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NewSplash Archive – August 2021

Issue 35 – August 31, 2021

Contaminated Screw Caddies: Why We Must Move to Individual Aseptic Packaging of Implantable Medical Devices by Lisa McKown, DrPH Student, MBA, CRCST, CIS, CHL, MBTI
There is mounting evidence in academic literature to substantiate that the current practices of reprocessing surgical implants, such as screw caddies, multiple times between patients increases the risk of infection. Implantable instruments are medical devices that will stay in a body more than 30 days and are intended to become an indefinite or permanent part of a patient’s anatomy (i.e., plates, rods, and screws for orthopedic fixations). Implants are single-use; therefore, once implanted they are not supposed to be placed into another patient, which is why manufacturers make trials to test the area to be implanted and ensure the right size is selected.

Research reveals COVID-19 is a vascular disease, not respiratory illness
New research led by the University of California San Diego revealed that COVID-19 is a vascular disease and not a respiratory illness, as previously thought. The findings of this research could explain blood clots and “COVID feet” that some patients experience.

Moderna seeks full FDA approval for COVID-19 vaccine
Moderna announced it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the full licensure of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation.

Johnson & Johnson announces data to support boosting its single-shot COVID-19 vaccine
Johnson & Johnson today announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. 

APIC says healthcare facilities must adopt aggressive infection and control measures to prevent C. auris from spreading
In light of the Centers for Disease Control and Prevention’s (CDC’s) July 23 announcement about the possible transmission of pan-resistant Candida auris in the U.S., the Association for Professionals in Infection Control and Epidemiology (APIC) urges healthcare facilities to implement aggressive infection prevention and control measures to ensure this pathogen does not become embedded in U.S. healthcare settings.

BD receives EUA for at-home COVID-19 test
Becton, Dickinson and Company (BD) announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the BD Veritor At-Home COVID-19 Test. The rapid antigen test uses computer vision technology in a smartphone to interpret and provide a digital display of testing results.

Register now for AAMI virtual conference
The AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation will be held virtually on October 18–20, 2021, with expanded program sessions. The conference offers many sessions covering digital health, in vitro diagnostic standards and regulations, quality systems, risk management, regulatory standards harmonization, emerging technologies, and much more.

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 7 features a conversation with Marjorie Wall about the cultural shift that needs to happen to make lasting change in SPDs that set up your staff for success. Marjorie outlines the planning for process improvements that will gain support and engagement from frontline staff and gain financial and budgetary resources from hospital administration.

 

Issue 34 – August 24, 2021

How to Cultivate a Culture of Open Communication in Sterile Processing by Rebecca Kinney
One weekend I had the opportunity to speak with fellow industry professionals for a virtual conference hosted by Central Service Association of Iowa (CSAI). A large group of professionals gathered, and one of the panel discussions regarded speaking up about safety in your department. The truth is we often see red flags or safety concerns and don’t feel that our voice or opinions are valid. So how exactly do we learn to speak up and develop a culture of open communication when the doors often feel very closed? 

FDA approves first COVID-19 vaccine
On Monday, August 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

Public health and medical experts recommend COVID-19 booster shots
Public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.

CDC announces new disease forecasting center
The Centers for Disease Control and Prevention (CDC) announced a new center designed to advance the use of forecasting and outbreak analytics in public health decision-making. Once established, the Center for Forecasting and Outbreak Analytics will bring together next-generation public health data, expert disease modelers, public health emergency responders, and high-quality communications to meet the needs of decision-makers.

WHO seeking experts for advisory group
The World Health Organization (WHO) issued an open call for experts to serve as members of the new WHO Scientific Advisory Group for the Origins of Novel Pathogens (SAGO). 

Register now for AAMI virtual conference
The AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation will be held virtually on October 18–20, 2021, with expanded program sessions. The conference offers many sessions covering digital health, in vitro diagnostic standards and regulations, quality systems, risk management, regulatory standards harmonization, emerging technologies, and much more.

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 13
On this final episode of Season 13, Michael Compton, CRCST, CHL, sterile processing leader at Intermountain Healthcare, discusses the challenges and opportunities around the transition period when old leaders step out and new leaders step in. Michael discusses strategy, collaboration, and change management.

 

Issue 33 – August 17, 2021

Got Mentors? Gain Mentorship, Part 3 of 3 by Sarah B. Cruz
Mentors are available in a multitude of capacities. Some can be right in front of us at our facility, while others are on social media. Is there someone you aspire to in the central sterile/sterile processing industry? Do any particular industry professionals really make you think? Know that mentors are not limited strictly to our professional industry. Regardless of who they could be, our prospective mentors are not some far off stars that we can only gaze upon; they are real professionals that we can reach out to. If we continue to look at industry professionals as people we can only look up to, mentorship will forever be unattainable.

CDC recommends COVID-19 vaccines for women who are pregnant or breastfeeding
The Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccination for people aged 12 years and older, including women who are pregnant, breastfeeding, or trying to become pregnant.

FDA authorizes vaccine booster for certain immunocompromised individuals
The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The amended EUA does not apply to people who are not immunocompromised.

Monoclonal antibody prevents malaria in small NIH trial
One dose of a new monoclonal antibody discovered and developed at the National Institutes of Health safely prevented malaria for up to nine months in people who were exposed to the malaria parasite. The small, carefully monitored clinical trial is the first to demonstrate that a monoclonal antibody can prevent malaria in people.

Register now for AAMI virtual conference
The AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation will be held virtually on October 18–20, 2021, with expanded program sessions. The conference offers many sessions covering digital health, in vitro diagnostic standards and regulations, quality systems, risk management, regulatory standards harmonization, emerging technologies, and much more.

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 13
This week’s guest is Brett Norton, VP of Operations at Beyond Clean and long-time sterile processing vendor. Brett provides his insights on the value you can provide to vendors by sharing your experiences, and gives some tips on getting a hold of the right people when you need product-related questions answered.

 

Issue 32 – August 10, 2021

Press Pause for Mental Health by Mike Mackenzie
Mental health has dominated headlines in recent weeks, as several athletes have effectively pressed pause during high-level competitions and tournaments, most notably tennis star Naomi Osaka and gymnast Simone Biles. Osaka withdrew from the French Open and decided not to participate in Wimbledon, and Biles withdrew from several gymnastics events at the 2020 (2021?) Summer Olympics.

Novavax COVID-19 vaccine booster provides four-fold increase in neutralizing antibody levels
Novavax, Inc. announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, NVX-CoV2373, given six months after an initial two-dose regimen, elicited a 4.6-fold increase in functional antibody titers. Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta (B.1.617.2) variant were more than 6-fold higher than the primary vaccination series.

Graphene binds drugs which kill bacteria on implants
Bacterial infections relating to medical implants place a huge burden on healthcare and cause great suffering to patients worldwide. Now, researchers at Chalmers University of Technology have developed a new method to prevent such infections by covering a graphene-based material with bactericidal molecules.

The future of medicine is nearer thanks to researchers’ invention
Researchers at the University of Massachusetts Amherst recently unveiled their discovery of a new process for making RNA. The resulting RNA is purer, more copious, and likely to be more cost-effective than any previous process could manage.

FDA aims to grant Pfizer shot full approval by Labor Day, insiders say
The FDA has set Labor Day, Sept. 6, as an unofficial deadline to grant full approval of Pfizer’s COVID-19 vaccine, several people familiar with the matter told The New York Times.

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 13
This episode, Jeff Holland, director of health sciences at Evoqua Water Technologies, discusses the machines, technology, and processes that are used to produce safe water that’s used to wash, rinse, and create steam for safe surgical instrument reprocessing.

 

Issue 31 – August 3, 2021

Hear Ye, Hear Me! On Education and Competition in Sterile Processing by Hank Balch
“May I have your attention, please? May I have your attention, please? Will the real sterile processing educators please stand up?”

Anyone choosing to read an article with the words “sterile processing” and “education” in the title is likely already convinced of the tremendous value education has on career growth, best practice, and patient safety for medical device reprocessors. But there may be some disagreements or misunderstandings around the impact that industry competition has on education itself. Is there such a thing as pure education? Is competition, by definition, a bad thing? How should these answers impact how and from whom you glean your sterile processing education resources? We will take a look at these questions and provide an honest vision for balancing education and competition below.

Highly potent, stable nanobodies stop SARS-CoV-2
Researchers in Göttingen have developed mini-antibodies that efficiently block the coronavirus SARS-CoV-2 and its dangerous new variants. These so-called nanobodies bind and neutralize the virus up to 1,000 times better than previously developed mini-antibodies.

Researchers identify approach for potential nontypeable Haemophilus influenzae vaccine
Scientists at Children’s Hospital of Philadelphia(CHOP) have identified two proteins that could be used for a potential vaccine against nontypeable Haemophilus influenzae (NTHi). Working in a mouse model, the investigators found that administering two bacterial adhesive proteins that play a key role in helping the bacteria to latch on to respiratory cells and initiate respiratory tract infection stimulated protective immunity against diverse NTHi strains, highlighting the vaccine potential.

Existing drug is shown to inhibit virus that causes COVID-19
Scientists from the University of Chicago have found that the drug masitinib may be effective in treating COVID-19. The drug, which has undergone several clinical trials for human conditions but has not yet received approval to treat humans, inhibited the replication of SARS-CoV-2, the virus that causes COVID-19, in human cell cultures and in a mouse model, leading to much lower viral loads.

AORN cancels in-person Global Surgical Conference & Expo
Due to the dramatic surge in new COVID-19 cases in Orange County, Florida, AORN made the decision to cancel the in-person Global Surgical Conference & Expo that was to happen August 7–10 at the Orange County Convention Center. The announcement follows a declaration by the mayor of Orange County that the county is currently facing a COVID-19 crisis due to the Delta variant.

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 13
This episode, Jake McHugh, CRCST, CIS, CHL, CER, instrument tracking coordinator at a hospital in Jacksonville, Florida, explains what happens when accreditation surveyors open your department documentation around process challenge devices (PCDs) and biological indicators (BIs). Jake discusses his approach to hardwiring compliance around PCD documentation and walks listeners through the basics of implementing communication, confidence, and checklists into your department workflow.