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Eliza Johnson, BS, CRCST, has a strong passion for helping others throughout the health care and medical device industries. She currently works as a quality specialist at ARCH Medical Solutions, where she delves into medical device manufacturing processes, utilizes quality and compliance systems, and completes essential quality system documentation. This role builds upon her 2 years as a CRCST at Exeter Hospital, where she gained experience decontaminating and sterilizing medical devices in preparation for surgical use.


The FDA's 21 CFR Part 820 and ISO 13485 are crucial in regulating medical device quality systems. Harmonizing these standards by 2026 will streamline compliance, improve patient access to devices, and align US regulations with global practices.

Implementing FDA 21 CFR Part 820 & ISO 13485 on Quality System Regulation

Utilizing robust quality systems is essential in medical device manufacturing to prevent infections and extend the lifespan of instruments, ensuring optimal patient safety.

Enhancing Infection Prevention in Medical Devices Through Quality Systems

Infection prevention personnel are aware that the risk of infection spread during construction is high. How can infections be prevented during construction? Is there a new product that could help with this problem?

) spoke with Jackie Otero, a senior territory sales representative at Abatement Technologies, who emphasizes the importance of maintaining indoor air quality (IAQ) in health care settings, particularly during construction projects. She explains that the SHIELD WALL modular containment system, developed by Abatement Technologies, consists of temporary prefabricated walls. It is ideal for various job sites, providing effective containment during construction or sectioning off flex spaces.

: Would you please describe what a SHIELD WALL is?

 Modular wall systems are temporary prefabricated containment solutions. Walls, such as SHIELD WALL by Abatement Technologies, are designed for quick, easy installation and are effectively used at various job sites to provide containment during construction projects or to section off flex spaces. And, to help navigate the complexities of labor shortages, contractors need a containment solution that is easy to assemble with fewer people. The surge in the demand for cost-efficient and sustainable solutions is accelerating the growth of modular wall systems.

: Can you describe the specific challenges Segars Group encountered regarding dust, debris, and noise control during the construction of the WellStar Kennestone Hospital pediatric intensive care unit (PICU)?

While maintaining indoor air quality (IAQ) is a top priority in any industry, it’s particularly crucial for contractors and facility managers in healthcare or critical environments. By definition, a critical environment is any area where something can be easily affected by external contamination. Health care-associated infections (HAIs) are a significant concern in hospitals and other healthcare facilities, especially in immunocompromised patients. Because of this, hospitals and contractors must follow an Infection Control Risk Assessment (ICRA) best practices to isolate, capture, and control airborne dust particles and pathogens.

: What were the primary considerations for Segars Group when selecting a containment system for this project, and how did Abatement Technologies' SHIELD WALL modular containment system meet those needs?

Previous containment methods relied on single-use materials like lumber, drywall, plastic or poly sheeting, and insulation. Both lumber and drywall often require custom cuts to fit each space, meaning these materials are difficult to reuse and become waste at the end of the project. With critical time frames to begin and end projects, waiting days to weeks until an area is contained can cause delays and missed deadlines. And time is always of the essence in intensive care units, and providing the best care is essential to the recovery of patients.

So, when the Segars Group evaluated containment systems for the WellStar Kennestone PICU project, it chose the quickest, most reliable, and most sensible option: temporary reusable modular containment walls.

Segars Group found the ideal solution from Abatement Technologies. The company chose to install SHIELD WALL modular containment system for its:

to adjust to changing construction needs,

to help lower noise and disruptions within patient areas,

Abatement Technologies’ SHIELD WALL modular containment systems are completely reusable and are easily and quickly assembled with minimal labor.

: In what ways did the SHIELD WALL system contribute to minimizing the risk of hospital-acquired infections (HAIs) during the construction process?

Dust and debris during construction projects in active health care facilities can negatively impact air quality and put vulnerable patients at risk for respiratory distress. Excess noise during construction can also be disruptive to patients and prevent them from getting the rest that is essential for recovery. SHIELD WALL containment played a key role in preventing dust and debris from infiltrating the air in occupied patient areas and drastically reduced noise to protect patients from disruptions.

: How did the modular flexibility and reusable nature of the SHIELD WALL™ system impact the timeline and efficiency of the PICU construction project?

The flexibility of SHIELD WALL allowed Segars Group to easily modify the walls to expand and encompass additional unit areas as the project progressed. This allowed essential areas to remain operational as long as possible, further minimizing disruptions to patient care. Segars Group now utilizes SHIELD WALL as a standard project containment procedure.

: Can you share any feedback from the hospital staff and patients regarding using the SHIELD WALL system, particularly its additional features like sound attenuation and the ability to use the walls for patient artwork?

While SHIELD WALL has a sleek, professional appearance designed to blend seamlessly into many environments. WellStar Kennestone Hospital staff decided they didn’t want the walls to blend in and used them to showcase artwork from patients in the PICU.

Jesse White, superintendent of Segars Group, said, “The nursing staff asked if the kids could come and draw on the walls. We initially thought about hanging whiteboards on them but then realized the material was compatible with dry-erase markers. It ended up being an unexpected advantage. Beyond keeping everyone safe, the walls have brought much-needed joy to our patients throughout the project. My team must watch a training video because the panels are easy to assemble. We’ll go in and mark the areas; they can take it from there. It’s easy to use and assemble once you learn how the containment system operates.”

Jackie Otero, senior territory sales representative at Abatement Technologies, discusses the SHIELD WALL modular containment system by Abatement Technologies, highlighting its quick assembly, durability, noise reduction, and benefits in maintaining indoor air quality in health care settings.


Infection Intel: Augmenting SHIELD WALL Modular Containment Systems by Abatement Technologies

Avian influenza, or bird flu, has caused multiple pandemics over the years, the most recent being the 2009 swine flu pandemic involving the H1N1 strain. In recent years, a new strain of highly pathogenic avian influenza, H5N1, has been circulating among various species. More recently, it has affected dairy cattle in the US, but is it a cause of concern?

Avian Influenza viruses are a type of Influenza A Virus. These negative sense, single-stranded RNA viruses belong to the family Orthomyxoviridea. Two of its main surface glycoproteins play an important role in pathogenesis-Hemagglutinin (HA) and Neuroaminadase (NA). Hemagglutinin binds to sialic acid receptors in humans' respiratory tract and alveolar type II cells to cause infection.

Avian influenza viruses are divided into 2 groups based on their pathogenicity- Low pathogenic avian influenza and High pathogenic avian influenza (HPAI). Low pathogenic avian influenza virus has a low mortality rate and cannot infect easily, while High Pathogenic Avian Influenza has a high mortality rate, can cross intestinal and respiratory barriers, and damages the tissues of birds.

 H5N1 is a High Pathogenic Avian Influenza Virus that can affect multiple species.

When Were the First Cases in Cattle Reported?

In February 2024, veterinarians in the US were informed of a syndrome affecting lactating dairy cattle in northern Texas. The cattle experienced reduced feed intake, rumination, and an abrupt drop in milk production. The milk of the affected animals was thick and creamy yellow, similar to colostrum. Affected farms reported a peak incidence 4 to 6 days after the first animals were affected. Though lab tests (blood, urine, feces, milk, and nasal swab samples) and postmortem tests were conducted, they failed to show a conclusive cause of the illness.

Farms in Kansas and New Mexico reported similar cases in early March 2024. Deaths of wild birds and domestic cats who were fed milk from sick cows were also reported in affected farms in Texas. The US Department of Agriculture National Veterinary Services Laboratory could later confirm that the affected animals were infected with Highly Pathogenic Avian Influenza H5N1.

 As of July 18, 2024, 13 states have been affected by outbreaks in dairy cows, and 48 states have been affected by outbreaks in poultry.

While avian flu, especially H5N1 and others, can affect other species, cattle were not considered a host for this Highly pathogenic avian influenza. A recent study found sialic acid (SA) receptors in dairy cattle's respiratory tract and mammary glands. The respiratory tract had both SA α2,3-galactose and SAα2,6-galactose, but unlike humans, SAα2,6-gal is mainly confined to the sub-epithelial region of the trachea.

However, SA α2,3-galactose continued to be expressed on the epithelium of the bronchi to alveolar pneumocytes, making it possible for avian influenza to infect the lower respiratory tract of cattle. The mammary glands of cattle also expressed both SA α2,3-gal-β GalNAc (MAL-II) and SAα2,6-gal (SNA) receptors. While the exact cause of mastitis in dairy cattle affected by HPAI H5N1 is unclear, an initial investigation showed strong epitheliotropism in the mammary glands.

While there is generally a low risk of humans getting infected by avian influenza, sporadic cases have occurred when humans were in close and prolonged contact with birds and cattle in recent cases.6 The first reported case of H5N1 in humans was in May 1973, and as of July 23, 2024, more than 890 people were reportedly infected with H5N1.

The first human-to-human transmission of H5N1 was confirmed in 2005 in Thailand after an 11-year-old girl transmitted the disease to her mother and aunt.8 When infecting a host, the H5N1 virus has a receptor preference like other Influenza A viruses. Human Influenza viruses bind to 2,6 linked sialic acids in the upper respiratory tract. In contrast, the avian influenza viruses bind to sialic acids through

 links present on the ocular epithelium and type II alveolar cells.

On April 1, 2024, the Texas Department of State Health Services reported that a farm worker had tested positive for high pathogenic avian influenza H5N1 after being in contact with infected dairy cattle. The worker developed conjunctivitis and was treated with Oseltamivir and was asked to isolate following CDC guidelines.

 On May 22, 2024, the Michigan Department of Health and Human Services reported the second cause of a presumed cow-to-human transmission of H5N1 transmission.

The third reported case of H5N1 in the US was the first to report respiratory symptoms, with the previous 2 cases complaining only of conjunctivitis. The third patient reported signs of upper respiratory tract infection, such as cough without fever and eye discomfort with watery discharge.

 There are currently no human deaths from the recent H5N1 outbreak in the US. A total of 13 cases have been confirmed in the US from April 2024 to 25th July 2024, with Colorado reporting the highest number of cases.

Although milk from infected cows is diverted and not included in the food supply chain, HPAI H5N1 was detected in raw milk from infected cows. A small study by the US Food and Drug Administration (FDA) consisting of 297 pasteurized milk samples from 17 states found viral RNA by qrRT-PCR in 20.2% of the samples. However, it is important to note that while viral RNA was found, no infectious virus was detected in these samples. A positive qrRT-PCR simply means that viral RNA entered the milk supply, but it cannot be determined if this virus was ever infectious.

While the majority of the milk in the US is pasteurized and, hence, safe to drink, it is not advised to drink raw milk as it can contain bacteria and viruses, including H5N1, and can cause serious illness.

In 2021, the FDA approved a multidose vial formulation of AUDENZ, making it the first-ever adjuvanted, cell-based influenza vaccine. The FDA had previously approved a single-dose prefilled formulation of the same vaccine. However, this vaccine is currently unavailable to the general public and is only reserved for individuals aged 6 months and above who are at an increased risk for H5N1.

Influenza A viruses can cause pandemics due to the plasticity and segmentation of their genome, making them more susceptible to acquiring mutations. Most avian influenza viruses affect birds, but some, like H5N1 and H1N1, affect multiple species. The current findings of sialic receptors in dairy cattle show that avian influenza may have other hosts.

While the risk of animal-human or bird-human transmission of H5N1 remains relatively small for the general population, the recent increase in H5N1 infections in various species may pose a risk for a pandemic. Increasing cases among animals and birds and an increase in hosts should prompt a discussion on managing a possible pandemic in the future.

. Published online February 11, 2020. doi:10.1007/s12098-020-03214-1

Simancas-Racines A, Cadena-Ullauri S, Guevara-Ramírez P, et al. Avian Influenza: Strategies to Manage an Outbreak. 

. 2023;12(4):610. doi:10.3390/pathogens12040610

Chmielewski R, Swayne DE. Avian Influenza: Public Health and Food Safety Concerns. 

. 2011;2(1):37-57. doi:10.1146/annurev-food-022510-133710

Burrough ER, Magstadt DR, Petersen B, et al. Highly Pathogenic Avian Influenza A(H5N1) Clade 2.3.4.4b Virus Infection in Domestic Dairy Cattle and Cats, United States, 2024. 

H5N1 Bird Flu: Current Situation. Centers for Disease Control and Prevention.

. Published June 18, 2024. Accessed June 19, 2024. 

https://www.cdc.gov/bird-flu/situation-summary/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fflu%2Favianflu%2Favian-flu-summary.htm

Nelli RK, Harm TA, Siepker C, et al. Sialic Acid Receptor Specificity in Mammary Gland of Dairy Cattle Infected with Highly Pathogenic Avian Influenza A(H5N1) Virus. 

Past Reported Global Human Cases with Highly Pathogenic Avian Influenza A(H5N1) (HPAI H5N1) by Country, 1997-2024. Centers for Disease Control and Prevention. 

https://www.cdc.gov/bird-flu/php/avian-flu-summary/chart-epi-curve-ah5n1.html?CDC_AAref_Val=https://www.cdc.gov/flu/avianflu/chart-epi-curve-ah5n1.html

Gottlieb S. Research confirms human to human transmission of avian flu. 

. 2005;330(7485):211. Accessed October 27, 2023. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC546057/

World Health Organization. Avian Influenza A(H5N1) – United States of America. 

https://www.who.int/emergencies/disease-outbreak-news/item/2024-DON512

. Centers for Disease Control and Prevention. Published June 21, 2024. 

https://www.cdc.gov/bird-flu/situation-summary/index.html

Looi MK. Bird flu: US confirms first case with respiratory symptoms. 

CDC Confirms Three Human Cases of H5 Bird Flu Among Colorado Poultry Workers. Centers for Disease Control and Prevention. 

https://www.cdc.gov/media/releases/2024/s0725-three-human-cases-of-h5-bird-flu.html#:~:text=Counting%20that%20case%2C%20there%20have

Spackman E, Jones DR, McCoig AM, Colonius TJ, Goraichuk IV, Suarez DL. Characterization of highly pathogenic avian influenza virus in retail dairy products in the US. 

CSL Seqirus. FDA Approves Multi-Dose Vial Presentation for AUDENZ. 

https://www.cslseqirus.us/news/fda-approves-multi-dose-vial-presentation-for-audenz

The US faces an H5N1 outbreak affecting dairy cattle, poultry, and humans. Cases are rising, highlighting potential pandemic risks and the need for vigilant monitoring.

The US Faces an H5N1 Outbreak: What Do We Know About It?

The US Federal Drug Administration (FDA) and the International Organization for Standardization (ISO) play significant roles in the production of medical devices currently on the market. One area covered by both the FDA and ISO is 

 to uphold the Federal Food, Drug, and Cosmetic Act (FD&C Act) through quality system regulation.

 ISO is an international organization that creates standards based on input from experts in different industries.

 One standard that is widely recognized throughout the medical device manufacturing industry is 

. Professionals within this industry must understand the current requirements of the FDA and ISO 13485 to have a high-functioning, well-regulated quality system.

For companies that manufacture finished medical devices, implementing the regulations required by 21 CFR Part 820 allows these facilities to be compliant with the FD&C Act. 21 CFR Part 820 sets forth CGMP (current good manufacturing practices) for the regulation of facilities that partake in the manufacture or related practices for finished medical devices that are “manufactured, imported, or offered for import in any State or Territory of the US, the District of Columbia, or the Commonwealth of Puerto Rico.”

 This regulation takes place through a quality management system (QMS). Since a federal agency puts this regulation in place, facilities participating in the previously stated activities must comply with these requirements.

One of the main differences between the FDA and ISO is that ISO is a nongovernmental organization. ISO 13485 is an international standard that also sets forth principles managed by a QMS for facilities involved in the manufacture of medical devices. Although this means that registration for ISO 13485 certification is not currently required by law in the US, this is a highly recognized global standard. 

Since this is a globally recognized standard, this certification also considers some of the regulatory requirements from the European Union (EU), such as EU-MDR (Medical Devices Regulation) and EU-IVDR (In-Vitro Diagnostic Medical Devices Regulation).

 Although adhering to ISO 13485 in the US is currently optional for medical device manufacturers, companies that export their devices to other countries may find that registration to ISO 13485 is required.

 Within the next 2 years, the FDA has announced proposed changes to the necessity of adhering to ISO 13485 requirements.

Effective February 2, 2026, 21 CFR 820 will be amended to include ISO 13485 standards by reference.

 The FDA aims to revise its requirements in 21 CFR 820 by aligning the regulations with ISO 13485 standards in an amended Quality Management System Regulation (QMSR). This process is called a “harmonization”

 of the 2 requirements. The main takeaway from aligning the 2 is that this will provide timelier access to new finished devices with additional cost savings throughout the industry.

 In addition to cost savings, “The qualitative benefits of the rule include quicker access to newly developed medical devices for patients leading to improved quality of life of the consumers.”

 Although the benefits of this harmonization were stated, the anticipated addition of ISO 13485 to the amended QMSR has brought about some concerns from professionals within the medical device industry.

Although the management of quality systems according to FDA registration and ISO certification are similar, the 2 have some differences, including specific terminology. To address this, the FDA reviewed timely public comments regarding concerns with the alignment of the standard and the current regulation. 

One general comment requested that the FDA consider adding the term “correction,” as defined in ISO 13485.

 In the ruling, the FDA agreed with this commenter that adding this term would further align the QMSR with ISO 13485. The FDA also reiterated that modifications will be implemented to allow the QMSR to be consistent throughout.

 It is important to note that there are requirements in the current 21 CFR 820 regulation not included in ISO 13485 that companies must meet to comply with the FD&C Act. This will remain true in the updated QMSR.

It is recommended that medical device professionals become familiar with the requirements of the ISO 13485 standard before their anticipated implementation within the next 2 years. Understanding the FDA’s 21 CFR 820 regulations and the current ISO 13485 standard allows companies to prepare for the QMSR transition. 

Introducing new requirements to a quality management system may include some concerns. However, it is important to remember that improvement within a quality system is essential for managing the production of safe, high-quality devices.

21 CFR Part 820 -- Quality system regulation. Accessed August 29, 2024. 

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

ISO. Accessed August 29, 2024. About ISO. 

Medical devices; quality system regulation amendments. Federal Register. Published February 2, 2024. Accessed August 29, 2024. 

https://www.federalregister.gov/d/2024-01709

BSI. ISO 13485 Frequently asked questions. 2024. Accessed August 29, 2024. 

https://www.bsigroup.com/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-iso-13485-faqs-en-gb.pdf

(Editor's note: This article was originally published on our sister publication's website, Contemporary Pediatrics: 

https://www.contemporarypediatrics.com/view/hot-topics-in-diagnosing-preventing-and-treating-central-line-associated-bloodstream-infections

Recent studies and literature on central line associated bloodstream infections was the topic at one of this year's presentations at IDWeek 2023 in Boston, Massachusetts.

Jennifer Blumenthal, MD, an instructor, pediatric infectious diseases and critical care medicine at Boston Children’s Hospital and Harvard University School of Medicine in Massachusetts started with a definition of CLABSI, a laboratory-confirmed bloodstream infection not related to an infection at another site that develops within 48 hours of central venous catheter (CVC) placement.

Nationally across institutions during the COVID-19 pandemic, there was a rise in rates of CLABSIs. This trend was likely multifactorial due to an increased severity and acuity of patients, hospital staff shortages, additional demands upon infection and prevention control staff, and disruptions in typical procedures and supply chain issues.

Previously known risk factors for CLABSI development in children include clinical host-specific factors and situation-specific factors that can be explained by the known pathogenesis of CLABSIs. Specifically, previously known risk factors for CLABSIs include immunocompromised status such as neutropenia, prematurity among infants, multiple manipulations of the catheter and low nursing-to-patient ratios.

Blumenthal cited a recent study evaluating the outcomes of 8629 hospitalized patients with central lines identified significant disparities by race and language. After adjusting for known risk factors, Black patients were 1.8 times more likely and patients who spoke a primary language other than English were 1.6 times more likely than their counterparts to develop a CLABSI. 

These results suggest that systemic racism and bias may play a role in inequitable hospital care for hospital-acquired infections. To address these disparities, hospital-wide quality improvement work aimed at reducing CLABSIs should stratify outcomes by race, ethnicity, and primary language to assess for disparities prior to implementing quality improvement efforts in order to inform QI interventions to improve equity.

Blumenthal also highlighted the 2022 update to the SHEA/IDSA/APIC Practice Recommendations for preventing healthcare-associated infections. The update focuses on insertion and maintenance of central lines. Blumenthal notes that most CLABSIs are not insertion related, but to minimize insertion related infections, the recommendations stress use of an insertion bundle, full sterile barriers, and formal CVC insertion training. The risk for CLABSIs is highest for short-term central venous catheters compared to ports. Thrombosis is also a major risk factor for infection.

Regarding maintenance bundles, the new updates recommend chlorhexidine impregnated dressings and cap protectors containing alcohol as essential practices. As each additional day that a CVC remains in place increases the risk of infection, daily rounding and surveillance tools should be used to evaluate the necessity of CVC regularly. Whenever feasible, IV medications should be transitioned to PO to minimize unnecessary catheter manipulation. Line surveillance programs are effective at identifying high-risk CVCs for further interventions and to remove unnecessary CVCs.

Reducing CLABSIs, Blumenthal reminds us, can be done by engaging, educating, executing, and evaluating; equitably.


Blumenthal J. Hot topics in diagnosing, preventing and treating central line associated bloodstream infections. ID Week 2023. October 13, 2023. Boston, Massachusetts.

The latest news on CLABSIs in the pediatric population is presented at IDWeek 2023.

Updates for the Prevention and Treatment of Central Line Associated Bloodstream Infections

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Insights on Double-Gloving with Dr. Hudson Garrett

’s) conversation with Hudson Garrett, PhD, MSN, MPH, MBA, FNP-BC, IP-BC, CPHRM, CIC, CHIPP-B, LTC-CIP, CPPS, CPHQ, CVAHP, FACHDM, FAPIC, FAAPM, FNAP, FACHE, FSHEA, FIDSA, an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, and a professor of emergency medical services and critical care at Phoenix Institute and College, the importance of double-gloving in infection control was emphasized. Garrett highlighted how this simple yet effective practice significantly enhances protection for healthcare workers, especially in high-risk environments such as emergency and critical care settings.

Double-gloving involves wearing 2 layers of gloves, which provides an additional barrier against potential exposure to infectious agents. Garrett pointed out that while single-glove use is standard, the added layer from double-gloving can reduce the risk of glove perforation and contamination during procedures. This is particularly crucial during invasive procedures where the likelihood of exposure to blood-borne pathogens and other infectious materials is higher.

"Everything that we can do to reduce that risk of our own floor as health care providers being introduced into that surgical field is going to be huge, and that starts with surgical hand hygiene,” Garrett said. “It includes our personal protective equipment (PPE) protection and things like gloves. But it also, again, goes an extra layer of protection to make sure that my health care workers are safe too.”

Garrett stressed that double-gloving not only protects health care workers but also contributes to patient safety by minimizing the risk of cross-contamination. He advocated for the routine adoption of double-gloving in health care settings where the risk of infection is significant. The practice is especially important in the context of emerging infectious diseases and pandemics, where the safety of health care providers is paramount to maintaining a functional and responsive health care system.

“Keep in mind that the use of gloves, gowns, and other PPE is at the very bottom of our pyramid in terms of infection control interventions, but it is an important part of our sort of tool belt,” Garrett said. “My job is to always make sure, whether I'm working with a perioperative nurse or clinician, a surgeon or another [infection preventionist], that our tool belt is as wide and deep as possible.”

The conversation concluded with a call for more education and training on the benefits of double-gloving, ensuring that health care professionals are fully aware of its importance in infection control and patient safety.

In an ICT® interview, Dr. Hudson Garrett emphasized double-gloving in infection control as crucial for protecting health care workers and patients, especially in high-risk environments.

Eliza Johnson, BS, CRCST

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