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NewSplash Archive – March 2021

Issue 13 – 3/30

Train and Prevent: A Two-Pronged Approach to Successful Instrument Delivery by Mary Olivera
To walk into any sterile processing department (SPD) or operating room is to be astounded by the sheer number of instruments and tools that are on hand to help surgeons help their patients. From million-dollar robotic surgical aides and special instrumentation to run-of-the-mill forceps and clamps, each tool, instrument, and piece of equipment must be cared for to ensure appropriate time in circulation and safety for patients.

And caring for it all is serious business.

CDC real-world study confirms protective benefits of mRNA COVID-19 vaccines
A new Centers for Disease Control and Prevention (CDC) study provides strong evidence that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections in real-world conditions among healthcare personnel, first responders, and other essential workers. These groups are more likely than the general population to be exposed to the virus because of their occupations.

Learn more about COVID-19 vaccines from the FDA
The U.S. Food & Drug Administration (FDA) has created a COVID-19 vaccine Q&A page on its website to help clear up some common misconceptions about the vaccines available in the U.S., as well as answer questions about how the vaccines work, vaccine safety, new COVID-19 variants, how to get a vaccine, and more.

Unique AI method for generating proteins will speed up drug development
Artificial intelligence (AI) is now capable of generating novel, functionally active proteins, thanks to recently published work by researchers from Chalmers University of Technology, Sweden. 

Registration now open for APIC 2021 Annual Conference
Registration is now open for the APIC 2021 Annual Conference in Austin, Texas, June 28–30. For those who are unable or unwilling to attend the live conference, there is the option to register for a virtual conference.

IAHCSMM making a short video featuring sterile processing professionals like you
Want to be in a video? It’s effortless. Send your best selfie shot or a photo of you holding a sign that reads “I Am Sterile Processing.”

2021 IAHCSMM Conference & Expo
IAHCSMM has announced details for the 2021 IAHCSMM Annual Conference & Expo in Columbus, Ohio. Because of the pandemic, IAHCSMM is offering attendees the choice to attend the conference in person or virtually.

Beyond Clean rewind
All stages of instrument reprocessing include a great deal of waste, from preparation for a case, case setup, and case breakdown. What can be done about it?

 

Issue 12 – 3/23

The Cost of Saving a Life by Lisa McKown
What makes someone jump in a lake to save a drowning person? In the YouTube video “A drowning man, a selfless act, a life saved in Portland,” the urgency of knowing a life hung in the balance compelled a stranger to risk their own life to save another. Many of us in healthcare are trained for CPR and other emergency responses, but a layperson without experience has only adrenaline and compassion. For them, there is no other choice: do what it takes to save a life. What are the differentiating skills? First, assess the situation within seconds, and then immediately push through whatever the physical, mental, or emotional barriers are to provide the help that is required right now.

Variances in critical protein may guide fate of those infected with SARS CoV-2
Of the many perplexing questions surrounding SARS CoV-2, a mysterious new pathogen that has killed an estimated 2.6 million people worldwide, perhaps the most insistent is this: why does the illness seem to strike in such a haphazard way, sometimes sparing the 100-year-old grandmother, while killing healthy young men and women in the prime of life?

Tiny bubbles making large impact on medical ultrasound imaging
If you were given “ultrasound” in a word association game, “sound wave” might easily come to mind. But in recent years, a new term has surfaced: bubbles.

Antibody injections could become more affordable with new production method
Antibody injections are a highly desirable treatment for people with chronic diseases such as cancer, psoriasis, Crohn’s disease, and arthritis. And recently, antibodies have been in the news as a promising treatment for severe cases of COVID-19. 

Investigational gene regulation therapy could protect against Alzheimer’s
Researchers at the DZNE (Germany), Massachusetts General Hospital (USA), and the genomic medicine company Sangamo Therapeutics, Inc. tested a novel gene regulation approach to treat brain diseases, such as Alzheimer’s in laboratory studies.

Registration now open for APIC 2021 Annual Conference
Registration is now open for the APIC 2021 Annual Conference in Austin, Texas, June 28–30. For those who are unable or unwilling to attend the live conference, there is the option to register for a virtual conference.

2021 IAHCSMM Conference & Expo
IAHCSMM has announced details for the 2021 IAHCSMM Annual Conference & Expo in Columbus, Ohio. Because of the pandemic, IAHCSMM is offering attendees the choice to attend the conference in person or virtually.

Beyond Clean rewind
This episode from Season 6 features an interview with Emily Smith, clinical marketing specialist with CIVCO Medical Solutions. The topic is tangible solutions to the issues surrounding the reprocessing of ultrasound probes.

 

Issue 11 – 3/16

No Tech Left Behind by Sarah B. Cruz
Every technician has a “first job” story; however, we seldom see the grueling process behind attaining it. Although the profession itself is not overly saturated, given the number of sterile processing positions available within the job market, it’s why there are so many openings that should cause industry concerns. The number of available sterile processing technical programs has increased; therefore, more inexperienced technicians are joining the job marketplace. Aspiring technicians join these programs and complete the requirements to pass the course and some will even obtain provisional certifications. Unfortunately, many of these individuals will not be able to develop further professionally due to the inability to gain on-the-job experience or a certain amount of externship hours. Some will even lose their provisional certification that they worked so diligently to attain.

Leprosy drug holds promise as at-home treatment for COVID-19
Nature study authored by scientists at Sanford Burnham Prebys Medical Discovery Institute and the University of Hong Kong shows that the leprosy drug clofazimine, which is FDA approved and on the World Health Organization’s List of Essential Medicines, exhibits potent antiviral activities against SARS-CoV-2 and prevents the exaggerated inflammatory response associated with severe COVID-19. Based on these findings, a Phase 2 study evaluating clofazimine as an at-home treatment for COVID-19 could begin immediately. 

Experimental drug slowed Alzheimer’s disease progression in Phase 2 trial
Eli Lilly and Company presented results that expand on previously reported top-line data that found donanemab met its primary endpoint and showed significant slowing of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS), a composite measure of cognition and daily function, in patients with early symptomatic Alzheimer’s disease compared to placebo.

AstraZeneca to provide U.S. with 500,000 more doses of COVID-19 antibody cocktail
AstraZeneca has agreed to supply the U.S. with up to 500,000 additional doses of its experimental COVID-19 antibody combination therapy, bringing the total number of doses to 700,000. The announcement comes as several countries suspend injections of the vaccine following reports of abnormal blood clots in some recipients.

Study of coronavirus variants predicts virus evolving to escape current vaccines
A new study of the U.K. and South Africa variants of SARS-CoV-2 predicts that current vaccines and certain monoclonal antibodies may be less effective at neutralizing these variants and that the new variants raise the specter that reinfections could be more likely.

Registration now open for APIC 2021 Annual Conference
Registration is now open for the APIC 2021 Annual Conference in Austin, Texas, June 28–30. For those who are unable or unwilling to attend the live conference, there is the option to register for a virtual conference.

2021 IAHCSMM Conference & Expo
IAHCSMM has announced details for the 2021 IAHCSMM Annual Conference & Expo in Columbus, Ohio. Because of the pandemic, IAHCSMM is offering attendees the choice to attend the conference in person or virtually.

Beyond Clean rewind
Flexible endoscopes pose a safety risk, to the extent that they top the ECRI Institute’s Top 10 Health Technology Hazards for 2019 report. Mishandled flexible endoscopes have led to infectious outbreaks and death.

 

Issue 10 – 3/9

“But the Rep Said…”: Who to Listen to and Why It Matters for Your Sterile Processing Team by Hank Balch
We’ve all been there, standing around in a little half circle trying to hear some twenty-something former frat guy explain to our sterile processing team how to follow his instrument’s instructions for use (IFUs) in the decontamination stage. Thirty seconds in and everyone realizes he doesn’t understand his own IFUs and we’d be better off trying to figure it all out by ourselves.

This kind of experience is not universal for every sales representative or every sterile processing department, but it happens often enough for it to become the cliché in our industry. How should leaders handle situations when the competence of the rep is in question and teams are still trying to figure out which way is up? The answer has to take into account department culture, training, industry standards, and human nature. Here are a few important concepts to keep in mind.

CDC issues new guidance for fully vaccinated people
The Centers for Disease Control and Prevention (CDC) has released long-awaited guidance for fully vaccinated people. People are considered fully vaccinated two weeks after receiving the last required dose of a vaccine.

Merck to help manufacture Johnson & Johnson’s COVID-19 vaccine
Merck will help produce Johnson & Johnson’s COVID-19 vaccine to help enable worldwide distribution of the vaccine. Under the terms of the agreement, Merck will produce the drug substance, fill vaccine vials, and prepare them for distribution.

Baxter BioPharma Solutions and Moderna announce agreement for fill/finish manufacturing of COVID-10 vaccine
Baxter International Inc. and Moderna, Inc. announced that they have entered into an agreement for Baxter BioPharma Solutions to provide fill and finish sterile manufacturing services and supply packaging for approximately 60–90 million doses of the Moderna COVID-19 Vaccine in 2021. Baxter’s BioPharma Solutions business is a premier contract manufacturing organization that specializes in parenteral (injectable) pharmaceuticals, including vaccines.

FDA grants first EUA to at-home OTC molecular test for COVID-19
Cue has developed a battery-operated reader and associated cartridges to test for infectious diseases in around 20 minutes. The technology came to market for point-of-care use under the supervision of qualified medical personnel last summer, leading to its adoption by schools, nursing homes, hospitals, and other organizations.

Registration now open for APIC 2021 Annual Conference
Registration is now open for the APIC 2021 Annual Conference in Austin, Texas, June 28–30. For those who are unable or unwilling to attend the live conference, there is the option to register for a virtual conference.

2021 IAHCSMM Conference & Expo
IAHCSMM has announced details for the 2021 IAHCSMM Annual Conference & Expo in Columbus, Ohio. Because of the pandemic, IAHCSMM is offering attendees the choice to attend the conference in person or virtually.

Beyond Clean rewind
On this Season 6 rewind, Beyond Clean sat down with Keith Miles, executive director of Safe Surgery Initiative, a nonprofit organization that provides on-site surgical instrument refurbishment and education to medical facilities in low- and middle-income countries. Safe Surgery Initiative was born from a two-week mission that became a passion to help disadvantaged people around the globe receive lifesaving surgical care by providing safe instruments.

 

Issue 9 – 3/2

Installation Qualification: Step One in Ensuring Reliable, Predictable Operation of Your SPD Equipment by Jonathan A. Wilder, Ph.D., Managing Director
“Wherever you go, well, there you are.”—Confucius (or Buckaroo Banzai)
“How did I get here?”—David Byrne of Talking Heads

In my previous article for NewSplash, “The Nuts and Bolts of a Quality System,” I wrote about the three aspects of equipment qualification: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This article is a deeper dive into the first of these, Installation Qualification. IQ is the first step to make certain that the equipment purchased is, in fact, what you think it and is compatible with the utilities you can supply to it. To know where you are, you have to know how you got there, so answer David Byrne’s question.

Johnson & Johnson COVID-19 vaccine authorized by U.S. FDA for emergency use
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. 

Microfluidic chip simplifies COVID-19 testing, delivers results on smartphone
Researchers at Rice University have developed a microfluidic chip that measures the concentration of SARS-CoV-2 protein in blood from a finger prick. The chip is a dongle for a smartphone, which can provide test results within 55 minutes.

CDC launches COVID-19 vaccine finder tool
Many Americans have expressed frustration with finding vaccines or scheduling vaccine appointments in their area. They often face confusion, long lines, crashing registration websites, a lack of available doses, or any combination as they try to vaccinate themselves or family members.

Scientists repair spinal cord injuries using patients’ own stem cells
Researchers from Yale University, with investigators at Sapporo Medical University in Japan, have shown that intravenous injection of bone marrow-derived stem cells in patients with spinal cord injuries significantly improved motor functions.

Registration now open for APIC 2021 Annual Conference
Registration is now open for the APIC 2021 Annual Conference in Austin, Texas, June 28–30. For those who are unable or unwilling to attend the live conference, there is the option to register for a virtual conference.

2021 IAHCSMM Conference & Expo
IAHCSMM has announced details for the 2021 IAHCSMM Annual Conference & Expo in Columbus, Ohio. Because of the pandemic, IAHCSMM is offering attendees the choice to attend the conference in person or virtually.

Beyond Clean rewind
In this episode from Season 6, the hosts of Beyond Clean sat down with Thor Rollins to discuss the reasons and risks of coloration on surgical instrumentation. Can color additives cause harm to patients? How do manufacturers make decisions about these kinds of design questions?