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NewSplash Archive – June 2021

Issue 26 – 6/29

Operational Qualification: Step Two in Ensuring Reliable, Predictable Operation of Your SPD Equipment by Jonathan A. Wilder, Ph.D., Managing Director
“When all else fails, read the manual.”—Jonathan A. Wilder

In one of my previous articles 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 second of these, Operational Qualification. OQ is the step in qualification of the equipment in which we get to answer the question, “Does it do what I expect it to do?” OQ provides a baseline so that you know what the machine is capable of right after handoff from the installer/manufacturer, so you can know if things aren’t going as well as they could (should!) later in its lifetime.

Flexible bronchoscopes and updated recommendations for reprocessing: FDA safety communication
The U.S. Food and Drug Administration (FDA) is providing updated information about medical device adverse event reports and recommendations for health care providers on bronchoscopes.

Researchers engineer cells to destroy malignant tumor cells but leave the rest alone
Researchers at McMaster University have developed a promising new cancer immunotherapy that uses cancer-killing cells genetically engineered outside the body to find and destroy malignant tumors.

Escape room simulation promotes infection control adherence at the Temple VA
Designed initially for entertainment purposes, escape rooms are proving their value as medical training tools as demonstrated by the Central Texas Veterans Health Care System. Staff there have used the concept for a flu pandemic escape room and are reporting increased staff handwashing and acceptance of flu vaccines as a result.

New approach to molecular drug design yields highly promising bladder cancer drug candidate
A new approach to molecular drug design has yielded a highly promising bladder cancer drug, which induced rapid shedding of tumor cells and resulted in a significant reduction in tumor size when used in clinical trials.

Muscle’s smallest building blocks disappear after stroke
After suffering a stroke, patients often are unable to use the arm on their affected side. Sometimes, they end up holding it close to their body, with the elbow flexed.

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 special episode
This special episode is from a recent Expert Series conference session featuring Beyond Clean team members Hank Balch, Lindsay Brown, Michael Matthews, and Adam Okada. The team discusses the power and pitfalls of networking and what sterile processing professionals should and shouldn’t do to build their own networks.

 

Issue 25 – 6/22

Got Mentors? Define Your Mentor Part 2 of 3 by Sarah B. Cruz
We are not limited to the initial way we’ve carried ourselves in our profession. There is no cap on the amount of knowledge and expertise we can attain as we grow into the future of our industry; however, we must be willing to move outside the confines of what we already know. In Part 1 of our three-part series, we discussed why seeking mentorship will help us transcend the current limitations of our professional expertise. By introducing the professional experience of others to our development, we broaden our scope and possibilities. Mentors help us personify our limitations, define our underdeveloped skills, and inspire professional trajectory. Now that we have learned    why mentorship is important, we can decide which type of mentor is best for us.

REGEN-COV Phase 3 recovery trial improves survival in hospitalized COVID-19 patients
Regeneron Pharmaceuticals, Inc. announced positive results from the largest trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19. The UK RECOVERY trial found that adding investigational REGEN-COV to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own.

Researchers identify link between gut microbes and stroke
Researchers at Cleveland Clinic have shown that the gut microbiome affects stroke severity and functional impairment following stroke. The finding could lay the groundwork for potential new interventions to treat or prevent stroke.

Scientists prepare for next coronavirus pandemic, maybe in 2028?
Scientists are already preparing for a possible next coronavirus pandemic to strike, keeping with the seven-year pattern since 2004.

23% of people who had COVID-19 still have at least 1 condition, study finds
Among a study of nearly 2 million people who had COVID-19, more than 20 percent were left with at least one post-COVID-19 condition at least 30 days after their initial diagnosis, according to findings published June 15 by Fair Health, a national nonprofit organization.

Register now 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 special episode
In this special release episode from a recent Expert Series conference session, vendor management expert Jeff Wertz, VP business development at Surgio Health, discusses the duties of device representatives. What are their priorities, challenges, and what kind of training do they receive regarding SPD activities?

 

Issue 24 – 6/15

Monitoring and Releasing of Sterilization Loads by Mary Olivera
New sterile processing (SP) technicians begin their careers in the field following new standards and using the latest technology in instrument reprocessing. They study a curriculum that includes sterilization basics; however, once SP techs begin working at the hospital, they must adhere to processes and protocols set by new regulatory guidelines.

Years ago, the sterilization process was simple, and SP techs followed parameters set by the operating room (OR). When a new instrument was purchased, there was no emphasis on reading and following instructions for use (IFUs). Sterile processing techs were required to process (or gas) any instrument that looked like plastic by using the ethylene oxide sterilizer. Instruments were manually recorded and placed into the sterilization process; steam or gas were the only options in most hospitals. After instruments were taken out of the sterilizer (or the oven) and cool to the touch, SP techs sent them the OR.

Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in Phase 3 trial
Novavax announced that its recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety, and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.

NIH launches clinical trial of universal influenza vaccine candidate
A first-in-human, Phase 1 trial assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine designed to provide long-lasting protection against multiple flu virus strains has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland. Healthy participants 18 to 50 years old will receive either a licensed seasonal influenza vaccine or the experimental vaccine, FluMos-v1. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) developed FluMos-v1 to stimulate antibodies against multiple influenza virus strains by displaying part of the influenza virus hemagglutinin (HA) protein on self-assembling nanoparticle scaffolds.

Washable, Wi-Fi powered smart clothes will monitor your health
Engineers at Purdue University have developed a method to transform existing cloth items into battery-free wearables that can be cleaned in a washing machine. These smart clothes are powered wirelessly through a flexible, silk-based coil sewn on the textile.

New treatment stops progression of Alzheimer’s disease in monkey brains
A new therapy prompts immune defense cells to swallow misshapen proteins, amyloid beta plaques, and tau tangles, whose buildup is known to kill nearby brain cells as part of Alzheimer’s disease, a new study shows.

Register now 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 special episode
This week’s episode from a recent Expert Series conference session features enzymatic expert Peggy Spitzer, A.A.S., B.A., MA.Ed., clinical education manager at Certol International. The session focuses on debates in the industry related to cleaning chemicals, including time, dosing, whether or not it’s mandatory to use chemicals offered by equipment manufacturers to obtain chemical success, and what personnel can do to stay safe around harsh chemicals.

 

Issue 23 – 6/8

Power for the People: How and Why to Use Your Influence for the Good of the Industry by Hank Balch
Are you hungry for career growth? Are you looking to build a name for yourself in the sterile processing industry? Do you dream of the day when someone calls you a subject matter expert, key opinion leader, thought leader, or industry influencer? All are worthy goals in and of themselves, but without a purpose for your passion, you’ll end up at the end of your career with a stack of magazines in the corner with your name in them and a few plaques hanging on the wall. Is that really what you’re aiming for? The potential for using your influence for good is so much greater than a few feel-good moments and a little bit of name recognition. In this article, I’ll sketch out a short philosophy of thought leadership in sterile processing and argue for a particular purpose for growing your influence in your corner of the healthcare universe.

Lessons from the last pandemic point the way toward universal flu vaccines
A new study from the University of Chicago and Scripps Research Institute shows that during the last great pandemic—2009’s H1N1 influenza pandemic—people developed strong, effective immune responses to stable, conserved parts of the virus. This suggests a strategy for developing universal flu vaccines that are designed to generate those same responses, instead of targeting parts of the virus that tend to evolve rapidly and require a new vaccine every year.

FDA grants accelerated approval for Alzheimer’s drug
The U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

Radiation drug tracks and kills cancer cells
An experimental drug that delivers radiation directly to cancer cells is reportedly improving the survival rate in men with advanced prostate cancer. While there are a few such drugs currently approved, the approach may become a new way to treat patients with difficult-to-reach or inoperable cancers.

Filter membrane renders viruses harmless
Viruses can spread not only via droplets or aerosols like the new coronavirus, but in water, too. In fact, some potentially dangerous pathogens of gastrointestinal diseases are water-​borne viruses.

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 special episode
This special episode features a recent Expert Series conference session with manual cleaning expert Jamie Zarembinski, CCSVP, clinical educator at Key Surgical. Jamie discusses the state of manual cleaning today, if there have been changes to procedures over the last few years, whether industry organizations are paying more or less attention to it, and more.

 

Issue 22 – 6/1

IAHCSMM Should Change Its Name by Marjorie Wall
What does it mean to be a professional? More money? More perks? Respect? A voice? The sterile processing industry has struggled for decades to be seen as more than glorified dishwashers. We are technical experts in decontamination, inspection and assembly, disinfection, high-level disinfection, sterilization, and so much more. We memorize hundreds of thousands of surgical instruments across a spectrum of service lines. We are experts on how to take them apart, put them back together, and every step in between. We know manufacturers’ instructions for use for hundreds of thousands of instruments like the back of our hands. We know what surgical case will need which instruments, what is critical, what needs to be turned around, and what always must be sterilized. We know what the operating room needs.

WHO and Switzerland launch global BioHub for pathogen storage, sharing, and analysis
The World Health Organization (WHO) and the Swiss Confederation today signed a Memorandum of Understanding to launch the first WHO BioHub Facility as part of the WHO BioHub System, which was announced in November 2020. This facility will enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally.

Moderna seeks full FDA approval for COVID-19 vaccine
Moderna announced it is seeking full approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine. The vaccine currently has emergency use authorization (EUA) status from the FDA.

Penn researchers discover drug that blocks multiple SARS-CoV-2 variants in mice
The drug diABZI—which activates the body’s innate immune response—was highly effective in preventing severe COVID-19 in mice that were infected with SARS-CoV-2, according to scientists in the Perelman School of Medicine at the University of Pennsylvania. The findings suggest that diABZI could also treat other respiratory coronaviruses.

Technology that predicts protein stability is released by UK university spin-off company
A cutting-edge digital tool that will make it cheaper, safer, and faster for pharmaceutical companies to predict protein stability—a vital step in the development of new medicines—is being rolled out by scientists from the UK’s University of Bath through their spin-off company, BLOC Labs.

Fight against antibiotic-resistant bacteria has a glowing new weapon
In the perpetual arms races between bacteria and human-made antibiotics, there is a new tool to give human medicine the edge, in part by revealing bacterial weaknesses and potentially by leading to more targeted or new treatments for bacterial infections.

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 Season 12
Beyond Clean released three special episodes at once featuring conversations with experts in water quality, steam sterilization, and gas sterilization. Tune in to hear from water quality expert (and NewSplash feature writer) Jonathan Wilder, steam sterilization expert Joel Schafer, and gas sterilization expert Ted May.