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FDA approves Ohio-based Battelle’s mask-sterilizing technology to resolve PPE shortages

Hospitals all around the United States are starting to run low on personal protective equipment (PPE) like masks, gloves and goggles. As a result, health care professionals’ health and well-being are in danger as the number of COVID-19 cases grow larger and larger.

Latonya Shoulders, a health care professional who has been in the health care field for 18 years, is an Adult-Gerontology Nurse Practitioner at Pinnacle Integrated Health (Pinnacle) which is located in Youngstown, Ohio. According to Shoulders during a phone interview, Pinnacle is suffering from low PPE supplies.

“We are now implementing wearing masks on a regular basis; however, there are shortages in every discipline (ex. clinic, hospital, surgery center). We are very low on masks, so we limit our masks. We use one mask per day, all day so we need to be careful not to soil the mask,” Shoulders said. She also indicated that Pinnacle now only has one box of masks to distribute to their entire medical staff.

Shoulders said in order to preserve PPE supplies while also providing the best treatment to its patients, Pinnacle staff members are enforcing universal precautions with every patient that they come into direct contact with.

“Universal precautions are when you don’t know what anybody has so you follow a procedure of making sure that you wash your hands constantly, and make sure you limit unnecessary contact. And, when a patient does have something, we put into effect the PPE equipment. But we still need to wash our hands with every patient encounter,” Shoulders said. “We constantly wipe down in between every single patient and that’s also apart of universal precaution.”

Additionally, as an extension to their universal precautions, Pinnacle staff members are urging patients who may be sick or are uncomfortable with their environment to stay in their homes and call their office for a remote assessment over-the-phone or do virtual visits in order to preserve the health and well-being of other patients (and Pinnacle staff members) who physically come to the building for tests and diagnostics. They also check the temperatures of every single person (including their own staff) who enters the premises as well.

Shoulders is well-aware of the difficult circumstances that her job environment is forced to deal with and decided to take measures into her own hands for her own safety as well as the safety of others she comes into close contact with.

“Personally, for myself, I have reached out to someone that I know that would be able to make me a mask that was a little bit more doable that I can wash and reuse so that when the masks do run out at our job I will have a mask,” Shoulders said.

Joe Milicia, Director of PR and Communications at Cleveland Clinic Akron General, said via email that they are aligning their PPE recommendations with the Center for Disease Control’s (CDC) international and national guidelines to protect the general public and medical personnel.

The CDC’s new guidelines recommend wearing cloth masks in public settings. Cleveland Clinic Akron General are now offering disposable cloth masks to patients and visitors and washable cloth masks for their caregivers and vendors according to Milicia.

Cloth masks enhance cough etiquette, prevent people from touching their faces and can be a visual reminder to practice social distancing. However, these cloth masks are not considered PPE. Health care professionals are required to remove their cloth mask and wear appropriate PPE in order to carry out their duties properly.

In an effort to protect the exposed healthcare professionals, President Trump and Stephen Hahn, the commissioner and M.D. of the U.S. Food and Drug Administration (FDA), fully-approved the use of new technology to sterilize surgical masks that are much needed in Ohio as well as other areas across the United States.

The FDA authorized Columbus-based Battelle to execute its services which has the capability of sterilizing and decontaminating up to 80,000 surgical masks per system per day.

The system that is responsible for the decontamination process is known as The Critical Care Decontamination System (CCDS). Matt Vaughan, Battelle’s President of Contract Research, said via email that the system itself uses concentrated, vapor phase hydrogen peroxide (VPHP) and works by exposing used respirator masks to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-Cov-2.

Battelle also intends to send one machine to New York City as well as Stony Brook, New York which will supply up to 160,000 sterilized surgical masks for New York’s healthcare workers each day. Machines will also be delivered to Washington.

“This technology is meant to protect our frontline healthcare workers and the patients they serve in areas hardest hit by COVID-19, while PPE supplies are increased throughout the country. We at Battelle hope that Americans know there are many organizations doing everything they can to support our health and safety during this challenging time,” Vaughan said via email.

“This technology is meant to protect our frontline healthcare workers and the patients they serve in areas hardest hit by COVID-19, while PPE supplies are increased throughout the country. We at Battelle hope that Americans know there are many organizations doing everything they can to support our health and safety during this challenging time.”

Matt Vaughan, Battelle’s President of Contract Research

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