By Kelly M. Pyrek
2017 promises to present a number of continuing and new challenges for the infection prevention and healthcare epidemiology community. One of the most significant for the field as well as the entire country is a new Presidential Administration. Sara Cosgrove, MD, MS, FSHEA, FIDSA, associate professor of medicine and epidemiology at Johns Hopkins University, and the 2017 president of the Society of Healthcare Epidemiologists of America (SHEA), acknowledges what she characterizes as "an enormous amount of uncertainty" about how a revamped White House and Congress could impact infection prevention and antibiotic stewardship-related issues.
Cosgrove, an infectious diseases physician, director of the antimicrobial stewardship program and associate hospital epidemiologist at the Johns Hopkins Hospital, alludes to the slow progress made on incorporating matters of interest to healthcare epidemiologists and infection preventionists into healthcare reform efforts.
"Over the past several years we have developed policy levers in infection prevention largely through value-based purchasing which puts more attention at the level of hospital administration on infection prevention and control activities," Cosgrove says. "I don't think the Affordable Care Act (ACA) is in any danger even though after the election people were asking themselves, is this the end of the ACA; I'm not certain that we know anything conclusive yet. It's still hearsay at this point that elements of the ACA that drive better and less expensive care, like value-based purchasing, could be separated from the more hot-button components of the ACA, at least based on campaign rhetoric. I don't necessarily think it's the end of value-based purchasing and I think those infection prevention-based levers will still be there, and be potentially unchanged. I think we need to wait and see what happens.
The legislation known as Obamacare has been polarizing, and Americans are divided on what should happen following the election's sweeping changes. According to the Kaiser Family Foundation Health Tracking Poll from October 2016, one-third of all voters recently polled want the law expanded, one-third want it repealed, and only 9 percent want the administration to scale back what it offers.
Cosgrove continues, "With antibiotic stewardship, our levers were still in development, so I think there is more uncertainty there. I'm fairly sure the Medicare conditions for participation for long-term care are going forward since they were essentially finalized and meant to go into play at the end of November. But the acute-care conditions -- which have infection prevention language also -- will probably be on hold for a little while, and hopefully not permanently. Fortunately, this is not really a partisan issue. The fact that the Joint Commission has put forth the standard on antimicrobial stewardship which goes into play on Jan. 1, 2017, will allow us to move forward. Hospitals tend to respond more to accreditation standards than they do these global conditions for participation, so from that standpoint I think that lever is still in place. SHEA is a relatively small organization and so we don't have a lobbying arm; however, I think we can work strategically within our own membership because many of our members are in academic settings in institutions that have government affairs staff and we may be able to rally the troops beyond just our membership. We will also work closely with APIC and IDSA when appropriate in order to have a united front."
Healthcare epidemiologists and infection preventionists have a critical role to play in advocacy work, Crosgrove says, from the standpoint of holding steady on existing work. "I think there is value in just pushing forward with the message we are already giving to hospital administrators, and that is, maybe we don't have acute-care conditions for participation but we have a Joint Commission standard and we need to move forward and increase the resources that are available to make sure we have good infection prevention and antimicrobial stewardship programs. We recognize that something could happen with the Affordable Care Act and value-based purchasing in 2017, but for now, we need to focus on how we have implemented solid work to have the safest environment possible for patients, so why would we stop doing that? So I would advise people to persevere with their current good work and all we can do right now is watch and see -- we may not be at risk at all."
Regarding a state of readiness to follow antimicrobial stewardship mandates that exist, Cosgrove remarks, "Speaking first for acute-care, I have been very happy and reassured to see that many more hospitals are having discussions about what stewardship looks like for them, examining more closely the different models they think will work with their institution's infectious disease mission, and ensuring that pharmacists without infectious disease training get some knowledge. I think we have come a long way from even five years ago when it was really only the academic medical centers that had antimicrobial stewardship programs, to having this renaissance of many more institutions getting involved in antimicrobial stewardship. It's important that as a group, we make sure that implementation is going well. One of my passions is that we not have people say for the purpose of a Joint Commission visit that they have identified a physician and a pharmacist to lead their program and they have an IV-to-PO conversion program in place and that's their entire stewardship effort. Obviously, to combat antibiotic resistance we have to have serious, well-implemented and actionable stewardship programs. We can't ask for too much too soon, and so the fact that people are getting organized and are thinking about this seriously, is a wonderful first step; we also want to encourage everyone to think about this -- not just the leadership of a stewardship program but all antibiotic prescribers."
Cosgrove continues, "Another critical component is to take it outside of the acute-care hospital and so I think we'll be watching with great interest how stewardship is implemented in the long-term care setting. I know there is a great deal of interest in supporting that work, and recognizing staffing challenges in that environment. We continue to work with our colleagues who are SHEA members and who work in long-term care environments to truly understand what's helpful and how we can assist them in their valiant efforts of doing more with fewer resources. We must also think about the ambulatory setting; now that the CDC has released its core elements document for stewardship in the ambulatory setting, we have the triad in place."
Cosgrove, along with a colleague, will be undertaking an AHRQ-funded research project to conduct true implementation work in antibiotic stewardship across the three settings. "It's broken down into several phases, the first being putting together a toolkit," Cosgrove explains. "It will address issues such as safety culture and behavioral change about antibiotic prescribing. AHRQ has made a significant investment in antibiotic stewardship and it's important to recognize that because there is concern the agency's funding could be affected by the Administration change."
Cosgrove adds, "One feature that crosses all infection prevention and patient safety initiatives is that we must do a better job in implementation. Essentially, how do we take what we know to be good evidence of anything that helps a patient have a safer hospital stay, and how do we make that be the standard practice? We are not so good at that across the country, and so AHRQ has been a leader in providing funding for true implementation work; I fear if that were to go away, we would understand the practice but fail to implement that practice. When we talk about implementation, it's not just stewardship implementation, it's also implementation of hand hygiene, prevention of SSIs, and other key basics. I feel we often get lured by the siren song of new technology and I think hospital administrators sometimes do too, and I get why it is more enticing to spend on technology than on more people. However, we shouldn't just throw up our hands and say technology will save us, when we haven't implemented basic practices. It's a harder approach because it involves behavior change, constant education and human-to-human interaction, but it is important that we not lose sight of that work."
To that end, Cosgrove says a project funded by the CDC and underway currently at Johns Hopkins Hospital opened her eyes to the need to reassess old presumptions. "We are interested in understanding more about how hospital rooms are cleaned so we are conducting a qualitative research project on environmental services workers' perceptions of their job. We want to learn about what they feel is hard about their job and how they view their role as part of the healthcare team. We haven't stopped to talk to the actual human beings doing the cleaning and how is it going; we need to ask them if they have the right tools for the job and we must ask them about what they perceive as the barriers to good cleaning and disinfection. These are the people who need to be considered as part of the healthcare team, and we have sometimes failed to include EVS workers, medical assistants, CNAs, those who interact with patients. We perhaps don't provide enough attention in our infection control work to these people who are so important."
Cosgrove emphasizes a return to not only the basics but a real-world approach to infection prevention and control. "SHEA has put some thought into whether it should be writing guidelines or whether it should be writing guidance documents instead," Cosgrove says. "There are so many issues in infection prevention and control that do not have a strong evidence base, so we all struggle with the same issues but there's not a paper we can point to that necessarily fully answers our questions. So SHEA has moved more into the area of developing guidance documents. One example that has been very popular is last year's guidance on animals in the hospital environment and how to balance the importance of interaction with the animal but not having an animal-associated outbreak. Our upcoming work includes three guidance documents of interest. The first is in the stewardship arena, looking at legal issues; this is an area that has not been investigated that much and we always get questions about it. Another guidance document in the works looks at how we diagnose infection and how we use antibiotics in the best possible way in the long-term care setting. I think it's a significant issue for practitioners in that setting. The third impending guidance document focuses on issues relating to anesthesia processes and infection prevention. By opening ourselves to writing guidance documents as opposed to guidelines, it allows expert opinion to play a role; I think for our membership, this may be more helpful than calling something a guideline and being more tied to the literature, which in infection prevention can be challenging."
Let's take a look at other imperatives for the New Year.
HAI Action Plan Target Goals
In late 2016, the U.S. Department of Health and Human Services (HHS) announced new targets for the national acute-care hospital metrics for the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination (HAI Action Plan). The target goals, which use data from calendar year 2015 as a baseline, replace the previous targets that expired in December 2013. The measures will track population-based harm from healthcare-associated infections (HAIs) at the national level. These measures address the following goals from the HAI Action Plan:
- Reduce central line-associated bloodstream infections (CLABSI) in intensive care units and ward-located patients
- Reduce catheter-associated urinary tracts infections (CAUTI) in intensive care units and ward-located patients
- Reduce the incidence of invasive healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infections
- Reduce facility-onset methicillin-resistant Staphylococcus aureus (MRSA) in facility-wide healthcare
- Reduce facility-onset Clostridium difficile infections in facility-wide healthcare
- Reduce the rate of Clostridium difficile hospitalizations
- Reduce surgical site infection (SSI) admission and readmission
- Adherence to process measures to prevent surgical site infection (SSI)
The initial set of acute care hospital targets and metrics included a measure on Surgical Care Improvement Project (SCIP) processes. That measure is no longer part of the HAI Action Plan because these processes are now widely accepted as standards of practice. To access the action plan overview, visit: https://health.gov/hcq/prevent-hai-action-plan.asp
On Sept. 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to make major changes to improve the care and safety of the nearly 1.5 million residents in the more than 15,000 long-term care facilities that participate in the Medicare and Medicaid programs. The policies in this final rule are targeted at reducing unnecessary hospital readmissions and infections, improving the quality of care, and strengthening safety measures for residents in these facilities. These changes are an integral part of CMS’s commitment to transform our health system to deliver better quality care and spend U.S. healthcare dollars in a smarter way, setting high standards for quality and safety in long-term care facilities.
The health and safety of residents of long-term care facilities are our top priorities,” said CMS acting administrator Andy Slavitt in a statement “The advances we are announcing today will give residents and families greater assurances of the care they receive.”
To learn more about these efforts to support person-centered care and improved safety for long-term care facility residents, visit the CMS Blog at http://blog.cms.gov/2016/09/28/commitment-to-person-centered-care-for-long-term-care-facility-residents/.
As the first comprehensive update since 1991, this rule will bring best practices for resident care to all facilities that participate in Medicare or Medicaid, implement a number of important safeguards that have been identified by resident advocates and other stakeholders, and include additional protections required by the Affordable Care Act. CMS received nearly 10,000 public comments, which were considered in finalizing this rule.
Changes finalized in this rule include:
- Strengthening the rights of long-term care facility residents, including prohibiting the use of pre-dispute binding arbitration agreements.
- Ensuring that long-term care facility staff members are properly trained on caring for residents with dementia and in preventing elder abuse.
- Ensuring that long-term care facilities take into consideration the health of residents when making decisions on the kinds and levels of staffing a facility needs to properly take care of its residents.
- Ensuring that staff members have the right skill sets and competencies to provide person-centered care to residents. The care plans developed for residents will take into consideration their goals of care and preferences.
- Improving care planning, including discharge planning for all residents with involvement of the facility’s interdisciplinary team and consideration of the caregiver’s capacity, giving residents information they need for follow-up after discharge, and ensuring that instructions are transmitted to any receiving facilities or services.
- Allowing dietitians and therapy providers the authority to write orders in their areas of expertise when a physician delegates the responsibility and state licensing laws allow.
- Updating the long-term care facility’s infection prevention and control program, including requiring an infection prevention and control officer and an antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.
CMS set out to revise the long-term care facility standards and originally issued the proposal being finalized today, in conjunction with the White House Conference on Aging in 2015, which marked the 50th anniversary of Medicare and Medicaid. The final rule is available on the Federal Register at https://www.federalregister.gov/public-inspection/.
Additionally in the long-term care arena, the Joint Commission and the CDC are in the process of identifying strategies for improving nursing home infection measurement. While multiple risk factors often put more than 1.5 million U.S. nursing home residents at risk for common infections and high rates of preventable adverse events due to infection, little is known about the challenges nursing homes face in implementing a standardized measurement program to track infections. To address this gap, The Joint Commission’s Department of Health Services Research is conducting a 12-month study of nursing home infection measurement supported through a research contract from the Center for Disease Control and Prevention’s (CDC) Antibiotic Resistance Solutions Initiative.
The study will utilize the CDC’s National Healthcare Safety Network (NHSN), a measurement system for infection rates at U.S. healthcare facilities. NHSN provides a free, systematic way to track infections, identify problematic trends, measure progress with prevention strategies and help reduce the prevalence of healthcare-associated infections. NHSN’s Long Term Care Facility component was released in 2012, but only a small percentage of more than 16,000 nursing care facilities have enrolled.
The Joint Commission’s study “Implementing standardized measurement of infections in nursing homes: challenges and facilitators” will: train a new cohort of nursing homes to enroll and initiate data reporting into the CDC National Healthcare Safety Network for infections caused by Clostridium difficile and multidrug-resistant organisms; measure organizational and individual characteristics and perceptions known to affect the ability to successfully implement quality improvement initiatives; and prospectively identify challenges and facilitators to implementation and analyze these factors relative to organizational characteristics.
The results of the study will inform policy makers on how prepared nursing homes are to implement standardized measurement of infections. Most importantly, standardized measurement has the potential to benefit residents and families. The overall goal is to prevent healthcare-associated infections. Understanding infection rates helps target improvement efforts.
“Standardized measurement of infections is critical to improving health, enhancing patient safety, and reducing morbidity and mortality, and this study will help uncover the challenges nursing homes face when enrolling and collecting National Healthcare Safety Network data,” says Beth Ann Longo, RN, NHA, MBA, MSN, associate project director in the Department of Health Services Research, Division of Healthcare Quality Evaluation, at the Joint Commission. “As more nursing homes participate in the CDC’s National Healthcare Safety Network, benchmarks for healthcare-associated infections can be determined—which aids national efforts to understand the spread and prevention of infections.”
Antibiotic stewardship will be a key driver of interventions for 2017. Antibiotic overuse has contributed to the growing problem of C. difficile infection and antibiotic resistance, and although progress has been made, more work is needed to address Clostridium difficile infection and CAUTI. In response to this challenge, the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare & Medicaid Services (CMS) have both developed initiatives for antibiotic stewardship. HHS has also developed an Agency Priority Goal to increase antibiotic stewardship programs.
Antibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world. Today, however, the emergence of drug resistance in bacteria is reversing the miracles of the past eighty years, with drug choices for the treatment of many bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States alone. Thus, combatting antibiotic resistance has become a priority for both the White House and the Department of Health Human Services (DHHS) Secretary. In response to outgoing-President Barack Obama’s Executive Order: Combating Antibiotic-Resistant Bacteria (CARB), the National Strategy and the National Action Plan for CARB were developed to provide a roadmap to guide the Nation in rising to this challenge. One of the core strategies within the action plan is improving the use of antibiotics, also known as antibiotic stewardship. This Agency Priority Goal (APG) will help advance efforts related to antibiotic stewardship in hospitals, where complications of and risk factors for antibiotic resistance are most concentrated. The APG also aligns with the strategic goals listed in the 2014-2018 HHS Strategic Plan.
At least one-third of antibiotics used in inpatient settings are either unnecessary or inappropriately prescribed. Antibiotic stewardship interventions have been proven to improve individual patient outcomes, reduce the overall burden of antibiotic resistance, and save healthcare dollars. Implementation of antibiotic stewardship programs in hospitals will help ensure that hospitalized patients receive the right antibiotic, at the right dose, at the right time, and for the right duration. Improved antibiotic use leads to reduced mortality, reduced risk of Clostridium difficile-associated diarrhea, shorter hospital stays, reduced overall antibiotic resistance within the hospital, and increased cost savings. Despite all of these benefits, the uptake of antibiotic stewardship programs and interventions among U.S. hospitals is variable. Data from 2014 show that only about 40 percent of U.S. acute-care hospitals report having antibiotic stewardship programs that incorporate all of the CDC Core Elements for Hospital Antibiotic Stewardship Programs.
HHS OPDivs and STAFFDivs are exploring a variety of strategies to accelerate the implementation of high-quality antibiotic stewardship programs in hospitals. These include:
- Working with existing quality improvement efforts (e.g., Quality Improvement Networks-Quality Improvement Organizations (QIN- QIOs)) to enhance stewardship programs
- Working with state health departments to support the implementation of stewardship programs
- Conducting research to build the evidence base that will support stewardship programs and interventions and to develop improved methods for conducting stewardship and for promoting the implementation of stewardship programs.
- Developing tools and recommendations and disseminating them to help with implementation of stewardship programs and interventions, and raising awareness about the importance of implementing stewardship programs as part of the National Strategy for CARB
- Increasing data for action by expanding enrollment in the National Healthcare Safety Network’s Antibiotic Use Option.
- Exploring regulatory/accreditation mechanisms to enhance compliance with antibiotic stewardship program recommendations.
- Developing diagnostic tools to allow clinicians to swiftly determine appropriate treatments for infected individuals and use antibiotics effectively.
- Identifying new treatment strategies to optimize and preserve the use of currently available antibiotic agents for healthcare-associated and drug-resistant pathogens.
In 2017, the CDC plans to launch a prevalence survey in approximately 150 nursing homes to help identify opportunities to prevent HAIs and improve AU in nursing homes. The agency also plans to complete a study of antibiotic selection and duration for the treatment of community acquired pneumonia, a leading cause of antibiotic prescriptions, using a large proprietary database.
Also in January 2017, the Joint Commission will enact its new antimicrobial stewardship standard for accredited critical access hospitals, hospitals and nursing care centers. The new standard, which goes into effect on Jan. 1, 2017, was developed to promote patient safety and quality of care, as well as to align critical-access hospital, hospital and nursing care center accreditation programs with current recommendations from professional and scientific organizations. The Joint Commission also plans to develop an antimicrobial stewardship standard for ambulatory and office-based surgery.
“This standard is based on current scientific literature and addresses the growing threat of antimicrobial-resistant organisms. It provides direction to hospital and nursing care center settings through requiring an antimicrobial stewardship program,” says Kelly Podgorny, DNP, CPHQ, RN, project director of the Division of Healthcare Quality Evaluation at the Joint Commission.
Antimicrobial/antibiotic stewardship is a proven method for improving the correct use of medications that treat infections, according to scientific and professional organizations. When implemented with organizational support, antimicrobial stewardship programs can help decrease the progression of antimicrobial resistance and improve how antimicrobials are used and prescribed.
The last several years have witnessed the emergence of pathogens such as MERS, the re-emergence of Ebola virus, and just last year, the world grappled with Zika virus. In late 2016, the CDC announced that it has identified 13 cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally. The CDC’s Morbidity and Mortality Weekly Report (MMWR) was the first to describe U.S. cases of C. auris infection, which is often resistant to antifungal drugs and tends to occur in hospitalized patients. In June 2016, CDC issued a clinical alert describing the global emergence of C. auris and requesting that laboratories report C. auris cases and send patient samples to state and local health departments and CDC. Since then, CDC has been investigating reports of C. auris with several state and local health departments. The agency expects to continue to investigate possible cases as awareness of the emerging infection increases.
“We need to act now to better understand, contain and stop the spread of this drug-resistant fungus,” said CDC director Tom Frieden, MD, MPH, in a statement “This is an emerging threat, and we need to protect vulnerable patients and others.”
Among seven cases detailed in the MMWR report, patients with C. auris were reported in four states: New York, Illinois, Maryland and New Jersey. All of the patients had serious underlying medical conditions and had been hospitalized an average of 18 days when C. auris was identified. Four of the patients died; it is unclear whether the deaths were associated with C. auris infection or underlying health conditions. In two instances, two patients had been treated in the same hospital or long-term-care facility and had nearly identical fungal strains. These findings suggest that C. auris could be spread in healthcare settings. Six of the seven cases were identified through retrospective review of hospital and reference laboratory records. Identifying C. auris requires specialized laboratory methods because it can easily be misidentified as another type of Candida infection, in which case patients may not receive appropriate treatment. Most of the patient samples in the current report were initially misidentified as another species of Candida.
Most of the C. auris strains from U.S. patients (71 percent) showed some drug resistance, making treatment more difficult. Samples of C. auris strains from other countries have been found to be resistant to all three major classes of antifungal medications. However, none of the U.S. strains in this report were resistant to all three antifungal drug classes. Based on laboratory testing, the U.S. strains were found to be related to strains from South Asia and South America. However, none of the patients travelled to or had any direct links to those regions. Most patients likely acquired the infections locally.
“It appears that C. auris arrived in the United States only in the past few years,” said Tom Chiller, MD, MPH, chief of CDC’s Mycotic Diseases Branch, in a statement. “We’re working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people.”
The CDC recommends that healthcare professionals implement strict Standard and Contact Precautions to control the spread of C. auris. Facilities should conduct thorough daily and after-discharge cleaning of rooms of C. auris patients with an EPA-registered disinfectant active against fungi. Any cases of C. auris should be reported to CDC and state and local health departments. CDC can assist in identifying this particular type of Candida if needed.
In 2013, CDC issued a report describing antibiotic resistance threats in the United States that needed prompt action, including Candida infections. CDC’s Antibiotic Resistance Laboratory Network is providing additional lab support in four regional laboratories to test fungal susceptibility of Candida species and identify emerging resistance. CDC is also expanding tracking of this fungus through the Emerging Infections Program. Information gathered through these networks plays a key role in tracking resistance and informing policies and interventions.
The challenge of emerging antibiotic resistant threats like C. auris highlights the need for urgent, coordinated federal, state, local, and international public health response and the importance of CDC’s AR Solutions Initiative. The timely investments in the AR Solutions Initiative empower CDC to rapidly detect, investigate, and respond to emerging threats, like C. auris; prevent resistant infections from occurring and spreading across healthcare settings and the community; and innovate, supporting development of new diagnostics and drugs to test, treat, prevent infections, and save lives.
Cosgrove warns against settling into a "bug of the month" mentality. "The whole area of preparedness can apply both to our daily work as well as to an outbreak circumstance," Cosgrove emphasizes. "There are many outbreaks, not just Ebola; there are small clusters of outbreaks related to pathogens that every infection prevention and control program faces. So the more we do to educate each other and new people in the field about how to work through that, the better we all will be prepared, and it will be valuable for our daily work as well as when an unfortunate event happens. To that end, the CDC has funded a project to develop a whole training program on outbreak response, called the Outbreak Response Training Program. I have seen the preliminary courses and I'm excited about the level of education and training it will provide. It’s an effort that stems from the Ebola outbreak, but is really something people can use all of the time; it's not just how to work up an outbreak but all of the other critical parts of that endeavor. It should be available in 2017."
Medical Device-Related Risks
The safe use of health technology and medical devices requires that healthcare facilities recognize the possibility of danger or difficulty with those technologies and that they take steps to minimize the likelihood of adverse events. The ECRI Institute's Top 10 Health Technology Hazards List for 2017, produced each year by ECRI Institute’s Health Devices Group, identifies the potential sources of danger that ECRI believes warrant the greatest attention for the coming year. The guidance that accompanies the list provides practical strategies for reducing the risks, making the list a practical tool for both establishing priorities and enacting solutions.
"Technology safety can often be overlooked when hospital leaders are dealing with so many other issues," says David T. Jamison, executive director, health devices group, ECRI Institute. "As an independent medical device testing laboratory and investigator of technology-related incidents, we know what can go wrong and what steps hospitals can take to reduce patient harm related to specific technologies and processes."
This year’s No. 1 hazard calls attention to infusion errors that can still occur when using large-volume infusion pumps. Although today’s pumps incorporate features that reduce the risks of infusion errors, these safety mechanisms cannot eliminate all potential errors, and the mechanisms themselves have been known to fail. ECRI Institute continues to receive reports and investigate incidents of uncontrolled flow of medication to the patient—a potentially fatal circumstance known as “IV free flow”—and other infusion errors. Fortunately, as ECRI points out in its guidance document, a few simple steps can help catch use errors and component failures before patient care is affected.
Inadequate cleaning of complex reusable instruments, including duodenoscopes, remains high on the list this year in the No. 2 spot due, in part, to the severity of the infection risks and also the persistence of the problem: ECRI Institute regularly sees reports of contaminated medical instruments being presented for use on a patient.
According to the list, another technology posing significant risk is heater-cooler devices (HCDs), which are stand-alone devices needed for heat exchange in heart-lung machines used in some 250,000 surgeries annually in the U.S., according to the CDC. A recent study in Infection Control and Hospital Epidemiology by Sommerstein, et al. (Nov. 14, 2016) reported on a global outbreak of Mycobacterium chimaera, an invasive, slow-growing bacterium, linked to heater-cooler devices. This study adds interim guidance to recent field reports on the outbreak, providing precautionary recommendations to hospitals and health systems to reduce the risk of infections.
“It is surprising that a global outbreak like this could go unnoticed for years," says said Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland, lead author of the study. "This dangerous infection has put many patients at risk all over the world. Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”
In response to an increasing number of infections, investigators looked into hospital water sources and found M. chimaera in HCD water circuits; they also found the bacteria in air samples during surgeries with HCDs, suggesting transmission through air particles. To prevent future cases of invasive M. chimaera infections, the researchers made the following recommendations for hospitals and health systems, as well as public health authorities, based on their personal experience with the outbreak:
- Ensure strict separation of contaminated HCDs from air of critical medical areas
- Educate clinicians on the risks for and dangers associated with M. chimaera
- Screen patients who had open heart surgery, heart transplantation or those who were exposed to ventricular assist devices and demonstrate prolonged and unexplained fevers.
“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,” said Sommerstein.
Device-related infections is on SHEA's radar for 2017, according to Cosgrove. "We must align in our needs and strategies as big issues face us, and those include device-related infections," she says. "Regarding outbreaks related to heater-cooler devices, we need everyone's input to figure out what to do and manage an incredibly difficult situation where you have a device that is essential to perform CABG yet it has fundamental flaws that have not been addressed by the manufacturer. Both SHEA and APIC would like to see an improvement in how devices are being designed and manufactured. And the continued problems with endoscopes and related outbreaks will linger into 2017. It's just the latest in a series of issues that have plagued us for a while. It's an example of something that if it didn't happen, it would have saved hours and hours of IP and hospital epidemiologist time, because you have to conduct contact tracing for patients who had a CABG surgery in their institution over a long period of time. It's obviously a suboptimal situation; it takes time, it causes enormous anxiety in healthy patients who likely are not affected but who have to receive a letter or phone call regarding potential risk. This has an enormous impact on resources."
In late September, the Association for the Advancement of Medical Instrumentation (AAMI), in collaboration with the American Hospital Association, the CDC, the Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH), and the Joint Commission, held a two-day, invitation-only forum on medical technology and HAIs. The event served as a follow-up to the 2011 AAMI/FDA summit on medical device reprocessing, which convened 100 experts who were tasked with identifying a list of HAI-related hazards and articulating potential solutions and mitigation strategies. The HAI risk factors they identified included facility design, water quality, device reprocessing, and competency and training.
According to AAMI, one of the most recent high-profile cases of HAIs associated with medical devices occurred between 2012 and the spring of 2015 when at least 250 patients, based on a U.S. Senate committee report, were infected with antibiotic-resistant bacteria after undergoing endoscopic procedures with devices that had not been properly disinfected.
As we have seen, the FDA sent out a safety communication after the heater-cooler units found in bypass machines used during open-heart surgery were linked to the transmission of nontuberculous mycobacterium. The agency said it had received 32 reports of patient infections associated with these devices between January 2010 and August 2015. Still, the FDA said it is unsure exactly how many people may have been impacted by this HAI, as it can take years for symptoms to develop, making it “challenging for a healthcare facility, healthcare provider, manufacturer, or patient to recognize that infections…may be associated with the use of or exposure to a particular medical device.”
This type of indirect exposure to potentially harmful bacteria is something that hadn’t been on the radar for many healthcare professionals, said Lisa Waldowski, an infection control specialist at the Joint Commission. “I don’t think we’ve paid enough attention…to the impact (of) water and air…with regard to healthcare-associated infections."
The role of heating, ventilation, and air conditioning systems was just one factor identified during the forum as contributing to HAI risk. Other factors—which were named by a diverse group of clinicians, sterilization and reprocessing professionals, microbiologists, regulators, healthcare technology management professionals, representatives from accreditation bodies, and other experts—included:
- Inadequate facility design
- Inadequate surface/fixture disinfection
- Inadequate risk management practices
- Issues with steam/water quality
- Aged/outdated facilities
- The actions of healthcare providers, housekeeping and environmental services staff, as well as the C-suite
- Failure to consider reprocessing requirements when purchasing equipment
- Inadequate resources and training for sterilization and reprocessing staff
- The complexity of reusable devices and other design issues that make them difficult to clean
- Issues with instructions for use (IFU)
- Inadequate point-of-use treatment, such as decontamination
- Insufficient maintenance and repair of equipment and devices
AAMI says that for many in attendance of this forum, implementing a quality management system seemed like the most effective way to structure solutions to many of these problems. In fact, a new standard—ST90—that adapts the quality management system guidance found in ANSI/AAMI/ISO 13485 to device processing in healthcare facilities is expected to be published sometime in 2017. However, fixing the issue of device-related HAIs does not rest solely on the shoulders of standards developers or central sterile processing staff ? everyone has a role to play, Suzanne Schwartz, associate director for science and strategic partnerships at CDRH, articulated during her keynote speech. “Solutions are needed at an ecosystem level,” she said. “Until we change our model to more of a systems approach, our siloed efforts will only get us so far.” This event was a first step in gaining the consensus needed to take such a systems approach. AAMI is planning to develop a guide to help healthcare delivery organizations conduct HAI risk assessments in 2017.
For many in the healthcare industry, the most polarizing debate this fall has not been who should win the White House, but how far the Food and Drug Administration (FDA) ought to go in regulating the service and repair of medical devices. Last week, these divergent views came to a head during the agency’s two-day workshop on the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices by third-party entities and original equipment manufacturers (OEMs).
During the forum—held Oct. 27-28, 2016 at the FDA’s headquarters in Silver Spring, Md.—OEMs, third-party vendors, and hospital-based healthcare technology management (HTM) professionals all voiced a commitment to patient safety but clashed over fundamental questions related to reporting requirements for device-related incidents, access to information and parts, competition in the marketplace, and even whether there is truly a service problem to debate. For every point offered by one presenter, there was a counterpoint, and the tension in the room was sometimes palpable.
OEMs called for the FDA to extend the regulations that cover the service and repair of medical devices by manufacturers, known as the Quality System Regulation, to anyone who performs these functions. Such a change would “level the playing field, drive accountability, and have a positive impact on patient care,” said Jeff Lersch, vice president of sales at Karl Storz Endoscopy.
According to OEMs, some third parties, such as independent service organizations (ISOs), have at times used unqualified personnel to service devices, installed parts that have not been validated, and inadequately documented their work, leading to patient safety concerns. During the workshop, OEM representatives showed pictures and cited examples of improper service ranging from a woodscrew used to repair an angiographic power injector to the now infamous report of an endoscope repaired with chewing gum.
ISOs and hospital-based HTM professionals, however, criticized such examples as anecdotal, not evidence of a systemic problem. They cited the results of a study conducted by ECRI Institute, which found that servicing activities were related to just 0.005% of adverse events reported between 2006 and 2015.
“Even if the rate doubled, it would not be significant enough to warrant regulation by the FDA,” said Barbara Maguire, CCE, vice president of quality and Geisinger Clinical Engineering at ISS Solutions.
In her role as a representative of the American College of Clinical Engineering, Maguire also pointed out that the “vast majority of services” are already regulated by the Centers for Medicare & Medicaid Services, through state agencies, or through accreditation agencies like The Joint Commission. “Additional regulation would be redundant,” she contended.
A number of ISO representatives, including David Anbari, vice president and general manager of Mobile Instrument Service and Repair Inc.?expressed concern that additional regulation would have the unintended effect of creating a “de facto OEM monopoly” in the service industry. However, OEMs maintained that the focus was ensuring quality patient care, not gaining a larger market share.
“Our goal is to ensure the performance of these activities always results in the safe and effective operation of medical devices,” said Peter Weems, director of policy and strategy for the Medical Imaging & Technology Alliance. “It is not our goal to limit competition or drive companies out of business.”
Over the course of the two days, presenters and audience members also sparred over the availability of replacement parts and service manuals, as well as the training of service technicians. And in a sign that business and cost considerations are very much a part of this debate, an attorney for the Federal Trade Commission (FTC) spoke at the workshop.
Katie Ambrogi, attorney advisor with the FTC’s Office of Policy Planning, urged the FDA to keep in mind the “significant benefits of competition” and to “narrowly tailor” any future regulations.
When it comes to finding solutions, several presenters urged all stakeholders to focus on their common ground—and build on that. “There is so much mistrust from all sides,” said outgoing AAMI president Mary Logan. “We need to find middle ground in the areas where we are not so far apart and start building trust there. Once that trust is built, then we can start to find middle ground on the bigger issues.”
As for the FDA, it does not have any “pre-conceived solutions to this problem,” said Capt. Sean Boyd, deputy director for regulatory affairs in the FDA Center for Devices and Radiological Health’s Office of Compliance. The agency is still in the process of gathering information and will likely include patients and physicians in further discussions. “FDA alone is not going to solve and resolve this problem,” Boyd said. “We together are going to solve and resolve these issues moving forward … This workshop is a starting point.”