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Ethylene oxide sterilization: how hospitals can adapt to the changes.

Ethylene oxide (EtO) gas sterilizers have been used by hospitals for over 40 years to sterilize surgical equipment and supplies that are heat sensitive or that cannot tolerate excessive moisture. However, in recent decades, EtO has been recognized as a potential mutagenic, reproductive, neurologic, and fire and explosion hazard to workers, and one agency has reportedly voted to classify EtO as carcinogenic to humans. Strict regulations concerning EtO exposure have been imposed by the Occupational Safety and Health Administration (OSHA), and the use of EtO, along with other toxic pollutants, is also being monitored by the Environmental Protection Agency (EPA) under the Clean Air Act. In addition, the use of chlorofluorocarbons (CFCs) as EtO diluents has focused attention on the EtO-CFC mixtures used in many sterilizers because CFCs have been linked to destruction of the ozone layer. Concerns about restrictive regulations related to these issues have prompted many hospitals to examine their use of EtO sterilization and propagated the misinformation that EtO sterilization is being phased out. In this article, we address some commonly asked questions regarding the use and regulation of EtO mixtures, as well as alternative sterilization agents and methods; provide two case studies illustrating how hospitals can evaluate various sterilization options; and summarize our conclusions and recommendations for hospitals facing decisions about sterilization techniques. For related topics, also see our Evaluation Update on endoscope reprocessors and our Hazard Report on improperly connected EtO-CFC cylinders to EtO sterilizers in this issue.

Air Pollution↗

Optimization of moist heat sterilization.

The use of different combinations of sterilization time and temperature in a pilot scale autoclave, GEV 612 AR-2 (Getinge Ab, Sweden), in optimizing the sterilization process was studied. All three programs used had the same sterilization efficacy (F0 = 15 minutes) but different sterilization temperatures (116, 121, and 126 degrees C) and total process times (98, 57, and 44 minutes). The heat distribution during the sterilization phase was, in all cases, very uniform, the greatest difference being 0.5 degrees C. Also the F0 values differed only by +/- 0.5 minutes from each other. The F0 value increases linearly with all programs until the beginning of the cooling phase. The main effect of different sterilization temperatures on the cumulative F0 curves is an increase in the slope of the curves with increasing sterilization temperature. First order temperature change constants were determined both for the heating phase and the cooling phase. The numeric values of the rate constants for the heating and the cooling phases were 0.20 +/- 0.03 and 0.046 +/- 0.005 min-1, respectively. It is concluded that the pilot autoclave used in this study controls the sterilization process very accurately. The observed variations between F0 values at different positions in the autoclave chamber are acceptable. On the basis of this study an accurately engineered and controlled autoclave is required in process optimization. It also is possible to use higher sterilization temperatures than usually suggested in pharmacopeias and thus to shorten the process time.

Hot Temperature↗

Analysis of sterilization failure in Brazil.

A study of 13,423 female sterilization procedures performed from 1981 to 1984 in Rio de Janeiro, Brazil, was conducted to determine the level of sterilization failure. The lifetable cumulative failure rate was 0.54 at 12 months per 100 initial sterilizations, increasing to 1.04 at 48 months. Results of a multivariate analysis indicated that the differential in the rate of sterilization failure by woman's age at sterilization at 12 and 24 months was statistically highly significant. However, the differential rate of failure by the other variables such as whether sterilized during a training period, number of sterilizations per surgeon per day, and year of sterilization were not statistically significant.

Actuarial Analysis↗

Regret following female sterilization at a young age: a systematic review.

Women who undergo sterilization may later regret this decision. This systematic review examines whether age at sterilization is associated with poststerilization regret. Using MEDLINE and EMBASE, we identified 19 articles that examined associations between women's age at sterilization and later regret, requests for sterilization reversal and undergoing sterilization reversal or requesting in vitro fertilization (IVF) procedures. Study results showed that the younger women were at the time of sterilization, the more likely they were to report regretting that decision. Women undergoing sterilization at the age 30 years or younger were about twice as likely as those over 30 to express regret. They were also from 3.5 to 18 times as likely to request information about reversing the procedure and about 8 times as likely to actually undergo reversal or an evaluation for IVF. Results of studies that examined risk by continuous age showed a consistent inverse relationship between women's age at sterilization and their likelihood of regretting having had the procedure.

Age Factors↗

Tubal sterilization: focus on the U.S. experience.

OBJECTIVE: To review the frequency, effectiveness, and clinical sequelae of tubal sterilization with a focus on the U.S. experience. DESIGN: A review of U.S. health care statistics and English-language literature using a MEDLINE search, bibliographies of key references, and U.S. government publications. PATIENT(S): Women seeking tubal sterilization. INTERVENTION: Tubal sterilization. MAIN OUTCOME MEASURE(S): Effectiveness and long-term risks and benefits. RESULT(S): Half of the 700,000 annual bilateral tubal sterilizations (TS) are performed postpartum and half as ambulatory interval procedures. Eleven million U.S. women 15-44 years of age rely on TS for contraception. Failure rates vary by method with one third or more resulting in ectopic pregnancy. Reversal is most successful after use of methods that destroy the least tube. Evidence of menstrual or hormonal disturbance after TS is weak, although some studies find higher rates of hysterectomy among previously sterilized women. Decreased risk of subsequent ovarian cancer has been observed among sterilized women. CONCLUSION(S): Tubal sterilization is highly effective and safe. Failures, although uncommon, occur at higher rates than previously appreciated. Evidence for hormonal or menstrual changes due to TS is weak. Tubal sterilization is associated with decreased risk of ovarian cancer.

Adolescent↗

[Psychodynamics of the desire for refertilization in women after sexual sterilization].

From October 1979 to April 1982 forty two women with previous tubal ligations presented themselves at the Centre for Obstetrics and Gynaecology in Giessen with a high desire of restoration of their fertility. With questionaires and partly structured interviews these women were evaluated at the Centre for Psychosomatic Medicine in Giessen. The results largely confirm previous findings known in the literature regarding the background of tubal ligations in women with desire for restoration of fertility. Most of the patients (N = 37) had the sterilization performed under conditions which are known to have an adverse prognostic effect such as sterilization for medical indications in ten women, sterilization during a marital crisis in eighteen women, and sterilization in conjunction with a therapeutic abortion, confinement or a gynaecological operation in twenty eight women. The psychodynamics of women with a desire for restoration of fertility show two main groups. First: in twenty five women a sterilization and desire for restoration of fertility are an effort to resolve a specific conflict in their marital relationship inasmuch as a new infant should serve as a bonding function and documentation of the new partnership. Second: in sixteen patients sterilization and desire for refertilization are a symptom of an unresolved conflict of the role as woman and mother. The new infant or the restoration of fertility should eliminate the narcistic deficit suffered by the sterilization or restore the self esteem which suffered a female identity blow by the sterilization. Implications of these findings for the counselling practice are discussed.

Female↗

Female sterilization in New South Wales, 1981 to 1994-1995.

This paper investigates and confirms the dramatic decline in female sterilization in New South Wales over the past decade, a period when male sterilization has remained fairly constant. The most significant decline occurred among women under 30 years of age, which resulted in a rise in the mean age at sterilization. In 1994-1995, 70% of sterilization operations were performed for contraceptive management only, 11% were concurrent with Caesarean section, and 9% with abortion. Incidental findings were an increase in Caesarean section and the proportion of women having concurrent sterilization, and a large decline in intrauterine device removals, more than half of which were accompanied with sterilization in 1994-1995. Currently-married women accounted for 80% of sterilization cases. Immigrant women generally had lower incidence of sterilization compared to the Australian-born.

Adult↗

Risk factors for tubal sterilization regret, detectable before surgery.

Brazil has one of the highest prevalence rates of female surgical sterilization in the world. At the same time there is an increased demand for sterilization reversal. In order to understand which women tend to later request reversal of the procedure, a case-control study was carried out comparing 216 women who requested reversal with sterilized women who did not, paired by year of surgery. The relative risk of requesting reversal for women sterilized before age 25 was 18 times that of women sterilized after age 29. The elevated risk remained even after controlling for a number of variables present at the time of surgery. Multiple regression analysis showed that request for reversal was associated with younger age, less information about the procedure, and fewer contraceptive methods known before sterilization. These results support the recommendation that women should be fully informed about the tubal ligation procedure and have access to other contraceptive options before being sterilized.

Adult↗

Study of male sterility in Taiwania cryptomerioides Hayata (Taxodiaceae).

A study of male sterility over a period of three consecutive years on a conifer species endemic to Taiwan, Taiwania cryptomerioides Hayata (Taxodiaceae), was done for this article. With the aids of fluorescence and electron microscopic observations, the ontogenic processes in the fertile and sterile microsporangia are compared, using samples collected from Chitou Experimental Forest and Yeou-Shoei-Keng Clonal Orchard of the National Taiwan University, Nantou, Taiwan. The development of male strobili occurred from August to the end of March. Microsporogenesis starts with the formation of the archesporium and ends with the maturation of 2-celled pollen grains within the dehiscing microsporangium. Before meiosis, there was no significant difference in ultrastructure between the fertile and sterile microsporangia. Asynchronous pollen development with various tetrad forms may occur in the same microsporangium of either fertile or sterile strobili. However, a callose wall was observable in the fertile dyad and tetrad, but not in the sterile one. After dissolution of the callose wall, the fertile microspores were released into the locule, while some sterile microspores still retained as tetrads or dyads with intertwining of exine walls in the proximal faces. As a result, there was no well developed lamellated endexine and no granulate ectexine or intine in the sterile microspores. Eventually, the intracellular structures in sterile microspores were dramatically collapsed before anthesis. The present study shows that the abortion in pollen development is possibly attributed to the absence of the callose wall. The importance of this structure to the male sterility of T. cryptomerioides is discussed.

Cupressaceae↗

Qualitative inheritance of water-stress induced apical sterility in wheat (Triticum aestivum).

Grain number per unit area is an effective component of grain yield in bread wheat. Water-stress induced apical sterility (tip sterility) reduces the number of grains and, consequently, the grain yield in semi-arid regions with a shortage of available water during the pre-anthesis period. Crosses between apical sterile and apical fertile varieties and selection lines were made and F1, BC1, and F2 populations were subjected to moderate water-stress to study the inheritance of this character. The F2 and BC1 plants were qualitatively categorised into two phenotypes and tested for monohybrid and dihybrid segregation hypotheses. All the spikes of F1 plants obtained from crosses between apical fertile and apical sterile varieties were fully fertile indicating apical fertility is dominant to apical sterility. The F2 segregation Results from crosses between apical fertile lines and Y82187 suggested two complementary dominant genes segregating independently were involved in tolerance to water-stress induced apical sterility. In other words, two dominant genes determine apical fertility in these crosses and if one of these loci is homozygous, recessive waterstress will induce apical sterility. One F2 population segregated for both apical sterility and vernalisation response. Semi-winter plants had more sterile spikelets and the result of chi-square test confirmed monhybrid segregation for vernalisation response.

Adaptation, Physiological↗

Hybrid sterility, Haldane's rule and speciation in Heliconius cydno and H. melpomene.

Most genetic studies of Haldane's rule, in which hybrid sterility or inviability affects the heterogametic sex preferentially, have focused on Drosophila. It therefore remains unclear to what extent the conclusions of that work apply more generally, particularly in female-heterogametic taxa such as birds and Lepidoptera. Here we present a genetic analysis of Haldane's rule in Heliconius butterflies. Female F(1) hybrids between Heliconius melpomene and H. cydno are completely sterile, while males have normal to mildly reduced fertility. In backcrosses of male F(1) hybrids, female offspring range from completely sterile to fully fertile. Linkage analysis using the Z-linked triose-phosphate isomerase locus demonstrates a "large X" (Z) effect on sterility. Expression of female sterility varies among crosses in this and a previous study of Heliconius. Sterility may result from the production of normal but infertile eggs, production of small infertile eggs, or from a complete failure to develop ovarioles, which suggests multiple routes to the evolution of hybrid sterility in these Heliconius species. These results conform to the expectations of the "dominance" rather than "faster male" theories of Haldane's rule and suggest that relatively few loci are responsible. The two species are broadly sympatric and hybridize in the wild, so that female hybrid sterility forms one of several strong but incomplete barriers to gene flow in nature. The effect of female sterility is comparable to that of selection against non-mimetic hybrids, while mate choice forms a much stronger barrier to gene transfer.

Animals↗

Translocations, the predominant cause of total sterility in sons of mice treated with mutagens.

Histological and cytological analyses of the testes were carried out in 42 sterile sons of males treated in the spermatozoal or spermatid stage with 250 mg/kg ethyl methanesulfonate (EMS) alone or after prefeeding with butylated hydroxytoluene (BHT); or treated with 200 R X-rays. Of the 42 sterile males, 17 had some mature spermatids, nine were blocked at diakinesis, 15 were blocked in pachytene, and one lacked spermatogenic cells altogether, having Sertoli cells only. Mitotic (spermatogonial) metaphases could therefore be analyzed in 41 of the males and meiotic configurations in 26.-(1) None of the males showed abnormalities in chromosome number, such as monosomy, trisomy, or mosaicism for either of these conditions. Certain classes of chromosome abnormalities that have been found associated with male sterility in other investigations, namely trisomies, XXY's, and X-autosome translocations, are not expected from treatment of 19A + Y cells when F(1) males are studied. (2) A very high percentage of the sterile males carried translocations. Direct meiotic evidence for this was found in 22 of the animals. In addition, 11 of the 16 that were blocked (or virtually blocked) in pachytene, and thus could be analyzed in mitosis only, consistently showed one abnormally short chromosome (or, one short plus one long), which presumably had resulted from unequal exchange (or sizable deficiency). Of the meiotically detected translocation males, 1 carried a T(A;Y), 17 had single autosomal translocations, and 4 had multiple autosomal rearrangements involving three, four, four, and six breaks, respectively. In addition, three males showed failure of X-Y pairing. (3) Translocations that cause sterility, rather than partial sterility, in males appear to be those in which at least one of the breaks occurs close to one end of a chromosome. The mitotic and meiotic evidences for this were found to be correlated. (4) It is proposed that many cases of induced F(1) male sterility may be the result of position effects produced when paracentromeric regions are translocated to euchromatic regions of certain other chromosomes. Since many translocations that produce partial sterility in the female cause complete sterility in the male, the male must be assumed to be more susceptible to disturbances of fertility by the postulated mechanism. (5) There is evidence that EMS, especially in the lower dose range, more often breaks chromosomes near one of their ends than does X-irradiation.

Animals↗

Medfly (Diptera: Tephritidae) genetic sexing: large-scale field comparison of males-only and bisexual sterile fly releases in Guatemala.

The effect of releases of bisexual (males and female) and unisexual (male only) sterilized medflies was compared in three large field evaluations over a 3-yr period (1995-1997) in southwestern Guatemala. The two strains tested were a genetic sexing strain, Vienna-4/Tol-94, carrying the temperature sensitive tsl gene to eliminate females in the egg stage, and the standard bisexual Petapa strain. Flies were mass-reared, sterilized by irradiation as pupae, shipped to a field center, and released by air as young adults over 2 km by 2 km core areas in the centers of separate 6 km by 6 km test plots. Strain performance was monitored weekly by trapping sterile and wild male adults in core and buffer areas and by collecting eggs from coffee berries to determine induced sterility. Results indicated a several-fold advantage for the males-only strain as measured by the level of induced sterility, especially at the very high release ratios of 100:1 recorded in 1997. During that final test year, sterile-fly release rates were increased to provide high sterile:wild (S:W) fly ratios in the field, and egg sterility reached levels in excess of 70% in plots were the male-only strain was used. However, in the plots where the bisexual strain was released, induced sterility only reached 12% despite S:W ratios above 1,000:1.

Agriculture↗

Survey of sterile product compounding practices in Canadian hospital pharmacies.

Improper preparation of sterile products by hospital or community pharmacies may have serious consequences. Recent reports of deaths or injury to patients as a result of receiving products that were contaminated during their preparation in a pharmacy have highlighted the importance of maintaining good sterile compounding practices. Efforts are now underway to develop revised guidelines for the compounding of sterile products in order to minimize the potential for future recurrence of similar incidents. This survey study was undertaken to provide background data on current sterile products compounding practices and procedures in Canadian hospital pharmacies. It was also anticipated that these data would be helpful in identifying issues that needed to be addressed in the new guidelines. Surveys were distributed to 700 Canadian hospitals with 50 or more beds. Responses from returned surveys were entered into and analyzed using the database program RBase. A total of 306 hospital pharmacies responded, with 200 indicating that sterile products were compounded within their department. The information provided by respondents provides insight into the types of sterile products being prepared in Canadian hospitals, the training background of staff involved in sterile product preparation, the type of facilities and equipment used for compounding these preparations, and the quality control/quality assurance procedures that are in place in hospital pharmacies. The information arising from this survey underscores the need for comprehensive guidelines or standards with respect to sterile product compounding, and the need for improved training of personnel involved in sterile product compounding. The results should be of interest to hospital pharmacy administrators, pharmacy regulatory bodies, and government agencies responsible for assuring the safety of pharmaceutical products used in patient care.

Canada↗

[Analysis of leaf proteins of Zidao male-sterile line by 2D-PAGE].

Using two-dimensional gel electrophoresis (2D-PAGE), seven protein maps of leaf protein were obtained and analyzed. The results showed that the protein maps of four male sterile lines, Zidao male sterile line, Yebai male sterile line, Honglian male sterile line and Maxie male sterile line, were different from each other; The maps of Zidao male sterile line and maintainer of trefoil stage were similar and so did the maps of stooling stage; Either the sterile line map of two stages or the maintainer's was different. It can be deduced that the difference of maps of two stages might relate to male sterility of Zidao male sterile line.

Crosses, Genetic↗

[Clinical evaluation on effects of Ca(OH)2-glycerol paste for dental canal sterilization].

OBJECTIVE: Through clinical observation on an formula containing mainly Ca(OH)(2) for dental canal sterilization to confirm it as an ideal canal sterilizer. METHODS: 5% (M/V) of Ca(OH)(2) in glycerol was used as dental canal sterilizer. Patients with acute or chronic apical periodontitis were randomly selected, and their symptoms were recorded before treatment. The dental canals were prepared routinely only with exception of that the sterilizer was 5%(M/V) of Ca(OH)(2) in glycerol and paper point or cotton point soaked with and the canals were sealed for 5 to 7 days. Then the canals were filled if there was no positive symptom or re-sterilized, if symptom did not totally disappear. RESULTS: Through sterilization with the formula used in this study, the symptom disappeared swiftly. Specifically, after the canals sterilized for one to two times, there was no symptom that could be seen in all patients studied. The rate of symptom disappeared from 89% to 98% could be detected in acute apical periodontitis and the rate of no symptom was from 94% to 99% in chronic periodontitis. Additionally, through the study for more than one year, the formula maintained thin paste state that was convenient for use. CONCLUSION: In addition to safety, using the formula with Ca(OH)(2) as main sterilizer is effective in dental canal sterilization for the formula dramatically improving the symptom.

English Abstract↗

[The cytochemical observation of anthers of Chinese cabbage's male-sterile].

A Chinese cabbage (Brassica campestris L. ssp. chinensis Makino) produces 1/4 male sterile and 3/4 fertility in offspring. The sterile plant can be identified from the color of corolla that is some white when it grows out. The fertile and sterile anthers were researched using cytological and cytochemical methods. Thick sections of both anthers of different developmental stages were stained with Toluidine blue for general cytological observation and stained with the periodic-acid-Schiff's (PAS) technique to detect polysaccharides (red), with Sudan black B (SBB) to detect lipids (black). Before meiosis of microspore mother cells, connective tissue of both fertile and sterile anthers stored a lot of starch grains. Neither starches nor lipid drops were in tapetal and microspore mother cells. The only difference of both anthers was that the tapetal cells of sterile anthers contained more vacuoles than those of fertile anthers. After meiosis of microspore mother cells, the starch grains in connective tissue of fertile anthers disappeared, the tapetal cells synthesized abundant lipid drops, and the microspores also began to accumulate lipid drops. In sterile anthers, the starch grains in connective tissue also disappeared, but only a few lipid drops appeared in tapetal cells. The tapetal cells, however, became red, suggesting the cell contained some polysaccharide material. Pollen abortion in sterile anthers occurred in this stage. The aborting microspores accumulated very less lipid drops in its cytoplasm than those in fertile the starch This result suggested that in the cabbage, the starch grains in connective tissue were transformed into polysaccharide and transported to tapetal cells, then these cells transformed polysaccharide into lipid material that was absorbed by developing microspore. In sterile anthers, however, polysaccharide in the tapetal cells could not be transformed to lipid. The functional default of tapetal cells during lipid metabolism led to microspore abortion. This is new sample in which the functional default of tapetal cells will make pollen abort, and will enhance research field in male sterile in higher plants.

Brassica↗

[The discovery of a specific DNA fragment associated with maize cytoplasmic male sterility and its differential display].

Three pairs of PCR primers were designed according to the mitochondrial DNA sequence. PCR amplification was applied to 3 sets of isonuclear alloplasm materials and 3 sets of isoplasm allonuclear materials. Multiplex PCR and general PCR protocol were adopted with total genomic DNA. As for the primers having detected polymorphsim between male sterility and its maintainers, differential display was conducted with mRNA from different development stage of microspore. The results showed as follows: with total genomic DNA template, primer P1-P2 has amplified a specific fragment only in all the male sterile materials, primer P5-P6 has amplified a specific fragment only in maintainer Huangzaosi, primer P3-P4 has no amplification in all the experiment materials. So primer P1-P2 can be used to distinguish male sterile cytoplasm and normal cytoplasm. RT-PCR was conducted with primer P1-P2 in inbred line huangzaosi and 48-2 with male sterile cytoplasm and normal cytoplasm, mRNA was separately isolated from tetrad stage, uninucleate stage and binucleate stage of microspore development, cDNA was obtained with random hexanucleotide primers. With the cDNA template, specific amplified fragments were also detected by primer P1-P2 in the male sterile materials at different development stage of microspore, but there was no amplification by primer P1-P2 in the 2 maintainer lines. This result indicated that primer P1-P2 can be transcripted at 3 development stages of microspore in all male sterile materials, and same transcript was produced by primer P1-P2 among all male sterile materials include 3 sets of isonuclear alloplasm and 3 sets of isoplasm allonuclear. It was suggested from this experiment that the specific DNA sequence detected by primer P1-P2 in all male sterile material total genomic DNA might be related to the cytoplasmic male sterile character.

Cytoplasm↗