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NewSplash Archive – November 2021

Issue 46 – November 30, 2021

How to Conquer Chaos in Sterile Processing: Taking Back Control Starts with You; 3 Ways to Start Taking Back Control Today by Rebecca Kinney
Sterile processing (SP) is a controlled environment. Humidity, staffing, case volumes (variable, but outside of your direct control), specialties, vendor set quantities, inventory, etc. are all controlled. Things are documented, instructions for use (IFUs) are followed, and there are many leather-bound volumes of AAMI Standards in your hypothetical library. So why is it that a so-called controlled environment can feel so chaotic and out of control at times? The answer is humans; we change everything. We make mistakes, have emotions, and often our ability to perform at a high level is variable from hour to hour, day to day, and month to month. We are affected by the operating room staff, co-workers, and management decisions. Yet, the one thing that remains steady is you, my friend: your ability to control your own response to situations, your own personal and professional development, and your own self-care. Now before you check out and think this article is a “woo-woo” feel-good write-up, hear me out.

CDC issues statement on Omicron variant
On November 26, 2021, the World Health Organization (WHO) classified a new variant, B.1.1.529, as a Variant of Concern and has named it Omicron. No cases of this variant have been identified in the U.S. to date. CDC is following the details of this new variant, first reported to the WHO by South Africa.

CDC expands COVID-19 booster recommendations
The U.S. Centers for Disease Control and Prevention (CDC) has strengthened its recommendation on booster doses for individuals who are 18 years and older. Everyone ages 18 and older should get a booster shot either when they are 6 months after their initial Pfizer or Moderna series or 2 months after their initial J&J vaccine.

How T cells recognize infection or disease
Monash University researchers have expanded their knowledge of how T cells might recognize infections or disease, providing key insight into how an often-overlooked T cell lineage becomes activated when encountering pathogens such as viruses, bacteria, and cancers.

Researchers discover new strategy for antibodies to disable viruses
It is widely understood that antibodies neutralize viruses by latching onto their surfaces and blocking them from infecting host cells. But new research reveals that this barrier method isn’t the only way that antibodies disable viruses.

Beyond Clean rewind
This episode from Season 8 features a conversation with Dr. Aakash Agarwal, director of research and development for Spinal Balance Inc. Dr. Agarwal has been working extensively on research projects to study the effects of reprocessing implantable pedicle screws and their subsequent infection risk.


Issue 45 – November 23, 2021

Performance Qualification (PQ): The Proof by Jonathan A. Wilder, Ph.D., Managing Director
This is the final article on the subject of process equipment qualification. As a reminder, we qualify process equipment to ensure:

  • The equipment is what was ordered
  • The utilities are sufficient
  • The cycles run as expected
  • The cycles run really do what you need them to do

This last point is the subject of this article, performance qualification. As you may recall, in the first of these articles, I provided the following definition of the array of testing and my interpretation of it…

Happy Thanksgiving!
As we gather with family and friends this Thanksgiving, we celebrate all that we are thankful for. We all need to remain vigilant to stay safe and healthy so that next Thanksgiving we can all be thankful for putting COVID-19 behind us.

FDA expands eligibility for COVID-19 vaccine boosters
The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. 

Pfizer to provide 10 million oral antiviral treatment courses to U.S. government
Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, PAXLOVID, subject to regulatory authorization from the U.S. Food and Drug Administration (FDA). If approved or authorized, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2.

Hepatitis drug increases antibiotic potency, limits antibiotic resistance
An FDA-approved drug for hepatitis C can increase bacterial sensitivity to antibiotics and reduce the likelihood of antibiotic resistance, according to a new study led by New York University researchers published in Cell Chemical Biology. The drug called telaprevir works by blocking the function of chaperones—important proteins that fold other proteins in the cell—in bacteria.

Beyond Clean Season 14
In the final episode of Season 14, Monique Albornoz, principal at Clinical 5S Space Innovations, discusses the best way to handle interdepartmental battles for shared storage space in your facility. Who stocks it, pulls supplies from it, where does the space reside—in short, who owns it?


Issue 44 – November 16, 2021

Collective Competence for Sustainable Interdisciplinary Teamwork by Lisa M. McKown
In recent years there has been a greater focus on teamwork for improving patient care with an emphasis on building communication skills, both at the department level and across disciplines. A recent study entitled “How Communication ‘Failed’ or ‘Saved the Day’: Counterfactual Accounts of Medical Errors,” concluded that in “64% [of medical error] accounts [studied], communication played a prominent role.” A research project titled “Falling through gaps: primary care patients’ accounts of breakdowns in experienced continuity of care,” “found that experiences of gaps in care were common and arose from failures in communication and coordination of care.” Heightened awareness for the importance of prioritizing interdisciplinary communication is imperative for healthcare organizations, but implementing programs that facilitate sustainable collaboration is often met with tremendous challenges. Of particular significance is the need to integrate competency-based education with contextually relevant interdisciplinary communication.

Pfizer will allow other companies to manufacture its COVID-19 oral antiviral
Pfizer and the Medicines Patent Pool (MPP) announced an agreement that will enable MPP to facilitate additional production and distribution of Pfizer’s COVID-19 oral antiviral treatment candidate, which is administered in combination with low-dose ritonavir. Under the terms of the agreement, qualified generic medicine manufacturers worldwide that are granted sublicenses will be able to supply the drug in combination with ritonavir to 95 countries, covering up to approximately 53% of the world’s population.

Researchers successfully repair spinal cord injuries in mice
Northwestern University researchers have developed a new injectable therapy that harnesses “dancing molecules” to reverse paralysis and repair tissue after severe spinal cord injuries. 

CDC/NIOSH to host panel discussion on protecting health worker mental health
On Thursday, November 18, 2021, from 2:30 to 3:30 p.m. ET, the CDC’s National Institute for Occupational Safety and Health (NIOSH) will host a virtual event with NIOSH Director Dr. John Howard, Surgeon General Dr. Vivek Murthy, and other experts from labor and medicine on the mental health of the nation’s critical health workforce.

Researchers repackage gold nanoclusters to potentially fight antibiotic resistance
Researchers from the Southern University of Science and Technology, Fudan University in China, and the University of Leeds in the UK have found a way to repackage gold nanoclusters to make them more engaging to bacteria and less damaging to the human body.

Microban announces new range of antiviral technologies
Microban International announced a new range of antiviral technologies that are proven to reduce viral loading on products and surfaces. The technology can be incorporated into various materials during manufacturing, becoming part of the product’s structure to provide inherent and enduring protection from microbes.

Beyond Clean Season 14
Case cart programs affect everything from on-time case starts to turnovers, point-of-use compliance, and off-site transportation, making the case cart the unsung superheroes of the sterile processing department. This week’s guest is William (Bill) Filipponi, director of sterile processing at North Kansas City Hospital and member of the Beyond Clean Advisory Group. Bill discusses how surgical case carts move sterile goods from the SPD to the patient and back again.


Issue 43 – November 9, 2021

Department Newsletters 101: How This One Thing Could Change Your Entire Hospital by Hank Balch
When I began my first department newsletter as a new sterile processing manager in the fall of 2015, I honestly had no idea what I was doing. Besides enjoying writing, everything else about creating a newsletter sounded hard.

It would have to be designed.
It would have to be worth reading.
It would have to be released on a regular schedule.
And where am I going to find the time for all of this?

Fast-forward to today and I am a huge fan of the power of department newsletters to change departments, perceptions, careers, and yes, even entire hospitals. Before we get to all of that, let’s take a quick look at what I mean when I say “department newsletter.”

NIH scientists identify mechanism that may influence infectivity of SARS-CoV-2 variants
Scientists at the National Institutes of Health have found that a process in cells may limit infectivity of SARS-CoV-2, and that mutations in the alpha and delta variants overcome this effect, potentially boosting the virus’s ability to spread.

Natural immunity vs. COVID-19 vaccination
Natural immunity, or exposure to a disease that helps the immune system fight future infections, is better than no immunity. But with COVID-19, it’s not better than a vaccination.

Pfizer’s oral COVID-19 antiviral candidate reduces hospitalization and death by 89%
Pfizer announced that its experimental COVID-19 oral antiviral pill significantly reduced hospitalization and death by 89% in high-risk adults, based on analysis of the Phase 2/3 study. Pfizer joins competitor Merck in the race to make easy-to-use medication readily available to treat COVID-19.

HPV vaccine yields nearly 90% drop in cervical cancer cases
A new study published by The Lancet revealed that cases of cervical cancer significantly decreased among British women who received the human papillomavirus (HPV) vaccine.

FDA grants Breakthrough status for Alzheimer’s treatment
The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation status to Renew Bioscience for its Cerezen Device, a novel treatment for Mild Cognitive Impairment due to Alzheimer’s Disease (MCI) and mild dementia of the Alzheimer’s type (mild AD).

Beyond Clean Season 14
On Season 14, Episode 6, sterile processing professional Dannie O. Smith describes the unique challenges faced by SPD teams on the night shift. Tune in to get a greater understanding of exactly what is happening in sterile processing and what it has to do with your sterile storage area.


Issue 42 – November 2, 2021

Recognition When the Spotlight Is Off by Rebecca Kinney
Sterile Processing Week has come to a close. The pizza parties, cookies, and banners have all come down, and here we sit in our hospital basements waiting for the next 51 weeks to slide by until recognition hits and our department comes into the spotlight once again. The impact of sterile processing (SP) we know and understand is monumental, but how can we feel acknowledged, valued, and a critical component of patient care daily as we step into our scrubs and personal protective equipment (PPE)? This article will outline ways we can keep what we do in the spotlight year-round.

FDA authorized Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

Vaccination offers higher protection than previous COVID-19 infection
The Centers for Disease Control and Prevention (CDC) published new science reinforcing that vaccination is the best protection against COVID-19. In a new MMWR examining more than 7,000 people across nine states who were hospitalized with COVID-like illness, CDC found that those who were unvaccinated and had a recent infection were five times more likely to have COVID-19 than those who were recently fully vaccinated and did not have a prior infection.

Scientists identify the cause of Alzheimer’s progression in the brain
For the first time, researchers have used human data to quantify the speed of different processes that lead to Alzheimer’s disease and found that it develops in a very different way than previously thought. Their results could have important implications for the development of potential treatments.

Long COVID can negatively impact physical and cognitive function, employment, and quality of life for at least one year
Patients experiencing post-acute COVID syndrome (PACS, also known as “long COVID”) may have symptoms for at least 12 months after initial COVID-19 infection, significantly and negatively impacting their cognition, ability to work, participation in physical activity, interaction with others, and overall quality of life, according to a new Mount Sinai study. 

Merck to allow other drugmakers to manufacture oral COVID-19 medicine
Merck announced that it will allow Medicines Patent Pool to manufacture its investigational oral COVID-19 antiviral medicine, molnupiravir, for the treatment of mild to moderate COVID-19 in adult patients who are at risk of developing severe cases or being hospitalized. The agreement will allow access for molnupiravir use in low- and middle-income countries following appropriate regulatory approval.

Beyond Clean Season 14
Episode 5 of Season 14 features a conversation with Alessandra Nicholson, sterile processing leader and educator, about the importance of structure and organization in the sterile processing department. Alessandra provides insights to help you with storage best practice that will work for you and your patients.