CMS: Review Infection Prevention and Control Policies and Practices Now

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The Centers for Medicare & Medicaid Services (CMS) has issued a memo reminding healthcare facilities about the importance of compliance with infection control practices.

The memo was released as the spread of the novel coronavirus (2019-nCoV) continues. As of February 13, the number of confirmed deaths surpassed 1,350 and confirmed cases exceeded 60,000. There are close to 600 confirmed cases of the coronavirus in more than 25 countries and territories outside mainland China. World Health Organization announced an official name for the disease causing the outbreak: COVID-19.

CMS makes the intent of its memo clear from the beginning, stating, "Every Medicare participating facility in the nation's healthcare system must adhere to standards for infection prevention and control in order to provide safe, high quality care."

CMS goes on to encourage facilities to review the various coronavirus-related materials produced by the Centers for Disease Control and Prevention (CDC) — including these recommendations — and reminds facilities of the guidance CMS issued last year concerning emergency preparedness.

CMS then highlights several requirements and expectations. These include the following:

  • Complying with basic infection control practices.

  • Adherence to standard, contact and airborne precautions, including the use of eye protection.

  • Adherence to CDC recommendations on standard hand hygiene practices, including using alcohol-based hand rub/hand sanitizer as the preferred method of hand hygiene in most clinical situations.

  • Ensuring appropriate personal protective equipment (PPE) use and availability.

  • Ensuring PPE measures and protocols are included in emergency plans.

To assist facilities in self-assessment and review of practices, CMS concludes the memo by sharing the following resources:

FDA Approves New Pandemic Influenza Vaccine

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The U.S. Food and Drug Administration (FDA) has approved a new vaccine designed to protect against pandemic influenza A (H5N1).

Developed by Seqirus, Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against H5N1 in the event of a pandemic. It was approved for children aged 6 months or older.

The World Health Organization states that an influenza pandemic occurs when "a new influenza virus emerges and spreads around the world, and most people do not have immunity."

Seqirus notes in a news release that Audenz is designed to be deployed rapidly and can be stockpiled for first responders in the event of pandemic.

The vaccine combines two technologies: MF59 adjuvant and cell-based antigen manufacturing.

The MF59® adjuvant and formulated prefilled syringes used in the Audenz vaccine are produced in a Seqirus production facility built and supported through a public-private partnership between the company and the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

In the Seqirus release, BARDA Director Dr. Rick Bright states, "Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives. With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza – we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic."

FDA Approves Duodenoscope With Disposable Endcap From Olympus

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The U.S. Food & Drug Administration (FDA) has cleared the Olympus TJF-Q190V, a duodenoscope with a sterile, disposable distal endcap, the company announced.

This is the latest approval of a duodenoscope designed to improve the cleaning and reprocessing of the device, helping to reduce potential device contamination.

To date, the FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing:

  • Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope)

  • Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope)

  • Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope)

  • Pentax Medical, Duodenoscope model ED34-i10T (disposable endcap duodenoscope)

  • Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope)

As we previously noted, FDA has advised providers to transition away from fixed endcap — and more infection-prone — duodenoscopes and begin using duodenoscopes with disposable components that help with or even eliminate the need for reprocessing.

It is encouraging to finally see the development and approval of these devices. We drew attention to the challenges associated with the cleaning, disinfection and sterilization of duodenoscopes in a 2015 Special Report and recently included "endoscopes testing positive for bacteria after cleaning and disinfection" on our list of "10 of the Scariest Healthcare Infections and Threats."