Personnel breathing zone sevoflurane concentration adherence to occupational exposure limits in conjunction with filling of vaporisers.

BACKGROUND: Work place pollution during filling of anaesthetic vaporisers has been a matter of concern. We studied personnel breathing zone ambient air sevoflurane concentrations during filling of sevoflurane with three different filling systems: Quik-Fil™ for Abbott and Dräger Fill™ resp. Easy-Fil™ adapters for Baxter sevoflurane bottles, referred to as 'Abbott and Baxter filling systems'. METHOD: Sequential filling of three vaporisers was performed for a 15-min period, once with each of Abbott and Baxter filling systems, by four nurses. Ambient-air sevoflurane p.p.m. concentration in the breathing zone was continuously measured using a Miran 1a device during filling, and the mean 15 min sevoflurane concentration was calculated. RESULTS: All eight measured (4 × 2 sequences) 15-min mean breathing zone sevoflurane concentrations covering filling of three vaporisers were well below the recommended short-term value (STV) provided by the Swedish Work Environment Authority (STV 20 p.p.m.). CONCLUSION: The breathing zone sevoflurane concentration during filling of sevoflurane with Baxter or Abbott filling systems, in an ordinary operating theatre, was found to be reassuringly below the Swedish recommended STV (20 p.p.m. average for a 15-min period).

Anaesthetic gas monitoring comparison between two side-stream monitors.

End-tidal gas monitoring has become standard of care during inhaled general anaesthesia. We studied the performance of a new side stream gas monitor the ISA multi-gas monitor. The performance was studied at constant low flow of calibration gas and end-tidal anaesthetic measure was studied during routine day case anaesthesia. Pair wise readings of end-tidal halogenated anaesthetic concentration were recorded during low flow anaesthesia. Performance was found to be high; all calibration gas measures were within 0.1 vol% deviation. During routine anaesthesia mean bias was -0.036 vol% and 93 out of 97 pair-wise readings were within the agreement limits as compared to the reference Datex instrument.

A summer school on vaccinology: Responding to identified gaps in pre-service immunisation training of future health care workers.

Immunisation is one of the corner stones of public health. Most health care consumers see the health care worker as their major source of information on immunisation and vaccine safety. Doctors, nurses and midwives should be appropriately and timely trained for that role. Within the Vaccine Safety, Attitudes, Training and Communication (VACSATC) EU-project a specific work package focused on the possible improvements of pre-service training of future health care workers. Surveys to assess current pre-service training about knowledge, skills and competences towards immunisation were distributed to students and curriculum managers of medical schools, universities and nursing training institutions in seven EU countries. In all responding institutions training on vaccines and immunisation is disseminated over a wide range of courses over several academic years. Topics as immunology and vaccine-preventable diseases are well covered during the pre-service training but major gaps in knowledge and competences were identified towards vaccine safety, communication with parents, addressing anti-vaccine arguments and practical skills. This assessment underlined the rationale for adequate pre-service training and identified opportunities for improvement of pre-service training. A prototype of an accurate pre-service immunisation curriculum was developed, implemented and evaluated in the summer of 2009 with a group of 36 students from 19 countries during a summer school on vaccinology at the Antwerp University, Belgium.

VACSATC (vaccine safety: attitudes, training and communication): why such a project?

The Vaccine safety: attitudes, training and communication (VACSATC) project was established in 2006 to study perceptions of immunisation and vaccine safety, to improve training of healthcare professionals on vaccine safety and to improve the availability of information on vaccine safety on the internet that adheres to good information practices. The three year project is funded by the European Commission's Directorate General for Health and Consumers and by the partners. The project complements the activities of the Vaccine Safety Net project and the Vaccine European New Integrated Collaboration Effort (VENICE) project.

[Essential to monitor vaccine safety]. / Väsentligt värdera vaccinsäkerheten. Samkörning av vaccinationsregister med ett hälsoregister skulle ytterligare förbättra övervakningen.

Vaccinations are one of the most successful public health measures. However, vaccinations are not without risks. An improved infrastructure is needed to facilitate the conduct of large clinical trials and/or phase IV studies. Vaccination registers and large linked database studies are examples of such structural improvements. A vaccination register pilot project carried out by the Swedish Institute of Infectious Disease Control (SIIDC) showed that parents with few exceptions gave consent to enrolling their children in the pilot register and that bar code labelling of vaccines is a reliable and practical manner in which to record vaccinations. Two EU projects with the aim to improve the information infrastructure have recently started. In the project Development of Vaccination Registers existing and planned immunisation registers are reviewed and a plan of action will be proposed. The aim of the project EUSAFEVAC is to improve vaccine safety through systematic reviews of the literature, to develop standard case definitions, to develop a model immunisation register and to improve reporting systems. SIIDC in collaboration with the Swedish National Board for Health and Welfare and the Medical Products Agency is exploring the feasibility of establishing a Swedish immunisation register and linked database information system.

Demyelinating disease and hepatitis B vaccination: is there a link?

The recent decision by the French government to compensate 3 recipients of hepatitis B vaccine preceding the onset of multiple sclerosis presumes a possible causal link and brings into question the use of current rules of causality assessment. Available evidence does not support a causal link or is equivocal but the accuracy of current methods of vaccine surveillance should be urgently improved. Larger and longer randomised trials, updated summaries of evidence, linked databases, prospective vaccination registers, bar-coding of vaccines and standardisation of adverse event definitions are possible measures to address current problems.

Vaccine safety--improving monitoring.

The growing numbers of vaccines and vaccine combinations make monitoring of vaccine safety increasingly complex. At the same time, health agencies and the public request better information on the safety of vaccines. The following steps should be taken to improve monitoring of vaccine safety: bar code labelling of vaccines to improve accuracy and completeness of information on administered vaccines, establishing immunisation registers to provide numerator data on exposure to vaccines, to facilitate long term follow-up and to do linked database studies. Development of improved case definitions to increase comparability between studies. Organising systematic assessments of all information on suspect or alleged vaccine reactions.

Report of a US public health service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization.

Hypotonic-hyporesponsive episode (HHE) is a term used to describe a somewhat heterogenous group of clinical disorders that have been reported primarily in association with whole-cell pertussis vaccination. A 1991 review by the Institute of Medicine determined that the evidence available was indeed consistent with a causal relation between whole-cell pertussis-diphtheria-tetanus immunization and HHE, but that the evidence was insufficient to indicate a causal relationship between HHE and the subsequent development of permanent neurologic damage. More recent data from clinical trials conducted in Europe suggest that HHE also occurs after vaccination with acellular pertussis vaccines. The US Food and Drug Administration, in collaboration with the US Public Health Service, sponsored a workshop on HHE in Rockville, Maryland, on June 19, 1997. The primary goals of the workshop were to develop a case definition of HHE and to evaluate the general design and feasibility of possible studies of HHE using the federal Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system. The goals of such studies would be to understand better the acute HHE event and to evaluate the possibility of long-term sequelae. Case Definition. There has been no generally accepted definition of HHE, and a standard definition would be useful for vaccine safety work and would potentially facilitate interstudy comparisons of the growing number of licensed vaccines containing acellular pertussis components. The workshop defined HHE as an event of sudden onset occurring within 48 hours of immunization, with duration of the episode ranging from 1 minute to 48 hours, in children younger than 10 years of age. All of the following must be present: 1) limpness or hypotonia, 2) reduced responsiveness or hyporesponsiveness, and 3) pallor or cyanosis or failure to observe or to recall skin coloration. HHE is not considered to have occurred if there is a known cause for these signs (eg, postictal), if urticaria is present during the event, if normal skin coloration is observed throughout the episode, or if the child is simply sleeping. This inclusive (sensitive) case definition will allow investigators, through the technique of stratification according to certain characteristics (eg, time from vaccination to onset of HHE), to attempt to hone the definition and make it more specific. Refinement of the definition of HHE has been hindered by the lack of information on its pathophysiology and by the lack of pathognomonic signs, symptoms, and diagnostic tests. Another hindrance is that by the time the child presents for medical evaluation, the signs of HHE often have normalized. Moreover, different mechanisms may be involved in different individuals whose events meet this workshop's HHE definition. Further Study of HHE. Probably the most important question about HHE is whether it has any permanent sequelae. The workshop assessed the possible contribution VAERS-based studies could make to answering this question and found substantial methodologic problems; however, ongoing studies in Sweden and The Netherlands have the potential to provide useful information on this question. The most useful contribution of VAERS data would be in a descriptive study of HHE, with a possible case-control study of factors that may affect the risk of HHE after vaccination, rather than a study of possible permanent sequelae. The workshop participants felt that a detailed descriptive study of approximately 100 HHE events reported during a 1- to 2-year period could provide a more in-depth description of HHE cases in greater numbers than has been published previously, but the study would not address the issue of long-term sequelae of HHE. Better descriptive data may lead to new hypotheses concerning risk factors, etiology, and pathophysiology of HHE that might be evaluated further by studying subsequent cases and controls from VAERS or from other sources, depending on the hypoth

Randomised controlled trial of two-component, three-component, and five-component acellular pertussis vaccines compared with whole-cell pertussis vaccine. Ad Hoc Group for the Study of Pertussis Vaccines.

BACKGROUND: Trials in Italy and Sweden showed high efficacy for three-component and five-component pertussis vaccines, and poor efficacy for a whole-cell vaccine licensed in the USA and a two-component vaccine. We compared the efficacy of three acellular vaccines with a UK whole-cell vaccine. METHODS: We enrolled 82,892 babies aged 2-3 months. Babies were vaccinated at age 3 months, 5 months, and 12 months, or age 2 months, 4 months, and 6 months. They were randomly assigned a two-component acellular diphtheria-tetanus-pertussis (DTP) vaccine (n = 20,697), a three-component acellular DTP vaccine (n = 20,728), a five-component acellular DTP vaccine (n = 20,747), or a UK whole-cell DTP vaccine (n = 20,720). We collected data for all reported cases of culture-confirmed pertussis during 3 years of follow-up. The treatment status of the two-component-vaccine group had to be made known midway through the trial for boosting because of poor efficacy. We included data for the two-component vaccine in the analysis of safety and immunogenicity, and data up its unmasking in secondary analyses of relative efficacy. Analyses were by intention to treat. FINDINGS: During follow-up from the third dose (mean 22 months), in the 3 months, 5 months, 12 months schedule, there were 15 cases of culture-confirmed pertussis with at least 21 days of paroxysmal cough in the whole-cell group, relative risk 1.00, compared with 13 in the five-component group (0.85 [95% CI 0.41-1.79]), and 21 in the three-component group (1.38 [0.71-2.69]). For culture-confirmed pertussis, with or without cough, there were 19 cases in the whole-cell group (1.00). 27 in the five-component group (1.40 [0.78-2.52]), and 49 in the three-component group (2.55 [1.50-4.33]). In the intention-to-treat analyses, from the first dose in the 3 months, 5 months, 12 months schedule the whole-cell vaccine was significantly more protective than the three-component vaccine against typical pertussis. Between the second and the third doses, culture-confirmed pertussis with any cough and with at least 21 days of paroxysmal cough was significantly more frequent in the two-component group than in the three-component group, and in the three-component group than in the five-component and the whole-cell groups, respectively. The serological response of the acellular vaccines in the 2 months, 4 months, 6 months schedule were similar to those previously reported. The whole-cell vaccine was highly immunogenic for fimbriae, pertactin, and filamentous haemagglutinin, but had a low antipertussis toxin response. Hypotonic hyporesponsiveness occurred significantly more frequently in the whole-cell group (p < 0.05) and was more frequent in the acellular groups than previously reported. High fever and seizures occurred more frequently after whole-cell vaccine than after any of the acellular vaccines (p < 0.001). INTERPRETATIONS: The efficacy of the UK whole-cell vaccine and the five-component and three-component vaccines was similar against culture-confirmed pertussis with at least 21 days of paroxysmal cough. The lower efficacy of the three-component vaccine against mild disease suggests that fimbriae have a role in protection against infection. The efficacy of acellular vaccines depends on the number of components, and different whole-cell vaccines have variable efficacies.

Cumulative incidence of childhood-onset IDDM is unaffected by pertussis immunization.

OBJECTIVE: To identify a possible effect of pertussis vaccination in infancy on the risk for developing human IDDM. RESEARCH DESIGN AND METHODS: A comparison was made of the cumulative incidence of IDDM in children age 0-12 years between two birth cohorts born before pertussis vaccination and two birth cohorts born after pertussis vaccination had been excluded from the Swedish national immunization program. The Swedish Childhood Diabetes registry was used to identify cases of IDDM. Yearly nurse reports on administered vaccines were used to determine coverage for diphtheria/tetanus/pertussis (DTP) and diphtheria/tetanus (DT) vaccines. Pertussis vaccine coverage was estimated based on number of doses of vaccine made available on license. RESULTS: No difference in cumulative incidence rate of IDDM up to the age of 12 years was found when the birth cohorts for 1978 and 1979 with high DTP vaccination coverage were compared with the cohorts of 1980 and 1981 with low pertussis vaccination coverage. CONCLUSIONS: The comparison of the cumulative incidence of IDDM, up to the age of 12 years, in birth cohorts with high and low exposure to pertussis vaccine does not support the hypothesis that pertussis could induce autoimmunity to the beta-cell that may lead to IDDM.

An outbreak of gastrointestinal illness caused by Staphylococcus aureus in a prison population.

Overcrowded conditions in a closed setting may contribute to the occurrence of disease outbreaks among the population.

Outbreak of diarrhea in a day care center with spread to household members: the role of Cryptosporidium.

From August 1 to November 1, 1984, 80 (43%) of 186 children attending a day care center (DCC) in Tulsa, OK, had diarrhea. Seventy-one percent of children less than 3 years of age had diarrhea, compared with 17% of children 3 to 8 years old. The duration of illness was 1 to 42 days (median, 8 days). At least one stool specimen was obtained from 142 (76%) of the 186 children. Children who had had diarrhea were more likely to have a specimen positive for Cryptosporidium (27 of 77, 35%) than were children who had not had diarrhea (8 of 65, 12%) (P less than 0.01). The presence of Giardia, Campylobacter, enterovirus, or rotavirus was not statistically associated with diarrhea. These results suggest Cryptosporidium as a causative agent. The secondary attack rate for diarrhea among household contacts exposed to DCC children with diarrhea was 77 of 204 (38%) compared with 25 of 273 (9%) for household contacts of children in the DCC who did not have diarrhea (P less than 0.001). Stool specimens were obtained from 79 household contacts. Six (23%) of 26 household members exposed to a Cryptosporidium-positive child had a stool specimen positive for Cryptosporidium, compared with 1 (2%) of 53 household contacts exposed to a DCC child whose stool specimen was negative for Cryptosporidium (P less than 0.01). The outbreak resolved within 2 weeks after cohorting children with diarrhea and stressing the importance of handwashing among staff and older children. cryptosporidium can cause outbreaks of diarrhea in DCC settings, can be spread within households and may be more common than previously recognized among DCC attendees and their household members.

Comparison of sedimentation and flotation techniques for identification of Cryptosporidium sp. oocysts in a large outbreak of human diarrhea.

Cryptosporidiosis, previously seen mostly among immunocompromised patients, is now recognized among immunocompetent patients. During a large outbreak of cryptosporidiosis in two day-care centers, we compared two procedures for the demonstration of the organism in preserved stool specimens. Of 703 stool specimens tested by both techniques, Sheather sucrose flotation (SSF) identified 127 (18.1%) as positive for Cryptosporidium sp. oocysts. Ritchie Formalin-ethyl acetate sedimentation (F/EA) plus a modified cold Kinyoun acid-fast stain (MCK) of the sediment identified 129 (18.4%) as positive for Cryptosporidium sp. oocysts. The degree of agreement between the two tests was statistically highly significant (P less than 0.0001). A total of 161 (22.9%) were positive by one technique or the other; 95 (13.5%) were positive by both techniques. A total of 32 specimens were positive by SSF but negative by F/EA plus MCK, and 34 specimens were positive by F/EA plus MCK but negative by SSF. The discrepancies between the two techniques occurred in stool specimens that contained rare to a few oocysts. Other parasitic forms were found by both techniques. F/EA plus trichrome staining recovered 126 (17.9%) specimens with Giardia lamblia, whereas SSF recovered only 42 (6.0%) specimens with G. lamblia. No association (chi 2 = 0.02, P = 0.89) was observed between the presence of G. lamblia and Cryptosporidium sp. in these stool specimens. We concluded that F/EA plus MCK of the sediment was as effective in the concentration and identification of Cryptosporidium sp. oocysts as SSF. F/EA plus MCK may be advantageous as a single concentration method for general parasitology when Cryptosporidium sp. is also being sought.