Respiratory protection - Community and Healthcare
October 14, 2009
- Update – October 14, 2009
- Introduction
- Masks and N95 respirators
- FDA Resources on Facemasks and Respirators
Update - October 14, 2009
In mid-October 2009, the CDC published a comprehensive guidance to prevention and control of 2009 H1N1. The recommendations for use of personal protection equipment (PPE) for healthcare personnel were presented in light of current conditions of PPE equipment shortages. "Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings. Including Protection of Healthcare Personnel", plus "Q&A" can be downloaded at this link.
The information below provides the background to the current recommendations from CDC and provides additional detail.
Introduction
To reduce risk of transmission of influenza during a widespread flu outbreak or pandemic, government agencies issue recommendations for the use of a facemask, N95 respirator, or other type of respirator protection equipment.
This Web site provides information on the types of respiratory protection available, and the current recommendations from governmental agencies on indications for use, including the 1) type of respiratory protection (mask or N95 respirator) 2) type of setting, [home, community, and occupational (healthcare and non-healthcare)], and 3) health status of person needing the respiratory protection, e.g., non-ill and healthy or non-ill but at increased risk of severe illness from influenza. Recommendations are also summarized for managing individuals who are ill with H1N1 to prevent transmission in the home, healthcare and non healthcare settings.
Masks and N95 respirators
CDC Update - Interim Guidance for Healthcare Personnel; Q&A for Guidance & Respirator 10.14.09
As noted above – the CDC revision of the Interim Guidance for Healthcare Personnel published October 14, 2009 is the current guidance for healthcare. Community recommendations described below have not changed since September 24, 2009.
- Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel - (10.14.09)
Masks
Masks refers to disposable masks cleared by the U.S. FDA for use as medical devices and are loose fitting and designed to keep sprays from coughs and sneezes from reaching the mouth and nose of the wearer and also to keep infectious particles from being spread by the person wearing them. They include facemasks labeled as surgical, dental, medical procedure, isolation or laser masks. They have several designs, for example, a soft (pleated or duck billed) shape and affixed to the head with two ties or ear loops, conforming to the face with a flexible adjustment on the nose bridge. There is also a pre-molded type that adheres to the head with a single elastic band and has a flexible adjustment for the nose bridge.
N95 Respirators
N-95 or high filtering facepiece respirators are designed to protect a person from breathing in very small particles by filtering out at least 95 percent of the airborne particles. Many facemasks and respirators look similar in appearance, however, filtration efficiency is one of the primary differences. The filter and a proper fit determine the effectiveness of the product.
N95 Respirators for Industrial Settings: Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles. These respirators are evaluated for effectiveness by the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC). These are labeled "For occupational use” and when used in the workplace, employers are required by OSHA to provide training and “fit-testing” to make sure they fit properly. N95 Respirators for Healthcare settings: N95 respirators cleared by FDA for use in the healthcare setting are called surgical N95 respirators. These devices meet some of the same performance standards as surgical face masks and are also NIOSH-certified to meet the N95 respirator performance requirements. OSHA also requires surgical N95 respirators to be “fit-tested.” N95 Respirators for Public Use: In 2007 the FDA approved some N95 respirators for use by the public during public health emergencies. (Refer to FDA Resources below for examples of respirators.) In May, 2009, as cases of the novel H1N1 virus began to rapidly increase in the U.S., there was concern about a potential shortage of N95 respirators. CDC requested the U.S. Food and Drug Administration (FDA) to release masks and N95 respirators from the Strategic National Stockpile and also to authorize the surgical N95 respirators used in healthcare to be allowed for use by the public. Freeing up N95 respirators for emergency use by the public was done under an official "Emergency Use Authorization" or EUA. |
Masks vs. Respirators for Novel H1N1
Background: The Oct 14, 2009 "Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel" are the current guidelines to be used for infection control in healthcare settings. The May 2009 guidance “Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission" applies only to community or home care settings.
Healthcare: There has been much confusion over the type of respiratory protection, that is, mask or N95 respirator, that is needed for H1N1, in part, because of in incorrect and interchangeable use of the terms and prior and conflicting guidance on respiratory protection for seasonal flu.
- Masks for seasonal flu: The current “CDC Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007” recommends use of disposable surgical masks in healthcare settings when caring for patients with seasonal influenza (caused by strains of both influenza A and B). Masks were considered sufficient since the primary method of transmission is through large droplets that can move 3-6 feet before dropping out of the air. Droplet precautions (masks; eye protection) are appropriate since large droplets are not carried long distances by air currents (airborne transmission).
- N95 Respirators for novel H1N1 flu: Although seasonal influenza is associated with known strains of influenza A, because the novel influenza A-H1N1 virus was a totally new strain, health officials felt the need to be very cautious until more was known about transmissibility of the virus. Therefore, CDC recommended the use of disposable NIOSH-certified N95s, which are recommended to be used for infections that are transmitted by the airborne route, such as measles.
- Mask vs. respirator controversy: Experts from clinical settings, professional organizations, research scientists, and state and federal agencies disagree on the most appropriate respiratory protection to reduce the risk of transmission of the novel H1N1 virus. One position being taken by a number of infection prevention professional groups, including APIC, SHEA and IDSA is the use of masks for both seasonal or H1N1 when providing routine care for patients in the healthcare setting and the use of N95 respirators for certain procedures that have the potential to generate aerosols, such as open airway suctioning or bronchoscopy. CDC’s Hospital Infection Control Practices Advisory Committee (HICPAC) supports this position in an official statement. The opposing view, held by OSHA, the unions, some clinicians and research scientists is routine use of N95 respirators for all direct patient contact.
- IOM called on to review available data and make a recommendation: In August, 2009, the Institute of Medicine (IOM) held a meeting with invited experts to examine the evidence for airborne transmission of influenza and the potential impact of a requirement for routine use of N95 respirators for all patients ill with influenza, seasonal or H1N1. A report from the IOM is expected in September. CDC announced it will review recommendations from all groups and provide a final recommendation for respiratory protection by early October 2009. Check back for updates.
- Decision made October 14, 2009 See "Interim Guidance for Infection Control" below.
CDC Interim Recommendations for Facemask and Respirator Use for Novel H1N1 in Healthcare, Home and Community Setting
The initial respiratory guidance from CDC issued in May, 2007 was revised in May, 2009, and several more times in light of the continuing spread of H1N1. The current October 14, 2009, Interim Guidance (1.) applies to healthcare personnel only. The September 24, 2009 Interim Recommendations for Facemask and Respirator Use (2.) remain unchanged and apply only to home, community and non-health occupational settings. Each document should be consulted for detailed information on assessing risk and setting priorities on use of masks and respirators.
- "Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel (October 14, 2009)
- "Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission." (September 24 2009) CDC provides general guidance on facemask and respirator use in home, community and non-healthcare occupational settings to prevent infection and to prevent transmission. Tables 1 and 2 provided below from this CDC guideline summarize the recommendations for non-ill and ill persons to reduce risk of acquiring infection and transmitting infection to others.
FDA Resources on Facemasks and Respirators
The FDA provides information on definitions and use of disposable masks and N95 respirators, and answers to commonly asked questions on their use for novel H1N1 influenza. FDA also provides a listing of specific N95 respirators and manufacturers that 1) have been cleared by the FDA for use by the general public in public health emergencies and 2) are approved for use in healthcare settings and are now allowed to be used by the public as part of an Emergency Use Authorization (EUA). The N95 respirators on both lists do not have to be fit-tested when used by the public.
- FDA N95 Respirators Cleared For Use by the General Public
The N95 disposable respirators cleared by the FDA in 2007 (listed on its Web site and last updated June 19, 2009) for use by the general public in public health medical emergencies are labeled "NOT for occupational use,” do not require “fit-testing” and include:- 3M™ Particulate Respirator 8670F
- 3M™ Particulate Respirator 8612F
- Pasture Tm F550G Respirator
- Pasture Tm A520G Respirator
Visit the FDA Web site for updates.
- N95 Respirators for Healthcare Settings Cleared for Public Use with an Emergency Use Authorization
A number of N95 Respirators that were approved for use in health care setting have been authorized to be used by the public as part of FDA’s Emergency Use Authorization (EUA).
The models listed below are excerpted from the EUA for use by the public:
The authorized N95 respirators are as follows:
Manufacturer Model 3M 8210 8000 9210 1860 1870 Moldex 2200 2212 2201 Moldex-Metrics 3000 3001 3002 3003 Gerson 1730 Kimberly-Clark PFR95-170 PRF95-174
The above products, as deployed from the Strategic National Stockpile before or after the signing of this letter of authorization, are authorized to be made available to recipients when accompanied by the following written information pertaining to the emergency use:- Summary Fact Sheet for Disposable Respirators for Use During the Swine Flu Emergency, as attacheds7
Download EUA (.pdf) (1MB) 5.09