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At least 19 recordsLinked to original sources

Integration of the Diagnostic Radiological Health Sciences Learning Laboratory films into a radiology elective for medical students.

The basic Diagnostic Radiological Health Sciences Learning Laboratory (ACR Teaching File) consists of 5000 films (1400 cases). This educational system was developed under contract with the Bureau of Radiological Health, Food and Drug Administration and made available by the American College of Radiology. We report our experience with our own course and the ACR Teaching File for medical student teaching. For 24 of 75 students, the ACR Teaching File provided the basic core film material during a fourth-year elective clerkship. We compared the ACR Teaching File films with our own film material when used in similar teaching circumstances. ACR Teaching File films, when combined with established teaching methods, proved to be satisfactory for medical student teaching.

Audiovisual Aids↗

Radiological health; evaluation of radiation exposure in diagnostic radiology examinations; availability of draft recommendations--FDA. Notice.

The Food and Drug Administration (FDA) announces the availability for public review and comment of draft recommendations on evaluation of radiation exposure in diagnostic radiology examinations, prepared by FDA's National Center for Devices and Radiological Health (NCDRH). In addition to the draft recommendations, FDA is making available background information, rationale, and NCDRH's response to comments that were received on a notice of inquiry regarding the need for and content of such recommendations. FDA is also encouraging private groups and individuals to join in the research efforts needed to develop further technique/exposure guidance and suggests a number of principles to be followed in these efforts so all interested parties may achieve consistent and useful results. Final recommendations, when developed, will be published as a technical report in NCDRH's radiation recommendation series.

Radiation Dosage↗

A dental radiologic health laboratory teaching method.

The School of Dental Medicine at Tufts University has given new direction to the understanding of radiologic health through a program in which all students participate in some laboratory activities directly related to the problems of radiologic health in dental practice. This article presents an explanation of the background of this program and the experiments performed and discusses the interest in the program and its effect on the dental students. The laboratory program described is held for 3 1/2 hours on Wednesday afternoons at the Dental School, since this is a period of minimum patient load in the Radiology Department. The course is presented for third-year dental students who already have takin a lecture course in the fundamentals and techniques of radiology and have received training in the proper procedures for taking radiographs. The program is designed as a series of experiments dealing with machine output, filtration, collimation, exposure factors, scatter radiation, film density, patient protection, and shielding. The students are introduced to various radiation-detection instruments and given the opportunity to use these instruments to measure output and scatter-radiation levels under varying conditions. The laboratory teaching method presented can also be reprogrammed for different group sizes and time schedules.

Boston↗

Radiological health attitudes of college students.

The purpose of this study was to measure and evaluate attitudes of college students regarding various aspects of radiological health hazards. The attitudes surveyed were related to controversial issues such as nuclear power plant operations, color television sets, microwave ovens and genetic effects from medically related x-ray exposure.

Adolescent↗

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.

Equipment Safety↗

Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect redelegations to other officials within the Center for Devices and Radiological Health (CDRH) pertaining to: Certifying true copies and using the Department seal, disclosing official records, issuing reports of minor violations, and medical device reporting procedures. This amendment is intended to reflect those redelegations.

Decision Making, Organizational↗

Technology assessment of medical devices at the Center for Devices and Radiological Health.

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

Device Approval↗

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.

Decision Making, Organizational↗

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.

Device Approval↗

Amendments to the Center for Devices and Radiological Health federal performance standard for laser products.

Federal law requires that all laser products that are imported into or introduced into commerce in the United States comply with the performance standard published in the Code of Federal Regulations (CRF), Title 21, Parts 1040.10 and 1040.11, administered by the Center for Devices and Radiological Health (CDRH), US Food and Drug Administration. Although it contains somewhat different requirements for hazard classification, engineering controls and labeling, the ANSI Z136.1 standard defers to the CDRH standard. The CDRH standard became effective in August, 1976 and was amended, in 1978 and also in 1985. In the early 1990s, US experts met to formulate an approach to bring the requirements of the CDRH standard and those of the International Electrotechnical Commission (IEC) standard, IEC 825, into closer agreement in order to lower barriers to international trade and to remove any excessive compliance burdens on manufacturers. In 1993, the CDRH published, formally in the Federal Register and informally, a Notice of Intent to amend the CDRH standard. Responses to those notices have now been analyzed and informal draft amendments were distributed in 1996. This draft is now being prepared for formal issuance as a Notice of Proposed Rulemaking. Meanwhile, the IEC standard was amended in 1993 and republished as IEC 825-1; these amendments created considerable controversy since they resulted in over classification of the hazard of many products, especially light emitting diodes (LEDs) that have a large divergence and increased source dimensions. Additional amendments are now being developed to correct this problem. The CDRH has carefully monitored developments in the IEC and actively participated in its proceedings as a guide in developing its own proposal. This paper describes the major changes that are being proposed for the CDRH standard and presents some rationale for the major changes. The more significant changes include expansion of applicability to include LEDs, reduced emission durations for classification, revised measurement for hazard classification, reduced performance requirements for lower power visible radiation products, and revised requirements for medical products.

Air Pollutants, Radioactive↗

Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to premarket approval of products that are or contain a biologic, a device, or a drug. The amendment grants directors, deputy directors, and certain other supervisory personnel in the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) reciprocal premarket approval authority to approve such products.

Biological Products↗

Radiological health implications of lead-210 and polonium-210 accumulations in LPG refineries.

Radon-222, a naturally occurring radioactive noble gas, is often a contaminant in natural gas. During fractionation at processing plants, Radon tends to be concentrated in the Liquified Petroleum Gas (LPG) product stream. Radon-222 decays into a number of radioactive metallic daughters which can plate out on the interior surfaces of plant machinery. The hazards associated with gamma-emitting short-lived radon daughters have been investigated previously. The present work reports an analysis of the hazards associated with the long-lived daughters; Pb-210, Bi-210, and Po-210. These nuclides do not emit appreciable penetrating radiation, and hence do not represent a hazard as long as they remain on the inside surfaces of equipment. However, when equipment that has had prolonged exposure to an LPG stream is disassembled for repair or routine maintenance, opportunities for exposure to radioactive materials can occur. This paper reports a series of measurements made on an impeller taken from a pump in an LPG facility. Alpha spectroscopy revealed the presence of Po-210, and further measurements showed that the amount on the impeller surface was well above the exempt quantity. Breathing zone measurements made in the course of cleaning the impeller showed that an inhalation exposure equivalent to breathing Po-210 at the Maximum Permissible Concentration (MPC) for 60 hours could be delivered in less than half an hour. It was concluded that maintenance and repair work on LPG and derivitive product stream equipment must be carried out with the realization that a potential radiological health problem exists.(ABSTRACT TRUNCATED AT 250 WORDS)

Air Pollution, Radioactive↗

[Radiology, health care structural reform and health system research--status, developments and challenges].

Through the health care reform act of 1993 and the next reform step currently under discussion, the financing mechanisms of both the ambulatory and the hospital sector of the German health care system will be changed drastically which will effect radiology earlier and more than other specialties. In the ambulatory care sector, fee-for-service has led to the tendency of more services, especially through self-referral to diagnostic imaging. Currently, managed care structures are under discussion which will lead to fewer services. In the hospital sector, reimbursement of all costs on a per-diem basis also had the effect of much diagnostic imaging. Beginning in 1996, diagnostic-related groups with pre-determined fixed reimbursements will supplement per-diem charges. Internal financial billing will lead to fewer demands for imaging services. Health services research in radiology is necessary to demonstrate the efficacy of imaging procedures at all levels from structure (technical efficacy) through process (clinical efficacy) to outcome (outcome efficacy).

Ambulatory Care↗