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Enmetazobactam (Exblifep; Orchid Pharma) has received FDA approval for treating complicated urinary tract infections (cUTIs), offering a promising solution in the battle against antimicrobial resistance.

FDA Approves Enmetazobactam for Complicated UTIs: A Breakthrough in Antimicrobial Therapy

In a recent study, vaccination administered during pregnancy was effective against severe lower respiratory tract illness associated with respiratory syncytial virus in infants.

Infants benefit from RSV vaccine when administered to mothers during pregnancy

. To clarify why the investigation was done, what the parameters were, and how this investigation applies to infection prevention personnel, 

 spoke with the author, Loveleen Tina Joshi, PhD. Joshi is an associate professor of molecular microbiology at the University of Plymouth, UK. She specializes in clinical microbiology and infectious diseases and provides advice to key national groups in these areas. Her research is focused on infection prevention and control, as well as molecular diagnostic testing to help tackle the global health care challenge of antimicrobial resistance (AMR).

: Would you explain your background that led to this study?

I am an academic researcher. I'm a scientist, and I'm interested in the pursuit of knowledge out of curiosity and to tackle some of the world's greatest challenges like antimicrobial resistance (AMR). So, the whole rationale for doing research like this is to understand whether disinfection is being conducted appropriately and whether there is triggering AMR in microorganisms.

since 2008. I'm an expert and have done a PhD in the area. In terms of disinfection, for a very long time, I've been very interested in understanding where the 

spores survive certain chemical treatments; it goes back to a 

, looking at how spores sit on surfaces and whether they bind to inorganic surfaces or organic surfaces better. 

American Society for Microbiology’s Applied and Environmental Microbiology

], what we looked at was trying to understand whether spores of 

 band to stainless steel surfaces, for example, or when they bound better to the apical microvilli of human epithelial cells (Caco-2 and MRC-5 cells) or HT-29 cells.

All the work we do is in the laboratory; it’s in vitro. And it's for the pursuit of general academic knowledge. We were very clear about that. And we found very interesting differences in the way spores stick to surfaces. 

What's important about the work that we did there was we realized that spores from trying different strains behave differently. You can't take 1 microorganism and say every single strain of one microorganism behaves the same way. I think that's a crucial problem and a big disconnect between the academic scientific world and the infection prevention and control (IPC) world.

In terms of practice, we're seeing things in the laboratory that don't translate very well into IPC practice because, by the sounds of it, IPC treats all microorganisms in the same way. In [many] tests, like the environmental monitoring (EM) tests and the United States Environmental Protection Agency [EPA] test, 1 strain represents [all the strains of a pathogen].

When you look at a whole range of different strains across 1 species, [many] have different strains. We found that with that [2012] study, and then it moved on, and it's several other studies, and what we're examining was the ability of these spores from different strains to interact with NaDCC. So that's a chlorine-releasing agent. In 2017 [we] published that data, we found that suboptimal levels of NaDCC didn’t work on 

, maybe actually exacerbating their ability to adhere to surfaces. This is a small form of the organism.

A spore is not the same as a vegetative bacterium. Many studies that people have done are with vegetative C difficile, which is irrelevant; it leaves [the body] as a spore, which is dormant, and it stays on a surface as a spore. These spores are made of calcium dipicolinic acid, very, very strong and have an exosporium layer on the outside. And that allows it to stick to surfaces. 

It's an interesting thing where we find that adherence levels are a bit off 

 because strains may change in response to biocide exposure. And that feeling is back then after that, in 2019, 

 that did go quite big in America and, and it was NaDCC, versus 

, in liquid, and again, across surgical gowns and scrubs. In that study, we found NaDCC was not efficacious at all.

We were approached by a hospital in America, who said they thought that their single-use gowns were transmitting 

. And I [thought], why is that even relevant? When a single-use gown is supposed to be a single-use gown, don't you throw it away? Well, their practitioners weren't throwing it away. To save money, they were wearing them again and again.

We did 2 different studies, though; we looked at how 

 transmitted on those surgical gowns, and we published a small study there. Then, we published a big study with 

of biocides and the NaDCC. We tried to disinfect the gown to see if that would work; a quick spray on the gown would get rid of the 

There was all this as a huge problem. We tried to help that hospital manage their 

 and give them a bit of advice. Then, in response to that study, because we proved that 

 had a high resistance level to NaDCC, we got a huge backlash from the Americans. Many people said to me your studies are irrelevant. The EPA testing you've done isn't doesn't match the EPA; the EPA doesn't think your standards are correct.

: For this study, what was your goal, and what were the parameters?

I did this in the pursuit of knowledge, not as an applicable test to the EPA and not to verify a product; it was to try and understand whether the spores are resistant or not. 

It's a bigger question beyond whether your product works or not, and it is a question about AMR. and whether the spores are contributing to it. And I got a lot of pushback and people telling me to go and do a study on hypochlorite. Because hypochlorite is the thing that everyone wants to use or everyone does use in America.

I went on almost on my own and continued impartially in a neutral way to test sodium hypochlorite. So we did that in the laboratory. And that's the study that [

We were looking at the Department of Health UK guidelines. And we were looking at what they recommended for 

, and whether it works. So 1000 parts per million of chlorine-releasing agent versus 

and 5000 parts per million, the contact time of 10 minutes. We replicated those types of testing using biocides, susceptibility testing, or suspension tests in liquid using purified spores of varying strains that were clinically relevant. That's where it differs.

So many companies use this kind of EN testing methodology with 1 strain on 1 type of 

, which may not be may not necessarily be representative of the microorganism itself.

In this particular study, we used a very high concentration of 

 spores because we wanted to replicate and see what could be the highest toleration amount of 

 in an environment. So, we put 1 x 108 spores in our test; we didn't look at varying other things. 

(So what we could have looked at and, and that's work that we're doing right now is looking at pH, looking at temperature, and time-kill assays over a range of time to understand a bit more about the organism.) 

, 3 clinically relevant strains, and sodium hypochlorite. What we found was that with high concentrations of high 

, the hypochlorite didn't even penetrate.

spores purified in a solution, and you add varying concentrations of hypochlorite. And it's not even penetrating the spore. And you're only seeing 1 log reduction, if that. And there are so many questions scientifically about this. 

From my end, it's how the exosporium works. And whether biocide is binding to different 

 exosporium layers, creating almost like a shield. We don't know what it's doing in that scenario. What we do know is that based on all the previous research and evidence that I've done, it's becoming quite clear that this tolerance of 

 to chlorine-releasing agents, there are questions to be asked and laboratory testing to be done to see if resistance is emerging.

We did these experiments, and then we thought to replicate the previous study; let's try and get some patient gowns, and since surgical scrubs, spike them or deposit them with 

 spores, and just see that they're transferred over. And then once you apply biocide to it, whether it causes a change in the transferability of the spores, and it causes some change. It just showed us that result that the spores still survived in these fabrics. There's something at play there that we don't understand.

It's great that these personal protective equipment (PPE) fabrics can retain spores, but it's not very great if autoclaving (disinfecting) them at 121 degrees in a steamer doesn't work because there's research that shows that. And it's also not great if a biocide can't penetrate the fibers of those surgical scrubs. You've got a process during laundering where the spores are still in the laundry process too. And when we're trying to address those kinds of questions as well.

It's like a big picture, and we don't know the full answer, but that's what we were doing and these tests that we were doing laboratory, again, as I said, it was the pursuit of scientific knowledge, but we were neutralizing biocide activity after 10 minutes.

Now, there are so many scientific publications that I've seen where people don't neutralize biocide activity. So how do you know whether your results are correct? You need to have a set contact time, shut off the activity of the biocide, and have a definitive cut-off where [you put in] that biocide in with the 

 for 5 minutes, and it neutralizes and sees how many 

 has left. And you can have a real true determination of sporicidal activity at that point.

: What should IPs and other IPC personnel take away from this study?

There are several things here. The first thing is about practice. What's done in the laboratory is potentially reflective of what can hit your clinical practice in the next 4 to 5 years. If we're seeing resistance emerging in laboratory environments, it's very likely to emerge across the board. And we've already seen that.

I know in the UK, we're seeing that there's chlorine resistance and tolerance emerging in practice, and many people have come to me after the study and said, we're seeing the same thing. And I'd say, Okay, if you, if you choose to accept that what we've said is real. We know it's real. But if it's different when people do it, IPC practitioners accept this is coming on the horizon; they need to start seeking alternative disinfection measures to ensure that 

 if that's a problem in their clinical environment, is dealt with efficaciously.

But then, if you want to go bigger and higher level to 

, IPC clinicians have a massive part to play in ensuring patient safety and ensuring that the appropriate antimicrobials or appropriate disinfection is used and patient or patients aren't exposed to dangerous microorganisms in a clinical environment, and hospital-acquired infections are persisting.

IPs are recognizing that they have a role to play and can be fantastic stewards. So, antimicrobial stewards help us save antibiotics and stop the infection from spreading. I would like to see them empowered to do something in an ideal world. I don't think there's a need to panic yet. Because we have many other biocides available, many of the technologies available can do the job. 

Please read the literature before making comments and try to understand that there is a gap between academic scientific research and clinical practice. Try to bridge those gaps and be informed of those changes in research.

: It is well known that soft surfaces cannot be disinfected. In fact, there is no EPA registration for soft surfaces. However, if I understand correctly, this study was pure research.

 It wasn't associated with EPA. It was a different set of questions that were in pursuit of trying to get rid of the microorganism from the environment, understanding more about [spores'] ability, physiochemically, to adhere to surfaces, not replicating something that disproved [how] a product works. That's not what we were doing here. I hoped the chlorine would work.

if you read the paper, I did 2 things. I did a liquid suspension study, a biocide test, and a soft surface study if you want to pass it as that, in IPC and people who are in disinfection and class it in that way, then those are the 2 things that I did. But from a scientific point of view, I did a susceptibility test using a biocide and then tested for adherence ability. So, again, is a different question for me, but that's how it translated to people. And I just think it's interesting that sort of like the misinterpretation of everything. AMR is a real thing. People need to realize that it's bigger than climate change.

We need to be able to disinfect, and that's the first 

The best infection is the one that didn't happen. The first thing is to clean properly. Because years and years ago, people used antibiotics like [candy]. At the time, I was like, oh, no, I think we'll be fine; antibiotics are available. And then what now? We've got our last lines of antibiotics only, and we're all desperately searching for new antimicrobials. And I'm sitting there saying biocide resistance is probably a thing, and we want to reconsider how we're using our biocides effectively. Are we using them at the right time, at the right concentration, and at the right dose for the right microorganism? And if we're not, we're contributing to that problem.

There will be a time when these microorganisms do what they did with AMR. They will become resistant to these disinfection processes. And where does that leave us? If we bury our heads in the sand now and continue to use things that don't work properly, we're going to be in trouble, and we will be scrambling for new disinfectants like we are antimicrobials. 

I am on antimicrobials. I'm going to go in and work on hypochlorite and figure out whether it is efficacious or not, or we'll work on multidrug-resistant pathogens and try and find the best way to kill them to try and save people's lives in the long run. That's my moral duty as a scientist to try and find solutions.

Please read the literature. Understand that [AMR] is an important issue that affects all of us as a species. It's important for you to understand that genuinely and for the public to understand it. Again, it shows a lot of myths about communication from the academic and scientific worlds to the public. Again, I think there's a disconnect, and we've got to do more to get that message out about antimicrobial resistance.

: In your study, sodium hypochlorite was diluted using sterile water. The point was made that this is not how it's done in the real world.

That’s an interesting comment that’s not necessarily true. I would like anyone who comments on that to go and watch [an EVS], disinfect, and clean in practice. You can't take a bottle of EPA-registered chlorine bleach and spray it; it has to be diluted, or if it isn't diluted, then it has to be made fresh, no matter if it's EPA-registered or not. 

So we got [the bleach] from a commercial company, a big scientific company. It had a certain amount of active chlorine in it. When we opened the bottle, we made the sodium hypochlorite fresh in terms of dilution to the parts per million that we wanted, and then we checked it. 

We could just get through bottle after bottle when we need to do it at the time; we won't use the same bottle again and again. And I wonder, for cost-cutting measures, do [EVS] do that? What do cleaners actually do? We just don't know what's going on in practice, where the cost-cutting measures are put in place, or how effective their training is.

After pushback on social media, Tina Joshi, PhD, spoke with Infection Control Today to clarify and explain her study, her lifelong research, and what she hopes IPs and other IPC personnel can take from them.


Pure Science: Bleach Study’s Author Discusses Research on Eliminating C difficile on Soft Surfaces 

Medical devices have advanced significantly over the years, now involving highly complex instruments with intricate features. Utilizing quality systems to prevent infection within these features is essential for optimal use. The 

 describes a quality system as “a formalized system that documents the structure, responsibility, and procedures required to achieve effective quality management.”

To extend the lifespan of a medical instrument and contribute to infection prevention, quality initiatives must be present in the medical device industry.

For these processes to be effective, they must be implemented from the source of creation and throughout the medical device manufacturing process. Various agencies regulate quality systems within medical device manufacturing against highly organized standards. This can include registration for 

: Quality System Regulation (QSR) for Medical Devices

 certification. According to these systems, one important aspect of a well-regulated QMS within a medical device manufacturing facility is maintaining the 

 of all instrumentation. This includes ensuring all devices are properly marked according to customer specifications with traceable information such as part numbers and lot codes. This information is essential to include, as it allows the product to be traced back to its origin if an infection occurs.

In addition to traceability, standards are set up by a QMS to assess the integrity of the instrument before leaving the facility. Numerous operations within these systems require inspection to verify conformance with customer specifications. At the final inspection checks, it is crucial to ensure products are free from dents, burrs, and any other defects that could expose the instrument to further damage or provide areas for moisture and bacteria to accumulate. 

Generally, when a manufacturer receives a product from a supplier that does not conform to design requirements, the lot of products will be returned to the supplier, and a nonconformance report and corrective action plan will be developed. This step in the process prevents defective instrumentation from being sent to end users and raises manufacturers' awareness of improvements that can be made in their quality systems.

Quality systems are equally important in health care facilities. One department that particularly benefits from a QMS is the sterile processing department. These professionals play a crucial role in infection prevention by ensuring that medical devices are properly cleaned and sterilized between patients. This includes following manufacturer 

 (IFUs). The Association for Professionals in Infection Control and Epidemiology (APIC) published a May 2024 whitepaper requesting an update on IFUs. The whitepaper, 

Modernizing Medical Device Instructions for Use(IFUs): Infection Preventionists Speak Up for Patient Safety

,” illuminates the complexities, inefficiencies, and frustrations associated with IFUs.

“One of the most important parts of the white paper was their recommendations. That standardized format for IFUs and making the IFUs last for the lifespan of the product [and] indicate when the IFP was last updated because that's important as well,” Michelle W. King, MT(ASCP), MPH, CIC, told 

. King is the corporate director of infection prevention and control for the Department of Epidemiology at the McLeod Health System in Florence, South Carolina, and a member of the APIC Communications Committee.

 states that IFUs “include the steps required for cleaning, disinfection, the level of disinfection required (eg, sterilization, high-level disinfection, 

 disinfection), the frequency of disinfection, and the products which are compatible for use on the device.”

 Once a piece of instrumentation arrives at a facility, health care professionals must understand how to properly use the device and appropriately decontaminate and sterilize the instruments, according to the IFUs. 

For patient safety, health care professionals must also handle instruments properly and use them as intended, allowing for effective bioburden removal and a prolonged lifespan. To reinforce this, certifications like the 

 Advanced Sterile Processing Certification

 set high standards requiring extensive planning to ensure proper care of instrumentation. To obtain a certification such as the DNVs, implementing quality systems is required. This certification, in particular, has guidelines for processes regarding metric tracking, including the number of sets and instruments sterilized, compromised instrument trays, and 

 (SSI) rates. These metrics provide insight into areas of improvement within the facility to address potential inefficiencies and ensure consistent prioritization of patient safety.

As medical devices continue to evolve rapidly, it is essential to implement quality systems. These systems can significantly extend a device's lifespan and reduce the risk of infection. By prioritizing quality systems from manufacturing to cleaning and sterilizing, the professionals who handle these products can better protect patients from device-related complications. This can improve outcomes for facilities and, most importantly, the patients on which the devices are used.

Peiffer SE, Story PB, Duffy GL. The impact of human factors on a hospital-based quality management system. Journal for Quality and Participation. 2016;42(1). 

https://asq.org/quality-resources/articles/the-impact-of-human-factors-on-a-hospital-based-quality-management-system?id=2e5fcc7c02b94cc3b9a9c627782b01f3

Office of the Federal Register, National Archives and Records Administration, Quality system regulation. Govinfo. (April 1, 2023), 

https://www.govinfo.gov/app/details/CFR-2023-title21-vol8/CFR-2023-title21-vol8-part820

ISO 13485 - Medical devices. International Organization for Standardization. March 11, 2020. Accessed May 27, 2024. 

http://www.iso.org/iso-13485-medical-devices.html

Manufacturers instructions for use - Expectations regarding access To IFUs for medical Instruments and devices. The Joint Commission. October 21, 2021. Accessed May 27, 2024. 

https://www.jointcommission.org/standards/standard-faqs/ambulatory/infection-prevention-and-control-ic/000002250/

DNV Healthcare’s sterile processing program certification. Det Norske Veritas. Accessed May 27, 2024. 

https://www.dnv.us/supplychain/healthcare/SterileProcessing/

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

's) Editorial Board members—a diverse group of professionals dedicated to advancing infection prevention and control practices. This series highlights each member's unique expertise and contributions to the field. 

From groundbreaking research to innovative strategies, these experts are at the forefront of enhancing health care safety. Join us as we learn their insights, experiences, and visions for the future, providing valuable knowledge and inspiration to elevate infection control protocols.

, MSN, CIC, CPHQ, an infection preventionist in Saudi Arabia and health care policy consultant. 


: Please tell me about your health care and infection prevention journey. How did you become an infection preventionist?

My journey in health care began with a passion for helping others and a keen interest in science. After earning my degree in nursing, I started working in a clinical setting, where I quickly became aware of the critical importance of infection control. Observing how infections could severely impact patient outcomes, I was motivated to specialize in this area.

To gain deeper knowledge, I pursued further education and training in infection prevention and control. This included obtaining certification from recognized organizations such as the Certification Board of Infection Control and Epidemiology (CBIC). I also participated in various workshops and seminars to stay updated on the latest best practices and emerging threats in infection prevention. Additionally, I pursued a master’s degree in Nursing Administration, which provided me with a comprehensive understanding of health care systems, leadership skills, and strategic planning.

Further enhancing my expertise, I earned my Certified Professional in Healthcare Quality (CPHQ) certification. This equipped me with advanced skills in quality management and process improvement, which are essential for effective infection prevention and control.

My first role as an infection preventionist involved working closely with a multidisciplinary team to develop and implement infection control policies. I conducted regular audits, provided staff education, and analyzed infection data to identify trends and areas for improvement. Over time, I took on more responsibilities, such as leading infection prevention committees and participating in research projects to enhance our understanding of infection control measures.

Throughout my career, I've been driven by the goal of ensuring a safe environment for both patients and health care workers. The combination of my master's degree and CPHQ certification has enabled me to integrate quality improvement methodologies into our infection prevention strategies effectively. The challenges presented by outbreaks and the ongoing need for vigilance have only strengthened my commitment to this field. Today, I continue to advocate for evidence-based practices and collaborate with colleagues to advance infection prevention strategies in our health care system.

: What trends do you see in infection prevention?

Infection prevention is a dynamic field that continually evolves in response to emerging threats and advancements in health care. Several key trends are shaping the landscape of infection prevention today:

: Technology is playing a significant role in infection prevention. Electronic health records (EHRs), predictive analytics, and artificial intelligence (AI) are being leveraged to identify infection trends, predict outbreaks, and monitor compliance with infection control protocols in real-time.

: Hand hygiene remains a cornerstone of infection prevention. There is a growing emphasis on improving adherence through innovative methods such as electronic monitoring systems, which provide real-time feedback to health care workers, and the integration of hand hygiene education into routine training programs.

: The rise of antimicrobial resistance has increased the focus on antimicrobial stewardship programs. These programs aim to optimize the use of antibiotics, reduce the spread of resistant bacteria, and preserve the effectiveness of current treatments.

: New disinfection technologies, such as UV-C light and electrostatic sprayers, are being adopted to enhance the efficacy of environmental cleaning. There is also an increased focus on high-touch surfaces and their role in transmitting pathogens.

: The COVID-19 pandemic has underscored the importance of robust outbreak preparedness and response strategies. Healthcare facilities are investing in better infrastructure, training, and protocols to respond to infectious disease outbreaks quickly.

: Vaccination remains a critical component of infection prevention. Efforts are being intensified to improve vaccine coverage, combat vaccine hesitancy, and develop new vaccines for emerging infectious diseases.

: Continuous education for patients and health care staff is crucial. There is a growing emphasis on providing comprehensive infection prevention education, including online modules, workshops, and simulation-based training.

: What topics would you like to see in Infection Control Today for the rest of the year?

 can cover a wide range of topics to address the evolving challenges and advancements in the field of infection prevention and control. Here are some suggested topics for the rest of the year:

: Updates on recent outbreaks and emerging pathogens, their impact, and strategies for control and prevention.

: Strategies to combat antibiotic resistance, including stewardship programs, new antimicrobial agents, and innovative therapies.

Infection prevention in health care settings

: Best practices for infection control in hospitals, long-term care facilities, and outpatient settings. Focus on topics like hand hygiene, sterilization techniques, and environmental cleaning.

: Strategies to reduce HAIs, including catheter-associated urinary tract infections, central line-associated bloodstream infections, and surgical site infections.

Innovative technologies in infection control

: Advances in UV disinfection, antimicrobial coatings, and telemedicine for infection prevention.

: Challenges and strategies for infection control in low-resource settings, global health initiatives, and the impact of climate change on infectious diseases.


Meet the experts shaping infection prevention: Infection Control Today's Editorial Board members share insights, experiences, and cutting-edge strategies to enhance health care safety and quality. Meet Hebah al Zamel, MSN, CIC, CPHQ.

Celeste Krewson

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