[Sterilization and storage of sterilizing and sterile equipment].
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Central Supply, Hospital↗
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[The functioning of the hot-air table-model sterilizers Aero-Steril 724 B and 846 B and the necessary prevention of recontamination of the sterilized materials].
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Hot Temperature↗
Comparative evaluation of the sporicidal activity of new low-temperature sterilization technologies: ethylene oxide, 2 plasma sterilization systems, and liquid peracetic acid.
OBJECTIVE: This study was undertaken to evaluate the efficacy of 4 new low-temperature sterilization technologies: ethylene oxide with hydrochlorofluorocarbons, a liquid peracetic acid immersion system (Steris System 1 Processor), and 2 plasma sterilization processes that use vaporized hydrogen peroxide (Sterrad 100 and the Sterrad 100S). The Sterrad 100S system potentially improves sterilizer efficacy by using 2 cycles of a diffusion stage and a plasma stage per sterilization cycle. METHODS: Flat stainless steel carriers were inoculated with approximately 10(6) Bacillus stearothermophilus spores. These carriers were aseptically placed in the middle of 40 cm long stainless steel lumens (hollow tubes). Two types of lumen were used:(1) a lumen test unit with a removable 5 cm center piece (1.2 cm diameter) of stainless steel sealed to the narrower steel tubing by hard rubber septums and (2) a straight lumen. Three different diameters of the lumen test unit (1, 2, and 3 mm) and a single diameter of the straight lumen (3 mm) were studied. At least 40 replicates were performed for each type of lumen and sterilization method. After inoculation, the test unit was evaluated in 1 of the low-temperature sterilization technologies. After sterilization, the carriers were cultured in trypticase soy broth for 14 days at 55 degrees C and assessed for growth of B stearothermophilus spores. RESULTS: Our results demonstrated that ethylene oxide with hydrochlorofluorocarbons, the Sterrad 100s, and the Sterrad 100S half cycle were highly effective in killing approximately 10(6) B stearothermophilus spores present in the center of narrow-lumen stainless steel tubes. As the lumen diameter decreased with the lumen test unit, the Sterrad 100 demonstrated reduced ability to kill B stearothermophilus spores present on the carrier. At the smallest diameter tested (1 mm), the Sterrad 100 system failed 74% of the time. The Steris System 1 was not effective in completely eliminating the 10(6) inoculum under test conditions. CONCLUSION: The Sterrad 100S was significantly superior to the Sterrad 100 system and equivalent to ethylene oxide with hydrochlorofluorocarbons. Introduction of this new Sterrad 100S system should improve the margin of safety and reduce processing costs by its use of a shorter cycle time. The Steris System 1 is limited by diffusion of the chemical sterilant into the interior of the lumen test unit.
Disinfectants↗
Contamination of bronchoscopes with Mycobacterium tuberculosis and successful sterilization by low-temperature hydrogen peroxide plasma sterilization.
BACKGROUND: The transmission of mycobacteria by bronchoscopes has been reported several times in the last years. To explore methods to prevent transmission of tuberculosis in this way, we sterilized contaminated bronchoscopes with low-temperature hydrogen peroxide gas plasma sterilization. METHODS: Bronchoscopes were contaminated with Mycobacterium tuberculosis and decontaminated with a washer/disinfector ("normal washing"). Some were additionally disinfected with glutaraldehyde ("intensive washing"). Afterward the bronchoscopes were sterilized by low-temperature hydrogen peroxide plasma sterilization. RESULTS: After normal washing, 8/17 samples had positive results by culture, and 7/17 had positive results by nucleic acid amplification technique. After intensive washing, all samples had negative results by culture, and 10/25 had positive results by nucleic acid amplification technique; after sterilization with low-temperature hydrogen peroxide plasma sterilization, all samples had negative results by culture and nucleic acid amplification technique. CONCLUSION: Washing of bronchoscopes, as performed normally, is not sufficient for decontamination of bronchoscopes. Additional disinfection is recommended. If the nucleic acid amplification technique is used for diagnostic procedures, sterilization by low-temperature hydrogen peroxide plasma sterilization is recommended to avoid false-positive results.
Anti-Infective Agents, Local↗
The attitudes of sterilized women to contraceptive sterilization.
Six years after their sterilization, 206 of 216 consecutively sterilized women were interviewed. Included in the semistructured interview was a series of questions about their more general attitudes to tubal sterilization. Half of the women considered the early thirties the appropriate age for contraceptive sterilization. Sixty-four women argued for male sterilization, 59 for female. The protagonists for vasectomy were younger. Twenty-seven women said contraceptive sterilization should not be more widespread, 38 believed postoperative regret was common. The abortion situation was considered inappropriate in the discussion of sterilization by 66 women; 131 found it sensible. While 84 women considered the new, liberal sterilization legislation an improvement, 110 did not agree, mainly because they considered the age limit of 25 years too low.
Abortion, Induced↗
A comparison of definable traits in women requesting reversal of sterilization and women satisfied with sterilization.
More women of reproductive age are being sterilized. Some of these women regret the decision and subsequently request a reversal of sterilization, whereas others do not. This study was undertaken to develop a profile of easily definable traits of 159 women who requested a reversal of sterilization and compare it with that of 160 women who apparently were satisfied with sterilization. Statistically significant differences were found. Remarriage was the most common cause for regret among women in the group which requested reversal of sterilization. Women in this group married younger, completed their family earlier, and were sterilized at a younger age. These women had significantly fewer live children and had undergone more therapeutic abortions (p less than 0.005).
Abortion, Therapeutic↗
The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization.
OBJECTIVE: Our purpose was to determine the risk of pregnancy after tubal sterilization for common methods of tubal occlusion. STUDY DESIGN: A multicenter, prospective cohort study was conducted in U.S. medical centers. A total of 10,685 women who underwent tubal sterilization was followed up for 8 to 14 years. The risk of pregnancy was assessed by cumulative life-table probabilities and proportional hazards models. RESULTS: A total of 143 sterilization failures was identified. Cumulative 10-year probabilities of pregnancy were highest after clip sterilization (36.5/1000 procedures) and lowest after unipolar coagulation (7.5/1000) and postpartum partial salpingectomy (7.5/1000). The cumulative risk of pregnancy was highest among women sterilized at a young age with bipolar coagulation (54.3/1000) and clip application (52.1/1000). CONCLUSIONS: Although tubal sterilization is highly effective, the risk of sterilization failure is higher than generally reported. The risk persists for years after the procedure and varies by method of tubal occlusion and age.
Age Factors↗
Electron-beam sterilization of laboratory animal diets--sterilizing effect of 10-MeV electrons from a linear accelerator.
Electron beam sterilization for laboratory animal diets was examined as an alternative to 60Co gamma rays. Solid, powder diets for "mice and rats" and solid diets for "rabbits and guinea pigs" which are the main products sterilized by 60Co gamma rays were irradiated with 10-MeV electrons from a linear accelerator at the Research Institute for Advanced Science and Technology, Osaka Prefecture University. At least 20 kGy was required to sterilize the samples irrespective of solid or powder diets, which was in good accordance with the results for 60Co gamma rays. Using a set dose of 30 kGy, a thickness of 45 mm for solid diets and 30 mm for powder diets could be sterilized by "one-sided" irradiation. "Dual-sided" irradiation could sterilize all the solid diets and the powder diets contained in the thicknesses of 90 mm and 75 mm, respectively. Irradiation effects of 10-MeV electrons on the nutrient quality of each diet were almost equivalent to those of 60Co gamma rays. These results suggest that commercially adopted sterilization doses for 60Co gamma rays are applicable to electron sterilization without modification if the depth-dose profile and the minimum dose of irradiated samples are precisely assessed.
Animal Feed↗
Surgery, sterilization and sterility.
The history of sterilization was not linked from the first with surgery. Surgery came first, fully 600 years before the principles of asepsis and anesthesia were even introduced in the middle of the 1800s. Also in the 1800s, the beginnings of thermal sterilization were being developed in the food industry. The basic principles of antisepsis and prevention of wound suppuration, including the destruction of germs on instruments, dressings, the hands of the surgeon and his assistants, and everything else in contact with the wound were clearly elucidated by Lister in the 1870s and remain the inviolate principles of surgical asepsis today. In general, the marriage between the surgeons and the sterilizers was a successful one; the major handicap to eternal bliss and harmony, however, was an incompatibility between the partners. As in many marriages, the partners made unwarranted demands upon each other, and became frustrated when these demands were unfulfilled. The field of surgical sterilization and surgical safety is less confused by technical inconsistencies than it is by semantic nightmares, such that we will never reach a universal definition of sterility. However, we do not really need a universal definition of sterility. Rather we should learn how to translate sterility tests in terms of the real world infections hazards.
Attitude of Health Personnel↗
[Sterile packing materials for formaldehyde sterilization].
Apart from the already widely applied sterilization by ethylene oxide, the sterilization by gaseous formaldehyde is another reliable procedure for the sterilization of thermolabile instruments. An essential advantage of the sterilization by gaseous formaldehyde over the so-called wet sterilization is that it can be performed in a recontamination-proof sterile packing. Packing materials produced in the GDR, the germ-tightness and toxicological safety of which were already known, were tested to evaluate their suitability for sterilization by gaseous formaldehyde. An appropriate packing variant was found and tested for microbiological reliability.
Equipment and Supplies↗
Heat and cold-induced male sterility in Drosophila buzzatii: genetic variation among populations for the duration of sterility.
Here we studied three phenotypic traits in Drosophila buzzatii that are strongly effected by temperature, and are expected to be closely associated with fitness in nature. The traits measured were thermal threshold of male sterility, time for males to gain fertility when reared at a sterility-inducing temperature and transferred to 25 degrees C on eclosion and survival after development. The last two traits were measured under four temperature regimes, constant 12 degrees C, 25 degrees C, 31 degrees C, and fluctuating 25 degrees C (18 h) and 38 degrees C (6 h). We looked for genetic variation in these traits and relations among them in four lines of D. buzzatii originating from Argentina and Tenerife. The thermal threshold of heat-induced male sterility was found to lie within the range of 30.0-31.0 degrees C. When measuring the time for males to gain fertility, males reared at a nonstressful temperature (25 degrees C) were fertile 58-67 h after emergence with only minor differences among lines. When reared constant 31 degrees C, males were fertile 174-225 h after hatching. The Argentinean lines were significantly faster in recovering from sterility than were the lines from Tenerife. When reared in a fluctuating temperature regime, differences among lines increased, dividing the lines into three significantly different groups, with a sterility period of 135-215 h. When reared at 12 degrees C from the pupal stage, males were fertile after 106-130 h with significant difference in the variance but not in the mean duration of sterility. Significant differences in viability were found among development temperatures, but not among lines, and viability and the duration of sterility seem to be genetically independent.
Adaptation, Physiological↗
[Sterility--a woman's concern? Coping behavior and partnership structure of sterile couples of various diagnostic groups].
Three groups of sterile couples with functional, tubal and andrologically caused sterility were compared for the evaluation of sex- and diagnosis-dependent kinds of overcoming of their disease. Anamnestic data, anxiety, the coping strategy of sterility and as well the couple and personality structure are analysed. Independent of the organic cause of sterility the women showed a higher emotional reaction level (anxiety, coping stress) than their husbands. In all groups the "healthy" partners dominate. The subfertile men seem to be more subordinate, less engaged and interested and not so anxious as their wives and as the husbands of tubal sterile women. The healthy women with andrologically caused sterility present a highly emotional engagement in the overcoming and treatment of their disease. Possible emotional mechanisms and social stereotypes of self-presentation are discussed, which may cause the intense engagement of the women independent of the organic cause of sterility.
Adaptation, Psychological↗
The risk of menstrual abnormalities after tubal sterilization. U.S. Collaborative Review of Sterilization Working Group.
BACKGROUND: The existence of a post-tubal-ligation syndrome of menstrual abnormalities has been debated for decades. We used data from the U.S. Collaborative Review of Sterilization to determine whether the likelihood of persistent menstrual abnormalities was greater among women who had undergone tubal sterilization than among women who had not. METHODS: A total of 9514 women who underwent tubal sterilization and 573 women whose partners underwent vasectomy were followed in a multicenter, prospective cohort study for up to five years by means of annual telephone interviews. All women were asked the same questions about six characteristics of their menstrual cycles in the presterilization and follow-up interviews. Multiple logistic-regression analysis was used to assess the risk of persistent menstrual changes. RESULTS: The women who had undergone sterilization were no more likely than those who had not undergone the procedure to report persistent changes in intermenstrual bleeding or the length of the menstrual cycle. They were more likely to have decreases in the number of days of bleeding (odds ratio, 2.4; 95 percent confidence interval, 1.1 to 5.2), the amount of bleeding (odds ratio, 1.5; 95 percent confidence interval, 1.1 to 2.0), and menstrual pain (odds ratio, 1.3; 95 percent confidence interval, 1.0 to 1.8) and to have an increase in cycle irregularity (odds ratio, 1.6; 95 percent confidence interval, 1.1 to 2.3). Among women who had had very heavy bleeding at base line, women who had undergone sterilization were more likely than women who had not undergone the procedure to report decreased bleeding (45 percent vs. 33 percent, P=0.03). CONCLUSIONS: Women who have undergone tubal sterilization are no more likely than other women to have menstrual abnormalities.
Adult↗
Risk of wound and pelvic infection after laparoscopic tubal sterilization: instrument disinfection versus sterilization.
To determine if disinfection, rather than sterilization, of laparoscopic equipment leads to an increase in the risk of postlaparoscopy infection, the authors analyzed data from a multicenter prospective study conducted by the Centers for Disease Control on the safety of sterilizing operations. From September 1978 through July 1981, 3903 women underwent laparoscopic tubal sterilization procedures in which the equipment was sterilized with ethylene oxide (58%) or disinfected with glutaraldehyde (42%). The overall risk of wound infection in each group was 1.5 per 100 women. The relative risk of wound infection for disinfection versus sterilization of the equipment was 0.5 when adjusted for differences in the two groups. The corresponding relative risk of pelvic infection was 1.2. These results suggest that laparoscopy equipment disinfected with glutaraldehyde is not associated with an increased risk of wound or pelvic infection compared with equipment sterilized with ethylene oxide.
Adolescent↗
Thermal sterilization of heat-sensitive products using high-temperature short-time sterilization.
High-temperature short-time (HTST) sterilization with a continuous-flow sterilizer, developed for this study, was evaluated. The evaluation was performed with respect to (a) the chemical degradation of two heat-sensitive drugs in HTST range (140-160 degrees C) and (b) the microbiological effect of HTST sterilization. Degradation kinetics of two heat-sensitive drugs showed that a high peak temperature sterilization process resulted in less chemical degradation for the same microbiological effect than a low peak temperature process. Both drugs investigated could be sterilized with acceptable degradation at HTST conditions. For the evaluation of the microbiological effect, Bacillus stearothermophilus ATCC 7953 spores were used as indicator bacteria. Indicator spore kinetics (D(T), z value, k, and E(a)), were determined in the HTST range. A comparison between the Bigelow model (z value concept) and the Arrhenius model, used to describe the temperature coefficient of the microbial inactivation, demonstrated that the Bigelow model is more accurate in prediction of D(T) values in the HTST range. The temperature coefficient decreased with increasing temperature. The influence of Ca(2+) ions and pH value on the heat resistance of the indicator spores, which is known under typical sterilization conditions, did not change under HTST conditions.
Geobacillus stearothermophilus↗
[Contraceptive choices and experience of sexuality: a comparison between sterilized and non-sterilized women in a metropolitan area of southeastern Brazil].
A cross sectional study involving 357 women, 174 of them sterilized and 183 non-sterilized, with a view to comparing their sexual and reproductive behaviour, was undertaken. The questionnaire was based on previous focus group discussions with both women and men, to find out the best way to approach related questions. The results show that sterilized women-who are older and more often have steady partnerships than non-sterilized women-fulfil traditional gender roles more closely than the others. Furthermore, no sterilized woman had used the condom in the month prior to the interview. It is suggested that public messages for the prevention of the spread of the HIV, sexually-transmissible disease and cervical cancer should target women who have been sterilized for the purpose of increasing the use of the condom in accordance with specific strategies.
Adult↗
Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products." The draft guidance is intended to provide recommendations and offer alternative methods for sterility testing to confirm the integrity of container and closure systems for sterile biological products, human and veterinary drugs, and medical devices. The draft guidance applies only to the replacement of the sterility test with an appropriate container and closure integrity test in the stability protocol, and it is not offered as a replacement for sterility testing for product release.
Drug Packaging↗
Aeration time following ethylene oxide sterilization for reusable rigid sterilization containers: concentration of gaseous ethylene oxide in containers.
Because ethylene oxide (EO) gas is toxic to humans, restrictions have been imposed on its use for sterilization, specifying allowable levels of residual EO remaining in sterilized apparatus and materials. However, the aeration time that optimizes the removal of the remaining EO when a rigid sterilizing container is used for a vessel had not been identified. Therefore, polyvinyl chloride, which easily adsorbs EO, was placed in rigid sterilizing containers, and aeration was carried out after 1, 8, 12, 17, and 24 hours. After standard EO sterilization, the EO concentrations remaining in the air in the rigid containers were measured. The results indicate that a period of 17 hours of aeration is appropriate when a rigid sterilizing container is used.
Air↗