RESUMEN
"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.
Asunto(s)
Equipos y Suministros/normas , United States Food and Drug Administration/legislación & jurisprudencia , Seguridad de Equipos/normas , Equipos y Suministros/economía , Estudios de Evaluación como Asunto , Cooperación Internacional , Comercialización de los Servicios de Salud , Estados UnidosRESUMEN
Condoms from five manufacturers were subjected to controlled exposures of heat, humidity, and air and to different natural environments in five countries. Under aerobic conditions (condoms in permeable packages or unpackaged), stress properties declined. The relationship between rate of decline as a function of temperature was quadratic. Under oxygen-restricted conditions (foil-wrapped packages) at average storage temperatures of 30 degrees C and lower, strain properties declined with little or no significant change in stress properties. The effect is to cause condoms to become stiffer; high-breakage rates in use have been correlated with product stiffening. A new rationale for accelerated-aging tests to predict condom shelf stability is suggested, including a test to control the trend of condoms to stiffen. Silicone lubricant, impermeable packaging, and inclusion of antioxidants in the condom formulation can prevent or minimize aerobic breakdown of latex condoms. Specifying low-modulus condoms can prevent excessive stiffening.
Asunto(s)
Condones , Látex , Aire , Estabilidad de Medicamentos , Falla de Equipo , Calor , Humedad , Oxígeno , Factores de TiempoRESUMEN
The regulatory management by the FDA of medical products should be thought of as a form of risk assessment and risk management. This is a new approach, a new way of thinking about product review and postmarket management processes. This paper outlines several aspects of risk assessment and management that have recently been incorporated into the FDA processes that will simplify reviews and lower the risks involved with the use of medical devices. These aspects include development of a new process for selecting the appropriate resources to dedicate to individual device applications, an increased emphasis on good experimental design for clinical studies, and continued development of a biomaterials database.
Asunto(s)
Seguridad de Equipos , Equipos y Suministros/efectos adversos , Prótesis e Implantes , Gestión de Riesgos , United States Food and Drug Administration , Falla de Equipo , Predicción , Humanos , Vigilancia de Productos Comercializados , Gestión de Riesgos/legislación & jurisprudencia , Gestión de Riesgos/tendencias , Estados UnidosRESUMEN
An interlaboratory comparison of four gas chromatographic test procedures for the quantification of ethylene oxide in an acrylic polymer was conducted by thirteen laboratories. The procedures included extractions with water, acetone, and N,N-dimethylformamide, and headspace gas analysis. The results of this study, using only the data from the labs that did not deviate from the procedure, showed that the average estimated total coefficient of variation ranged from 8 to 22% for the four different methods. Each of the methods is suitable for use as a reference test method for determining residual ethylene oxide in polymeric materials.