Subject user safety

Safety-Critical Equipment Equipment that can present safety hazards to users (e.g.. X-ray and laser equipment) as well as equipment used to control exposures to recognized hazards, and whose improper use could subject users to harm (e.g., fiime hoods, biological safety cabinets, respirators, automated him processors). 

Industries which produce chemical substances are the main sites at risk for chemical lesions as one would expect. However, they are not the only ones. All industries which utilize chemical products are evidently of concern. This is in view of the transformation of primary products or with the purpose of maintaining machine tools accidents can occur in all the users. Even small enterprises have some non-negUgible risks. The home of each of these latter is the least protected by regulations. Finally, transportation probably represents the greatest risk because this generates accidents outside of sites subject to safety regulations and, in this way, involves the unprotected and unprepared neighboring population. 

The book does not focus on occupational safety and health issues, although improved process safety can benefit each area. Detailed engineering designs are outside the scope of the book. This book intends to identify issues and concerns in batch reaction systems and provides potential solutions to address these concerns. This should be of value to process design engineers, operators, maintenance personnel, as well as members of process hazards analysis teams. While the book offers potential solutions to specific issues/concerns, ultimately the user needs to make the case for the solutions that best satisfy their company s requirements for a balance between risk reduction and cost. In many instances the book provides one or more sources of additional information on the subject which could be of value to the reader. 

The labels which are the subject of this paper are those to be put on products to let the user know how to handle them safely and correctly. It covers the regulations issued by three different US government agencies the Department of Labour, the Department of Transportation and the Consumer Product Safety Commission US,DEPT.OF LABOR US,DEPT.OF TRANSPORTATION US,CONSUMER PRODUCT SAFETY COMMISSION... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

Viscous systems are the subject of continuing research by the US DIERS Users Group and in Europe. Research projects include the flow of high viscosity two-phase mixtures in safety valves, and the effect of bends and pipe fittings on high viscosity two-phase flow in pipes. 

This definition needs some explanation. The viewpoints mentioned in it represent the stakeholders concerns about the system (the trustee) under consideration. A viewpoint can represent an individual user who decides about involving herself/himself in the co-operation with the system depending on its trustworthiness (consider for instance e-commerce or e-health applications) or can represent a class of users. An example of a latter is a non-profit institution which assesses a given Web service on behalf of its users (this is what Health On the Net foundation [1] does for the users of e-health services). A viewpoint can be highly formalized, for instance in the situation where the criteria to be met by the trust case (to consider it satisfactory) are documented and supported by regulations (like in the case for safety critical applications [2]) or are documented and widely accepted (which is the case for security critical systems [3]). For some viewpoints satisfactory may mean convincing and valid whereas for some other satisfactory may have more subjective interpretation. 

Loss Prevention on CD-ROM is a product of the American Institute of Chemical Engineers, and it contains more than 1,000 technical papers or 20,000 pages of process safety information. It contains technical papers from 31 years of Loss Prevention Symposia (1967-1997), which were sponsored by the AIChE s Safety and Health Division. The user can easily search based on author, title, subject, or keywords. There are conference and workshop proceedings of the Center of Chemical Process Safety from 1987 to 1994. This was published in 1998 and available for 124. A second edition of Loss Prevention on CD-ROM was scheduled for release in late 2003 to cover the same sources until 2002. 

Cocaine use may account for up to 25% of acute myocardial infarctions among patients aged 18-45 years. The safety of a 12-hour observation period in a chest pain unit followed by discharge in individuals with cocaine-associated chest discomfort who are at low risk of cardiovascular events has been evaluated in 302 consecutive patients aged 18 years or older (66% men, 70% black, 84% tobacco users) who developed chest pain within 1 week of cocaine use or who tested positive for cocaine (59). Cocaine use was self-reported by 247 of the 302 subjects and rest had urine positive for cocaine 203 had used crack cocaine, 51 reported snorting, and 10 had used it intravenously. Of the 247 who reported cocaine use, 237 (96%) said they had used it in the week before presentation and 169 (68%) within 24 hours before presentation. Follow-up information was obtained for 300 subjects. There were no deaths from cardiovascular causes. Four patients had a non-fatal myocardial infarction during the 30-day period all four had continued to use cocaine. Of the 42 who were directly admitted to hospital, 20 had acute coronary syndrome. The authors suggested that in... 

For releasing materials it is likely that there will be a focus on the releasing component and its authorisation as a food additive, including any quantitative restriction or a restriction on the types of food. The information on efficacy may be important, e.g., in the case of a released preservative the final efficacy in the food should be demonstrated. A general rule may be considered that if the released component shows insufficient or no technical effect on the food, then the food additive does not comply with the requirements on food additives or any other relevant regulation on the composition of food and its additives, e.g., the requirements on food flavours. As a consequence such a material may not obtain a favourable opinion. Some information may be requested on the carrier of the releasing substance, but as this will not be part of an authorisation the safety of the carrier is the responsibility of the producer and the final user. In many cases the carrier may be subject to other provision on food contact materials. In principle the carrier should be inert and should not migrate to the food at an unacceptable concentration. 

The responsibilities of the regulatory authority are to ensure that all products subject to its control conform to acceptable standards of quality, safety and efficacy and that all premises and practices employed to manufacture, store and distribute these products comply with requirements to assure the continued conformity of the products to these standards until such time as they are delivered to the end-user. 

However, subjective and objective analyses of these devices are required to make sure both scientific, regulatory and consumer needs are met. The devices in development are costlier and more complicated when compared with conventional transdermal patch therapies. As such they may contain electrical and mechanical components which could increase the potential safety risks to patients because of poor operator technique or device malfunction. In addition, effects of the device on the skin must be reversible, since any permanent damage to the SC will result in the loss of its barrier properties and hence its function as a protective organ. Regulatory bodies will also require data to substantiate the safety of the device on the skin for either short- or long-term use. Thus, for any of these novel drug delivery technologies to succeed and compete with those already on the market, their safety, efficacy, portability, user-friendliness, cost-effectiveness and potential market have to be addressed. 

The experiment design involves selecting multiple levels of each factor to define the conditions for each experimental run, and some subject matter expert/end-user knowledge is required to select the range of the factor levels to cover. As the optimum level of the response is not known in advance, at least five factor levels should be used, and the range of these levels should be as wide as possible with the low and high levels determined by the end user s input of feasibility and safety considerations. 

Safety considerations are of special importance in the use of these tubes, since their breaking pressure varies and may depend on microscopic faults in construction. We subjected our tubes to numerous pressure tests. In two cases the tube assemblies broke in both cases the epoxy adhesive (Araldite AV 138M and a HV 998 hardener, from Ciba-Geigy) detached at about 50 MPa. These tubes have been in use for more than one year in several laboratories, with a maximum working pressure of 10 MPa. No accident has occurred to date. Nevertheless, the tubes are always used with a protection device (Fig. 4.33) developed in our laboratory that ensures that the user is never exposed directly to the tube while it is pressurized. 

Due to changing regulatory requirements and revisions to consensus standards the user should contact the subject matter expert (e.g.. Fire Protection Engineer, Industrial Safety Engineer, Industrial Hygienist, Environmental Engineer, etc.) to ensure that the most current document is used, as applicable, depending on site contractual requirements. 

Any risk-benefit analysis should be clearly set out in the safety case with the appropriate justification, rationale and supporting evidence. The complexity of the arguments involved warrant close cooperation between manufacturers, users and regulators. In most cases the inclusion of potential benefits in the safety case is simply not required in HIT CRM and, if anything, introduces subjective noise into an otherwise objective methodology. 

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