Infection Prevention eBug Bytes January 2016

1. Infection PreventioneBug BytesJanuary 2016 Gram negative bacilli – in cell division (approximately every 20 minutes)

2. Recovery of resistant bacteria from mattresses • Hospital bed mattresses are a potential reservoir of pathogens. The surfaces of mattresses may be contaminated by microorganisms that colonize a patient’s skin, by body fluids such as urine and wound exudates, or by feces. Mattresses with a high microbial load may contribute to the horizontal transmission of microorganisms between patients and other surfaces. Researchers evaluated 51 mattresses . A total of 26 had resistant bacteria on the surface; the predominant species were Acinetobacter baumannii (69.2%), Klebsiella pneumoniae (11.5%), and Pseudomonas aeruginosa (11.5%). The median length of hospital stay was 41 days; the bed occupancy for patients under contact precautions and the time at which the patient was diagnosed as a carrier of resistant bacteria was 18 days. • When the bacteria recovered from the mattress were phenotypically different from the bacteria associated with the bed’s current occupant, we sought to identify if the bed’s previous occupant had been a carrier of a resistant microorganism. In those cases, microbiology laboratory records of strains of K pneumoniae, P aeruginosa, and MRSA isolated from the mattresses were phenotypically similar to the microorganism carried by the bed’s previous occupant. Source: Recovery of resistant bacteria from mattresses of patients under contact precautions AJIC Dec 2015

3. Fewer Than 1 in 5 Nurses Comply With Guidelines for Standard Precautions • Only 17.4 percent of ambulatory care nurses reported compliance in all nine standard precautions for infection prevention. Researchers from Northwell Health (formerly North Shore Long Island Jewish Health System) conducted a study of 116 ambulatory care nurses to measure self-reported compliance with standard precautions, knowledge of hepatitis C virus (HCV), and behavioral factors influencing compliance. The highest rate of compliance was reported with always wearing gloves (92 percent), followed by always wearing a face mask (70 percent). Only 63 percent of participants reported that they always wash hands after removal of gloves and 82 percent reported that they always wash hands after provision of care. The study also found knowledge of HCV was variable, with more than one in four (26 percent) erroneously believing that it is commonly spread through sexual contact, 14 percent incorrectly believing that HCV causes premature death, 12 percent not knowing HCV antibodies can be present without an infection, and 11 percent not knowing there are multiple HCV genotypes. Standard precautions are the minimum infection control practices that should be used in the care of all patients at all times, whether or not they appear to be infectious. They are used to protect healthcare workers and patients from transmission of diseases that can be spread by contact with blood, body fluids, non-intact skin, and mucous membranes • Source:January 2016 issue of the American Journal of Infection Control

4. FDA – Heater-Cooler Machines • The Food and Drug Administration has issued a warning letter to LivaNova, a London-based medical device manufacturer, stating the company does not provide adequate cleaning information to prevent bacteria from accumulating inside its heater-cooler machines, which were linked to deaths at WellSpan York (Pa.) • Hospital in October and Penn State Hershey Medical Center in November. Between the two hospitals, 3,600 patients were notified that they may be at risk from infections due to the devices. The heater-cooler devices, used during open heart surgery to regulate temperature, never come into contact with patients. However, the machines are at risk of accumulating biofilm, which contains harmful bacteria that can be transmitted to patients through the air during surgery. Between Penn State Hershey Medical Center and WellSpan York Hospital, at least six deaths have been linked to the devices. In addition to finding the manufacturer-issued device-cleaning protocol to be ineffective, the FDA's investigation revealed the devices were misbranded and the company was operating without an approved application for pre-market approval. "Given the serious nature of the violations … the FDA is taking steps to refuse entry of these devices in the U.S., known as 'detention without physical examination,' until these violations are corrected," the letter reads. The FDA has demanded LivaNova to provide a written response detailing its plans to correct the numerous violations cited in the warning letter. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm

5. Ecologist finds another cause of antibiotic resistance • A senior research ecologist with the Savannah River Ecology Laboratory and Odum School of Ecology, believes environmental contaminants may be partly to blame for the rise in bacterial resistance, and he tested this hypothesis in streams on the U.S. Department of Energy's Savannah River Site. The 310-square mile site near Aiken, South Carolina, east of the Savannah River, was closed to the public in the early 1950s to produce materials used in nuclear weapons. This production led to legacy waste, or contamination, in limited areas of the site. This waste impacted some of the streams in the industrial areas. The results, published in the journal Environmental Microbiology, revealed high levels of antibiotic resistance in eight of the 11 water samples. The highest levels were found at the northern location of Upper Three Runs Creek, where the stream system enters the site, and on two tributaries located in the industrial area, U4 and U8. The level of antibiotic resistance was high in both water and sediment samples from these streams. McArthur conducted a second screening using 23 antibiotics on U4, U8 and U10, a nearby stream with little to no industrial impact. More than 95 percent of the bacteria samples from these streams were resistant to 10 or more of the 23 antibiotics," McArthur said. These included front-line antibiotics -- gatifloxacin and ciprofloxacin, which are used to treat basic bacterial infections from pink eye to urinary tract and sinus infections. The contaminated streams U4 and U8 had the highest level of antibiotic resistance. "These streams have no source of antibiotic input, thus the only explanation for the high level of antibiotic resistance is the environmental contaminants in these streams -- the metals, including cadmium and mercury. It is possible that antibiotic-exposed wildlife may have dumped waste into these streams but only streams with a history of industrial input had antibiotic-resistant bacteria. Bacteria in the six streams in the pristine areas of the site were susceptible to the antibiotics. Source: 1. McArthur, D et al. Patterns of Multi-Antibiotic-Resistant Escherichia Coli from Streams with No History of Antimicrobial Inputs. Microbial Ecology, 2015

6. TB outbreak leaves 3 deadin Alabama • The CDC calls TB one of the world's deadliest diseases: 26 people are infected and three have died from the infection in Alabama. • 1. As of January 2014, 26 people, including four children, have been diagnosed with TB, and three adults have died. Most cases are from Marion, Ala., a town in Perry County with 3,600 residents. There, the TB case rate is 253 per 100,000 population, far exceeding the TB case rate of 2.5 per 100,000 in the whole state of Alabama last year. • 2. The Alabama Department of Public Health has sent nurses and TB investigators to Marion to find patients with TB and provide preventative therapy to people who may have been exposed to the illness. • 3. The ADPH plans to pay people to come in and get screened for the illness. "This is so important and of such concern that we are giving monetary incentives to people who come in for screening and necessary treatment," Pam Barrett, director of the division of TB control, said in a statement. In an interview with Becker's, Ms. Barrett noted that the ADHP has "never done this before. • 4. Paid screenings will be available Jan. 11 through Jan. 29 at the Perry County Health Department. People will be paid $20 for getting an initial screening, an additional $20 if they come back to get the result and a third $20 if they keep a recommended chest X-ray appointment. A final $100 will be offered to people if they complete any recommended treatment. Ms. Barrett says they expect a large turnout • 5. The outbreak is believed to have originated from one or two active TB cases in the area from early 2014 Source: http://www.adph.org/news/assets/160107.pdf

7. Patients test positive for Hepatitis C 2 Utah hospitals • Roughly two months after two Utah hospitals began warning roughly 7,200 patients of possible exposure to hepatitis C, the CDC has confirmed an undisclosed number of patients have tested positive for the disease. A CDC official and the Utah Department of Health have confirmed positive test results among that pool of 7,200 former patients. Exact numbers will be released once the investigation is completed, according to a KSL report. • At the end of October 2015, McKay-Dee Hospital mailed letters to patients who may have been exposed to hepatitis C after a former nurse and a patient tested positive for the virus. In November, a second hospital — Davis Hospital and Medical Center in Layton, Utah — was linked to the outbreak, as the nurse in question had been caught stealing intravenous drugs while working there, according to KSL. According to KSL, 4,800 McKay-Dee Hospital patients and 2,369 Davis Hospital patients received warning letters regarding possible exposure. • The exposure period at Davis Medical Center was from June 2011 to April 2014. The exposure period at McKay-Dee Hospital was from June 2014 to November 2014. Both McKay-Dee and Davis hospitals are offering free hepatitis C tests to patients who may have been affected in this outbreak. Tests are offered through Jan. 31. Source: http://health.utah.gov/epi/diseases/hepatitisC/investigation

8. Federal judge enters consent decree against Downing Labs • Downing Labs (formerly known as NuVision Pharmacy) manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). “Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under unsanitary conditions, putting the health and safety of patients at risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA pursued appropriate and aggressive action to protect the public health.” The U.S. Department of Justice brought the action on behalf of the FDA. The consent decree prohibits Downing Labs and its owners from manufacturing, holding or distributing drugs until they comply with the FD&C Act and its regulations, in addition to other requirements. Most recently, as a result of serious deficiencies identified by the FDA during an inspection of Downing Labs ending in October 2015, the company voluntarily conducted a nationwide recall of its purportedly sterile drug products due to a lack of sterility assurance and ceased sterile operations. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481228.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

9. Number of scope-related infections higher than previously reported by FDA • More than 250 infections are linked to duodenoscopes worldwide in a three-year span, and U.S. hospitals were generally slow to report such infections, a newly released Senate committee report found. Sen. Patty Murray (D-Wash.) pushed for the investigation after duodenoscopes were linked to infections caused by antibiotic-resistant bacteria like carbapenem-resistant Enterobacteriaceae at hospitals like Seattle-based Virginia Mason Medical Center and Las Angeles-based Ronald Reagan UCLA Medical Center. According to the Seattle Times, the Food and Drug Administration identified 142 infections caused by duodenoscopes since 2010. The Senate committee estimates the number is closer to 250 between 2012 and spring 2015. • 1. At least 16 hospitals in the U.S. traced infections to duodenoscopes, but "generally did not raise alarms about these infections with federal regulators." When they did report the adverse events, the hospitals tended to do so informally and did not include all necessary information. • 2. Olympus, a major duodenoscope manufacturer, knew about two lab reports finding the closed-channel duodenoscope could harbor and spread bacteria in early 2013, the investigation found. But Olympus "never brought this information to the FDA, and did not alert hospitals, physicians or patients in the U.S. to the risk of infection until February 2015," according to the investigation. • 3. The FDA started investigating duodenoscopes for infection risk in September 2013 but did not tell hospitals or other organizations of the possible risks for 17 months — a span of time when at least 68 patients contracted an infection from the scopes. • 4. The FDA's adverse event database is "outmoded," according to the report. • 5. The Senate committee report suggests several changes to "minimize future delays in identifying and addressing device safety issues," including: • •Congress requiring unique device identifiers to be included on insurance claims and to fund a National Medical Device Evaluation System. The FDA possibly recalling closed-channel duodenoscopes after evaluating their design . Hospitals being required to report adverse events related to medical devices to participate in Medicare. • http://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf

10. 300 Massachusetts hospital patients possibly exposed to HIV, Hepatitis • Baystate Noble Hospital in Westfield announced on Friday that due to a lapse in disinfection protocols, 293 patients may have been exposed to blood-borne pathogens. The affected patients are those who underwent colonoscopies from June 11, 2012 to April 17, 2013. Hospital officials explained that Noble Hospital started utilizing new equipment for the procedure during the said start period. The new devices required different strategies for cleaning, but because of lack of training, inadequate disinfection practices were performed. • More specifically, disinfection between procedures did not sufficiently expose the single water irrigation port to a high-level of disinfection come the last part of the cleaning. • To address the issue, Baystate Noble Hospital intricately compiled all patients affected. The hospital sent out notification letters by mail starting Jan. 20. The letter contains instructions and details of recommended precautionary screening. The patients will not be responsible for any medical expenses that the procedures will incur. In the news release of the hospital, it states that the lapse occurred only at a certain part of the colonoscopy device and for this, the risk low. However, it is not zero so the hospital is taking the necessary steps to address the issue. The hospital also explained why it only released the news now. The reason is because the hospital was not aware of the potential risk until after the Massachusetts Department of Public Health raised the issue following a site visit. Source: http://www.techtimes.com/articles/127181/20160123/nearly-300-massachusetts-hospital-patients-possibly-exposed-to-hiv-hepatitis.htm