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May / June 2008
NEW PRODUCTS & SERVICES
TRENDS
Thermo Fisher Scientific Receives FDA Clearance for MRSA Test Medium
Thermo Fisher Scientific, Inc., announced that it has received U.S. Food and Drug Administration (FDA) clearance for Spectra™ MRSA, a test designed to screen for methicillin-resistant Staphylococcus aureus (MRSA), more commonly known as the "superbug." With the highest Positive Predictive Value commercially available for MRSA screening, Spectra provides accurate results within 24 hours. The Spectra MRSA test is manufactured, distributed and sold under the Thermo Fisher specialty brand, Remel.
MRSA has become a major public health concern, with occurrences on the rise in healthcare facilities nationwide. According to a recent report by the Association for Professionals in Infection Control and Epidemiology (APIC), MRSA is prevalent in 46 of 1,000 patients in the U.S. — 8 to 11 times higher than previous estimates. Moreover, their findings suggest that MRSA, which is antibiotic-resistant and difficult to treat, may lead to as many as 119,000 patient deaths in U.S. hospitals annually.
In response to these findings, APIC issued a guide for the elimination of MRSA transmission in hospital settings. The guide includes comprehensive prevention measures, such as adherence to Centers for Disease Control and Prevention guidelines for hand hygiene, use of contact precautions, and targeted screening cultures.
"The need for more aggressive prevention measures to stop the spread of MRSA means that healthcare facilities are looking for cost-effective ways to test more patients, around the clock," said Marijn E. Dekkers, president and chief executive officer of Thermo Fisher Scientific. "Spectra MRSA offers healthcare facilities a high-performance solution that integrates with routine laboratory workflows, enabling them to take a more proactive approach to patient care and safety."
Spectra MRSA is a ready-to-use, labor-saving test easily adopted in any healthcare facility to enable continuous testing of patients. The test medium is easy to read, with MRSA appearing as distinctive dark blue colonies. Its use can help to simplify MRSA screening programs, allowing patient testing 24 hours a day, 7 days a week.
To learn more about Spectra MRSA, visit www.remel.com/mrsa. Remel is part of Thermo Fisher Scientific.
Redsense Medical Receives FDA Marketing Clearance for Blood Loss Detection Device
Redsense Medical's blood loss detection device is intended to monitor for potential blood loss from the hemodialysis access site in patients undergoing continuous hemodialysis treatment up to 5 hours in the clinical setting. The Swedish company's patented Redsense blood loss detection system is the first to enter the U.S market. Having met Europe's rigorous health and safety standards, the device has already been granted CE approval. Redsense Medical is the first to market a blood loss device of this kind in the U.S.
About 1.5 million patients worldwide receive over 200 million dialysis treatments every year. The size of the market is forecast to increase due to an aging population and the rise of diseases such as type II diabetes.
Medical professionals have long been aware of the risk of venous needle dislodgement during dialysis treatment. In the U.S. alone, 7 to 10 patients die each year due to needle dislodgement. It is feared that the true death rate is 3 to 4 times higher than reported. The total number of serious incidents is estimated to be in the thousands1.
"Blood loss resulting from disconnection of the venous needle during hemodialysis is a potentially serious event. Redsense has developed an ingenious device to provide prompt warning when this adverse event occurs," said recognized hemodialysis expert Dr. Christopher R. Blagg, professor emeritus of medicine, University of Washington. Until now, the typical method of needle dislodgement detection for this common form of renal therapy has been venous pressure monitoring, a built-in function of all dialysis machines. However, incidents have been reported whereby significant blood loss occurred before the venous pressure alarm sounded, resulting in serious, even fatal consequences2,3.
Developed in response to demands made by dialysis professionals, Redsense is intended to increase patient safety and thus become a vital aid to the dialysis caretaker. "Even with careful monitoring by dialysis professionals, needles do become dislodged, and significant blood loss can occur before dislodgement is detected," Patrik Byhmer, CEO of Redsense Medical, explains. "Other monitoring systems rely on blood pressure or moisture detectors and can be unreliable. The Redsense blood loss detection device has been clinically tested and is proven to be reliable4. Patients can change position or rest and feel more comfortable that the alarm will sound if their needle becomes dislodged. For care providers, this device may offer freedom to move more freely around the unit."
Redsense consists of two parts: a sensor patch and an alarm unit. An infrared signal is transmitted from the alarm unit to the sensor patch using fiber optic cable. In the event of bleeding, inner layers of the patch smear blood over the optical sensor, which is designed to trigger the alarm. Redsense doesn't react to perspiration or water, so moisture alone will not cause an alarm. And because the signal to the sensor is continuous, the alarm reacts instantly to the first milliliter of blood. Nurses and doctors have increased freedom to focus on the tangible problems of hemodialysis.
INA's Technology Helps Physicians Meet Requirements of Medical Home Model
Physician practices including primary care MDs and DOs, OB/GYNs and others, are adopting CINA's Protocol Engine to help fast-track the achievement for levels of recognition required of the Physician Practice Connections®-Patient-Centered Medical Home(PPC-PCMH™) developed by the National Committee for Quality Assurance (NCQA). CINA (www.cina-us.com), a leading developer of an innovative suite of electronic solutions, facilitates the technical components for physicians to meet many of the "Must-Pass" elements and associated requirements outlined by NCQA in the areas of access and communication, patient tracking and registry functions, care management and performance reporting and improvement.
"We recognize the importance of the medical home to all stakeholders and remain committed to helping physicians better serve all Americans," says Jim May, president and CEO of CINA. "Physicians using CINA's Protocol Engine in conjunction with their current electronic health record can implement the changes to score the points necessary to meet requirements of a medical home model as defined by NCQA Level One and in many offices, Level Two."
NCQA, a non-profit organization dedicated to improving health care quality, accredits and certifies a wide range of health care organizations utilizing PPC-PCMH content and scoring guidelines that include nine essential elements. According to the NCQA, a patient-centered medical home model includes: a personal physician, physician-directed medical practice, whole-person orientation, coordinated care, quality and safety, enhanced access and adequate payment.
May explains the value of CINA in four key areas for the Medical Home designation:
- Access and Communications: Patient specific point-of-care-reports for identifying patients in need of screening or disease management interventions.
- Patient Tracking and Registry Functions: Storage and maintenance of both administrative and clinical data in a searchable format to allow registry functionality and reporting for patient population management.
- Care Management: Implementation of evidence based guidelines for commonly occurring chronic conditions such as hypertension, diabetes, coronary artery disease, and heart failure, as well as nationally recognized recommendations for preventative screening.
- Performance Reporting and Improvement: Measurement and trending at both the provider and practice level to facilitate quality improvement and pay for performance activities.
Georgia Tech Forms Health Care Performance Group to Apply Lean Management Principles
To help address rising costs and improve the quality of health care, the Enterprise Innovation Institute (EII) at Georgia Tech has created a health care performance group. The new group will work with health care providers and service organizations to apply lean management principles — a set of tools derived mostly from the Toyota Production System widely used in manufacturing — that helps identify and steadily eliminate waste from an organization's operations.
"The United States is facing a health care crisis because of rising costs, bottlenecks in the system, and declining customer satisfaction," said Wayne Hodges, vice provost in the Enterprise Innovation Institute. "Health care is an integral part of our economy, and this group will explore the opportunities to improve efficiency in the health care sector."
Project leaders in the newly-formed group will work with health care professionals to conduct lean assessments, teach basic lean concepts, develop value stream maps to analyze the flow of materials and information, and implement rapid process improvement projects. The group has already begun working with nine hospitals across the state.
One of the group's first projects was with the emergency department at Meadows Regional Medical Center in Vidalia, Georgia. As a result of the lean health care implementation, Meadows realized outstanding results. Physicians, on average, are seeing more patients per hour than before the lean implementation. In 2005, average length of stay per patient was 247 minutes; in 2007, it was 139 minutes — a 44 percent reduction. Success is also reflected in a 92 percent patient satisfaction rating.
At Meadows, the lean implementation in the emergency department was just the first step.
"Our next steps involve applying lean to the registration process, including online patient registration, self check-in kiosks and barcoding. In addition, when we build a new, state-of-the-art facility, we want to use lean processes before architects even draw up the building," said Alan Kent, president and CEO of Meadows. "We'll draw a building around the parameters of the number of ER visits, OR visits, square footage needed, beds needed, budget, et cetera. We want to optimize process before we draw the first line. We want form to follow function."
Steve Mayfield, senior vice president of quality and performance improvement at the American Hospital Association's Quality Center, believes Georgia Tech's lean health care methods could improve hospitals nationwide. "Hospitals that focus on the flow of the patient while reducing non-value added steps see accompanying gains that include improved outcomes, increased operational performance, enhanced safety and higher satisfaction for patients and care providers," he said. "The Quality Center is licensing Georgia Tech's simulation model, and we regularly partner with them to demonstrate these tools and techniques to hospital leaders."
For more information on lean health care services offered by Georgia Tech's Enterprise Innovation Institute, contact Frank Mewborn: 706-338-0072; frank.mewborn@innovate.gatech.edu.
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