Nontuberculous Mycobacterium Infections Associated With Heater-Cooler Devices.

BACKGROUND: Disseminated nontuberculous mycobacterium infections have occurred following surgical procedures involving extracorporeal circulation; contaminated water from heater-cooler devices (HCDs) has been implicated as the source. The purpose of this review was to evaluate the public health concern and to educate physicians who care for this patient population. METHODS: The Food and Drug Administration Medical Device Reporting (MDR) database was queried for reports received between January 2010 and August 2016 for patient infections and device contaminations associated with the use of HCDs. Reports were reviewed for type of infection, patient demographics or outcome, reporting country, HCD manufacturer, and the time to event occurrence. RESULTS: A total of 339 MDR reports involving 99 facilities and 5 HCD manufacturers were found. MDR reports originated within (n = 154) and outside the United States (n = 185), and included 107 MDR reports describing patient infections involving at least 86 patients and 232 MDR reports describing HCD contamination without known patient infections. The MDR reports identified the surgical procedure in 94 reports and infection location in 83 reports. The time from surgical procedure using an HCD to infection diagnosis was calculable in 67 reports and was reported up to 60 months following the initial surgery. Nontuberculous mycobacterium was the most frequent organism identified, with M. chimaera being the predominate isolate. CONCLUSIONS: Nontuberculous mycobacterium infections associated with HCDs used during cardiothoracic surgery may have a long latency period and may be lethal. Cardiothoracic surgeon awareness or involvement in this issue is critical in helping to mitigate this emerging public health concern.

Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery - United States.

In the spring of 2015, investigators in Switzerland reported a cluster of six patients with invasive infection with Mycobacterium chimaera, a species of nontuberculous mycobacterium ubiquitous in soil and water. The infected patients had undergone open-heart surgery that used contaminated heater-cooler devices during extracorporeal circulation (1). In July 2015, a Pennsylvania hospital also identified a cluster of invasive nontuberculous mycobacterial infections among open-heart surgery patients. Similar to the Swiss report, a field investigation by the Pennsylvania Department of Health, with assistance from CDC, used both epidemiologic and laboratory evidence to identify an association between invasive Mycobacterium avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices, all manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) (2). M. chimaera was described as a distinct species of M. avium complex in 2004 (3). The results of the field investigation prompted notification of approximately 1,300 potentially exposed patients.* Although heater-cooler devices are used to regulate patients' blood temperature during cardiopulmonary bypass through water circuits that are closed, these reports suggest that aerosolized M. chimaera from the devices resulted in the invasive infections (1,2). The Food and Drug Administration (FDA) and CDC have issued alerts regarding the need to follow updated manufacturer's instructions for use of the devices, evaluate the devices for contamination, remain vigilant for new infections, and continue to monitor reports from the United States and overseas (2).

Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.

What's in a Name? Recent Key Projects of the Committee on Organization and Delivery of Burn Care.

The Committee for the Organization and Delivery of Burn Care (ODBC) was charged by President Palmieri and the American Burn Association (ABA) Board of Directors with presenting a plenary session at the 45th Meeting of the ABA in Palm Springs, CA, in 2013. The objective of the plenary session was to inform the membership about the wide range of the activities performed by the ODBC committee. The hope was that this session would encourage active involvement within the ABA as a means to improve the delivery of future burn care. Selected current activities were summarized by key leaders of each project and highlighted in the plenary session. The history of the committee, current projects in disaster management, regionalization, best practice guidelines, federal partnerships, product development, new technologies, electronic medical records, and manpower issues in the burn workforce were summarized. The ODBC committee is a keystone committee of the ABA. It is tasked by the ABA leadership with addressing and leading progress in many areas that constitute current challenges in the delivery of burn care.

Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.

Impact of diabetes on burn injury: preliminary results from prospective study.

Reducing diabetes mellitus complications has been a major focus for Healthy People 2010. A prior retrospective cohort of our burn center's admissions revealed worse outcomes among diabetic patients, that is, increased infection rates, grafting and graft complications, and increased length of hospital stay. Therefore, a prospective study has been designed to carefully assess wound repair and recovery of diabetic and nondiabetic burn patients. Our long-term aim is to determine the characteristics of the wound milieu along with global responses to injury that may predict poor outcome among diabetic patients. This is an initial phase of a larger observational study of in-hospital diabetic (types 1 and 2) and nondiabetic patients, prospectively matched for age (18-70 and >70 years) and burn size (<5, 5-15, and 16-25%). Time (days) to complete index wound closure, documented through serial photography, is the main outcome measure. Secondary measures compare delays in presentation, prevalence of infections, graft rates, wound and graft complications, adverse events, and length of hospital stay. Detailed history, physical, and baseline hemoglobin A1C are elicited from all subjects who are assessed daily over the initial 72 hours poststudy entry, then weekly until complete index wound closure, and finally monthly through 3 months. Forty subjects are presented herein, 24 diabetic and 16 nondiabetic patients. Time to index wound closure was significantly prolonged in diabetic patients, despite increased grafting. These findings suggest that excision and grafting in diabetic patients may not alone be sufficient to ensure rapid closure, as graft complications may contribute to protracted closure. Evaluating graft need may be more complex among diabetic patients, suggesting the need for alternative management strategies. The current prospective study confirms our previous retrospective analysis, notably manifested by significant delays in index wound closure. Our efforts continue in identifying the most important predictors of outcome, especially modifiable factors that would create a basis of intervention to improve care.

An active wound dressing for controlled convective mass transfer with the wound bed.

Conventional wound dressings-gauze, plastic films, foams, and gels-do not allow for spatial and temporal control of the soluble chemistry within the wound bed, and are thus limited to a passive role in wound healing. Here, we present an active wound dressing (AWD) designed to control convective mass transfer with the wound bed; this mass transfer provides a means to tailor and monitor the chemical state of a wound and, potentially, to aid the healing process. We form this AWD as a bilayer of porous poly(hydroxyethyl methacrylate) (pHEMA) and silicone; the pHEMA acts as the interface with the wound bed, and a layer of silicone provides a vapor barrier and a support for connecting to external reservoirs and pumps. We measure the convective permeability of the pHEMA sponge, and use this value to design a device with a spatially uniform flow profile. We quantify the global coefficient of mass transfer of the AWD on a dissolvable synthetic surface, and compare it to existing theories of mass transfer in porous media. We also operate the AWD on model wound beds made of calcium alginate gel to demonstrate extraction and delivery of low molecular weight solutes and a model protein. Using this system, we demonstrate both uniform mass transfer over the entire wound bed and patterned mass transfer in three spatially distinct regions. Finally, we discuss opportunities and challenges for the clinical application of this design of an AWD.

Diabetes and burns: retrospective cohort study.

Burn injuries are often associated with multisystemic complications, even in otherwise healthy individuals. It is therefore intuitive that for the diabetic patient, the underlying pathophysiologic alterations in vascular supply, peripheral neuropathy, and immune function could have a profoundly devastating impact on patient outcome. The effects of diabetes on morbidity and mortality of the burn-injured patient have not been examined in great detail. The purpose of this retrospective study was to compare clinical outcomes between diabetic and nondiabetic burn patients. We reviewed the charts of 181 diabetic (DM) and 190 nondiabetic (nDM) patients admitted with burns between January 1996 and May 2000, matched by sex and date of admission. Burn cause and size, time to presentation, clinical course, and outcomes were evaluated. Because age was a factor, the analysis was done by three age groups: younger than 18 years, 18 to 65 years, and older than 65 years. Of patients 18 to 65 years, 51% (98/191) were diabetic, whereas 84% (81/96) of those older than 65 and only 4% (3/85) of patients younger than 18 were diabetic. Because of the disproportion in numbers of diabetics compared with nondiabetics in the younger than 18 and older than 65 years-old groups, these patients will not be discussed. Diabetics were more likely to incur scald injury from tub or shower water rather than hot fluid spills (33% DM vs 15% nDM; P < or = 0.01), and have a delayed presentation (45 vs 23%; P = 0.00001). There was no difference in total burn size in all groups. Diabetics in the 18 to 65 years group had a higher rate of full-thickness burns (51 vs 31%; P = 0.025), skin grafts (50 vs 28%; P = 0.01) and burn-related procedures (57 vs 32%; P = 0.001), infections (65 vs 51%; P = 0.05), and longer lengths of stay (23 vs 12 days; P = 0.0001). Although there was no statistically significant difference in incidence of specific infections, the rates of cellulitis, wound infection, urinary tract infection, line infection, and osteomyelitis, were consistently higher in the diabetic population. Partial graft slough was 6% in diabetics 18 to 65 years with a 3% regraft rate, whereas nondiabetics had a 1% regraft rate. Comparing diabetics with controlled vs uncontrolled glucose levels, diabetics with uncontrolled glucose had higher rates of infection (72 vs 55%; P < or = 0.025), all burn-related procedures (68 vs 45%; P < or = 0.025), and longer ICU stays (24 vs 10 days; P = 0.048). Mortality rate was 2% for diabetics and for nondiabetics. In summary, presence of diabetes in the burn patient was associated with a worse outcome. A predilection for burn injuries in the diabetic was noted in the older adult population. Deeper burns, delayed presentation, higher rates of infection, graft failure and operations, and longer lengths of stay translate into an increased cost to society both economically and in lives. This data would suggest a need for better burn education for diabetics and health care professionals, recognizing the elderly population as a "high-risk" group. We believe that targeted prevention measures and treatment strategies, emphasizing earlier and more aggressive intervention for this population, may have a favorable effect on morbidity and mortality.