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Comparison of a rapid readout biological indicator for steam sterilization with four conventional biological indicators and five chemical indicators.

OBJECTIVE: In this study, we compare a new biological indicator that provides results within 3 hours with four conventional, 48-hour biological indicators and five chemical indicators. DESIGN: Biological indicators tested included the conventional Attest 1262, Proof Plus, Assert, and Biosign, and the new Attest 1292 Rapid Readout biological indicator. Chemical indicators tested included Comply, Propper, Chemdi, Sterigage, and Thermalog S. Spore survival following 121 degrees C in a gravity displacement sterilizer was measured by media color change after incubation for 24 and 48 hours at 56 degrees C for the conventional biological indicators, fluorescence at 3 hours for the Attest 1292 Rapid Readout biological indicator, and color change for the chemical indicators. Each exposure time was replicated 12 times with 5 samples of each indicator per run (ie, 60 replicates per indicator). RESULTS: At 48 hours, the conventional biological indicators Attest 1262, Proof Plus, Assert, and Biosign showed 100%, 95%, 88%, and 93% spore survival at 5 minutes' exposure 0%, 0%, 0% and 8% at 10 minutes; and all showed 0% survival at 15 minutes' exposure. Following a 3-hour incubation, the Attest 1292 Rapid Readout biological indicator showed fluorescence at 100%, 72%, and 0% at 5, 10, and 15 minutes, respectively. The chemical indicators Comply, Propper, Chemdi, Sterigage, and Thermalog S revealed sterilization failure rates of 100%, 100%, 100%, 100%, and 100% at 5 minutes' exposure; 0%, 0%, 0%, 92%, and 100% at 10 minutes; and 0%, 0%, 0%, 3%, and 27% at 15 minutes' exposure, respectively. CONCLUSIONS: The sensitivity of the Attest 1292 Rapid Readout biological indicator parallels that of conventional biological indicators. These data suggest that a 3-hour rapid readout biological indicator is equivalent to a standard 48-hour biological indicator. Some chemical indicators (eg, Thermalog S) failed to indicate adequate sterilization at 15 minutes' exposure. These chemical indicators have the potential of causing unnecessary recall of adequately sterilized items.

Equipment Contamination↗

Evaluation of a rapid readout biological indicator for flash sterilization with three biological indicators and three chemical indicators.

OBJECTIVE: Flash sterilization is most commonly used for emergency sterilization of unwrapped items in a gravity displacement sterilizer for three minutes. Sterilization quality assurance is monitored by biological indicators that require a 24-hour incubation prior to reading. In this study, we compared a new biological indicator that provides results within 60 minutes with three conventional, 24-hour biological indicators for monitoring flash sterilization and three chemical indicators. DESIGN: Conventional biological indicators tested included the conventional Attest 1261, Proof Flash and Assert, while the rapid readout indicator tested was Attest 1291. Attest Rapid Readout detects the presence of a Bacillus stearothermophilus enzyme by reading a fluorescent product that is produced by the enzymatic break-down of a nonfluorescent substrate. Chemical indicators tested included Comply, Incheque, and Thermalog S. Survival at 132 degrees C in a gravity displacement sterilizer was measured by media color change after incubation for 24 hours at 56 degrees C for the three conventional biological indicators, fluorescence at 60 minutes for the Attest Rapid Readout biological indicator, and color change for the chemical indicators. Each exposure time was replicated four times with 10 of each biological and chemical indicator per run. RESULTS: The conventional biological indicators (Attest, Proof Flash, and Assert) had 90%, 48%, and 40% spore survival at two minutes exposure; 23%, 3%, and 0% at three minutes exposure; and 3%, 0%, and 0% at four minutes exposure respectively. The Attest Rapid Readout biological indicator had 88%, 33%, and 0% enzyme activity detectable at 2, 3, and 4 minutes exposure. The chemical indicators Comply, Incheque, and Thermalog S revealed sterilization failure rates of 100%, 100%, and 100% at 0 minutes exposure; 100%, 100%, and 45% at one minute; 0%, 0%, and 28% at two minutes exposure; 0%, 0%, and 18% at three minutes exposure; and 0%, 0%, and 0% at four minutes exposure, respectively. CONCLUSION: The sensitivity of the Attest Rapid Readout parallels the conventional biological indicators. These data suggest that a 60-minute rapid readout biological indicator is equivalent to the 24-hour biological indicators. If further studies demonstrate that a four-minute flash sterilization cycle provides a needed safety margin to ensure sterilization, then consideration should be given to requiring a four-minute flash sterilization cycle. Chemical indicators were too sensitive to the processing conditions (eg, steam) and are inadequate to ensure adequate sterilization.

Evaluation Studies as Topic↗

Definition of mixing rate of indicator by indicator dilution method: evaluation of relationship between mixing rate of indicator and cardiac output determination.

It is generally agreed that complete mixing of the indicator is one of the most important factors of the indicator dilution method, however, no clear definition of the mixing state has been established. We established a formula for the mixing rate of the indicator by the indicator dilution method, using the concept of entropy in the information theory, and compared the mixing rate of indocyanine green in one mixing chamber (left ventricle) with that in the two mixing chamber system (including the aortic system). The mixing rate of the indicator (M) is shown as M(%) = 100 H/Hcm = -100 (lk sigma ni = 1 Ci + log Ci + log k) (l & k: correction factors in each dye dilution curve, C: mean concentration of the indicator in the region). Left heart and aortic catheterizations by retrograde femoral and carotid artery approach were performed in five anesthetized dogs. Simultaneous dye dilution curves were recorded at the aortic root and at the bifurcation of the abdominal aorta, following the injection of indocyanine green (2.5 mg/1 ml of indocyanine green for each injection) by impulse into the left ventricle at the endsystole, triggered on the R wave of ECG, using the automatic injector devised by the authors. Twenty-five pairs of dye dilution curves were obtained by simultaneous recording in the aortic root and the abdominal aorta under several hemodynamic conditions, and the cardiac output, mean circulation time and the mixing rate of the indicator were determined.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

An approach to the evaluation of quality indicators of the outcome of care in hospitalized patients, with a focus on nosocomial infection indicators. The Quality Indicator Study Group.

The Quality Indicator Study Group was created by the governing boards of three national professional organizations that have interest and experience in epidemiology, nosocomial infection control and prevention, and quality of care improvement. The Study Group has reviewed the existing literature concerning quality indicators (QIs), interviewed experts in the field, and focused on how best to evaluate such indicators, with an emphasis on nosocomial infection indicators as a paradigm for all QIs. In this report, we review pertinent issues and, where possible, provide specific advice on how to evaluate QIs and QI systems.

Cross Infection↗

Physician ratings of appropriate indications for three procedures: theoretical indications vs indications used in practice.

We previously reported substantial disagreement among expert physician panelists about the appropriateness of performing six medical and surgical procedures for a large number of theoretical indications. A recently completed community-based medical records study of about 4,500 patients who had one of three procedures--coronary angiography, upper gastrointestinal endoscopy, and carotid endarterectomy--shows that many of the theoretical indications are seldom or never used in practice. However, we find that there is also substantial disagreement (5, 25, or 32 per cent for angiography, endoscopy, or endarterectomy, respectively) about the appropriateness of indications used in actual cases if disagreement is defined by first discarding the two extreme of nine ratings, then looking for at least one rating near the bottom (1 to 3) and one near the top (7 to 9) of the 9-point scale. Patients should know that a substantial percentage of procedures are performed for indications about which expert physicians disagree.

Attitude of Health Personnel↗

[Application of a new method for the calculation and description of the resistance of microbiological indicators. I. Testing of several common microbiological sterilization indicators (author's transl)].

The method described by SPICHER and PETERS (1975) for the calculation and description of the resistance of microbiological indicators was tested. As test objects served spore-containing earth according to DIN 58946, Attest indicators (3 M Company, Minnesota) and Oxoid Spore Strips (Oxoid Ltd., London). The tests were performed not only for different batches of indicators but also for preparations of different age. After application of steam (120 degrees C), the indicators were examined for the presence of surviving germs capable of multiplication. When plotting the frequency of indicators with surviving germs (q) against the duration of steam action, S-shaped curves were obtained as expected. By altering the scale of the ordinate (y = lg (-ln(1 - q))), the S-shaped curves could be transformed into straight lines. Thus, the experimentally established paired values could be used for a calculation of regression. This method of calculation proved to be suitable in all cases studied. By indicating the position and the slope of these straight regression lines, the resistance of microbiological indicators can be exactly described (cf. Table 2). This method is applicable not only to indicators containing culture spores but also for native spore-containing earth. The indicators examined differed in their resistance and stability. Seven out of eight batches of Attest indicators (cf Figs. 1 and 2 and Table 1) fulfilled the requirements of DIN 58946, Part 4, for the resistance of bio-indicators for steam sterilization. One of the batches had a slightly higher resistance. The Attest indicators tested were of good stability (see Fig. 1 and Table 1). Where surviving germs were present on the indicators after treatment by steam, their growth was recognizable, in 99% of cases, already after incubation of the cultures for 24 hours. Only two batches of Oxoid Spore Strips were available for testing. One batch was of a higher resistance than required by DIN 58946. The second batch was slightly above the lower limit of the permissible range (see Fig. 3). During storage for 12 months, the resistance of both batches was reduced by 3--4 min. Where the indicators exhibited surviving germs after treatment by steam, growth was recognizable in 87% of the cases after incubation for 24 hours, while for the other indicators, incubation for 48 hours was necessary. The experiments confirmed the good stability of native spore-containing earth (see Fig. 5). Within 4--5 years, the steam resistance of the preparations decreased only by 3--4 min.

Bacteriological Techniques↗

QSPR modeling: graph connectivity indices versus line graph connectivity indices

Five QSPR models of alkanes were reinvestigated. Properties considered were molecular surface-dependent properties (boiling points and gas chromatographic retention indices) and molecular volume-dependent properties (molar volumes and molar refractions). The vertex- and edge-connectivity indices were used as structural parameters. In each studied case we computed connectivity indices of alkane trees and alkane line graphs and searched for the optimum exponent. Models based on indices with an optimum exponent and on the standard value of the exponent were compared. Thus, for each property we generated six QSPR models (four for alkane trees and two for the corresponding line graphs). In all studied cases QSPR models based on connectivity indices with optimum exponents have better statistical characteristics than the models based on connectivity indices with the standard value of the exponent. The comparison between models based on vertex- and edge-connectivity indices gave in two cases (molar volumes and molar refractions) better models based on edge-connectivity indices and in three cases (boiling points for octanes and nonanes and gas chromatographic retention indices) better models based on vertex-connectivity indices. Thus, it appears that the edge-connectivity index is more appropriate to be used in the structure-molecular volume properties modeling and the vertex-connectivity index in the structure-molecular surface properties modeling. The use of line graphs did not improve the predictive power of the connectivity indices. Only in one case (boiling points of nonanes) a better model was obtained with the use of line graphs.

Journal Article↗

Current status of biological indicators to detect and quantify previous exposures to radiation. Biological Indicators Working Group.

Hematologic changes following whole-body exposure to gamma or x-ray radiation have been used to estimate dose. The usefulness of this biological indicator is limited because of the recovery of these cells with time, thus making it unsuitable for estimation of dose years after exposure. The same is true for spermatogenic indicators; recovery and restoration of sperm numbers and fertility makes this biological indicator impractical for assessing radiation dose decades after radiation exposure. As noted in the text of the report, immunological concepts are in a state of rapid development, and it is possible that improved methods for applying immunologic procedures as biological indicators of radiation may be developed in the future. However, at the time, immunological indicators are not useful, even in an early time period, for quantitating radiation dose after total-body irradiation. A semiquantitative effect is observable in the early phase after total-body irradiation over a period of days to weeks, but there is little data available to indicate whether any of the immunological parameters can be indicative of a dose when the test is applied several years after radiation exposure. More detailed information regarding immunological indicators for estimating irradiation dose has been summarized elsewhere (Wasserman 1986). There is good agreement that ionizing radiation causes biochemical changes in the body; however, attempts to apply these changes to provide a reliable biological dosimetry system have not been particularly successful. The status of this research has been summarized by Gerber (1986). One of the difficulties has been the problem of establishing clear dose-effect relationships in humans. The lack of specificity in the response for radiation is another problem. Additional problems are due to the strict time dependency of biochemical changes and the limited duration of the changes during the postexposure period. Information on biochemical indicators is based on animal experiments; human experience is limited to a relatively few accidental human exposures and investigations involving patients undergoing radiation therapy. It appears that none of the biochemical indicators studied are currently useful for radiation dosimetry. Even if further developed, it is questionable whether or not biochemical indicators could be of use in estimating radiation dose received years and decades prior to the assay.

Blood↗

Indicators of accuracy of consumer health information on the Internet: a study of indicators relating to information for managing fever in children in the home.

OBJECTIVES: To identify indicators of accuracy for consumer health information on the Internet. The results will help lay people distinguish accurate from inaccurate health information on the Internet. DESIGN: Several popular search engines (Yahoo, AltaVista, and Google) were used to find Web pages on the treatment of fever in children. The accuracy and completeness of these Web pages was determined by comparing their content with that of an instrument developed from authoritative sources on treating fever in children. The presence on these Web pages of a number of proposed indicators of accuracy, taken from published guidelines for evaluating the quality of health information on the Internet, was noted. MAIN OUTCOME MEASURES: Correlation between the accuracy of Web pages on treating fever in children and the presence of proposed indicators of accuracy on these pages. Likelihood ratios for the presence (and absence) of these proposed indicators. RESULTS: One hundred Web pages were identified and characterized as "more accurate" or "less accurate." Three indicators correlated with accuracy: displaying the HONcode logo, having an organization domain, and displaying a copyright. Many proposed indicators taken from published guidelines did not correlate with accuracy (e.g., the author being identified and the author having medical credentials) or inaccuracy (e.g., lack of currency and advertising). CONCLUSIONS: This method provides a systematic way of identifying indicators that are correlated with the accuracy (or inaccuracy) of health information on the Internet. Three such indicators have been identified in this study. Identifying such indicators and informing the providers and consumers of health information about them would be valuable for public health care.

Child↗

Developing indicators for the Medicare Quality Indicator System (MQIS): challenges and lessons learned.

BACKGROUND: The Medicare Quality Indicator System (MQIS), initiated in 1993, was intended to form the basis for the Health Care Financing Administration's (HCFA's; Washington, DC) hospital-based quality measurement system. The MEDSTAT Group (Washington, DC) established quality indicator development methods for five clinical conditions, including early-stage breast cancer, diabetes mellitus, and upper gastrointestinal and lower intestinal bleeding. DEVELOPMENT OF QUALITY INDICATORS: Five national expert panels were convened to identify scientifically based hospital processes of care related to positive patient outcomes, as described in research studies and/or broadly accepted by the medical and allied health professions as indicators of high-quality care. LESSONS AND CHALLENGES: One of the most important lessons learned was the need for a narrow clinical focus for each quality indicator module. If the focus was adequately narrowed, all other tasks could be accomplished more efficiently and less ambiguously. Also, selection of the expert panel chair should occur early because of the chair's pivotal contributions to the clinical focus selection, literature review, and development of draft quality indicators. Perhaps the most starting finding and biggest challenge was the paucity of scientifically sound literature to support the clinical topics; except for the breast cancer studies, most of the available literature was categorized as flawed to some degree. A critical challenge for development of quality indicators is to translate what has been learned from the best scientific efficacy studies into indicators of effective rather than efficacious care. CONCLUSIONS: In choosing quality indicators, disease incidence and potential for quality improvement are important parameters. Although the former is relatively easy to define, the latter is not.

Breast Neoplasms↗

A comparison of cardiovascular risk as measured by compound blood lipid indices and two indices including lifestyle factors in occupational health service.

Healthy employees in a non-manufacturing firm (n = 252) were divided into low and high cardiovascular risk subjects in order to compare different indices of cardiovascular risk for use in occupational health service. The levels of total cholesterol (TC), a compound index of blood lipid components, the 'atherogenic index' (ATH-index) defined as ([TC-HDLc] x [apoB])/([HDLc] x [apoA]), and two other compound indices, one Norwegian (Westlund) and one Scottish (Dundee score) were compared. Information on smoking habits and blood pressure were part of the two last indices. Cut-off values to separate between low and high risk subjects were defined with TC = 6.5 mmol/l, HDLc = 0.9 mmol/l, apoA = 1.8 g/l and apoB = 1.3 g/l, all values based on clinical guidelines in Norway. No smoking and a systolic blood pressure < 150 mmHg was included as cut-off of the combined indices. According to the three indices (ATH, Westlund and Dundee) 102, 25 and 116 employees were allocated to the increased risk group. Persons allocated to the increased risk group by the combined indices and not by the compound index were practically all smokers. Systolic blood pressure differed between indices only for persons with extreme pressures. A compound blood lipid index of CV risk, which may be drawn easily in an occupational health setting in an unfasting state and sent by post to a laboratory, mimics the allocation of persons to an increased risk group using combined indices. Smokers with normal lipid values would be allocated to increased risk by the combined indices, but not necessarily by the compound index. The use of the compound index together with advice to stop smoking is suggested as a time-saving strategy.

Adult↗

A comparison of Doppler ultrasound waveform indices in the umbilical artery--I. Indices derived from the maximum velocity waveform.

Various Doppler waveform indices have been used for assessment of the fetal circulation. Comparisons were made to show what relations exist between the indices, and to identify any differences or difficulties which might arise from using one as opposed to another in clinical practice. Both normal pregnancy and cases of fetal growth failure were studied. Indices were obtained from the maximum velocity envelope of the umbilical artery waveform using a curve fitting technique. The values were very reproducible for all indices. The FHR, which varied over the entire normal range, did not significantly affect the values of any index. The downstream impedance indices calculated included the AB ratio, pulsatility index (PI) and Pourcelot ratio. These all gave very closely correlated results for normals but discrepancies occurred in the at risk group, where values were elevated. This could be attributed to differences in the underlying distributions. The indices suggested for cardiac contractility were not as closely related to each other, and moreover the differences between them showed no clear pattern. None of the indices varied independently of the others. The rising slope, which is by definition related to the PI, was more highly correlated with the downstream indices than the relative flow rate index.

Blood Flow Velocity↗

Peak negative myocardial velocity gradient in early diastole as a noninvasive indicator of left ventricular diastolic function: comparison with transmitral flow velocity indices.

OBJECTIVES: We sought to assess the clinical significance of peak negative myocardial velocity gradient (MVG) in early diastole as a noninvasive indicator of left ventricular (LV) diastolic function. BACKGROUND: Peak systolic MVG has been shown useful for the quantitative assessment of regional wall motion abnormalities, but limited data exist regarding the diastolic MVG as an indicator of LV diastolic function. METHODS: Peak negative MVG was obtained from M-mode tissue Doppler imaging (TDI) in 43 subjects with or without impairment of systolic and diastolic performance: 12 normal subjects, 12 patients with hypertensive heart disease (HHD) with normal systolic performance and 19 patients with dilated cardiomyopathy (DCM), and was compared with standard Doppler transmitral flow velocity indices. In a subgroup of 30 patients, effects of preload increase on these indices were assessed by performing passive leg lifting. In an additional 11 patients with congestive heart failure at the initial examination, the measurements were repeated after 26+/-16 days of volume-reducing therapy. RESULTS: Peak negative MVG was significantly depressed both in HHD (-3.9+/-1.3/s, p < 0.01 vs. normal=-7.7+/-1.5/s) and DCM (-4.4+/-1.4/s, p < 0.01 vs. normal). In contrast, transmitral flow indices failed to distinguish DCM from normal due to the pseudonormalization. Transmitral flow velocity indices were significantly altered (peak early/late diastolic filling velocity [E/A]=1.1+/-0.5 to 1.5+/-0.7, p < 0.01; E deceleration time=181+/-41 to 153+/-38 ms, p < 0.01), while peak negative MVG remained unchanged (-5.3+/-2.2 to -5.3+/-2.0/s, NS) by leg lifting. Volume-reducing therapy resulted in the apparent worsening of the transmitral flow velocity pattern toward abnormal relaxation, as opposed to peak negative MVG, which improved by the therapy (p < 0.05). CONCLUSIONS: Peak negative MVG derived from TDI may be a noninvasive indicator of LV diastolic function that is less affected by preload alterations than the transmitral flow velocity indices, and thereby could be used for the follow-up of patients with nonischemic LV dysfunction presenting congestive heart failure.

Adult↗

A comparison of Doppler ultrasound waveform indices in the umbilical artery--II. Indices derived from the mean velocity and first moment waveforms.

Umbilical artery Doppler recordings in both normal pregnancy and cases of fetal growth failure were processed by computer. Representative waveforms for the maximum velocity, mean velocity and first moment were obtained after ensemble averaging and correction for thump filtering. The same set of indices, which included the AB ratio, pulsatility index, rising slope and relative flow rate index, were calculated for each of the waveforms. The results were compared to identify differences which might arise in clinical practice if a waveform other than the usual (maximum velocity) was used. The ratio of the mean to the maximum velocity, which gives an indication of the velocity profile, was shown to be very error prone. The reproducibility of the mean velocity and first moment indices was inferior to that of the maximum velocity indices. The results from the different waveforms were highly correlated for normals for most indices. However, in the growth retarded group there was a tendency for the mean velocity and first moment indices to classify as normal studies classified as abnormal by the maximum velocity index. The values of indices derived from the first moment waveform were generally larger than the maximum and mean velocity values. For the relative flow rate index, where results were often different to the general trend, the values were more nearly equal.

Blood Flow Velocity↗

Regional indices of relative hepatic arterial perfusion from dynamic liver scintigraphy: the variability of indices and the use of parametric imaging.

Regional indices of relative arterial hepatic perfusion have been studied in 21 control subjects following dynamic radiocolloid scintigraphy of the liver (DLS). Three different indices have been calculated: the hepatic perfusion index (HPI); the hepatic arterial ratio (HAR) and the mesenteric fraction (MF). Three regions were defined in the upper, mid and lower right hepatic lobes and the three indices were calculated for each region. There was reasonable agreement between regional values of the same index with inter-regional correlation coefficients above 0.7 and standard errors in straight line fits of less than 0.093. There were significant regional differences for (1-MF) and HPI indices, but not for HAR. The index (1-MF) was calculated for each pixel and presented as a parametric image in 16 control subjects. The parametric images indicated the raised regional arterial indices due to overlying lung, right kidney and aorta. Parametric images may be of value to show the hepatic area free of significant overlying tissue and therefore available for analysis by DLS. However, the results suggest that the observed variability of single pixel indices limit the potential of parametric imaging for the localization of small focal lesions.

Humans↗

Decision-making in clinical practice: application of predictors, indicators and indices to the medical history obtained by a self-administered questionnaire.

A theoretical description of predictors, indicators, and health indices was presented in an earlier paper (Hall and Sebag, 1974). The application of predictors, indicators and health indices--including dynamic health indices--to anamnestic data obtained by a self-administered questionnaire is presented herein. Predictors and indicators showed a varying degree of 'decision-making significance' in the 122 questions examined. The health index distinguished between diagnosed individuals and those receiving no diagnosis(es). The dynamic health index was found to reflect changes in the health status of an individual over a period of time.

Decision Making↗