Hospital Infection Control

FDA should end `reckless disregard,’ ban latex gloves

April 27, 2011 – 2:58 pm | By Gary Evans | No comments yet

A consumer advocacy group is targeting one of the longstanding tools of infection prevention, saying latex gloves should be banned due to the risk of life-threatening allergic reactions in health care workers and patients. In an April 25^th petition to the Food and Drug Administration, Washington, DC-based Public Citizen argues that there are now safer alternatives to surgical and patient examination gloves that have cornstarch powder on them or are made of natural rubber latex. Alternative, such as powder-free, non-latex gloves, are readily available, the petition notes. Allergic reactions can occur when health care workers wear latex gloves or when they inhale cornstarch powder bound to latex proteins that has been released from latex gloves worn by others. Breathing in cornstarch powder bound to latex proteins can cause acute asthma attacks and anaphylactic shock in health care workers sensitized to latex. Patients can experience the same types of allergic reactions that occur in health care workers. Also, when cornstarch is deposited in tissues during surgery, it can promote infections, delay healing and cause inflammation, among other injuries, Public Citizen stressed. This is the second time the group -- famously founded by consumer advocate Ralph Nader in 1971 -- has petitioned the FDA agency to ban the use of cornstarch powder in latex gloves. A previous attempt in 1998 was not successful, thought the FDA did agree to reclassify surgical and patient examination gloves as class II devices requiring special controls, such as warning labels. Not mollified, the group now not only seeks much bolder action, but has thrown all latex gloves into the mix. “The FDA’s prolonged failure to take action eliminating the dangers posed by powdered surgical and patient examination gloves demonstrates a reckless and inexcusable disregard for the health and safety of patients and health care workers,” said Michael Carome, MD, deputy director of Public Citizen’s Health Research Group. “The dangers posed by powdered surgical and patient examination gloves and all latex gloves have been widely recognized throughout the medical profession and the world for many years and are indisputable. Safer, equally effective substitutes are available.”

FDA cracks down on MRSA product claims

April 26, 2011 – 3:06 pm | By Gary Evans | No comments yet

I am not aware of any study that shows that Methicillin-resistant Staphylococcus aureus (MRSA) is more difficult than susceptible staph strains to deactivate and remove by hand washing. The Centers for Disease Control and Prevention recommendation that health care workers “clean their hands with soap and water or an alcohol-based hand rub” before and after caring for a patient is the same for drug susceptible staph infections and MRSA. So in other words, MRSA is resistant to antibiotics, not hand hygiene. That said, companies that make prevention claims against MRSA are running afoul with the Food and Drug Administration, which doesn’t care if I am aware of any studies on the matter or not.  (Of course, any product claim that implies treatment – as opposed to prevention -- of MRSA infection would certainly be expected to raise a red flag in the FDA’s eyes.) The FDA has issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from MRSA. “Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents,” the FDA stated. “In addition, the labeling of some of the firms’ hand sanitizing drug products makes claims related to preventing infection from E. coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.” The FDA warning letters were sent to the following firms:

• Tec Laboratories for Staph aseptic First Aid Antiseptic/Pain Relieving Gel;
• JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protestant;
• Dr. G.H. Michener Antiseptic Co. for Dr. Michener’s Antiseptic Gel;
• Oh So Clean, Inc dab Clean Well Company for Clean Well All-Natural Foaming Hand Sanitizer, Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand soap

The warning letters explain that the companies are marketing these products in violation of federal law. “MRSA is a serious public health threat,” said Deborah Author, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.” The companies were given 15 days in the April 20 notice to correct the violations cited in the warning letters. Failure to do so may result in legal action including seizure and injunction. Health care professionals and patients are encouraged to report adverse events or side-effects related to the use of these products to the FDA's Med Watch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹ Consumers that have purchased these products should contact their physicians if they suspect a skin infection is either worsening or not improving, the FDA advised.

Lessons unlearned: Gram neg bugs conquer continuum

April 22, 2011 – 1:05 pm | By Gary Evans | No comments yet

Emerging multidrug resistant gram negative bacteria are spreading across the health care continuum, becoming entrenched in non-acute and long term care settings and threatening vulnerable hospital patients with untreatable infections, epidemiologists reported recently in Dallas at the annual conference of the Society for Healthcare Epidemiology of America (SHEA). Of course established heavyweights like Clostridium difficile and MRSA are still very much a concern, but multidrug resistant (MDR) gram negative rods like carbapenem-resistant Klebsiella pneumoniae (CRKP) and Acinetobacter baumannii (MDR-Ab) are a whole new threat. These pathogens are capable of pan-resistance, there are few drug options in any case, resistance-empowering plasmids can transfer among species, and infection mortality rates in the 40% range have been reported in vulnerable patient populations. Not exactly what you want moving through the health care continuum, but that appears to be what’s happening in a situation that could get considerably worse before it gets better. In the lessons unlearned category, we are reminded of the vancomycin resistant enterococi (VRE) outbreaks in the 1990s, when communication breakdowns between hospitals, nursing homes and other non-acute settings descended into accusations of who gave what to whom. “We spend a lot of time blaming each other,” said Jon Furuno, PhD, an assistant professor of epidemiology and public health at the University of Maryland School of Medicine in Baltimore. “If you talk to any nursing home administrator they will say that their infection control problems are primarily related to transferring residents to acute care. [Residents] come back colonized or infected with some resistant organism.” On the other hand, he told SHEA attendees, “If you talk to hospital medical directors and infection control, they tell you these nursing home patients are `cesspools’ of resistance and they spread it all over the hospital. The bad thing is that they are both right. We have to figure out how we are going to work together.” For more of this story and other SHEA coverage see the May 2011 issue of Hospital Infection Control & Prevention

Reality Check: Joint Commission lowers hand hygiene standard

April 15, 2011 – 3:51 pm | By Gary Evans | No comments yet

The touch of death in any given moment in a hospital may come from a ministering angel, literal “care” givers with a special place for patients in their hearts and transient colonies of some pan-resistant pathogen on their hands. “Wash ‘em,” we command yet again, lest the operation be successful but the patient die. But surely in an age of patient safety, top-flight hospitals have hung a scowling portrait of Ignaz Semmelweis in the main lobby and long-since banished the bane of the infection preventionist. Right? In a word, “no,” and don’t call me Shirley. Though ultimately a success story, a Joint Commission quality improvement project at eight “leading” hospitals has one startling footnote: the baseline hand hygiene compliance rate was a collective 48%. That’s right, we’re back to our old coin-flip analogy, and if you call heads the odds are slightly higher it’s going to be tails. (i.e., bread always hits the carpet with the buttered side down.) “When we first started this project all the organizations thought that they were around 80% – 85%,” says Melody Dickerson, RN, MSN, a Robust Process Improvement (RPI) Black Belt at the Joint Commission. “It was only when we did a true non-biased measurement that we found exactly where we were [48%].  It was surprising and shocking, but when you look at the literature that’s about where most people are.” The original goal of the project was to achieve and sustain 90% compliance. Collectively, the hospitals came up short, reaching 82% and causing the Joint Commission to rethink the wording in its hospital standards. Previously, the standard called for hospitals to demonstrate hand hygiene compliance at a rate greater than 90%. A hospital that failed to comply would receive a Requirement for Improvement (RFI) and have 90 days to show improvement to 90%. “Because of this project, we now know how difficult it is to reach 80% -- let alone 90%,” says Dickerson. “Now the standard says the hospital `needs to work to improve compliance’” Though the compliance level jumped an impressive 34% at the hospitals overall, the reality is that a disturbing number of patient encounters are still carried out with unwashed hands. “It begs the question: Was greater than 90% even an obtainable goal when you consider where you’re starting from?” she says. “What we found through this process is that some organizations are greater than 90%; others have not had as great of success. A lot of that depends where you start from. “

An inconvenient truth about mandated flu shots

April 11, 2011 – 3:32 pm | By Gary Evans | No comments yet

Everyone wants to have high rates of health care worker influenza immunization, but just who gets counted in their numbers? Not everyone. About half of hospitals face major barriers in tracking the immunizations of credentialed or other non-employees, according to a survey by the Centers for Disease Control and Prevention. The difficulty in tracking and documenting immunization is a reality that has to be faced as discussions begin about national mandates to immunize health care workers. The CDC is working to validate a National Quality Forum measure for influenza immunization of health care personnel, but first the agency must show that health care institutions can calculate the rates in a standardized way. Currently, hospitals use different methods of counting their employees and non-employees who are vaccinated or who decline vaccination, says Megan C. Lindley, MPH, epidemiologist with the CDC’s National Center for Immunization and Respiratory Diseases. “We know that things are being counted different ways and the rates are not necessarily comparable,” she says. “It makes it difficult to formally evaluate different policies for increasing influenza immunization rates when it’s not certain who’s being measured in those rates.” The ongoing CDC study involves three online surveys conducted during and at the end of the 2010-2011 influenza season at 216 health care institutions, including 80 hospitals, in four states. (One survey is still pending as of this post.) The institutions were asked to rate the ease of counting the vaccinated employees on a scale of 1 to 5. Hospitals responded that counting employees was relatively easy, with a score of 4.1. But counting credentialed non-employees, such as physicians, and other non-employees, such as contract workers or volunteers, was more difficult, with scores of 2.8 and 2.5. About half of the hospitals said their ability to determine the vaccination status of those non-employees was a major barrier. About a third said the time involved in collecting that information was a major barrier. The hospitals ranged in size from fewer than 75 beds to more than 500 beds. That mirrors a more informal survey conducted by Melanie Swift, MD, medical director of the Vanderbilt Occupational Health Clinic at Vanderbilt University in Nashville, TN. “By and large, people are able to provide vaccination to their direct employees and to track it,” she says. But the ability to track other non-employee groups – contractors, vendors, students, volunteers, credentialed professionals – varied widely, she says. A workgroup of the National Vaccine Advisory Committee, an expert panel that advises the U.S. Department of Health and Human Services, is considering the issue of mandatory influenza vaccination. If that becomes a federal recommendation, Swift predicts: “Everyone would comply in some fashion with that, but there would be large inconsistencies in the populations covered and in the ability to enforce that.” Special update from our sister publication, Hospital Employee Health –Michele Marrill

CDC and NIH new guidelines: BSIs largely preventable

April 7, 2011 – 2:27 pm | By Gary Evans | No comments yet

Public health officials and clinicians continue an unrelenting focus on a deadly infection that appears to be almost completely preventable: catheter-related bloodstream infections (CRBSI). The latest initiative comes in the form of new and updated guidelines by the Centers for Disease Control and Prevention’s Healthcare Infection Control Practices Advisory Committee (HICPAC). The guidelines were developed by a working group led by clinical scientists from the National Institutes of Health Clinical Center Critical Care Medicine Department (CCMD) along with 14 other professional organizations. They new guidelines are available at the HICPAC website. Major areas of emphasis in the guidelines include educating and training health care personnel, using maximal sterile barrier precautions during catheter insertion, cleaning skin with chlorhexidine (an antibacterial scrub), and avoiding routine replacement of certain catheters. Replacing a 2002 edition – a lot has changed in 9 years in BSI prevention - the new guidelines are titled "Guidelines for the Prevention of Intravascular Catheter-Related Infections" and were published April 1, 2011, in Clinical Infectious Diseases. They will also be included in a special supplement to the American Journal of Infection Control. Catheter-related bloodstream infections—like many infections in health care—are now seen as largely preventable," says lead author Naomi O'Grady, MD, medical director of procedures, vascular access, and conscious sedation services at the NIH Clinical Center CCMD. "Implementation of these critical infection control guidelines is an important benchmark of health care quality and patient safety." Efforts to track, report, and prevent bloodstream infections have improved in recent years. As part of its Action Plan to Prevent HAIs, the U.S. Department of Health and Human Services has a national goal of reducing one type of CRBSI, central line-associated bloodstream infections (CLABSI), by 50% by 2013. Starting in 2011, hospitals throughout the country must track and report CLABSIs in intensive care units in order to get an annual 2% Medicare payment increase. Hospitals will report their infection rates to CDC's National Healthcare Safety Network, and the data will be shared with the Centers for Medicare and Medicaid Services. These data will be made available to the public later this year on the Hospital Compare website.

MRSA patients urge SHEA, CDC to declare an epidemic

April 1, 2011 – 1:39 pm | By Gary Evans | No comments yet

A patient advocacy group called the MRSA Survivors Network is urging the Society of Healthcare Epidemiology of America (SHEA) and the Centers for Disease Control and Prevention “to finally declare MRSA an ongoing epidemic” during SHEA's annual conference that begins today in Dallas. A bacterial infection frequently acquired in the nation’s hospitals by patients seeking treatment for some other malady, MRSA is now killing more Americans than HIV/AIDS. Jeanine Thomas, founder of the Chicago-based network argues that infection control organizations and public health officials should finally recognize this “public health disaster” by acknowledging the enormous and growing scientific evidence that support active detection and isolation (ADI) for the control of MRSA. The MRSA group is calling for ADI to be mandated in U.S. healthcare facilities immediately. The U.S. Veteran's Administration hospital systems have taken the lead by implementing ADI for MRSA first in their intensive care units, now hospital-wide and in their long-term care facilities, the MRSA group noted. “This intervention has resulted in a significant reduction in infections, saved many lives and saved hospitals money,” the MRSA Survivors Network said in a statement. “So why does SHEA, CDC and the department of Health and Human Services continue with inaction, failure to lead or implement evidence-based, proven prevention interventions for MRSA as more Americans continue to be infected, disabled or die in U.S. healthcare facilities? The action follows a special report last year in the November and December issues of Hospital Infection Control & Prevention, which found that the VA system has reduced MRSA by 76% by using ADI and other strategies. The CDC is aware of the findings, but balks at urging widespread implementation of the VA policy. “Our job here at CDC is to make sure that all health care is safe — not to tackle a specific organism at the exclusion of others,” Michael Bell, MD, deputy director of the CDC division of Healthcare Quality Promotion, said in our report. You might fairly ask, “This, from the nation that eliminated polio and led the world in eradicating smallpox?” However, other epidemiologists also caution against tailoring infection control efforts against a single pathogen, arguing instead for a standard precautions approach that includes flexibility to go to more enhanced measures. Regardless, MRSA patient advocacy groups have caught the attention of state and federal lawmakers, and legislative mandates to prevent the bacterial infection continue to be discussed and implemented.