Agreement between activity-monitoring devices during home rehabilitation: a substudy of the AAA STOP trial.

As part of a home-based rehabilitation program, 24 older adult patients (71 ± 3 years) with abdominal aortic aneurysm (AAA) disease underwent 3 days (12 awake hr/day) of activity monitoring using an accelerometer (ACC), a pedometer, and a heart rate (HR) monitor, and recorded hourly activity logs. Subjects then underwent an interview to complete a 3-day activity recall questionnaire (3-DR). Mean energy expenditure (EE) in kcals/ day for HR, ACC, and 3-DR were 1,687 ± 458, 2,068 ± 529, and 1,974 ± 491, respectively. Differences in EE were not significant between 3-DR and ACC, but HR differed from both ACC (p < .001) and 3-DR (p < .01). ACC and 3-DR had the highest agreement, with a coefficient of variation of 7.9% and r = .86. Thus, ACC provided a reasonably accurate reflection of EE based the criterion measure, an activity recall questionnaire. ACC can be effectively used to monitor EE to achieve an appropriate training stimulus during home-based cardiac rehabilitation.

Medical devices; neurological devices; classification of the Near Infrared Brain Hematoma Detector. Final rule.

The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR) Brain Hematoma Detector into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; ear, nose, and throat devices; classification of olfactory test device. Final rule.

The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test Device." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device.

Food and Drug Administration regulation of in vitro diagnostic devices.

The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation.

Medical devices; immunology and microbiology devices; classification of cystic fibrosis transmembrane conductance regulator gene mutation detection system. Final rule.

The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device.

Medical devices; immunology and microbiology devices; classification of ribonucleic acid preanalytical systems. Final rule.

The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used in Molecular Diagnostic Testing)." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.

Medical devices: classification of the dental sonography device and jaw tracking device. Final rule.

The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

Medical devices; obstetrical and gynecological devices; classification of the breast lesion documentation system. Final rule.

The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

Glycohemoglobin analyzers.

For the millions of people with diabetes, maintaining near-normal glucose levels is vital for reducing or slowing the complications of the disease. A crucial tool for monitoring blood glucose levels is the glycohemoglobin (GHb) test. GHb analysis indicates the amount of glucose a patient's red blood cells were exposed to during the previous two to three months, allowing physicians to track trends and make appropriate changes in therapy. In the United States, this test is commonly performed on blood samples that have been sent to a laboratory, with written results provided to the physician several days later. Recently, though, analyzers have come onto the market that can be used at the point of care--a clinic or physician's office--or even in the home, providing results immediately. We evaluated five GHb analyzers from four suppliers: Axis-Shield, Bayer, Bio-Rad Laboratories, and Metrika. These products vary considerably--for example, one is a single-use test kit intended for point-of-care settings, while another is a batch analyzer that can run 15 samples at a time and is designed for low- to moderate-volume laboratory use. Our testing focused primarily on the analyzers' accuracy, precision, and ease of use. Different facilities will have different requirements, and none of these factors alone should determine a facility's purchasing decision. Rather, purchasers will have to balance all the performance factors--along with cost--when choosing a product. Consequently, we have provided separate ratings for hospital laboratory testing, point-of-care testing, and--for the one applicable unit--home testing.

The IVD directive: planning for compliance.

In less than 20 months, companies will only be allowed to place in vitro diagnostic (IVD) medical devices on the European market if they bear the CE mark. For this reason, the process of ensuring compliance with CE-marking requirements on or before the end of the transition period, if not already begun, should be initiated immediately. This article discusses important compliance issues.

IVD authorized representatives.

Under the In Vitro Diagnostic (IVD) Directive, a manufacturer of IVD medical devices located outside the European Economic Area must designate an Authorized Representative before placing those products on the European market. This article discusses the responsibilities of Authorized Representatives under the IVD Directive and some of the important differences of the role as it is defined in the Medical Device Directive.

[An analysis of X-ray diagnostic equipment at Moscow prevention and patient-care facilities]. / Analiz sostoiania parka rengenodiagnosticheskoi apparatury LPU Moskvy.

The paper contains the results of an analytical study held, 2001-2003, at prevention and patient-care facilities of Moscow and dedicated to classification of their X-ray diagnostic equipment (XDE) by models. On the basis of an analysis of typical XDE failures the methodological recommendations for the XDE technical expertise are defined that enable the possibility to evaluate objectively the serviceability of equipment after appropriate repair and to extend its exploitation time over several years without any noticeable worsening in X-ray diagnostics or radiation safety.

Occupant Kinematics in Laboratory Rollover Tests: ATD Response and Biofidelity.

Rollover crashes are a serious public health problem in United States, with one third of traffic fatalities occurring in crashes where rollover occurred. While it has been shown that occupant kinematics affect the injury risk in rollover crashes, no anthropomorphic test device (ATD) has yet demonstrated kinematic biofidelity in rollover crashes. Therefore, the primary goal of this study was to assess the kinematic response biofidelity of six ATDs (Hybrid III, Hybrid III Pedestrian, Hybrid III with Pedestrian Pelvis, WorldSID, Polar II and THOR) by comparing them to post mortem human surrogate (PMHS) kinematic response targets published concurrently; and the secondary goal was to evaluate and compare the kinematic response differences among these ATDs. Trajectories (head, T1, T4, T10, L1 and sacrum), spinal segment (head-to-T1, T1-to-T4, T4-T10, T10-L1, and L1-to-sacrum) rotations relative to the rollover buck, and spinal segment extension/compression were calculated from the collected kinematics data from an optical motion tracking system. Response differences among the ATDs were observed mainly due to the different lateral bending stiffness of the spine from their varied architecture, while the additional thoracic joint in Polar II and THOR did not seem to provide more flexion/extension compliance than the other ATDs. In addition, the ATD response data were compared to PMHS response corridors developed from similar tests for assessing ATD biofidelity. All of the ATDs, generally, drifted outboard and upward during the tests similar to the PMHS. However, accompanied with this upward and outward motion, the ATD head and upper torso pitched forward (~10 degrees) while the PMHS' head and upper torso pitching rearward (~10 to ~15 degrees), due to the absence of flexion/extension compliance in the ATD spine. The differences in these pitch motions resulted in a difference of 130 mm to 160 mm in the longitudinal position of the head at 195 degrees of roll angle. Finally, substantially less lateral spinal bending was also observed in the ATDs compared to the PMHS. The results of the current study suggests there is greater upper spine flexion/extension, and lateral bending stiffness in all of the ATDs in comparison to the PMHS, and provided information for improvement of ATD biofidelity in future for rollover crashes.

Ambulatory management of patients with sleep apnea: is there a place for portable monitor testing?

Portable monitor testing is being increasingly used as an alternative strategy for the diagnosis and treatment of patients with obstructive sleep apnea. Portable monitors have become progressively sophisticated but lack standardization. Recent studies comparing clinical outcomes of ambulatory management pathways using portable monitor testing support their use in patients with a high pretest probability for obstructive sleep apnea. Whether ambulatory management is cost-effective and will improve patient access to diagnosis and treatment requires further investigation.

Comparison of two combs in the detection of head lice in school children.

The diagnostic efficacies of two metal pin lice combs having different spacing between their teeth were compared in two cohorts of school children, aged between 7 and 15 years, from different villages of Manisa, Turkey. Head lice infestation was evaluated with comb A (0.18 mm of distance between the teeth) in 95 children in Cavusoglu village, and with comb B (0.15 mm of distance between the teeth) in 146 children in Yesilköy village, compared to visual inspection. Five of 95 (5.3%) children in Cavusoglu village and 5 of 146 (3.4%) children in Yesilköy village were found to harbor live head lice with combing, while none was detected during the visual inspection. The difference between the infestation rates of two cohorts was statistically insignificant (p > 0.05). With visual screening, 15 and 16 children with louse eggs were identified in Cavusoglu and Yesilköy villages, respectively. With combing in these villages, 5 and 8 children, respectively, with louse eggs were identified and 3 and 5 children, respectively, were detected only with combing, not with visual screening. In conclusion, combing is more effective than visual inspection in head lice detection, but there were no significant difference between the two combs either in lice detection or in usage.