Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems. Final order.

The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Efectos de bebidas carbohidratadas y proteicas sobre la recuperación del esfuerzo / Effects of carbohydrate-protein beverages on recovery from exercise

Este artículo aporta una revisión del efecto de la coingesta de la proteína de suero de leche y proteína caseína administradas en bebidas carbohidratadas, sobre la recuperación y los parámetros del daño muscular en ejercicios de larga duración. La búsqueda se ha realizado en abril de 2013 en las bases de datos del ISI Web of Knowledge, SCOPUS, Sport Discuss, PubMed, Medline, Sportdiscus, y en las bases de datos CINDOC en las redes CTI-CSIC, RESH, DICE y DIALNET cruzando los descriptores "Exercise", "Resistance training" y "Recovery" con los términos "Ergogenic beverage", "Casein Protein" y "Whey Protein". La estrategia nutricional más respaldada es la ingesta de un preparado líquido carbohidratado en donde se combinan proteínas de diferentes fuentes sobre pruebas de esfuerzos prolongados similares a la competición tanto en deportes individuales como en colectivos, con resultados discrepantes (AU)

This manuscript shows a review about the effects of the whey and casein protein on recovery and parameters of muscle damage in long-term exercise. The search was conducted in April 2013 in the databases of ISI Web of Knowledge, SCOPUS, PubMed, Medline, SportDiscus, and databases on Spanish networks CINDOC CTI-CSIC, RESH, DICE, and DIALNET crossing the descriptors "Exercise", "Resistance training" and "Recovery" with the terms "Ergogenic Beverage", "Casein Protein" and "Whey Protein". The most used nutritional strategies are based in a carbohydrate beverage which combines different protein sources on prolonged exercise tests similar to sports competition, in both individual and collective sports, with discrepant results (AU)

Medical devices; clinical chemistry and clinical toxicology devices; classification of the cardiac allograft gene expression profiling test systems.

The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test 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: Cardiac Allograft Gene Expression Profiling Test Systems." FDA classified 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 this device.

Interpretative reports and critical values.

In the clinical laboratory to allow an effective testing process, post-analytical activity can have two goals in trying to improve patient safety: result interpretation and communication of critical values. Both are important issues, and their success requires a cooperative effort. Misinterpretation of laboratory test results or ineffectiveness in their notification can lead to diagnostic errors or errors in identifying patient critical conditions. With the awareness that the incorrect interpretation of tests and the breakdown in the communication of critical values are preventable errors, laboratorians should make every effort to prevent the types of errors that potentially harm patients. In order to improve the reliability of laboratories, we attempt to explain how interpretative reporting and automated notification of critical values can be used to reduce errors. Clinical laboratories can therefore work to improve clinical effectiveness, without forgetting that everything should be designed to provide the best outcomes for patients.

An administrative intervention to improve the utilization of laboratory tests within a university hospital.

BACKGROUND: Improving the appropriateness of testing behavior and reducing the number of laboratory tests have been recognized as essential parts of quality improvement. OBJECTIVE: To assess the effectiveness of an administrative and a short-term educational intervention aimed at reducing clinical biochemistry laboratory utilization. DESIGN: An analysis comparing utilization of laboratory tests performed on in-patients before and after the intervention. SETTING: Computerized database of all laboratory tests performed in Hadassah Ein Kerem Medical Center, Jerusalem, Israel during 1999-2003. INTERVENTION: The administrative intervention included restricting available emergency laboratory tests and frequency of repeated orders. The educational measures included: discussion of the misuse of laboratory tests and its consequences with the hospital medical staff, and presentation of the new restrictive policy. A feedback of the intervention's results was sent to the wards and reviewed with senior medical staff. MAIN OUTCOME MEASURES: Change in utilization (measured as rates per 100 hospital days) of clinical biochemistry tests by hospital division and by selected laboratory tests. RESULTS: An overall reduction of 19% in laboratory tests (95% CI: 18.8-19.2%) was observed in the year after the intervention. Utilization decreased significantly in all the hospital's medical divisions, within a range of 14.9-43.8%. During the intervention period, utilization of hematology tests was reduced by 7.6% (P = 0.009). Statistically significant reductions were noted in the ordering of all 12 selected clinical biochemistry tests. Although the orders of total cholesterol decreased by 72.2%, the utilization of 'high-volume' tests, such as glucose and electrolytes, showed only a modest decrease (7.9% and 6.9%, respectively). CONCLUSIONS: The present study included all hospital medical staff and covered all the available clinical biochemistry tests. This rather simple and low-cost intervention resulted in significant reductions in clinical biochemistry test orders as well as in the ordering of hematological blood tests.

Medical devices; clinical chemistry and clinical toxicology devices; classification of the breath nitric oxide test system. Final rule.

The Food and Drug Administration (FDA) is classifying the breath nitric oxide test system into class II (special controls). 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 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), 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 announcing the availability of a guidance document that will serve as the special control for the device.

Clinical chemistry devices; classification of the biotinidase test system. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the biotinidase test system into class II (special controls). The special control that will apply to this device is restriction to sale, distribution, and use as a prescription device. 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 Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.

Medical devices; exemption from premarket notification; class II devices; triiodothyronine test system. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Action of 1997 (FDAMA).