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Saturday, October 24, 2020
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The Google Doc you should check out regularly

Covid-19   Medical Devices   Patient Safety   SDOH   Workplace Safety

Today’s Read: 4 minutes

Aerosol scientists have laid out all the information you should know about transmission of Covid-19 through the air, a Boston hospital is a Covid-19 cluster, the FDA warns a face mask disinfection system maker to get their processes together, and a value-based Medicare program saves money for all as well as improves the health of the patients enrolled. Plus, the winner of Fat Bear Week.

MORNING BRIEF

The Google Doc that should be your guide to airborne transmission of Covid-19

Before the CDC and the WHO released statements recognizing coronavirus spreads through the air, Jose-Luis Jimenez, a chemistry professor at the University of Colorado, Boulder, who has studied aerosols for 20 years, created this open-access Google Doc with nine other experts in the field. It offers everything you need to know about aerosol transmission, from best practices for masks to whether it’s safe to travel by plane.

In an interview with MIT Technology Review, Jimenez said that he and his colleagues created the document after answering the same questions about aerosol transmission of Covid-19 on Twitter and via email repeatedly. The document gets updated regularly as they discover more about the subject. 

“We’re effectively having to be a little WHO or CDC. We’re saying the things that they should be saying,” Jimenez said. “This is frustrating, but it’s the situation we find ourselves in. These organizations have been flat-out refusing to consider if aerosol transmission is important, which leaves people unprotected. So we feel it’s our duty to communicate with the public.”

When a hospital becomes a coronavirus cluster

Boston-based Brigham and Women’s Hospital has reported an outbreak of 52 cases of Covid-19 among employees and patients. While the hospital is still investigating how the virus spread, contributing factors have been identified. They include:

  • Many patients weren’t masked while interacting with staff
  • Providers were inconsistent in their use of eye protection during patient encounters
  • The first patient to test positive had received an aerosol-generating procedure prior to the positive test result
  • A staff member with mild symptoms, consistent with historical seasonal allergies, continued to work
  • Lack of physical distancing among staff while unmasked while eating

More than 3,000 Brigham and Women’s Hospital nurses called for improved safety measures on September 29th. Trish Powers, RN, chair of the Brigham Massachusetts Nurses Association Bargaining Unit, said the hospital’s “lax compliance with Covid-19 safety protections” is making it difficult for nurses to provide safe patient care. Now, employees and in-patients at high risk are to be tested every three days, according to a hospital statement. This is an ongoing situation.

What is your workplace doing to ensure your safety and that of your patients? Do you think it is enough? How is your workplace soliciting feedback? Is your workplace responsive to feedback?

The FDA is busy

In addition to creating stricter guidelines for a coronavirus vaccine, granting emergency use authorization (EUA) to a Covid-19 AI diagnostic tool, and issuing a Black Box Warning for Benzos, the FDA is sending out warning letters. 

On Tuesday, Battelle Memorial Institute received a warning letter from the FDA stating that they need to provide an adequate adverse reporting process for the Batelle Critical Care Decontamination System. The medical device is authorized under an FDA EUA for use in decontaminating certain N95 respirators for reuse by health care personnel when there are insufficient supplies of Filtering Facepiece Respirators due to the Covid-19 pandemic.

This isn’t the first letter Battelle has received. In August, the FDA requested information about their process for submitting reportable adverse events to the agency after it became aware that there may be deficiencies in Battelle’s process. 

Some of the examples of reportable events that the FDA cited were:

  • allergic reactions or eye, mouth, or nose irritation,
  • evidence that a decontaminated respirator is unable to perform its essential function,
  • events related to hydrogen peroxide residuals or user contact with hydrogen peroxide residuals,
  • infection in respirator wearers, or
  • malfunctions of the generator used to decontaminate the respirators.

Failure to respond to the FDA’s request within 15 days may result in regulatory action being initiated without further notice.

Health care professionals and consumers should report any adverse events related to devices to the FDA’s Adverse Event Reporting program.

In other FDA activity, the organization will also review a request from Lilly to give their experimental antibody therapy EUA based on early results that show the drug reduces the amount of virus, hospitalizations, and ED visits for patients with mild or moderate Covid-19. This drug is similar to one that President Trump received from Rengeneron Pharmaceuticals. Both medicines deliver concentrated versions of synthetic antibodies to help the immune system clear the coronavirus that causes Covid-19. It’s not clear if the evidence will be viewed as strong enough for the Food and Drug Administration to grant emergency use authorization, the Associated Press reports.

ONE BIG NUMBER

$4,000,000,000

The amount of money Humana saved through the first year of their value-based programs in 2019. The program enrolled 67% of their Medicare Advantage (MA)  members and those members would have incurred additional costs had they been enrolled in traditional, fee-for-service Medicare plans. In addition, MA members received preventive screenings in greater numbers and were able to avoid unneeded visits to the hospital.

DAILY DIVERSION

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