Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use. Final order.

The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special 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.

Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.

The Food and Drug Administration (FDA) is classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker's classification. 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.

[Testing of initial contamination for three kinds of surgical implants producted in Beijing].

The initial contamination of femoral head, femoral stem and femoral component producted by seven factories in Beijing is tested, all of the initial contamination values are 580 in total. Then these data is analyzed on statistics. The result indicates that the initial contamination values of three kinds of products according with normal distribution; The initial contamination values have not significant difference between femoral head and femoral component of the same factory; and the season has not significant effect on initial contamination in Beijing. According to the experimental data, the level of initial contamination is undulatory, so the factories should control the initial contamination and maintain the stability of initial contamination.

Making sense of the food and drug administration.

An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.

Actual and estimated costs of disposable materials used during surgical procedures.

It is difficult to estimate precisely the costs of disposable materials used during surgical operations. To evaluate the actual costs of disposable materials, we calculated the actual costs of disposable materials used in 59 operations by taking account of costs of all disposable materials used for each operation. The costs of the disposable materials varied significantly from operation to operation (US$ 38-4230 per operation), and the median [25-percentile and 75-percentile] of the sum total of disposable material costs of a single operation was found to be US$ 686 [205 and 993]. Multiple regression analysis with a stepwise regression method showed that costs of disposable materials significantly correlated only with operation time (p<0.001). Based on the results, we propose a simple method for estimating costs of disposable materials by measuring operation time, and we found that the method gives reliable results. Since costs of disposable materials used during surgical operations are considerable, precise estimation of the costs is essential for hospital cost accounting. Our method should be useful for planning hospital administration strategies.

An assessment of the clinical effectiveness of surgical drapes.

Questioning whether a 'sterile' material is actually sterile is something that many clinicians may not have considered. The equipment that comprises a sterile field for a major surgical or invasive procedure may also be taken for granted as the sterile pack would normally include sterile drapes. Under discussion is whether using sterile drapes is more effective than not using them. In furthering the debate, examination of the literature is centred on the degree of effectiveness of sterile drapes.

Equipamiento, experiencia mínima y estándares en la cirugía hepatobiliopancreática (HBP) / Equipment, minimum experience and standards in liver, pancreatic and bile-duct surgery

En la cirugía del hígado, páncreas y vías biliares hay ciertos tipos de procedimientos quirúrgicos como la hepatectomía y duodenopancreatectomía que se asocian a gran morbilidad y mortalidad. Es importante establecer equipamientos, experiencia y unos estándares mínimos aceptables. La optimización de la técnica radiológica (tomografía computarizada y resonancia magnética) con adquisición multifásica e inyección de dosis adecuadas de contraste es básica para obtener exploraciones de calidad que permitan un diagnóstico certero. La ecografía intraoperatoria se ha convertido en una pieza imprescindible en la cirugía del hígado. El uso del bisturí ultrasónico en la transección hepática ha demostrado que disminuye significativamente la hemorragia. Para la hemostasia parenquimatosa es muy útil el coagulador de argón. Cuando los pacientes con tumores del hígado no son candidatos a exéresis quirúrgica, la destrucción por radiofrecuencia o crioterapia es otra alternativa de la que se debe disponer. La mortalidad de la hepatectomía mayor debe ser inferior al 5 por ciento y la morbilidad inferior al 30 por ciento. En el hepatocarcinoma sobre hígado cirrótico la supervivencia a los 5 años debe ser superior al 50 por ciento, en las metástasis hepáticas superior al 30 por ciento y en el colangiocarcinoma hiliar superior al 20 por ciento. En cirugía pancreática se debe aceptar en general una mortalidad inferior al 10 por ciento. La morbilidad debe ser inferior al 50 por ciento. La supervivencia a los 5 años es mejor para los ampulomas e inferior para el carcinoma de páncreas, pero como media debe ser superior al 30 por ciento. Un centro de referencia debería realizar como mínimo 50 hepatectomías anuales y 24 duodenopancreatectomías anuales (AU)

Manual para la localización lógica de fallas y su corrección de equipo para la salud / Logical troubleshooting of scientific instruments

El manual está dirigido, principalmente, al personal técnico y especializado encargado del mantenimiento preventivo y correctivo del equipo y las instalaciones de salud. Aborda diversas materias, todas encaminadas a proporcionar un conocimiento práctico respecto al funcionamiento, mantenimiento y reparación de diversos aparatos que conforman el equipo médico, así como los materiales y procedimientos a seguir al efectuar reparaciones en los inmuebles. Se integra por los siguientes capítulos: I. Generalidades. II. Localización específica de fallas. III. Equipo de prueba y mediciones. IV. Componenetes y características. V. Interferencia y ruido. VI. No complique más sus problemas. VII. Medidas de seguridad. VIII. Técnicas de reparación. IX: Referencias y microprocesadores. Módulo especial de seguridad