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Surveillance passive

Baniak, J., Baker, G. Cunningham, A.M. and Martin, L. Silent Sentry passive surveillance Aviation and Space Technology, 7 June 1999... [Pg.21]

The monitoring system was a stimulated passive surveillance system. In other words, when vaccines purchased with federal funds were administered in the public sector, Important Information forms were given to recipients or their parents or guardians instructing them to report any illnesses requiring medical attention that occurred within four weeks of vaccination. System coordinators at each immunization project or grantee site and the state health department completed standardized forms that were reviewed for consistency and completeness and then forwarded to the CDC for data entry and analysis. [Pg.845]

Because ARMS is a form of passive surveillance that is based on spontaneous reports, it has a number of limitations. Most importantly, it cannot establish a definitive, causal relationship between the ingestion of an incriminated substance and the occurrence of symptoms. Since people are exposed daily to a myriad of food ingredients, it is inherently difficult to attribute an adverse event to a specific food substance. Moreover, symptoms reported are often vague or general in nature. Other confounders, which were discussed by Bradstock et al. (1986), include ... [Pg.149]

Events are under-reported in a passive surveillance system because of the failure to recognize an adverse event as being related to a food additive, the amount of effort involved, or other reasons. [Pg.149]

The United States is one of the only countries that has established a formal surveillance system for post-approval monitoring of adverse reactions to food additives. Despite the obvious limitations of a passive surveillance system, ARMS provides an important venue for the public and others to report health problems perceived to be related to food additives. It provides a means of spotting potential longer-term problems with additives which can then be investigated further. [Pg.162]

The issue here is whether use of a passive surveillance technology (a thermal imager in this case) is intrusive enough to amount to a search under the Fourth Amendment. The district court had concluded that the crude and limited nature of the imagery obtained meant that it did not show the kind of activities for which Kyllo had a legitimate expectation of privacy. [Pg.70]

From January 24 through March 15, 1994, 170 persons with laboratory evidence of acute coccidioidomycosis were identified in Ventura County, California. This number substantially exceeds the total number of coccidioidomycosis cases (52) reported through routine passive surveillance in 1993 in Ventura County—considered an area of low incidence for this disease. The increase in cases follows the January 17 earthquake centered in Northridge (in adjacent Los Angeles County), which may have exposed Ventura County residents to increased levels of airborne dust. [Pg.343]

Headaches can follow aspartame ingestion (14). Up to July 1991 the FDA had received over 5000 reports of adverse effects in a passive surveillance program in this and other studies the main complaints were of neurological symptoms, and headaches accounted for 18 5% of cases (15). It appears that some people are particularly susceptible to headaches caused by aspartame and may want to limit their consumption (16). In a double-blind, crossover study using volunteers with self-identified headaches after aspartame, some were particularly susceptible, and their headaches were attributed to aspartame (17). [Pg.349]

Intussusception after rotavirus vaccine was described as an example to underline the value of passive surveillance systems as an indicator for carefully designed follow-up studies. [Pg.3552]

Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995 85(12) 1706-9. [Pg.3572]

Data on vaccine safety and side effects are available from three sources prelicensure new drug investigational data, passive surveillance data associated with postlicensure use and several published studies (13,14). Prehcensure data of nearly 7,000 vaccine recipients who received over 16,000 initial doses and boosters resulted in severe local reactions (edema or induration greater than 12 cm) after 1% of the vaccinations. Moderate local reactions (edema or induration of 3-12 cm) occurred following 3% of vaccinations, and mild local reactions (erythema, edema and induration <3 cm) occurred after 20% of the vaccinations (13,14). Systemic reactions, such as fever, chills, body aches, or nausea occurred in four of the 7,000 recipients, a rate of less than 0.06% (13). [Pg.26]

The FDA s Spontaneous Reporting System (SRS) was in operation from 1968 to October 1997. The reports were transitioned to the AERS, which has been used from October 1997 to the present. A publicly released version can be purchased on a quarterly basis. It is a passive surveillance system where direct volunteer reporting accounts for 10% of reports from healthcare professionals and consumers. Ninety percent of reports in the FDA s postmarketing safety surveillance databases come from pharmaceutical companies, as they are mandated by regulations to report AEs that they receive. The combined SRS + AERS database currently contains more than 2.7 million reports and is growing rapidly, at about 465, 000 reports on an annual basis. The number of reports has more than doubled in the last 10 years and because the FDA is interested in serious, unlabeled reports, that has grown as a percentage of the total number of reports submitted to the FDA. [Pg.548]

The committee recommends a three-level assessment approach to determine appropriate in-market surveillance strategies. Level I assessments include monitoring the toll-free line or Internet website (passive surveillance). Level 2 assessments include in-market panels to review existing data (both published and proprietary). The same selection and composition recommendations presented earlier also hold with regard to in-market panels. Level 3 assessments include conducting retrospective and/or follow-up studies (active surveillance). [Pg.13]

As a matter of current practice, infant formula manufacturers routinely conduct passive surveillance via toll-free calls, contact with health care professionals, and reports from their field sales force. Since infants are unable to verbally communicate, any adverse effects must be observed and reported through the parents or caregiver, thus special attention must be paid to detect adverse or unusual reactions when feeding infant formulas containing new ingredients. [Pg.165]

Level 1 Assessment PASSIVE SURVEILLANCE 1-800 line or Internet web site ... [Pg.167]

Figure D-14 illustrates proposed in-market surveillance guidelines. Assuming that the recommended preclinical and clinical tests using probiotics detected no adverse effects, passive surveillance for in-market monitoring and level 2 long-term follow-up strategies are recommended. Chapter 7 provides more information about the committee s recommendations on in-market surveillance. Figure D-14 illustrates proposed in-market surveillance guidelines. Assuming that the recommended preclinical and clinical tests using probiotics detected no adverse effects, passive surveillance for in-market monitoring and level 2 long-term follow-up strategies are recommended. Chapter 7 provides more information about the committee s recommendations on in-market surveillance.
Skin Discoloration of the leg after immunization is a relatively unknown entity, which has been studied during a 10-year period after immunization of infants in the Dutch National Vaccination Program [4 ]. Discolored leg syndrome was defined as an even or patchy red, blue, or purple discoloration of the leg(s) and/or petechiae with or without swelling. In all, 1162 reports of adverse events after immunization were made to the passive surveillance system between 1994 and 2003. Red, blue, or purple discoloration and isolated petechiae were reported in 39%, 19%, 27%, and 14% of these cases respectively 1105 cases were considered to be related to immunization, based on a predefined risk window with the onset of symptoms after immunization—48 hours for discoloration and 2 weeks for petechiae. Of the 1105 cases, about 50% occurred after DTP-IPV - -Hibl immunization, and 30% occurred after DTP-IPV + Hib2 immunization. Discolored leg syndrome was often accompanied by fierce crying (78%). The median interval between immunization and the occurrence of the syndrome was 3.8 hours... [Pg.654]

The seventh chapter deals with aviation aspects of navigation. The contents of the seventh chapter concerns use of passive surveillance systems in aviation and the concept of the SWIM system in air traffic management. [Pg.9]

Passive surveillance systems are able to supplement and possibly replace older air traffic control systems. The fundamental principle is based on acquisition of radar signal of all airplanes in system coverage at least by three radio receivers for accurate airplane location. (Kurdel et al. 2014)... [Pg.249]

Cooperation of active and passive surveillance systems is able to provide air traffic control with aU important information. [Pg.249]

The beginnings of appl3nng of new technologies in the field passive surveillance systems enabled design of new and more precise systems such as Vera, Borap, MSS a Vera NG and the BCL concept. (Srubar2005)... [Pg.250]

Nowadays, there is a big competition between the systems of air traffic control, which operate on the basis of multisensory surveillance. These systems occupy a fixed position in the market air transportation. In view of the ever increasing air traffic and the number of travelers, extension ATC systems is inevitable. The main advantage of Passive Surveillance Systems is potential of changing system architecture according to the needed area operation. Thereby there is a chance to contribute to improved safety and fluency in air traffic. Included among tops system ATC is the MSS that is able supplement and gradually replace older technologies used at air traffic control. [Pg.253]


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