WHO, CDC, and FDA Offer PPE Updates for the COVID-19 Outbreak

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As COVID-19 cases continue to rise, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) are warning about potential shortages and proper use of personal protection equipment (PPE) such as gloves, masks, gowns, and face shields. Also, the Food and Drug Administration (FDA) and CDC are taking steps to increase access to respirators for healthcare personnel.

WHO Warnings

Severe and mounting disruptions in the global PPE supply caused by rising demand, panic buying, hoarding, and misuse is putting lives at risk from COVID-19 and other infectious diseases, WHO reports

Healthcare workers rely on PPE to protect themselves and their patients from being infected and from infecting others, WHO says, but shortages are leaving doctors, nurses, and other frontline workers dangerously ill-equipped to care for patients. 

“Without secure supply chains, the risk to healthcare workers around the world is real. Industry and governments must act quickly to boost supply, ease export restrictions, and put measures in place to stop speculating and hoarding. We can’t stop COVID-19 without protecting health workers first,” said WHO director-general Dr. Tedros Adhanom Ghebreyesus.

Since the start of the COVID-19 outbreak, prices have surges, WHO says. Surgical masks have seen a sixfold increase, N95 respirators have tripled, and gowns have doubled. Supplies can take months to deliver and market manipulation is widespread, WHO adds, with stocks often sold to the highest bidder.

So far, WHO has shipped nearly half a million sets of PPE to 47 countries, but it says supplies are rapidly depleting. Based on its modeling, about 89 million medical masks are needed for the COVID-response each month, while international demand for goggles stands at 1.6 million per month.

WHO guidance calls for the rational and appropriate use of PPE in healthcare settings and the effective management of supply chains. The organization is working with governments, industry, and the Pandemic Supply Chain Network to boost production and secure allocations for critically affected and at-risk countries.

To meet rising global demand, WHO estimates that industry must increase manufacturing by 40%. WHO also says that governments should develop incentives for industry to ramp up production, including easing restrictions on the export and distribution of personal protective equipment and other medical supplies.

CDC Guidance

Meanwhile, the CDC emphasizes that surgical facemasks are FDA as medical devices and should be worn once and then discarded. Its recommendations for single-use disposable masks for dental healthcare personnel (DHCP) are available in its Guidelines for Infection Control in Dental Health-Care Settings—2003

For example, DHCP should wear a surgical mask and eye protection with solid side shields or a face shield to protect the mucous membranes of the eyes, nose, and mouth during procedures likely to generate splashing or splattering of blood or other bodily fluids. Also, DHCP should change masks between patients or during treatment if the mask becomes wet.

Surgical masks protect against microorganisms generated by the wearer. They also protect DHCP from large-particle droplet spatter that might include bloodborne pathogens or other infectious microorganisms.

The mask’s outer surface can become contaminated with infectious droplets from oral fluid spray or from touching it with contaminated fingers. When a mask becomes wet from exhaled moist air, the resistance to airflow through the mask increases, causing more airflow to pass around the edges of the mask.

The CDC recognizes that healthcare facilities may experience temporary shortages even if they don’t care for patients with COVID-19. DHCP who are concerned about potential or imminent PPE shortages should alert their local or state health department and local healthcare coalition, who would be best positioned to help troubleshoot temporary shortages.

The CDC also says that DHCP concerned about healthcare PPE supplies should monitor its Healthcare Supply of Personal Protective Equipment for updated guidance and be familiar with the Interim Infection Prevention and Control Recommendations

When patients present with respiratory infection symptoms, DHCP may consider postponing non-emergency or elective dental procedures until they are no longer contagious with diseases that may be transmitted through airborne, droplet, or contact transmission such as sneezing, coughing, and contact with skin.

If urgent dental treatment is necessary, DHCP and medical providers should work together to determine the appropriate precautions on a case by case basis to avoid the potential spread of diseases among patients, visitors, and staff.

Dental settings typically aren’t designed to carry out all of the Transmission-Based Precautions recommended for hospital and other ambulatory care settings, the CDC advises, so DHCP and medical providers will need to determine whether the facility is an appropriate setting for the necessary services for a potentially infectious patient.

FDA Expands Respirator Use

Most respirators on the market are indicated for use in industrial settings, the FDA says. Now, the FDA and CDC are allowing certain respirators approved by the National Institute for Occupational Safety and Health (NIOSH) not currently regulated by the FDA to be used in healthcare settings by healthcare personnel during the COVID-19 outbreak.

“The FDA and CDC’s action to allow a wider range of respirators to be used in healthcare settings will help those on the frontlines of this outbreak and their patients, which will keep all Americans safe,” said Health and Human Services Secretary Alex Azar.

When properly fitted, respirators such as N95s can filter more airborne particles than face masks, the FDA says. The FDA regulates respirators intended for use in healthcare settings, though most respirators are used in construction and other industrial jobs and aren’t required to meet FDA requirements for testing.

However, the FDA has concluded that respirators approved by NIOSH but not meeting FDA requirements may be effective in protecting healthcare personnel from airborne exposure, including COVID-19, which can cause serious or life-threatening disease.

Given the current supply challenges in respirator availability, the FDA says, the decision will help provide alternatives that can enable more healthcare personnel to have access to this lifesaving PPE.

“At the FDA, we’ve been working diligently to mitigate any potential shortages in the supply chain, including addressing increased demand and supply challenges associated with personal protective equipment,” said FDA Commissioner Stephen M. Hahn, MD. “It is imperative that we assure healthcare personnel on the frontlines of this outbreak that we have sufficient supplies of respiratory protective devices.”

The agencies say they are not currently aware of specific widespread shortages of PPE but do note reports of increased ordering of these products and say that shortages have been observed in some healthcare institutions in the United States.

The FDA and CDC also are aware that as COVID-19 continues to expand globally, the supply chain for these products will continue to be substantially stressed as demand exceeds available supplies. The agencies anticipate nationwide shortages and say they are taking steps to address them by expanding the use of respirators as part of an overall strategy. 

However, the expanded use of respirators does not apply to the general public. The FDA says that the public should not wear these respirators to protect themselves from COVID-19, as there is no added health benefit in wearing them. The immediate health risk from COVID-19 is considered low, the FDA adds.

“It is important to remember the best way to prevent the spread of respiratory disease is by using everyday preventative actions,” said CDC director Robert R. Redfield, MD.

“These include hand washing, using tissues to cover a cough, disinfecting frequently touched surfaces, and keeping distance from people who are coughing and sneezing,” Redfield said. “CDC does not recommend the use of masks by the general public.”

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