Recognition and management of patients with frailty in the emergency department.

In the UK, around 10% of adults aged over 65 years and around one quarter to a half of adults aged over 85 years have frailty. Early identification of frailty can improve patient outcomes, so it is vital that emergency department (ED) healthcare professionals, including nurses, understand and can recognise the signs and symptoms of this health state. This article describes frailty and outlines the relationship between common presenting complaints in older people in the ED and frailty syndromes. The article summarises some commonly used frailty screening tools that have been validated for use in acute and emergency care settings and details a frailty screening tool used in the authors' hospital. The authors also outline some important principles of management of patients with frailty in the ED.

Medical devices and the pediatric population - a head-to-toe approach.

Introduction: This review uses a head-to-toe approach, a standardized approach similar to the format used by clinicians during the physical examination, to highlight important differences between children, adolescents and adults. The assessment of a pediatric patient is significantly different from an adult and the heterogeneity of the pediatric population requires knowledge of the inter- and intra-subpopulation differences in growth and development for all organ systems. Areas covered: A search of the English medical literature (PubMed and EMBASE) resulted in identification and review of articles that reported medical device use in the pediatric population based on specific organ systems. The review highlights unique considerations for the pediatric population with respect to growth and development as well as important physiologic and maturational differences between children and adults pertaining to the use of medical devices. Expert opinion: Children have unique medical device needs; adult devices are often adapted or configured to address these unmet needs. It is important that clinicians, and those who manufacture and design medical devices for the pediatric population, have a heightened awareness of the varied pediatric subpopulations (neonates to adolescents) with respect to growth and development, and the adjustments needed to ensure safe and effective use of devices for their unique needs.

Timely identification of patients with frailty at the 'front door' of acute hospitals.

Early identification of frailty at the front door of the acute hospital is vital to allow rapid comprehensive geriatric assessment and care pathway development in the most appropriate location. This article discusses the importance of developing robust processes to enable early identification and management of frailty in the acute hospital. It also highlights the benefits of developing a dynamic team of professionals at the front door of the acute hospital who are effectively trained to undertake comprehensive assessment. Effective care planning for older people with frailty requires meticulous coordination through collaboration across health and social care and this is demonstrated using an effective model which has been developed in a district general hospital in Scotland.

Pediatric medical devices: a look at significant US legislation to address unmet needs.

There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use.

FDA working to ensure the safety of medical devices used in the pediatric population.

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA.

Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.

BACKGROUND: Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S. Food and Drug Administration (FDA) for children ages 1-12 years. METHODS: A query was conducted of FDA's Manufacturer and User Facility Device Experience database from January 1, 1996, through December 31, 2009, in children ages 1-12 years involving insulin pumps. Report narratives were individually reviewed for age, gender, and seriousness of outcomes. Device or patient problems and potential contributory factors were assessed. RESULTS: Over the past 14 years, 1774 (7%) of all insulin pump adverse event reports were identified in children ages 1-12. Of these reports, 777 (43%) resulted in hospitalization. In hospitalized cases (n = 614), diabetic ketoacidosis and/or hyperglycemia were the predominant patient problems, and in other cases (n = 98), hypoglycemia was evident. There were 106 emergency room visits, 19 cases requiring paramedic attention, and five deaths. The majority of reports indicated that the devices were not returned to the manufacturer, and root causes were not always confirmed. CONCLUSIONS: Younger children with diabetes deserve careful consideration of the risk and benefit of insulin pump technology. Studies are needed to better understand pediatric safety issues and to identify the root cause of adverse events. Problems related to patient education, device misuse, and malfunctions were found, highlighting the need to strengthen user training for children and their caregivers.

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective.

Medical devices are often overlooked as a contributor to adverse events. In clinical practice, physicians are aware of the potential for adverse effects from drug products, which are routinely included in differential diagnoses of patients' presenting complaints. However, physicians may not always consider that the use, misuse or malfunction of a medical device, and/or its components, may result in a patient's presenting signs and symptoms or lack of improvement. Consideration of medical devices is particularly important in the pediatric population, who may be especially susceptible to device-related adverse events due to their smaller body size, weight and ongoing rapid growth and development.

Contractile and electrophysiological properties of pulmonary artery smooth muscle are not altered in TASK-1 knockout mice.

The acid-sensitive, two-pore domain K+ channel, TASK-1, contributes to the background K+ conductance and membrane potential (Em) of rat and human pulmonary artery smooth muscle cells (PASMCs), but its role in regulating tone remains elusive. This study aimed to clarify the role of TASK-1 by determining the functional properties of pulmonary artery (PA) from mice in which the TASK-1 gene was deleted (TASK-1/3 KO), in comparison with wild-type (WT) C57BL/6 controls. Small vessel wire myography was used to measure isometric tension developed by intact PA. Em and currents were recorded from freshly isolated PASMCs using the perforated patch-clamp technique. Reverse transcription-polymerase chain reaction (RT-PCR) was used to estimate K+ channel expression. We could find no difference between PA from WT and TASK-1/3 KO mice. They showed similar constrictor responses to a range of agonists and K+ concentrations, the K+ channel blockers 4-aminopyridine, tetraethylammonium ions and XE991. Treprostinil, proposed to dilate by activating TASK-1, was just as effective in TASK-1/3 KO arteries. Blocking Ca2+ influx with nifedipine (1 µM) or levcromakalim (10 µM) had no effect on resting tone in either strain. The resting Em of PASMCs and its responses to K+ channel blockers were unchanged in TASK-1/3 KO mice as were voltage-activated K+ currents, including the non-inactivating K+ current (IKN) measured at 0 mV. The Em was, however, depolarised in comparison with other species.Mouse IKN was much smaller than in rat and showed no sensitivity to pH. The results imply that TASK-1 does not form a functional channel in mouse PASMCs.

Organ culture mimics the effects of hypoxia on membrane potential, K(+) channels and vessel tone in pulmonary artery.

BACKGROUND AND PURPOSE: Blood vessel culture is gaining interest for use with transfection-based techniques, but alters the contractile properties of the vessels. The present study tested the effects of culture on the intrinsic tone of rat pulmonary arteries (PAs) and examined the function and expression of K(+) channels regulating the resting membrane potential (E(m)) and tone of pulmonary artery smooth muscle cells (PASMCs). EXPERIMENTAL APPROACH: Rat intrapulmonary arteries were isolated and cultured under standard and modified conditions. Contractile responses of fresh and cultured PA were compared using vessel myograph. Electrophysiology experiments on isolated PASMCs used the patch-clamp technique. K(+) channel expression was quantified using reverse transcription and real-time PCR. KEY RESULTS: After 4 days in culture vessels contracted to phenylephrine, but relaxation to carbachol was significantly impaired. Contractile responses to 10 mM KCl, 4-aminopyridine and tetraethylammonium increased, and vessels developed an uncharacteristic relaxation response to Ca(2+)-free solution, nifedipine and levcromakalim. PASMCs from cultured vessels were depolarized and K(+) currents reduced, in association with down-regulation of K(v)1.5, K(v)2.1 and TWIK-related acid-sensitive K(+) channel-1 mRNA. These changes were partially reversed by increased oxygenation of the culture medium or removing the endothelium before culture. CONCLUSIONS AND IMPLICATIONS: Culture of PA for 3-4 days induced loss of functional K(+) channels, depolarization of PASMCs, Ca(2+) influx, intrinsic tone and spontaneous constrictions, similar to the effects of chronic hypoxia. This limits the use of cultured vessels for studying excitation-contraction coupling, although oxygenating the culture medium and removing the endothelium can help to retain normal smooth muscle function.

Device safety and effectiveness in the pediatric population: a US FDA perspective.

The US FDA recognizes that there are many challenges to ensuring that medical devices are used responsibly and safely in the pediatric population. Education plays a key role, and manufacturers and healthcare providers must be informed of medical device issues unique to the pediatric population. Healthcare workers and device manufacturers must recognize that adverse events may differ between the adult and pediatric population and among pediatric subpopulations. Risk mitigation may also differ, and heightened awareness will reduce the potential for adverse events and promote the safe use of medical devices in children.

Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.

OBJECTIVES: From January 1, 2005, through December 31, 2005, the Food and Drug Administration received 5 adolescent death reports associated with the use of insulin pumps, raising concerns about use of this device in this age group. To understand better the types of infusion pump-related problems in adolescents, we performed a comprehensive evaluation of insulin and patient-controlled analgesic pump-related adverse events reported for adolescents that were received by the Food and Drug Administration from 1996 to 2005. METHODS: A search for medical device adverse event reports from January 1, 1996 through December 31, 2005, involving insulin pumps or patient-controlled analgesic pumps used by patients who were aged 12 to 21 years was conducted in the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Reports were reviewed for demographic characteristics, type of adverse event, and patient morbidity, and potential contributory factors were classified from narratives in the reports. RESULTS: A total of 1674 reports were identified: 1594 for insulin pumps and 53 for patient-controlled analgesic pumps. In reports of insulin pump events, there were 13 reported deaths, 2 reports that indicated possible suicide attempts, and several additional reports indicating severe hypoglycemic or hyperglycemic events that seemed to be device-related. A total of 102 (6.4%) insulin-pump reports highlighted factors that may have contributed to the adverse event, including problems associated with compliance, education, sports-related activities, and dropping or damaging the pump. Eighty-two percent of cases involving the insulin pump resulted in hospitalization. Half of the reports involving patient-controlled analgesic pumps indicated that the patient received an excess of medication; tampering and noncompliance were evident in some cases. CONCLUSIONS: Adolescents are a special population who deserve careful consideration of risk and benefit for use of device technology. Studies need to further identify safety problems in this age group.

FDA-approved neurologic devices intended for use in infants, children, and adolescents.

The US Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n = 8) include indications for use in children as well as adults. On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in children. The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices. We review risk assessment and ways to reduce risk for neurologic devices intended for use in children. We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.

Diagnosis of Parkinson's disease: why patient education matters.

Being diagnosed with Parkinson's disease can come as a great shock to patients, and that is sometimes underestimated by health professionals. This literature review highlights the value of educating patients about the condition and its implications. It considers research focusing on Parkinson's disease, chronic illness in general, and wider patient education issues.