Infection Prevention

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Infections cause human suffering. They cost the healthcare system millions of dollars. And, in many cases, they are avoidable. This month, Repertoire reports on two infection-prevention-related issues that also have caught the public’s eye: the reprocessing of medical devices and the rise of antibiotic resistance.

Too Much of a Good Thing?

Why relying heavily on antibiotics has contributed to the emergence of drug resistance in bacteria, and how healthcare stakeholders can respond

Since penicillin was discovered in 1928, antibiotics have been a “critical public health tool,” according to the Obama Administration’s recently published “National Action Plan for Combating Antibiotic-resistant Bacteria.” But the emergence of drug resistance in bacteria is reversing their beneficial effects. 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.

That’s the bad news. The worst news is, it’s not the antibiotics themselves that are to blame. It’s the people who prescribe them, and the people – i.e., patients – who want them.

“The typical situation is that patients often arrive in the physician’s office asking for antibiotics for a ‘cold’ when, in actuality, many more times than not, they have allergic rhinitis or a viral syndrome in which antibiotics are not indicated. We use entirely too many antibiotics for conditions that do not need them, and this contributes to the increasing antibiotic resistance we are experiencing.”

The solution is simple – and difficult. First, physicians should always practice evidence-based medicine, says Fleming. Second, they should take into consideration the patient’s medical and personal needs and preferences before prescribing antibiotics. And third, “good and effective communication between patients and physicians is always the key to securing good outcomes.”

Antibiotic resistance threats
The National Action Plan follows by two years a report from the Centers for Disease Control and Prevention titled “Antibiotic resistance threats in the United States, 2013.”

In that document, CDC reported that each year in the United States, at least 2 million people acquire serious infections with bacteria that are resistant to one or more of the antibiotics designed to treat those infections, and that at least 23,000 people die each year as a direct result of these antibiotic-resistant infections. Many more die from other conditions that were complicated by an antibiotic-resistant infection.

In addition, the agency reported that almost 250,000 people each year require hospital care for Clostridium difficile (C. difficile) infections. In most of these infections, the use of antibiotics was a major contributing factor leading to the illness. At least 14,000 people die each year in the United States from C. difficile infections, according to the CDC. Many of these infections could have been prevented.

Problem is well-recognized
“It is very well recognized that incorrect prescribing offers little benefit and increases risk factors of exposing patients to incorrect and/or unnecessary antibiotics, resulting in numerous complications, including the development of antibiotic resistant infections and Clostridium difficile (CDI),” says Vicki G. Allen, MSN, RN, CIC, infection prevention coordinator Beaufort (S.C.) Memorial Hospital and vice chair of the communications committee of the Association for Professionals in Infection Control and Epidemiology, or APIC. “These complications can result in increased length of stay and readmissions, exposure to numerous other antibiotics to treat the resistant infections, and/or CDI. CDI often recurs and can progress to sepsis and death.

“There is also the consideration of general adverse events related to antibiotic use. Again, if the patient has been incorrectly prescribed an antibiotic, or is taking one unnecessarily, it opens the risk to these types of events. Some hospitalized patients now have infections for which there are no antibiotics available to treat.

Gina Pugliese, RN, MS, FSHEA, vice president of Premier Inc’s Premier Safety Institute, says, “There is overwhelming agreement by all of the stakeholders – world health leaders, governments, professional and healthcare-related organizations, the public health community, providers, industry, and researchers – that antimicrobial resistance is a global concern, with an urgent call for improving the use of existing antibiotics as a crucial step.”

“Multiple reports have been issued describing the new forms of antibiotic resistance and the ease with which it is able to travel at incredible speed and cross international boundaries….” In fact, says Pugliese, world health leaders have described antibiotic- resistant microorganisms as “nightmare bacteria” that “pose a catastrophic threat” to people in every country in the world. “With a quick look at the statistics here in the United States, it would be very difficult for anyone to not recognize this as a major public health issue,” she adds.

The use of antibiotics is the single most important factor leading to antibiotic resistance around the world, says Pugliese. Ironically, up to 50 percent of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed, she adds.

Antibiotics are also commonly used in food animals to prevent, control, and treat disease, and to promote the growth of food-producing animals, she points out. “The use of antibiotics for promoting growth is not necessary, and the practice should be phased out. Recent guidance from the U.S. Food and Drug Administration describes a pathway toward this goal. It is difficult to directly compare the amount of drugs used in food animals with the amount used in humans, but there is evidence that more antibiotics are used in food production.”

The cost of antibiotic resistance
Human suffering aside, antibiotic resistance costs the U.S. healthcare system a lot of money, according to experts.

Says Pugliese, “In most cases, antibiotic-resistant infections require prolonged and/or costlier treatments, extend hospital stays, necessitate additional doctor visits and healthcare use, and result in greater disability and death compared with infections that are easily treatable with antibiotics.” Estimates of the cost of antibiotic resistance in the United States vary, but have ranged as high as $20 billion in excess direct healthcare costs, with additional costs to society for lost productivity as high as $35 billion a year (2008 dollars), she adds.

In September 2014, the CDC and Premier Inc. released research on the widespread use of unnecessary and duplicative antibiotics in U.S. hospitals, and concluded it could lead to an estimated $163 million in excess costs. The study was published in the October 2014 issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America.

Researchers conducted a retrospective analysis of inpatient pharmacy data from more than 500 U.S. hospitals from 2008 to 2011 to identify the potential inappropriate usage of 23 intravenous antimicrobial combinations. Their analysis showed that 78 percent of hospitals administered potentially unnecessary combinations of antibiotics for two or more days, with a total of 32,507 cases of redundant antibiotics treatment.

Overall, these cases represented 148,589 days of potentially inappropriate antibiotic therapy, resulting in nearly $13 million in potentially avoidable healthcare costs from antimicrobial drugs, alone. If these cases were representative of all U.S. hospitals over the same time period, an estimated $163 million could have been saved through appropriate prescribing. These costs do not include other operational factors, such as the associated supply and labor costs, or patient safety complications.

In addition to antimicrobial resistance and excess costs, unnecessary intravenous combinations can increase the risk of adverse drug events, noted the researchers. Each drug has a risk of side effects, and combinations increase those risks as well as the risks for drug-drug interactions.

National Action Plan
The issue of antibiotic resistance isn’t new. But the recently released National Action Plan by the White House has brought it front and center.

The plan outlines steps for implementing a national strategy for combating antibiotic-resistant bacteria, and addresses the policy recommendations of the President’s Council of Advisors on Science and Technology. Although its primary purpose is to guide activities by the U.S. government, the plan is also designed to guide action by public health, healthcare, and veterinary partners. Implementation of the National Action Plan will also support a World Health Assembly resolution urging countries to take action at the national, regional, and local levels, according to the White House.

The guts of the plan rest with its five goals.

Goal 1: Slow the emergence of resistant bacteria and prevent the spread of resistant infections. Activities include the optimal use of vaccines to prevent infections, implementation of healthcare policies and antibiotic stewardship programs that improve patient outcomes, and efforts to minimize the development of resistance by ensuring that each patient receives the right antibiotic at the right time at the right dose for the right duration. Prevention of resistance also requires rapid detection and control of outbreaks and regional efforts to control transmission across community and healthcare settings.
Goal 2: Strengthen national One-Health surveillance efforts. Improved detection and control of drug-resistant organisms will be achieved through an integrated “One-Health” approach, which integrates data from surveillance systems that monitor human pathogens with data from surveillance systems that monitor animal pathogens. Goal 2 activities will also enhance monitoring of antibiotic sales, usage, resistance, and management practices at multiple points along the food-production chain, from farms to processing plants to supermarkets.
Goal 3: Advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria. Improved diagnostics will help healthcare providers make optimal treatment decisions and assist public health officials in taking action to prevent and control disease, according to the plan.
Goal 4: Accelerate basic and applied research and development for new antibiotics, other therapeutics and vaccines.
Goal 5: Improve international collaboration and capacities for antibiotic-resistance prevention, surveillance, control and antibiotic research and development. Antibiotic resistance is a worldwide problem that cannot be addressed by one nation in isolation, according to the plan’s authors.

By 2020, the Obama Administration hopes that implementation of the National Action Plan will lead to “major reductions in the incidence of urgent and serious threats, including carbapenem-resistant Enterobacteriaceae (CRE), methicillin- resistant Staphylococcus aureus (MRSA), and Clostridium difficile. The Administration hopes that the plan will also result in improved antibiotic stewardship in healthcare settings, prevention of the spread of drug-resistant threats, elimination of the use of medically important antibiotics for growth promotion in food animals, and expanded surveillance for drug-resistant bacteria in humans and animals.

Other significant outcomes could include creation of a regional public health laboratory network, establishment of a specimen repository and sequence database that can be accessed by industrial and academic researchers, development of new diagnostic tests through a national challenge, and development of two or more antibiotic drug candidates or non-traditional therapeutics for treatment of human disease.

Editor’s note: “Antibiotic resistance threats in the United States, 2013,” by the Centers for Disease Control
and Prevention, can be viewed at www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf

The “National Action Plan for Combating Antibiotic-resistant Bacteria, March 2015,” by the White House, can be viewed at www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

The problem… simply stated

Poor antibiotic prescribing harms patients, says the Centers for Disease Control and Prevention. Antibiotic prescribing practices vary widely and errors are common. Some facts to ponder:

About half of patients receive an antibiotic for at least one day during the course of an average hospital stay.

The most common types of infections for which hospital clinicians write antibiotic prescriptions are lung infections (22 percent), urinary tract infections (14 percent), and suspected infections caused by drug-resistant Staphylococcus bacteria, such as MRSA (17 percent).
About one out of three times, prescribing practices to treat urinary tract infections and prescriptions for the critical and common drug vancomycin included a potential error; either the antibiotic was prescribed without proper testing or evaluation, or it was administered for too long.
Doctors in some hospitals prescribed up to three times as many antibiotics as doctors in similar areas of other hospitals. This difference suggests the need to improve prescribing practices.

Poor prescribing puts patients at risk, according to the CDC:

Although antibiotics save lives (for example, in the prompt treatment of sepsis, a life-threatening infection), they can also put patients at risk for a Clostridium difficile infection, a deadly diarrhea that causes at least 250,000 infections and 14,000 deaths each year in hospitalized patients. Decreasing the use of antibiotics that most often lead to C. difficile infection by 30 percent (this is 5 percent of overall antibiotic use) could lead to 26 percent fewer of these deadly diarrheal infections.
Patients getting powerful antibiotics that treat a broad range of infections are up to three times more likely to get another infection from an even more resistant germ.

Source: Centers for Disease Control and Prevention, www.cdc.gov/vitalsigns/antibiotic-prescribing-practices/index.html

Definition of terms

“Antibiotic resistance” results from mutations or acquisition of new genes in bacteria that reduce or eliminate the effectiveness of antibiotics. “Antimicrobial resistance” is a broader term that encompasses resistance to drugs to treat infections caused by many different types of pathogens, including bacteria, viruses (e.g., influenza and the human immunodeficiency virus, parasites (e.g., the parasitic protozoan that causes malaria), and fungi (e.g., Candida spp.). While all of these pathogens are dangerous to human health, the Obama Administration’s National Action Plan for Combating Antibiotic-resistant Bacteria focuses on resistance in bacteria that present an urgent or serious threat to public health.

Source: National Action Plan for Combating Antibiotic-resistant Bacteria, www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

Targeting antibiotic-resistant bacteria

The Obama Administration has set the following targets for 2020:

For CDC-recognized urgent threats:

Reduce by 50 percent the incidence of overall Clostridium difficile infection compared to estimates from 2011.
Reduce by 60 percent carbapenem-resistant Enterobacteriaceae (CRE) infections acquired during hospitalization compared to estimates.
Maintain the prevalence of ceftriaxone-resistant Neisseria gonorrhoeae below 2 percent compared to estimates from 2013.

For CDC-recognized serious threats:

Reduce by 35 percent multidrug-resistant Pseudomonas spp. infections acquired during hospitalization compared to estimates from 2011.
Reduce by at least 50 percent overall methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections by 2020 as compared to 2011.
Reduce by 25 percent multidrug-resistant non-typhoidal Salmonella infections compared to estimates from 2010-2012.
Reduce by 15 percent the number of multidrug-resistant TB infections.
Reduce by at least 25 percent the rate of antibiotic-resistant invasive pneumococcal disease among <5-year-olds compared to estimates from 2008.
Reduce by at least 25 percent the rate of antibiotic-resistant invasive pneumococcal disease among >65-year-olds compared to estimates from 2008.

Source: National Action Plan for Combating Antibiotic-resistant Bacteria, www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

How serious are the threats?

The Centers for Disease Control and Prevention characterizes the seriousness of antibiotic resistance the following way:

Urgent threats

Clostridium difficile
Carbapenem-resistant Enterobacteriaceae (CRE)
Drug-resistant Neisseria gonorrhoeae

Serious threats

Multidrug-resistant Acinetobacter
Drug-resistant Campylobacter
Fluconazole-resistant Candida (a fungus)
Extended spectrum ß-lactamase producing Enterobacteriaceae (ESBLs)
Vancomycin-resistant Enterococcus (VRE)
Multidrug-resistant Pseudomonas aeruginosa
Drug-resistant Non-typhoidal Salmonella
Drug-resistant Salmonella Typhi
Drug-resistant Shigella
Methicillin-resistant Staphylococcus aureus (MRSA)
Drug-resistant Streptococcus pneumoniae
Drug-resistant tuberculosis

Concerning threats

Vancomycin-resistant Staphylococcus aureus (VRSA)
Erythromycin-resistant Group A Streptococcus
Clindamycin-resistant Group B Streptococcus

Source: “Antibiotic-Resistant Threats in the United States, 2013,” Centers for Disease Control and Prevention (www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf)

Are your customers part of a HEN?

Knowledge-sharing can help improve efforts to combat antibiotic resistance.

The Partnership for Patients initiative is a public-private partnership designed to improve the quality, safety and affordability of healthcare for all Americans. An important component of the initiative are so-called Hospital Engagement Networks. Focused primarily on making care safer and improving care transitions, HENs work at the regional, state, national or hospital system level to help identify solutions and disseminate them to other hospitals and providers. More than 3,700 hospitals participate in one of 26 HENs, according to the Centers for Medicare & Medicaid Services.

According to Centers for Medicare & Medicaid Services, Hospital Engagement Networks:

Develop learning collaboratives for hospitals.
Provide a wide array of initiatives and activities to improve patient safety.
Conduct intensive training programs to help hospitals make patient care safer.
Provide technical assistance to help hospitals achieve quality measurement goals.
Establish and implement a system to track and monitor hospital progress in meeting quality improvement goals.
Identify high-performing hospitals and their leaders to coach and serve as national faculty to other hospitals committed to achieving the Partnership goals.

Approximately 350 hospitals participate in Premier’s QUEST quality improvement collaborative, as well as Premier’s Partnership for Patients HEN, or Hospital Engagement Network, reports Gina Pugliese, RN, MS, FSHEA, vice president of Premier Inc’s Premier Safety Institute. Together, they participate in performance improvement initiatives and use safety surveillance systems to drive antimicrobial stewardship techniques into patient safety practices, such as delivering early blood cultures and appropriate antibiotics to improve sepsis care, she says.

To find out if your hospital customers are part of a HEN, go to http://partnershipforpatients.cms.gov/about-the-partnership/hospital-engagement-networks/thehospitalengagementnetworks.html.

Antibiotic resistance: An outpatient problem too

Improving antibiotic usage in the acute-care setting is an important component of the battle against antibiotic resistance. But much can be done in the outpatient setting – including the physicians’ office – as well. The government will soon demand that physicians step up to the plate.

“There is little doubt that antibiotics are overused in healthcare,” says David Fleming, MD, MA, FACP, professor of medicine and chairman, Department of Medicine, University of Missouri School of Medicine, and immediate past president of the American College of Physicians. “The typical situation is that patients often arrive in the physician’s office asking for antibiotics for a ‘cold’ when, in actuality, many more times than not, they have allergic rhinitis or a viral syndrome in which antibiotics are not indicated.”

A study published in the July 22, 2013, issue of JAMA Internal Medicine found that 82 percent of patients who acquired Clostridium difficile – the most common cause of healthcare-associated infectious diarrhea – in the community had either a recent outpatient healthcare exposure or an inpatient healthcare exposure without an overnight say. The study was based on surveillance in eight U.S. states from 2009 through 2011.

Outpatient settings such as physicians’ offices, emergency departments, and dialysis facilities can be the source of C difficile acquisition by exposure to contaminated environmental surfaces, as well as the prescription of antibiotics that disrupt the lower intestinal microbiota, wrote the researchers,

In their study, 64 percent of patients with CDI received outpatient antibiotics within 12 weeks before infection, the most common indications being ear, sinus, or upper respiratory tract infection or a dental procedure. “Multiple studies have noted that ear, sinus, or upper respiratory tract infections are common reasons for inappropriate antibiotic use in outpatient settings,” the researchers noted.

Stewardship plans are ineffective
Antibiotic stewardship programs can help. But “the fact that we are having a national call to action underscores the reality that, in general, such stewardship plans are ineffective,” says Fleming.

Some providers may be harboring misconceptions about such programs, he says. One such misconception is that they are designed primarily for cost-savings, “when in actuality they are designed to engender high-value care, where quality outcomes as well as cost control are equally encouraged.” Another is that antibiotic resistance is primarily market-driven, “when, in reality, [it is] most often driven by patient expectations due to misperception and communication breakdown with the physician and healthcare system.”

To combat antibiotic resistance, physicians should always practice evidence-based medicine, he says. They should take into consideration the patient’s medical and personal needs and preferences before prescribing antibiotics. And they should strive for good and effective communication with their patients, which, he says, “is always the key to securing good outcomes.”

National Action Plan
The Obama Administration’s National Action Plan for Combating Antibiotic-resistant Bacteria addresses the outpatient arena and sets the following three-year goal: The Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality and other organizations will issue guidance on antibiotic stewardship and best practices for ambulatory surgery centers, dialysis centers, nursing homes and other long-term care facilities, doctors’ offices and other outpatient settings, pharmacies, emergency departments, and medical departments at correctional facilities.

In addition, the plan calls for CMS to expand the Physician Quality Reporting System (PQRS) to include quality measures that discourage inappropriate antibiotic use to treat non-bacterial infections.

Needed: Next-generation diagnostics

Healthcare practitioners agree that antibiotic resistance can be reduced simply by “just saying no” to patients who request antibiotics for simple viral conditions, like a cold. But healthcare providers could use some help from developers of technology, including diagnostics.

The Obama Administration’s recently announced “National Action Plan for Combating Antibiotic-resistant Bacteria” calls for researchers to use new technologies – including whole genome sequencing, metagenomics, and bioinformatic approaches – to develop point-of-need diagnostic tests to distinguish rapidly between bacterial and viral infections and identify bacterial drug susceptibilities.

Waltham, Mass.-based diagnostic manufacturer Alere is onboard.

‘A critical tool’
“The National Action Plan contains a number of goals and objectives that, when achieved, will help to slow the spread of antibiotic-resistant bacteria,” says Seth Radus, vice president, government affairs, Alere. “Incentives for expanded availability of existing rapid point-of-care tests and for the development of new tests will be instrumental in achieving this goal.

“Rapid point-of-care tests are a critical tool that healthcare providers can use in combating antibiotic-resistant bacteria,” he continues. “They provide essential information to the provider about whether their patient has a virus or a bacterial infection. This knowledge, in conjunction with signs and symptoms, inform the healthcare provider about whether an antibiotic prescription is appropriate and, if so, which antibiotic to prescribe.”

Alere already has next-generation tools on the market to help providers make sound diagnostic and treatment decisions, according to Radus.

“The Alere i platform allows the physician to generate a 15-minute molecular flu result and an eight-minute Strep A result,” he says. “The Alere i platform is CLIA-waived for flu, so the test can be performed near the patient and a result generated and shared with the patient prior to the patient leaving the physician office.

“The Alere i Strep A – which recently received marketing clearance from the FDA – and Flu test will help the physician provide the correct treatment result: for a Strep A infection, an antibiotic, and for flu, an antiviral. With regards to drug susceptibility testing, those tests are in development. Incentives, such as those in the National Action Plan, when implemented, will encourage further development of these types of products.”

The company is currently under contract with the Biomedical Advanced Research and Development Authority (BARDA), which lies within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, for the development of a next-generation version of the Alere i influenza test, says Radus. “The funds from this contract are assisting us in the development of a low-cost, rapid point-of-care test that can be deployed in the community for use during pandemic influenza outbreaks.”

Editor’s note: To learn more about the President’s “National Action Plan for Combating Antibiotic-resistant Bacteria,” go to www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

Who’s keeping track?

Without good data, who’s to say whether U.S. providers’ programs to curb inappropriate antibiotic usage are having any effect? That’s a problem.

“There are numerous measures of antimicrobial use, and until we have an agreed-upon measure to provide standardized data, we will not be able to assess the effectiveness of our antibiotic stewardship programs [ASPs] on a national scale,” says Gina Pugliese, RN, MS, FSHEA, vice president of Premier Inc.’s Premier Safety Institute.

“We need additional research to identify sound outcomes measures to evaluate the effectiveness of the components of ASPs. At present there are many structural components – e.g., ‘Do you have an ASP in place? – and process components – e.g., ‘percentage compliance with an antibiotic time-out at 48 hours post-initiation of antibiotic therapy’ measures. In other words, to identify the critical components, we need quantitatively validated, evidence-based, prioritized ‘drivers’ of the best outcomes from ASP models.”

Work is underway at the federal and state level to generate the data needed to achieve that goal. One vehicle is the Centers for Disease Control and Prevention’s National Healthcare Safety Network Antimicrobial Use and Resistance (NHSN AUR) module.

Said to be the nation’s most widely used healthcare-associated-infection (HAI) tracking system, the NHSN provides facilities, states, regions, and the nation with data needed to:

Identify infection prevention problems by facility, state, or specific quality improvement project.
Benchmark progress of infection prevention efforts.
Comply with state and federal public reporting mandates.
Drive national progress toward elimination of healthcare-associated infections.

NHSN now serves over 13,000 medical facilities tracking HAIs.

“NHSN AUR “has a standardized measure, and will be very helpful in achieving this goal of measuring our success with appropriate [antimicrobial] use and resistance,” says Pugliese. “Experts will be needed in each state to facilitate this and provide support and technical expertise and assistance to hospitals to assure success,” she adds.

Software can help
Meanwhile, the federal government is pushing providers and software developers to improve the quality and quantity of data on antibiotic resistance.

For example, the Obama Administration’s National Action Plan for Combating Antibiotic-resistant Bacteria, issued in March, calls for CMS to develop a tool to help software developers certify electronic health records and other health IT software for recording and submitting antimicrobial usage data. The plan also calls on CMS to complete an analysis of standards and terminologies for antimicrobial usage reporting to ensure alignment between NHSN reporting and CMS’s Hospital Inpatient Quality Reporting (Hospital IQR) program reporting.

In addition, the National Action Plan identifies the following milestones for reporting antibiotic usage in inpatient settings:

Within one year:

CDC will finalize arrangements for the purchase of proprietary data on inpatient antibiotic use to supplement NHSN data until a larger number of hospitals begin to use the NHSN module for antibiotic use reporting.
CDC will work with healthcare and public health partners to propose new healthcare-facility antibiotic use measures to the National Quality Forum.

Within three years:

CDC will use data collected through the NHSN AU module to provide annual national estimates of aggregated inpatient antibiotic use and feedback to healthcare facilities on antibiotic use, indicating whether antibiotic use rates are above or below the national average.
CDC will establish routine reporting of antibiotic use and resistance data from select hospital systems via the NHSN AU and AR modules.
The Department of Defense will centralize its reporting of inpatient antibiotic use to NHSN.

Within five years:

CDC will provide estimates of inappropriate inpatient antibiotic prescribing rates by state and region, and use this data to target and prioritize intervention efforts.

Editor’s note: To learn more about the CDC’s NHSN Antimicrobial Use and Resistance (AUR) Module, go to www.cdc.gov/nhsn/PDFs/training/AUR-training.pdf

“The National Action Plan for Combating Antibiotic-resistant Bacteria, March 2015” can be viewed at www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

Reprocessing guidelines are sign of the times

FDA document addresses concerns about complex, difficult-to-process instruments

It was four years in the making. But in March, the U.S. Food and Drug Administration issued its long-awaited final guidance document on reprocessing reusable medical devices – the first such update since 1996.

The document underscores the importance of manufacturers designing reusable medical devices with reprocessing in mind, and providing crystal-clear instructions to providers on how to clean, disinfect and sterilize them. It also draws attention to the need for providers to place well-trained, well-qualified people in reprocessing areas.

“This is the most comprehensive set of guidelines on reprocessing available to this point,” says Donna Swenson, president and CEO, Sterile Processing Quality Services Inc., Stickney, Ill. “If you read them, and if you’ve been involved with AAMI [the Association for the Advancement of Medical Instrumentation] and other organizations, you can see that they really have been listening to what the various stakeholders had to say.”

The guidance document reflects the dramatic changes in medical instrumentation and research on reprocessing that has taken place since 1996, says Susan Klacik, central sterile services manager, St. Elizabeth Health Center, Youngstown, Ohio, and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) representative to AAMI committees. It also points to the need for medical device manufacturers and hospital central sterile departments to partner with each other in the name of patient safety. “Our objectives are strategically aligned,” she says. “We both want medical devices to perform exactly as designed – each and every time.”

Complexity of today’s devices
The complexity of medical instrumentation – and hence, the difficulty of ensuring its cleanliness and safety – was one of the primary reasons the FDA began work several years ago updating its 1996 guidance document titled “Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities,” noted Geetha Jayan, PhD, senior science health advisor, Office of the Center Director of the FDA, during a webinar.

The new document, “Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling,” does a few things, she said:

Provides recommendations to medical device manufacturers for developing reprocessing instruction that can be easily understood and followed by users.
Outlines the FDA’s current recommendations to manufacturers on how to conduct scientifically sound testing to validate reprocessing methods
and instructions.
Describes measures the FDA is taking to enhance its oversight of the reprocessing of reusable devices.

The document also emphasizes the importance of designing devices that are less challenging to reprocess than some of those on the market today. It also provides recommendations on the “human factors” that can affect device reprocessing, including the ability of healthcare workers to clean and sterilize devices in the everyday work environment.

“In recent years, there has been an evolution toward the development of more complex devices with designs that are more difficult to reprocess,” said Elaine Mayhall, PhD, scientific review, Infection Control Devices Branch, Division of Anesthesiology General Hospital Respiratory & Infectious Diseases, Office of Device Evaluation in the FDA, during the webinar. “However, there have also been significant advances in the knowledge and technology involved in reprocessing reusable medical devices. The recommendations in this guidance reflect the scientific advances in these areas.”

Reprocessing instructions
The guidance document – a draft of which was issued for public comment in May 2011 – includes six criteria manufacturers must meet to ensure that providers understand and correctly follow reprocessing instructions.

Criterion 1: The reprocessing instructions should reflect the intended use of the device. Appropriate instructions depend on the physical design of the device, the intended use of the device, and whether it has direct or indirect contact with the patient. They also should reflect the type and extent of soiling and contamination to which the device is likely to be exposed during clinical use. Reprocessing methods are also dependent on the use of disinfectants or other chemicals that might leave harmful residues or adversely affect device materials or performance if inadequately rinsed, and any risk to the patient or the user.
Criterion 2: Reprocessing instructions for reusable devices should advise users to thoroughly clean the device. Adequate sterilization or disinfection depends on the thoroughness of cleaning. If a device cannot be cleaned, it cannot be disinfected or sterilized.
Criterion 3: Reprocessing instructions should indicate the appropriate microbicidal process for the device. The microbicidal process recommended is dependent upon the intended use of the device and is described by the Spaulding Classification for critical, semi-critical, and noncritical medical devices. (Critical devices are those introduced directly into the bloodstream or that contact a normally sterile tissue or body space during use. Semi-critical devices contact intact mucous membranes or non-intact skin, but do not ordinarily penetrate tissues or otherwise enter normally sterile areas of the body. Noncritical devices contact only intact skin but do not penetrate it.)
Criterion 4: Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed. The equipment and accessories needed to implement the instructions should be available for users to obtain. Also, the type of sterilizer, with manufacturer-validated sterilization cycle parameters and accessories, should be available to users.
Criterion 5: Reprocessing instructions should be comprehensive and include information about: special accessories and special protection needed during reprocessing; point of use processing or pre-cleaning instructions; disassembly and reassembly instructions, including step-by-step instructions with visual aids; the method of cleaning, including a list of parameters; the cleaning agent or the class of cleaning agent used in the manufacturer’s validation testing; instructions for rinsing the device following cleaning; the type and quality of water that should be used and the duration, volume, and temperature of the water; lubricating agent, if required; instructions for drying the device after processing and before storage; method of disinfection or sterilization, including the validated cycle parameters and accessories that should be used; instructions for reducing sterilant residuals following sterilization by ethylene oxide, hydrogen peroxide, or other processes that may leave sterilant residuals on the device; and more.
Criterion 6: Reprocessing instructions should be understandable. The instructions should be clear and legible. They should be presented in a logical, sequential order, from the initial processing step through the terminal processing step, and should be described using simple language. Charts, diagrams, and pictures that can be posted in a workstation are helpful.

Are instructions ‘technically feasible?’
Klacik applauded the FDA and the guidance document for a number of reasons. First, the document says that reprocessing instructions should be technically feasible and include devices and accessories that are legally marketed, she points out. That will eliminate one problematic area – that is, medical device instructions that call for extended sterilization cycles, even if the sterilizer (or indicators and CS wrap) has not been validated for the longer cycle.

Second, the document makes clear that manufacturers must plainly list everything needed to properly clean and sterilize their devices, down to what brush size should be used in lumens. “This helps me when a new product comes to the healthcare facility,” she points out. “CS should be able to look at the instructions to ask, ‘Can I service it? Can I thoroughly clean it? Do I have the right size brushes? The right ultrasonic cleaner? Do I have everything I need to process it?’”

Third, the guidance document discusses the handling of instruments at the point of use, most often, the OR. “That’s important, because a lot of things begin at the point of use,” says Klacik. For example, it has been documented that biofilm starts to form in as little as five minutes after use, she points out. Ideally, lumens should be flushed and gross debris wiped off before then.

Fourth, the guidance document stresses the importance of proper cleaning, and the importance of providing educational resources to those reprocessing their devices.

Fifth, the document talks about validation of reprocessing instructions. “Validation has to be done under the worst-case scenario,” that means inoculating with soils that mimic actual use and in the most difficult circumstances, she says. Instructions must also take into consideration “real life” conditions. “In the decontamination room, we wear thick utility gloves, personal protective equipment and gowns,” she points out. Tactile sensation is diminished, and glasses can fog up, as the work is often performed in crowded workspaces. Manufacturers must take all this into account when developing reprocessing instructions.

“Using simulated studies will identify difficulties in cleaning in the “real world,’” she says. “The difficulties cleaning the duodenoscope is an example of an instrument that is extremely complex to clean, requiring specialized training with proven competency with direct observation to ensure the tech performs the required flushing and raising and lowering of the elevator during cleaning. This scope also requires specific types of cleaning brushes.”

‘Revolutionary’
Swenson points to what she considers to be a revolutionary aspect of the FDA document.

Typically, when the agency issues a guidance document, it addresses activities that should take place “from this point forward,” but leaves intact instructions for what has already transpired. “But there is something in this document that makes it a little bit different,” she says.

In the new guidance document, the FDA says that reprocessing instructions for some older, legally marketed reusable devices may not be consistent with state-of-the-art science. Therefore, the provider following those instructions can’t ensure that their reusable devices are clean and safe to use after reprocessing.

“Never before have previous devices been considered adulterated,” Swenson points out. “They are approved, they are on the market and they are legally sold. New technology may come along and make the device obsolete, but if people are still using it, there was nothing to make them stop using it. But if the FDA is saying these devices could be considered adulterated or misbranded – that is, the labeling doesn’t bear adequate directions for reuse – it could potentially tell companies that their products have to be removed from the market.

“This makes a big difference to the hospital too,” she adds. “If the FDA decides these devices are no longer acceptable because the cleaning instructions aren’t adequate, hospitals would have to start replacing them. Having talked to FDA people in the past, they have been of the opinion that eventually, hospitals would stop using outdated devices, which would be phased out. But that hasn’t happened in a lot of cases. You still see first-generation laparoscopic devices out there.

“But this particular section of the document appears to say that if science moves beyond some of these older devices, then when the FDA inspects the manufacturer, they may ask, ‘What are you doing about that?’ Also, FDA shares information with other agencies, she says. And although the FDA does not directly regulate hospitals, other regulatory agencies may ask hospitals, “Why are you continuing to use devices that aren’t acceptable any longer?’”

Editor’s note: “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Final Guidance – March 24, 2015,” is available at www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf

Duodenoscope issues capture public’s attention

Every so often, even the most arcane aspects of healthcare operations – such as the reprocessing of medical devices – capture the public’s attention.

So it was that in February, following reports of injuries and deaths attributed to inadequate processing of duodenoscopes, the U.S. Food and Drug Administration issued a “Safety Communication,” warning healthcare providers and the public that even the most meticulous attention paid to cleaning and disinfecting the scopes may not be enough to protect patients from infection passed on by other users. One month later, on March 12, the Centers for Disease Control and Prevention issued an interim protocol for facilities that want to test their duodenoscopes for contamination with bacteria after cleaning and disinfection.

Perhaps the most alarming thing about the duodenoscope affair was that outbreaks of infection appeared to have occurred even in cases where healthcare providers followed manufacturers’ instructions for reprocessing them.

500,000 procedures each year
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum), explained William Maisel, MD, MPH, deputy director for science and chief scientist, FDA Center for Devices and Radiological Health, on an FDA blog in February.

The scopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography – or ERCP – in the United States each year, he said. ECRP is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones or other conditions. The duodenoscope is a more complex instrument than other endoscopes and can be more difficult to clean and disinfect.

In its Safety Communication, the FDA said it is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and Escherichia coli. From January 2013 through December 2014, the agency received 75 medical device reports encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes.

The agency issued its alert after UCLA’s Ronald Reagan Medical Center in Los Angeles reported in February that seven patients who had undergone procedures with duodenoscopes had been infected with CRE. Two of those patients died, and an additional 179 were notified that they may have been exposed.

Culturing could be costly
Writing on the CDC blog in mid-March, Michael Bell, MD, deputy director of CDC’s Division of Healthcare Quality Promotion, wrote that the agency’s interim protocol can help providers detect contamination, whether due to lack of adherence to manufacturer-recommended reprocessing practices or any other reason, and to prompt follow-up action to protect patients if needed.

The protocol suggests techniques for inspection and manual cleaning and drying of duodenoscopes (as well as other flexible endoscopes that have an elevator mechanism), as well as remedial actions to be taken if any duodenoscope is found to be contaminated.

In the protocol, the CDC notes that some facilities routinely culture their scopes to assess the adequacy of reprocessing. “Holding duodenoscopes out of use while surveillance culture results are pending could be considered, especially if performing surveillance cultures after each use,” wrote Bell. “Any duodenoscope found to be contaminated should not be returned to use” until appropriate steps are taken.

That portion of the document has led to consternation among some providers, a point Bell acknowledged in the CDC blog when he wrote: “We recognize that there are both pros and cons associated with using screening cultures. There can be concerns about cost, as using this method will mean that the duodenoscopes will not be available for use while waiting for the results of the cultures. This could mean that a facility would need to buy additional scopes in order to be sure they have the equipment available when needed. Additionally, the failure to grow bacteria from the areas sampled may not guarantee that there are no bacteria present anywhere on the scope.”

Is culturing necessary?
“I don’t agree with culturing scopes or instruments unless you have a specific reason for doing so – e.g., a cluster infection, and you’re trying to figure out the source,” says Donna Swenson, president and CEO, Sterile Processing Quality Services Inc., Stickney, Ill. According to Swenson:

Culturing is expensive. It’s expensive to run the test and to obtain the additional instrumentation needed while waiting for results.
Culturing comes with its own set of issues. “You have to be sure that whoever is doing the culture isn’t contaminating the device.”
Other methods are available to test for cleanliness, including the well-established technique of flushing lumens with hydrogen peroxide and looking for foam.

“People need to develop a comprehensive program, and look at water quality, temperature, the chemicals being used and whether they are being dosed correctly,” she says. “If you would do all of these things and then verify the cleaning of the actual devices, I don’t see why you would need to do culturing.”

Staff training and competency
The duodenoscope issue and CDC protocol demonstrate the importance of training and certification of personnel responsible for reprocessing medical devices, says Susan Klacik, central sterile services manager, St. Elizabeth Health Center, Youngstown, Ohio, and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) representative to Association for the Advancement of Medical Instrumentation (AAMI) committees. “The design of these scopes makes thorough cleaning difficult and requires a true expertise with demonstrated competency to perform this complex task with the specified cleaning brushes,” she says.

In fact, the CDC recommends that competencies be assessed at initiation of employee duties and at least annually and anytime a breach is identified or when a new technique or equipment is introduced. “Competency verification should include direct observation in addition to other assessments per facility policy (e.g., written tests),” says the CDC protocol. “Personnel responsible for reprocessing endoscopes are encouraged to seek certification [in sterile services].”

The good news, says Klacik, is that central sterile processing personnel have access to better information and training than ever before. “We’re evolving,” she says, and suppliers of medical devices can help by providing educational programs, graphics, posters and other sources of information about reprocessing. “We’re like a sponge,” says Klacik. “We’ll take all the information we can get.”

Editor’s note: The Interim Duodenoscope Surveillance Protocol: Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing” is at www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html