Questions regarding Personal Protective Equipment (PPE), including masks
Q: What do we do about the shortage of masks?
A: The increased world-wide demand for personal protective equipment (PPE) has resulted in apparent regional areas of shortage in the United States. The U.S. Food and Drug Administration (FDA) regulates and monitors the availability of medical devices, including masks, and continues to closely monitor the supply chain whose components are needed to manufacture PPE.
On Feb. 27, 2020, the FDA reported that it had contacted 63 manufacturers, representing 72 facilities in China that produce essential medical devices. “Essential medical devices” are those that could be prone to potential shortage if there was a disruption in the supply chain. Several of these facilities reported being adversely affected by COVID-19 and experiencing workforce challenges due in part to the necessary quarantine of workers.
While the FDA reported that it has heard reports of increased market demand and supply challenges for certain PPE, the agency has said that it is not aware of specific widespread shortages of medical devices, although the CDC and other U.S. partners have seen increased ordering of some medical products through distributors as some healthcare facilities in the U.S. prepare for anticipated needs in the event of a more severe outbreak. The FDA also reported that the agency has taken proactive steps to establish and remain in contact with medical device manufacturers and others in the supply chain.
FDA encourages manufacturers and healthcare facilities to report supply disruptions to the device shortages mailbox: email@example.com. The agency reports that the mailbox is closely monitored and is an important surveillance resource to augment FDA efforts to detect and mitigate potential supply chain disruption.
Q: Should masks be only single use?
A: CDC's guidance for single-use disposable facemasks has not changed. These masks are tested, and regulated by FDA to be single use. CDC's position is that a new facemask should be for each patient. CDC's specific guidance for facemasks is on page 41 of the Guidelines:
- Wear a surgical mask and eye protection with solid side shields or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures likely to generate splashing or spattering of blood or other body fluids;
- Change masks between patients, or during patient treatment if the mask becomes wet.
Q: Should we close the practice if we run out of masks and our vendors and distributors have put caps on how much, and how often, we can get new shipments?
A: Practices experiencing difficulty obtaining PPE may have to triage patients as a way to ensure that adequate PPE is available for patients whose appointments are most urgent. If your office is concerned about a potential or imminent shortage of PPE, CDC recommends you alert your state/local health department and local healthcare coalition, as they are best positioned to help facilities troubleshoot through temporary shortages.
You can also report the shortage to the FDA at firstname.lastname@example.org. CDC recommends that Dental Health Care Personnel (DHCP) concerned about healthcare supply for PPE regularly monitor Healthcare Supply of Personal Protective Equipment for updated guidance. They should also be familiar with the Interim Infection Prevention and Control Recommendations.
Q: I have noticed it is easier to purchase ASTM Level 1 masks than Level 2 or Level 3. What is the difference between the levels? How do I know which to buy?
A: ASTM International, formerly known as the American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services including masks. ASTM has established performance levels for masks based on fluid resistance, bacterial filtration efficiency, particulate filtration efficiency, breathing resistance and flame spread.
Masks that have been rated Level 1 have the least fluid resistance, bacterial filtration efficiency, particulate filtration efficiency, and breathing resistance. These can be worn for procedures where low amounts of fluid, spray or aerosols are produced, for example, patient evaluations, orthodontic visits, or operatory cleaning.
Level 2 masks provide a moderate barrier for fluid resistance, bacterial and particulate filtration efficiencies and breathing resistance. These can be used for procedures producing moderate to light amounts of fluid, spray or aerosols. Some examples of procedures are sealant placement, simple restorative or composite procedures or endodontics.
Level 3 masks provide the maximum level of fluid resistance recognized by ASTM and are designed for procedures with moderate or heavy amounts of blood, fluid spray or aerosol exposure. Some examples of these procedures are crown or bridge preparations, complex oral surgery, implant placement, or use of ultrasonic scalers.
Q: Should clinical staff wear N-95 respirators?
A: The type of personal protective equipment (PPE) that should be worn will depend upon the procedures being performed. Under OSHA, PPE is considered “appropriate” only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.
If the decision is made to use respirators in your facility, OSHA does maintain requirements for medical evaluation and fit-testing in their toolkit for health care use of respirators.
OSHA’s Bloodborne Pathogens standard (29 CFR 1910.1030) requires that workers be protected from exposures to blood and body fluids that may contain bloodborne infectious agents. OSHA's Personal Protective Equipment standard (29 CFR 1910.132) and Respiratory Protection standard (29 CFR 1910.134) require protection for workers when exposed to contact, droplet and airborne transmissible infectious agents.
CDC has more information on the differences between N-95 respirators and surgical masks.