Infection Intel

Product Locator

Advanced Technology

Bug of the Month

COVID-19

Environmental Health Care Corner

Environmental Services

HAIs

Hand Hygiene

IC Trends

Long-Term Care Chronicles

Long-Term Care

Operating Room

Mask Respirator

Personal Protective Equipment

IPC Career

IPLifeline

Pathogen Pulse

Prevention

Sterile Processing Perspectives

Sterile Processing

Surface Disinfection

Vascular Access

News

Media

ICView

Expert Perspectives

Medical World News

Videos

Webinars

Conferences

Conference Coverage

Conference Listing

Publication

Infection Control Today

Supplements And Featured Publications

Resources

CME/CE

Editorial Advisory Board

Job Board

Partners

Whitepapers

Subscribe

Educator of the Year

Educator of the Year Official Rules

2023 Educator of the Year Winner

Advertise

About Us

Editorial Board

Contact Us

Terms and Conditions

Privacy

Do Not Sell My Personal Information

Facebook

Twitter

LinkedIn

Spotlight

Topic

View More

1rem

Authors

Matthew Weissenbach, DrPH, CPH, CIC, FAPIC, is Senior Director of Clinical Affairs for Clinical Surveillance & Compliance at Wolters Kluwer, Health. He has practiced as an epidemiologist and infection preventionist for 15 years. He earned his doctor of public health and master of public health degrees from the University of South Florida College of Public Health. He is board-certified in infection control and epidemiology (CBIC) and public health (NBPHE). He is also a fellow of the Association for Professionals in Infection Control and Epidemiology (APIC) and an active member of both APIC and the Society for Healthcare Epidemiology of America.

As infectious diseases resurge in 2024, this article explores how IPs can manage outbreaks, allocate resources, use technology for surveillance, and collaborate with senior leaders to ensure business continuity and patient safety in health care settings.

Navigating Infection Prevention Challenges Amid 2024 Outbreaks: Strategies for Success

I am honored to have been asked to write the monthly column “The Clean Hospitals Corner.” I hope to explore some of the aspects of the field that I find especially relevant or interesting and share some of my passion for it with you

I want to use this platform to explore various topics: to talk about new technologies, look into implementation strategies, keep updated on the latest news, or delve into challenges faced in clinical settings. The format is still flexible, and I am happy to use this forum to explore topics you want to know more about or answer some of your questions.

The fact that health care environmental hygiene even gets a column in a prestigious infection prevention magazine attests to the recent changes we have seen in the field in the last 10 years. Yet, these changes feel like they have been long overdue. If you walk down the street and ask the first person you meet whether they think it is essential that hospitals are cleaned well to protect patients, their answer is almost always a resounding “yes.”

However, medical professionals and hospital administrators sometimes give different answers. The reason for this difference is that although there is long-standing biological plausibility about the importance of the health care environment to patient safety, the literature lagged decades behind. The main reason was that most people doing important research in infection prevention weren't as interested in the health care environment as in other subjects.

Reasons for this lack of interest are also multiple and couched in their socio-cultural contexts. We often hear environmental services (EVS) referred to as “housekeeping” services, and many health care facilities don't view those who clean as medical professionals. Traditionally, cleaning health care facilities were often managed in the same way as cleaning a hotel. It was considered “women’s work” and treated as an entry-level job for relatively uneducated, often immigrant populations who were willing to work long, hard hours with dangerous chemicals and alongside infectious people for low wages. The EVS workforce in much of the world remains predominantly female and often has a low level of education.

Thankfully, some pioneers in the field fought to get environmental hygiene recognized as a key domain in IPC. I want to dedicate this first column to Professor Stephanie Dancer, MD, MBBS, MSc, BSc, FRCPath, DTMH, FRCP(Ed), who is a consultant microbiologist in National Health Service Lanarkshire and Professor of Microbiology at Edinburgh Napier University, Scotland, who refers to health care environmental hygiene (HEH) as the “Cinderella of infection control” and whose work laid the foundations for many of the recent advances in the field. Only through the work of people like Dancer and her peers could HEH finally get an actual “seat at the table” in infection control and prevention.

Over the last 10 years, the literature has finally been able to show not only that the health care environment is a key factor in the transmission of pathogens but also that improvements in the health care environment can reduce health care-associated infections. We have seen the recent development of national guidelines and a huge upswing in the amount of research in the field (partly helped by COVID-19, of course, but not only).

So now the real work begins: HEH programs need to be analyzed globally, tools for improvement need to be developed and implemented, and facilities need to understand the value of investing in a field that traditionally was one of the first places they would cut budgets. Globally, of course, it is still early days: Quality is generally low, and there is virtually everything left to do. Although, in some ways, that is intimidating, it also means that every effort we make will likely have a measurable impact. Measuring improvement is much more complicated when the level of quality in a field is already quite high. This means that whatever you can do in your facilities, even on a ward level, will positively impact staff and patients.

If HEH is the “Cinderella of infection control,” then Professor Dancer is certainly its fairy godmother, and it’s time to go to the ball. If you want an excellent overview of the history of the field, then you can read her synopsis “Hospital Cleaning: Past, Present, and Future” 

I look forward to going on this journey with 

’s readers and am excited to be part of a field whose time has come.

Feel free to email me at Alexandra.peters@unige.ch.

This new column, Clean Hospital with Alexandra Peters, PhD, explores advancements in health care environmental hygiene, highlighting its growing recognition as a key component of infection prevention and honoring pioneers like Professor Stephanie Dancer.

The Evolution of Health Care Environmental Hygiene: A Long Overdue Shift in Infection Control

Candida auris in maryland

That nursing facilities in certain areas experience more outbreaks of 

 raises the question of why this happens. Though C auris is rare in the United States, it is commonly found in long-term care facilities and is more prevalent in socioeconomically disadvantaged regions. A study titled "

and Neighborhood Socioeconomic Vulnerability in Maryland" was presented at IDWeek 2023 in Boston, Massachusetts, and it sheds light on this issue.

 cases in Maryland between June 2019 and December 2021, finding that patients frequently lived in disadvantaged neighborhoods with elevated crowding, uninsured populations, and diverse racial backgrounds. These factors may contribute to the spread of C auris, with 30% of affected nursing facilities located in socioeconomically disadvantaged areas.

To find out more about the study’s findings, 

) spoke with Lauren Leigh Smith, MD, MAS, assistant professor, University of Maryland, Baltimore, Maryland, about the poster presentation she gave at IDWeek. 

“We looked at the neighborhoods where patients lived and the neighborhoods where nursing facilities were, “Smith said. The reason why we chose to look at neighborhoods is because you can get a lot of different information about the environment that patients live in, and how that can contribute to illness overall. So, we looked at something called a vulnerability index.”

Leigh then said that they also looked at an area deprivation index. “What that does is it builds upon information that is built into the US Census. It takes that information and looks at different variables of the neighborhood that a patient lives in. For instance, it'll look at things like poverty, housing, racial, and ethnic minority status, and then it'll give you a risk, a score. And you can see how vulnerable that community is compared to other communities in the nation or the state.”

Then Leigh and the other investigators were trying to get a better understanding of the nursing homes in the state of Maryland. “When we talk about vulnerability indices, we're really trying to get a better understanding of how disadvantaged neighborhoods are and how vulnerable the people in these neighborhoods are. Originally, the big indices that we use are something called the social vulnerability index. And that's put out by the CDC, and it looks at different domains. And really what it was used for was to help emergency response planners and public health officials map and plan communities that likely need more support.”

Click here for more coverage of IDWeek 2023.

A study in Maryland from June 2019 to December 2021 analyzed 140 Candida auris cases, revealing that patients often resided in disadvantaged neighborhoods with higher crowding, uninsured rates, and racial diversity. ICT speaks to the lead author. 


Examining Vulnerability Factors in Patients With Candida auris in Maryland

Are you interested in exploring disinfection technologies to enhance healthcare outcomes? Our comprehensive white paper, "Evaluating Disinfection Technologies for Improved Healthcare Outcomes," delves into critical environmental and functional factors, highlighting the challenges and solutions for achieving whole room disinfection in various hospital settings. Learn about the advantages and limitations of continuous and episodic disinfection methods, including UV-C and 405 nm visible light. Discover how Indigo-Clean’s innovative 405 nm technology provides safe, continuous, and automatic disinfection, significantly reducing Healthcare Associated Infections (HAIs). This resource is essential for healthcare professionals seeking to optimize infection control protocols, maintain bioburden reduction between terminal cleanings, and improve patient safety. Download now to enhance your facility’s disinfection strategy.

Fill out the form below to download the whitepaper:

Discover how to optimize disinfection practices in your healthcare facility. Our white paper explores innovative technologies and strategies to enhance patient safety and reduce healthcare-associated infections (HAIs).

Evaluating Disinfection Technologies for Improved Healthcare Outcomes

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


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.

Matthew Weissenbach, DrPH, CPH, CIC, FAPIC

Articles

Latest Updated Articles