Month: January 2021

• Clostridioides difficile (C. difficile) is a leading cause of healthcare associated infections in the USA, contributing to nearly 500,000 infections, 30,000 deaths, and $4.8B in annual excess acute care costs¹
• C. difficile is impervious to current standard-of-care cleaning with alcohol
• Study found zero growth of C. difficile inoculated stethoscopes protected with AseptiScope disk cover barriers (P<0.05)
• Study expands extensive body of evidence supporting the effectiveness of aseptic disk cover stethoscope barriers, available now in The DiskCover System, to protect patients from exposure to pathogens

  January 19, 2021 San Diego, CA – A new study in Mayo Clinic Proceedings entitled “Aseptic Stethoscope Barriers Prevent C. difficile Transmission In Vitro”² finds that aseptic disk covers from AseptiScope, available now commercially in the company’s flagship product, The DiskCover System™, completely blocked the growth of C. difficile on stethoscope diaphragms.  C. difficile infection (CDI), a significant public health issue, was estimated by the CDC in 2015 to result in nearly 500,000 infections and contribute to over 30,000 deaths and $4.8B in excess acute care costs.¹  C. difficile is an anaerobic gram-positive bacterium that generates infection-causing spores that are highly resistant to commonly used heat and alcohol disinfectants.  The persistence of C. difficile spores in clinical settings has led to a high prevalence of CDI, a reportable infection to the National Healthcare Safety Network (NHSN) and an inpatient outcome assessed by CMS quality measures aimed at reducing harm in the delivery of care.³   With over 5.5 billion annual auscultations in the U.S. alone, the stethoscope is the most frequently used medical instrument and is commonly referred to as the “clinician’s third hand.”  Stethoscopes are a ubiquitous, valuable clinical tool and a symbol of the trust between healthcare providers and patients, but they are also a proven vector of disease transmission.  CDC stethoscope cleaning guidelines are incompatible with intense level of usage and the high-paced workflow in clinical settings.  Recent observational studies reveal stethoscopes are seldom cleaned between patients and, even when cleaning attempts are made, less than 4% of stethoscope diaphragms in these studies met CDC requirements.  In instances where cleaning techniques such as alcohol swabs are employed in accordance with CDC guidelines, studies show resistant pathogens frequently persist.  Moreover, disposable, “single-patient” stethoscopes offer significantly compromised diagnostic accuracy⁴ and fail to address the risk of clinician-to-clinician infections.   “It is clear from the literature that poor stethoscope hygiene practices and techniques among clinicians are commonplace, positioning the stethoscope as a formidable vector of CDI,” said Sarathi Kalra, MD, MPH, co-author of the study and Assistant Professor, Research Director at the Department of Emergency Medicine, University of South Alabama in Mobile.  “This important study builds on a body of data supporting the use of aseptic disk covers to protect patients from exposure to an array of common and dangerous pathogens on the stethoscope diaphragm.  In now demonstrating that disk covers are an effective barrier against alcohol-resistant C. difficile spores, we have established the relevance of this practical solution against one of the most prominent and challenging drug-resistant superbugs that healthcare faces today,” Dr. Kalra added.   Study Results In this study, 16 stethoscope diaphragms were inoculated with C. difficile.  After the diaphragms were allowed to dry for 10 minutes, 8 stethoscopes had a disk cover barrier applied to the diaphragm while the other 8 stethoscopes served as controls with no barrier applied.  All stethoscopes were placed in an anaerobic incubator.  In the longitudinal assessment of C. difficile growth on stethoscope diaphragms without aseptic barriers, growth was detected at all time points (15 and 30 minutes, 2 and 4 hours, and 1, 2, 3, and 7 days).  The overall mean colony count on these 8 stethoscopes without barriers was 33 colony-forming units (CFU), with a peak count of 160 CFU at 2 days.  The C. difficile growth findings on the stethoscope diaphragms with barriers were in stark contrast, as the presence of a barrier resulted in no growth on 100% of these diaphragms for up to 1 week (7 days) after contamination.  At each pre-specified time point there was a significant complete absence (P<0.05) of C. difficile growth on stethoscope diaphragms with barriers as compared to those without barriers.   “In light of today’s elevated, intense focus on infection control in the clinical setting, the results of this study underscore the relevance, importance, and effectiveness of The DiskCover System, in protecting patients against even the most dangerous and prevalent pathogens,” said Scott Mader, co-founder and CEO of AseptiScope, Inc.  “Our touch-free DiskCover System sets a new standard by instantly dispensing single-use, medical-grade, acoustically invisible, aseptic stethoscope barriers at the point of care, providing the opportunity for a clean auscultation for each and every patient,” Mader added.   References

1. https://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html
2. https://doi.org/10.1016/j.mayocpiqo.2020.10.002
3. https://cmit.cms.gov/CMIT_public/ViewMeasure?MeasureId=831
4. https://www.mayoclinicproceedings.org/article/S0025-6196(20)31261-1/fulltext

  About AseptiScope, Inc. AseptiScope, formed in early 2016, is a privately funded San Diego, California based, clinical innovation company. The company is founded and led by clinical innovation experts, leading medical researchers and practicing physicians. The AseptiScope mission is to design, develop, manufacture and commercialize novel solutions that offer “Infection Protection for Clinician & Patient.”  The company has launched the first true and practical solution for the longstanding challenge of stethoscope contamination: The DiskCover System.  Visit www.diskcover.com for more information or https://store.aseptiscope.com to purchase directly.   AseptiScope, DiskCover and related logos are trademarks of AseptiScope, Inc. Media Contact: AseptiScope Inc. Irene Mulonni irene@mulonni.com 858.859.7001 DOWNLOAD PDF

• Auscultations using professional stethoscopes with disk cover barriers from AseptiScope resulted in 100% diagnostic accuracy and no loss of sound amplitude
• Auscultations employing disposable stethoscopes produced an overall error rate of nearly 11% in clinical diagnosis
• Compared to disposable stethoscopes, disk cover barriers from AseptiScope are cost-effective, clinically superior, and physician-preferred

 

January 11, 2021 San Diego, CA – A study described in a letter to the editor in the January issue of Mayo Clinic Proceedings entitled “Aseptic Disposable Stethoscope Barrier: Acoustically Invisible and Superior to Disposable Stethoscopes”¹ found that aseptic disk cover barriers from AseptiScope (www.diskcover.com), previously proven to block the growth of dangerous pathogens on stethoscope diaphragms, are acoustically invisible and allow for 100% diagnostic accuracy.  In contrast, the same study reported that disposable stethoscopes were found to present an 11% misdiagnosis rate for serious clinical conditions that may have auscultatory findings such as systolic and diastolic heart murmurs.

 

The stethoscope, commonly referred to as the clinician’s “third hand,” is the most frequently used medical instrument with over 5.5 billion annual auscultations in the US alone.  The stethoscope is also a proven vector of disease transmission, with CDC cleaning guidelines that are incompatible with the intensity of stethoscope use and the high-paced workflow in clinical settings.  A current approach to reduce the spread of healthcare acquired infection (HAI) is the use of disposable stethoscopes.  While the persistent risk of HAI with disposable stethoscopes has been established, this study is the first to describe the compromised performance associated with their use compared to an emerging alternative in aseptic single-use disk cover barriers.

 

“Failure to correctly identify auscultatory sounds 11% of the time presents a tremendous clinical and economic cost to the healthcare system,” said Sarathi Kalra, MD, MPH, principal investigator of this study who is also an Assistant Professor and Research Director in the Department of Emergency Medicine at the University of South Alabama, Mobile.  “Such a significant error rate creates a potential liability for health care providers who rely on accurate clinical assessments to develop appropriate, and often time-sensitive, treatment plans. The full impact of a missed diagnosis using disposable stethoscopes extends far beyond financial implications. Added morbidity and mortality from a delayed or missed diagnosis can often times lead to irreversible outcomes, especially in the acute care setting where disposable stethoscopes are frequently used,” Dr. Kalra added.

 

Study Design and Results

This prospective evaluation employed Littmann 3200 recording stethoscopes (3M), a simulation mannequin (iSTAN, CAE), disk cover barriers (AseptiScope), and disposable stethoscopes (Proscope 665, ADC. Inc.).  Twenty-eight physicians performed auscultations in prespecified locations and listened for 15 seconds of respiratory wheezes, normal heart sounds, systolic murmurs, and diastolic murmurs.  Physicians were blinded to the presence of barriers and received sounds in random order. Digital audio files were analyzed for amplitude differences (Logic Pro X, Apple Inc.), with and without a disk cover barrier in place.

 

Unblinded physicians then used Littmann stethoscopes with barriers and disposable stethoscopes without barriers and auscultation accuracy was recorded.  The Wilcoxon rank sum test was used to compare amplitude differences among groups and McNemar’s test was used to compare diagnostic accuracy.

 

In 800 matched observations of Littmann stethoscopes with and without disk cover barriers, there were no differences in sound amplitude (P=1.0) across all sounds.  Diagnostic accuracy of 110 auscultations using the Littmann plus disk cover barrier was 100%.  The 110 auscultations with the disposable stethoscopes saw an error rate of 10.9% (12 of 110) with misinterpretation of 9 systolic murmurs as occurring during diastole and 3 diastolic murmurs identified as occurring during systole.

 

In subjective evaluation, 95% of physicians reported a preference for their personal stethoscope with a disk cover barrier over the disposable stethoscope.

 

“This important study establishes the clinical and economic advantages that our DiskCover System delivers over the use of disposable stethoscopes,” said Scott Mader, CEO and co-founder of AseptiScope.  “Our innovation allows clinicians to use their personal stethoscopes, with no loss of fidelity, to make critical clinical diagnoses accurately while protecting patients from exposure to dangerous pathogens.  This study adds to an increasing body of evidence establishing The DiskCover System a clinically significant advance in the challenge of stethoscope hygiene,” Mader added.

 

References

1. S Kalra and JB Shewale. Aseptic Disposable Stethoscope Barrier: Acoustically Invisible and Superior to Disposable Stethoscopes (Letters to the Editor). Mayo Clin Proc. 2021 Jan 1;96(1):263-4. https://doi.org/10.1016/j.mayocp.2020.10.029

 

About AseptiScope, Inc.

AseptiScope, formed in early 2016, is a privately funded San Diego, California based, clinical innovation company. The company is founded and led by clinical innovation experts, leading medical researchers and practicing physicians. The AseptiScope mission is to design, develop, manufacture and commercialize novel solutions that offer “Infection Protection for Clinician & Patient.”  The company has launched the first true and practical solution for the longstanding challenge of stethoscope contamination: The DiskCover System.  Visit www.diskcover.com for more information or https://store.aseptiscope.com to purchase directly.

AseptiScope, DiskCover and related logos are trademarks of AseptiScope, Inc.

Media Contact:
AseptiScope Inc.
Irene Mulonni
irene@mulonni.com
858.859.7001

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