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.”