Showing papers in "Biomedical Instrumentation & Technology in 2012"

Monitor alarm fatigue: an integrative review.

Abstract: Alarm fatigue is a national problem and the number one medical device technology hazard in 2012. The problem of alarm desensitization is multifaceted and related to a high false alarm rate, poor positive predictive value, lack of alarm standardization, and the number of alarming medical devices in hospitals today. This integrative review synthesizes research and non-research findings published between 1/1/2000 and 10/1/2011 using The Johns Hopkins Nursing Evidence-Based Practice model. Seventy-two articles were included. Research evidence was organized into five main themes: excessive alarms and effects on staff; nurse's response to alarms; alarm sounds and audibility; technology to reduce false alarms; and alarm notification systems. Non-research evidence was divided into two main themes: strategies to reduce alarm desensitization, and alarm priority and notification systems. Evidence-based practice recommendations and gaps in research are summarized.

mHealth Consumer Apps: The Case for User-Centered Design

Abstract: mHealth applications, or “apps” as they are more commonly known, offer the opportunity to improve healthcare delivery and clinical outcomes. The ability to monitor patients remotely can enable patient risk-factor management and improve treatment compliance, thus allowing early detection of medical complications and ultimately preventing unnecessary hospitalizations. In addition to enhancing the delivery of care, one of the most significant opportunities that mHealth offers is in the consumer health domain, allowing patients to actively engage in and self manage their condition. Mobile phones also allow for the design of timely interventions based on user behavior. mHealth-mediated behavioral interventions can produce cognitive, behavioral, emotional, and social health-oriented responses. As such, mHealth apps are particularly appropriate for problems where treatments depend on patient behavioral change, such as those related to smoking, obesity, diabetes, and other chronic conditions. Despite the many potential benefits of mHealth apps, pilot studies aimed at evaluating the effectiveness of mHealth interventions have yielded mixed results. Furthermore, a quarter of all app downloads are used only once. Consumers often do not return to applications that do not immediately engage them, therefore undermining the intervention’s potential effectiveness. Regrettably, there is no simple formula for designing engaging and effective mHealth apps. Currently, many electronic health (eHealth) and mHealth interventions are designed on the basis of existing healthcare system constructs and may not be as effective as those that involve end users in the design process. Moreover, designers often base their designs on assumptions that are not validated with primary user input. The resulting systems may lack key features, and subsequent evaluations of the effectiveness of the interventions may be compromised. For this reason, we employ the user-centered design (UCD) process—an evidence-based approach informed by the needs and understanding of a specific end-user group. In our experience, designing mHealth and other apps, UCD plays a key role in achieving user engagement, thus improving the likelihood of the intervention’s effectiveness. The World Health Organization agrees, and advises that user evaluation be incorporated into the mHealth project lifecycle to ensure effective outcomes. mHealth Consumer Apps The Case for User-Centered Design

Reducing hospital noise: a review of medical device alarm management.

Abstract: Increasing noise in hospital environments, especially in intensive care units (ICUs) and operating rooms (ORs), has created a formidable challenge for both patients and hospital staff. A major contributing factor for the increasing noise levels in these environments is the number of false alarms generated by medical devices. This study focuses on discovering best practices for reducing the number of false clinical alarms in order to increase patient safety and provide a quiet environment for both work and healing. The researchers reviewed Pub Med, Web of Knowledge and Google Scholar sources to obtain original journal research and review articles published through January 2012. This review includes 27 critically important journal articles that address different aspects of medical device alarms management, including the audibility, identification, urgency mapping, and response time of nursing staff and different solutions to such problems. With current technology, the easiest and most direct method for reducing false alarms is to individualize alarm settings for each patient's condition. Promoting an institutional culture change that emphasizes the importance of individualization of alarms is therefore an important goal. Future research should also focus on the development of smart alarms.

Creating a culture of safety: reducing hospital noise

Abstract: Editor’s Note: In 2006, Susan E. Mazer wrote an article for BI&T that examined the impact of hospital noise on patient safety. Six years later, Mazer takes a fresh look at the issue In comparing the state of healthcare in the 19th century with that of the 21st century, it is clear that the uncontrollable and seemingly unmanageable ways that noise penetrates the hospital environment has changed for the worse. Florence Nightingale, whose environmental theory became the original basis for professionalizing nursing care, described noise as “that which damages the patient.” At that time, the noise to which Nightingale referred included squeaking floors, brushing crinolines, appropriate and inappropriate conversations— any sound that resulted in feelings of “apprehension, uncertainty, waiting, expectation, fear or surprise.” Today, hospital noise has been studied according to its physiological and psychological outcomes: increased respiratory rates, heightened blood pressure, increased heart rates, and increased stress. While some improvements have been made in acoustic treatment of corridors and rooms, they are not industry wide nor are they hospital wide. Generally, the improvements have been made in one unit of a hospital, clinical area, or clinic. Meanwhile, negative auditory factors have multiplied: growing populations, higher patient acuity levels, increased pressures on staff to perform, and the introduction of more technologies. Some new technologies have replaced older ones: Overhead paging has been traded in for mobile technologies, and the irritating broadcast of announcements has been replaced by the near-constant use (in corridors and rooms) of cellphones or other individual communication technologies. Each new technology has its own environmental impact, requires its own utilization policy, and introduces new risks as well as benefits. The studies to date have merged the technological sounds into the generic auditory environment and the outcomes remain the same: Hospital noise is pandemic. The auditory environment of the 21st century hospital is substantially louder, more complex, and more difficult to control than that of Nightingale’s time. Intensive care unit (ICU) psychosis or delirium has been directly linked to environmental stressors—noise, sleep deprivation, and social isolation, being primary. The costs related to sleep deprivation, agitation, stress, and lower pain thresholds that are a result of ambient hospital noise are measured in additional medication, length of stay, and subsequent complications.

Simulation of medical device network performance and requirements for an integrated clinical environment.

Abstract: About the Authors David Arney is a systems engineer with the Medical Device Plug-and-Play (MD PnP) Interoperability Program. Interoperability Program. Abhilasha Bhargav-Spantzel, Ph.D. CISSP, is a security architect at the Healthcare Solutions group at Intel, SC.

Early Detection of the Deteriorating Patient: The Case for a Multi-Parameter Patient-Worn Monitor

Abstract: Scott McCombie, BSBSE, is research engineer at Sotera Wireless, San Diego, CA. E-mail: scott.mccombie@ soterawireless.com Effective, efficient, and safe delivery of healthcare is dependent on the timely identification and treatment of a deteriorating patient condition. Failure to rescue patients in the early stage of physiological deterioration can result in permanent organ injury, extended medical treatment, increased recovery time, or death. These avoidable adverse events drive healthcare costs up and quality down. The primary indicator of failure to rescue is unsuccessful cardiopulmonary resuscitation. The American Heart Association created a national registry of cardiopulmonary resuscitation (NPCPR) in 2000 as a voluntary evidence-based patient safety initiative. A review by Peberdy and colleagues of 14,720 cases of cardiopulmonary arrest from the NPCPR database collected between 2000 and 2002 shows the following breakdown of physiology, immediate cause, and discovery.

mHealth and Developing Countries: A Successful Obstetric Care Model in Uganda

Abstract: Mobile health has tremendous potential to ease suffering and provide healthcare to individuals who have restricted access to medical staff, facilities, and technology. Many women around the world, particularly those in rural communities with few resources, have limited access to basic maternity health information, and such areas rarely have either ultrasound equipment or trained personnel to operate the equipment. As a result, preventable but untreated pregnancy and childbirth complications lead to large numbers of maternal and infant deaths in developing nations. One of the World Health Organization’s Millennium Development Goals is to improve global maternal health by reducing maternal mortality and increasing skilled care. More than half of the 358,000 maternal deaths that occur annually can be attributed to hemorrhage or obstructed labor. Increased access to prenatal obstetric ultrasound imaging could significantly reduce maternal and neonatal mortality rates in such populations. Antenatal care and access to ultrasound provide an opportunity to identify high-risk pregnancies and detect debilitating complications. A higher level of care at delivery can then be arranged in advance. Current barriers to deployment of ultrasound in remote areas include expensive equipment, high electrical power requirements, and the need for highly trained ultrasound operators. Traditional ultrasound programs involve six months to two years of training and are limited to on-site diagnoses. Such programs are expensive, time-consuming, and have limited sustainability. Together with G. Eli Morey (also at the University of Vermont), Matthew Rielly and Martin Anderson (Philips Healthcare), Alphonsus Matovu (Kamuli Mission Hospital, Kamuli, Uganda), Brian Garra (U.S. Food and Drug Administration), Michael Kawooya (Mengo mHealth and Developing Countries A Successful Obstetric Care Model in Uganda

Ethnographic field research for medical-device design.

Abstract: I was gratified to see in the standard, AAMI/ ANSI/IEC 62366:2007, Medical Devices— Application of usability engineering to medical devices, that, for the first time, a human-factors related, medical device standard called explicitly for user research. Annex D of the standard (Guidance on the Usability Engineering Process) lists user research as the first step of the “user interface design cycle.” While the annex says that “user input can be obtained in a variety of ways,” it also says that the approach advocated in the standard “necessitates an understanding of how users interact with the medical device in the actual use environment. This understanding can only come from user input and observation [italics added].” The draft guidance issued by the U.S. Food and Drug Administration (FDA), Applying Human Factors and Usability Engineering to Optimize Medical Device Design, similarly states:

Medical device SALs and surgical site infections: a mathematical model.

Abstract: It is commonly accepted that terminally sterilized healthcare products are rarely the source of a hospital-acquired infection (HAI). The vast majority of HAIs arise from human-borne contamination f...

Reverse Mentorships: Younger Workers Can Help Veterans Stay on Right Track

Abstract: We know that mentoring is a process where a person with more experience shares it with someone, usually younger, who has less. Now enter reverse mentoring, almost the same as traditional mentoring, but typically a junior employee shows a senior employee the way— highly unusual, you might initially think. Alan Webber, co-founder of the business magazine Fast Company, once offered this gritty observation about the process: “It’s a situation where the old fogies in an organization realize that by the time you’re in your forties and fifties, you’re not in touch with the future the same way the young twenty-something’s (are). They come with fresh eyes, open minds, and instant links to the technology of our future.” In fact, this upside-down mentoring concept was introduced more than a decade ago by former General Electric CEO Jack Welch. Not everyone is jumping on the bandwagon, but reverse mentoring is “trending.” Interested in pursuing a reverse mentorship? Have a formal plan before you dive in, recommends Diane Piktialis, a consultant and research working group leader at The Conference Board, a business membership and research association. She focuses on issues related to the aging and multigenerational workforce and cross-generational knowledge transfer. In a 2009 article for the website Encore Careers, she cautions both parties to be aware of age stereotypes and address them head on. ‘Learn Every Day’ Formal reverse mentoring may not be practiced in your office, but it is quietly occurring daily and informally in companies worldwide, as it wears different hats such as “interning.” “Most of our interns have very strong computer skills both from engineering, architectural level and programming software levels,” says Paul Canaris, director of clinical engineering for Central Texas Veterans Health Care System in Temple, TX. Canaris’ last college-related computer course was in the early 80s. “Now, I learn every day from the interns,” he says. In his highly administrative job, Canaris finds he needs more in-depth knowledge of computers. He’s grateful for interns “fresh out of college who live and breathe PCs, networks and social media. They’ve really opened my eyes.” AAMI President Mary Logan thinks reverse mentoring is really lifelong learning, no matter one’s profession. A disproportionately large segment of the healthcare technology management sector is between 45 and 70, “middle-aged,” she suggests. “We may think we hold all the cards of wisdom, but we don’t.” Once while she mentored, reverse mentoring just happened. “I told her I’d be her mentor if she’d be mine,” remembers Logan, describing the time while, in another job, she mentored a professional in her late 20s. Logan’s younger charge ultimately helped the executive enhance her own communications technology skills. While looking for a job, Logan’s own daughter, then 25, asked her mom questions about starting About the Author

Design considerations for medical device manufacturers.

Abstract: As technology advances, so does the complexity of reusable medical devices. This creates greater challenges for cleaning, disinfecting, and sterilizing devices between patient uses. There is increasing concern from the U.S. Food and Drug Administration (FDA) and the reusable device industry that inadequately reprocessed devices are contributing to infections acquired in hospitals and other healthcare facilities. This concern has led to a recently published draft guidance document for reusable device manufacturers, as well as meetings held by the FDA and AAMI in 2011, to address perspectives on these industry issues. The FDA has encouraged reusable device manufacturers to consider design features that allow for simple and more effective reprocessing procedures. This is a challenge for engineers whose primary focus is to design devices that can meet demands for increased sophistication and functionality. However, intensified regulatory scrutiny of reprocessing validations requires design innovation.

The study and design of a wireless ECG monitoring system.

Abstract: This paper describes a research project on wireless electrocardiogram (ECG) monitoring systems. A detection and measurement processor designed by a MSP430 microcontroller accomplishes the analog-to-digital conversion, digital filtering, QRS wave detection, and heart rate calculation. The data of detection can be sent to the central controller and personal computer (PC) by wireless on-chip MG2455 through a ZigBee network. This design can be used widely in home healthcare, community healthcare, and sports training, as well as in healthcare facilities, due to its characteristics of low power consumption, small size, and reliability.

Medical device interoperability and data integration to clinical information systems: medical device data alignment.

Abstract: Aligning and synchronizing data from disparate medical devices can be an impediment to interoperability with electronic medical record systems (EMR). While some medical devices support open standards-based data communication, like Health Level Seven (HL7), many medical devices still do not. Even when medical devices support open standards, terminology and units of measurement may not be consistent across medical devices. Devices that perform the same function may have different parameters and use different terminology. While to some this may seem a small issue, each medical device represents a data silo with a unique data model. This model’s terms and definitions must be aligned with a common data model to ensure that information derived at the point of care from any medical device, irrespective of vendor, conforms to common definitions employed by the clinical staff. Healthcare professionals require a unified representation of information to effectively support patient care. This paper discusses the problem of medical device data alignment and its impact on clinical information system (CIS) implementation.

Assurance Cases: Their Use Today and The Challenges Ahead

Abstract: Arnab Ray is a research scientist at the Fraunhofer Center for Experimental Software Engineering at the University of Maryland. E-mail: ARay@fc-md.umd.edu An assurance case may be looked upon as a documented body of evidence that provides a convincing and valid argument that a system is adequately safe for a given application in a given environment. Assurance cases, as a concept, are not particularly new. They have been used for many years to construct safety arguments for safety critical systems such as those in the aerospace, nuclear, and transportation industries. However, their use in medical device premarket submissions for infusion pumps has been fairly recent, brought about, to a large extent, by their inclusion in a recent infusion pump guidance document under a pilot program of the U.S. Food and Drug Administration (FDA). This article examines what an assurance case is, a few of the challenges behind assurance case development in a regulatory context for device software, and the ways in which these challenges may be handled.

Achieving interoperability: what's happening out there?

Abstract: INTEROPERABILITY What's Happening Out There? Achieving Interoperability is a popular word in the world of medical devices, and many believe it is the answer to some of healthcare's thorniest problems. This article takes a close look at what three healthcare facilities are doing today with one very important piece of the interoperability puzzle: the integration of device data into electronic medical records (EMRs). Their stories make it clear that what seemed impossible only a few years ago is now becoming commonplace.

Electrocardiogram interference: a thing of the past?

Abstract: This paper focuses on the problem of high and/or imbalanced electrode-skin impedances changing electrocardiogram (ECG) morphology. After reproducing ECG interference in a controlled laboratory setting-similar to what was observed during cardiopulmonary bypass surgery- and then understanding the cause, this knowledge was applied to clinical settings. Most interference was reduced by using electrode impedance meters and consistent skin prep.

Overview: HTM professionals and electronic health records.

Abstract: Revolutionary changes in healthcare delivery systems are impacting every facet of healthcare itself, including clinical engineering. While basic equipment services will always be needed, more time and human resources must be dedicated to emerging markets within health IT as a part of a large delivery team. Now is the time to initiate the changes necessary to promote the evolution of health IT.