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.

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.

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.

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.

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.

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.

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.

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.