headtop systems must hold particulate TH 2 or TH 3 ratings and facemask systems must hold particulate TM 2 or TM 3 ratings. In the US, per NIOSH, a filter of any of the nine following types listed may be used: N95/N99/N100, R95/R99/R100 and P95/P99/P100. US PAPR systems must be used with a HE particulate filter. In Australia and New Zealand, per AS1716, a P2 or P3 filter may be used. The effectiveness of a respirator is dependent upon a properly executed respiratory protection plan in accordance with local standards. EN 529, US OSHA 29 CFR , and AS1715 provide guidance for selection and use of respiratory equipment. Manufacturer s instructions must also be followed to ensure proper functioning of the respirator. This is important as respirators reduce the exposure to airborne contaminants but do not prevent all exposure. The guidance, selection and use standards enumerate assigned protection factors for different types of respirators. This accounts for observed historical performance of respirators from past workplace protection factor studies on other contaminants and the minimum levels of accepted leakage from all sources: filter and facepiece. The filtration efficiency of the selected filter for a respirator only covers leakage due to the filter and does not indicate the overall 3-UNI

4 leakage resulting from the equipment as maintained, fitted and worn. As such, no respirator will entirely eliminate the risk of exposure. Eye and face protection Goggles In order to be effective goggles must fit well around the eyes. For infection control indirectly vented or non-vented goggles with anti-fog coating are recommended to minimize the risk of penetration by splashes and/or sprays. Goggles do not provide protection to other parts of the face. Face shields A properly fitted face shield with crown and chin protection wrapping around the face is recommended in addition to a properly fitted set of goggles. Goggles and/or face shields are recommended for face protection when wearing a facemask or respirator. While a full facepiece respirator will provide eye protection, the facepiece may not fully cover the face to the points of the ears and therefore a faceshield in addition to a full facepiece respirator may be required for both eye and face protection. Protective suits that fully cover the interface of the respirator with the face may be used in lieu of a faceshield for protection against contact hazards. Only a full loose-fitting hood with Powered Air Purifying Respirator (PAPR) will provide both eye and face protection. PPE compatibility Since it is expected that a wide range of equipment may be used by personnel, it is important to note that most PPE are not approved as an ensemble with other types of PPE. It is the responsibility of those selecting the equipment to determine if the selected PPE are compatible and do not impair the performance of other PPE nor impede the ability of the wearer to safely conduct work. Given the importance of compatibility, those selecting the PPE ensemble should also be responsible for or in close coordination with those responsible for the respiratory protection program. Suitability factors include but are not limited to issues such as mobility, field of view, and heat stress. Respiratory Protection for those conducting PPE cleaning and disinfection Depending upon the application method and environment concentrations, some disinfectants such as chlorine may pose an additional inhalation hazard. In this case, the recommended PPE, including respiratory protection with filter appropriate for the disinfectant, should be used. For airborne concentrations of chlorine up to 10 ppm, when using a respirator with a minimum assigned protection factor of 10, a chemical cartridge classified as B type, per EN/AS standards, or CL per NIOSH standards may be used. PPE used during cleaning and disinfection should also be considered contaminated and included in the PPE cleaning, disinfection, and disposal cycle to minimize contamination. Reusable Respirator Cleaning and Disinfecting Guidance Cleaning and disinfection are normal considerations in typical respiratory protection programs with cleaning and disinfection required: as often as necessary to maintain the respirator in a sanitary condition, before being worn by different individuals, and after each use in fit testing and training. 4-UNI

5 Cleaning and disinfection per WHO and US CDC guidance must be conducted in line with manufacturer use instructions for the respirator. Scott Safety evaluates only the compatibility of its PPE with cleaning and disinfection agents. The efficacy of specific cleaning and disinfection agents for Ebola should be determined by the guidance of or consultation with the disinfection agent manufacturer and infection control authorities. For European and Australian products, Scott respirators may be disinfected with Distel wipes. o Note: Face and eye PPE can also be cleaned with Distel wipes. For Americas products, Scott respirators may be disinfected with Wescodyne. o The Xcel and Xcel HS elastomeric half mask have been evaluated for compatibility with several common disinfectants and may be disinfected using: liquid diluted quaternary ammonium, chlorine bleach with water (1:64 ratio), and isopropyl alcohol. o Rubber harness AV series and Promask facepieces may be disinfected using chlorine bleach with water (1 teaspoon per gallon). Use of non-approved disinfectants with Scott respirators may damage the respirator or reduce the expected operating life of the respirator, thereby requiring replacement after use and/or more frequent replacement of serviceable components such as valves and head harness straps. Good hand hygiene before and after touching the respirator should be practiced, along with avoiding touching the inside of the respirator when donning and doffing. The use instructions provided with the respirator must be followed to minimize the chance for damage to the respirator during cleaning and disinfection cycles. For air purifying respirators, the respirator components (mask and filter) should be separated along with whatever other sub components are specified in the use instructions. Cleaning per the use instructions should be completed and the components disinfected with the selected disinfection agent by thoroughly wiping the free surfaces which may have come in contact with the infectious agent. Following the disinfection, the components should be rinsed and allowed to air dry. Under no circumstances should solvents, hot water, bleaching agents, or drying by radiant heat be used, unless otherwise stated above. Filter elements should only have the outer housing surface wiped and are never to be submerged in water or other liquids. Finally, all components should be inspected and reassembled per the use instructions. For powered air purifying respirators, the respirator components (headtop, hose, blower, and filter) should be separated along with whatever other sub components are specified in the use instructions. Cleaning and disinfection guidance is the same as above with the exception that care must be taken to avoid contamination and/or introduction of liquids (e.g. water) into the breathing hose and clean breathing path so as not to contaminant and or damage the air handling components (e.g. motor and control electronics). In all cases, disposal of the respirator and its components must be carried out in accordance with local regulatory requirements. See appendix for a list of Scott Safety products. 5-UNI

6 References Australian Government Department of Health. Ebola Virus disease (EVD) outbreaks in West Africa. Centers for Disease Control and Prevention. Ebola (Ebola Virus Disease). Centers for Disease Control and Prevention. Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. Hospitals. European Centre for Disease Prevention and Control (ECDC). Directory of guidance on EVD patient management. Occupational Safety & Health Administration. Ebola. World Health Organization. Ebola virus disease. Appendix In the attached appendix, potential Scott Safety PPE products that may be used for protection against Ebola Viral Disease are listed. Please see for a complete listing of products. If you have any questions or need further information, please contact your local Scott Safety team. Australia Customer Service: Tel: ( ) scott.sales.anz@tycoint.com New Zealand Customer Service: Phone: scott.sales.anz@tycoint.com 6-UNI

7 DISPOSABLES P2 Respirator Unvalved, Small P2 Respirator Unvalved, Medium/Large P2 Respirator Valved, Small P2 Respirator Valved, Medium/Large HALF MASKS Profile 2 (Small) Profile 2 (Medium) Profile 2 (Large) Pro 2 Filter P2/P3* Profile² ReadyPak P2 (High Efficiency) - Small ANZ Profile² ReadyPak P2 (High Efficiency) - Medium ANZ Profile² ReadyPak P2 (High Efficiency) - Large ANZ Profile² Litehood ReadyPak A2P2 (High Efficiency) - Medium FULL FACE MASKS Promask Single (M/L) Promask Single (Small) Pro 2000 PF 10 P3 Filter Promask 2 Twin Pro 2 Filter P2/P3* Promask Twin Full Face Respirator ReadyPak - P UNI

8 PAPRS Phantom Vision (M/L) Phantom Vision (M) Phantom Vision (S) Particle Filter P3 for Phantom Vision PF251 Proflow SC 120 (Blue) Proflow SC 160 only with Promask Promask PAPR Full Face Breathing Hose for Promask Flowhood 2 PAPR includes hose Flowhood 2 Single Use PAPR Headtop (white) - No hose (5pk) T2/SU PF10 P3 Filter for Proflow Promask Proflow SC 120 Ready-Pak Flowhood 2 Proflow SC 120 Ready-Pak UNISAFE DISPOSABLES AND HALF MASKS P2 Respirator dust/mist/fume un-valved 20/box P2 Respirator dust/mist/fume valved 10/box P2 Flatfold Respirator dust/mist/fume un-valved 20/box P2 Flatfold Respirator dust/mist/fume valved 10/box Half Face Single Filter Respirator - Large RDP2000 RDP2000V RDP2F RDP2VF RP461L RP461SM Half Face Single Filter Respirator - Small/Medium Half Face Twin Filter Respirator - Large Half Face Twin Filter Respirator - Small/Medium Particle Filter P2 for RP461 & RP462 RP462L RP462SM RP104 8-UNI

9 GOGGLES Goggle Longbow high temp non vented foam Bound HCAF Clear lens WV850 FACESHIELD COMBINATION UNISAFE Faceshield C/W CL Poly 1mm W/F 175mm BL CG Visor VC107 Browguard Blue Ratchet Harnes without visor VV997 Visor + Chinguard CL 250x400 Polycarbonate VV501 CLEANING Distel Wipes Drum Trigene Sachet 20 Disinfectant Wipes Distel Advanced Solution 1L Distel Advanced Solution 5L *To decon/clean PPE normal dilution is 1:100 9-UNI