Safety surveillance methods

The aim is to develop a real-time surveillance method to ensure the safety of tests such as resistance tests and re-testing of pressure vessels, based on measurement carried out using acoustic emission technology. 

Thus, it is clear that the safety surveillance process is an iterative one. It looks at multiple data sources, whether screening large regulatory databases, looking at company databases or looking at manufacturing Lot related AEs for patential problems. The surveillance process screens the data using both the intraproduct and the interproduct methods. The object is to identify topics for further review to develop case definition, to compile a case series and then to characterize that case series. 

The demands related to the prolonged operation of the PHENIX reactor have led us to focus on hypothetical defects which, in the various operating conditions envisioned, might question the principle safety functions, and among these, the control of the reactivity. Therefore the extension of such defects, penetrating the great shells which make up the core support structure, had to be evaluated. In order to facilitate their early detection, the geometric disorders associated with much shorter defects constituted another point of interest in the specification of surveillance methods. 

Kulldorff M, Davis RL, Kolczak M. Lewis E, Lieu T, Platt R. 2011. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Sequential Analysis Design, Methods and Applications. 30(l) 58-78. 

A weapons country like the United States will implement international safeguards only as a diplonutic expedient to encourage other nations to accept IAEA inspedion. Although not yet in effect here, the safeguards may be expected to affect criticality safety mainly through process changes which may be required to assure that inventories can be verified independently by IAEA personnel. The presence of an on-site inspector and the use of containment and surveillance methods will also perturb the overall operations. 

A fourth phase known as postmarketing surveillance should be instituted after the NDA is approved. Postmarketing surveillance refers to all of the methods used to continue monitoring drug safety and effectiveness after approval for public use.19,21 These methods often consist of reports from health care providers that describe specific rare adverse effects that were not discovered during clinical testing.24 A certain drug, for example, could cause a specific adverse effect in only 1... 

Actual and perceived food safety concerns have necessitated an increase in the monitoring of foods for such natural contaminants as aflatoxins and for residues of pesticides. Immunoassays can provide rapid, simple, and relatively inexpensive methods for the detection of analytes with specificity and with sensitivities directed at the levels of concern. Particularly for aflatoxins, they are rapidly assuming a significant role in the monitoring of foods. However, the misuse of these techniques can potentially compromise any food safety improvement that may result from increased surveillance. Experiences of the Division of Contaminants Chemistry in the development, validation, and applications of immunoassays for natural toxins is discussed. 

In response to the need to better understand the parameters of safety and efficacy of traditional medical treatments, the WHO has prepared general guidelines to aid in the research and evaluation of these methods. This document presents useful methods that can be applied to the study of herbal medicines, procedure-based therapies, and clinical studies. It also includes discussions associated with pragmatic research issues, the ethics involved, the education and training of personnel, and the surveillance systems that might be imposed. It is emphasized that these studies be conducted in a... 

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards, and postmarketing surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. 

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