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[Possibilities of sterilization of medical equipment using ultrasonics combined with disinfectants and sterilizing agents].

An ultrasound Y3Y-0.25-0 unit was used to reach the sterilizing effect during the treatment of metal surgical appliances packed in a row by means of ultrasound combined with 6% hydrogen peroxide (40 degrees C) for 60 minutes and with 1% (according to peracetic acid) desoxone-1 (18 degrees C) for 45 minutes. This made it possible to attain a 3-fold reduction of the time required for sterilization during treatment of the appliances by combination of ultrasound and 6% hydrogen peroxide as compared to sterilization with the aid of the solution alone under the same conditions.

Cross Infection↗

Sterility assurance based on validation of the sterilization process using steam under pressure. Committee on "Microbial Purity". F.I.P. (International Federation of the Pharmaceutical Industries)

The F.I.P. has long been involved in the practical aspects of microbial quality in pharmaceuticals. This report deals with steam sterilization. A group of European experts from official laboratories and pharmaceutical industries has compiled this text which successively reviews the different pharmacopeias, defines some essential sterilization concepts and parameters, reviews the current approaches to steam sterilization and advises, for each of them, practices in validation and in-process control.

Europe↗

Change in the volatile fatty acids content of laboratory stored sterilized and non-sterilized swine wastes.

The influence of urine and microbial activity was studied as possible factors leading to the generation of volatile fatty acids in non-sterilized stored swine wastes. Urine was found to promote the generation of the volatile acids. The microbial origin of the volatile acids in the wastes was ascertained by the growth of an anaerobic bacterial strain (Peptostreptococcus anaerobius). Significant generation and transformation of these acids was observed in sterilized swine waste samples stored under conditions similar to the non-sterilized samples.

Animals↗

Immediate sequelae following tubal sterilization. A multicentre study of the ICMR Task Force on Female Sterilization.

A total of 32,177 female sterilizations performed by different surgical procedures under different time scales were studied with reference to the effectiveness of the procedure and immediate, short-term and long-term complications arising out of the procedure. The results of immediate sequelae only are being reported in this article. Laparoscopic technique was employed in 7.1% of cases, culdotomy in 6.9% and minilaparotomy/laparotomy in the remaining 86% of cases. The findings indicate that minilaparotomy performed in the postpartum period is most suitable and safe for Indian women under existing conditions. Complications including mortality were least when the operation was performed as a minilaparotomy in the early postpartum period. Visceral injuries were maximum with the laparoscopic technique (10.45/1000). Mortality of interval sterilization was higher than that of postpartum sterilization (6.19/10,000 Vs 0.7/10,000) but this rate is lower than the current maternal mortality of the country (41.76/10,000). In view of the results obtained, it appears that minilaparotomy will continue to be "the method" of choice on a mass scale.

Adult↗

Randomised study of sterile versus non-sterile urethral catheterisation.

Indwelling urethral catheters are the most common cause of urinary tract infections (UTI), yet there is no direct evidence that technique of catheter insertion affects this. In a prospective study, 156 patients underwent preoperative urethral catheterisation, randomly allocated to 'sterile' or 'clean/non-sterile' technique groups. There was no statistical difference between the two groups with respect to the incidence of UTI. There was a considerable cost difference between the two groups, the 'sterile' method being over twice as expensive as the 'clean' method. Strict sterility is not necessary in preoperative short-term urethral catheterisation and is more expensive and time consuming.

Adult↗

Ogura cytoplasmic male-sterility (CMS)-associated orf138 is translated into a mitochondrial membrane polypeptide in male-sterile Brassica cybrids.

Transcription of a putative mitochondrial gene (orf138) has previously been correlated with Ogura cytoplasmic male-sterility (CMS) in rapeseed cybrids. In this paper, studies performed on a Brassica cybrid with a different organization of the orf138 locus confirm this association. We also show that mitochondria isolated from male-sterile rapeseed plants synthesize a polypeptide of 19 kDa, which is absent in fertile revertants. Antibodies against a glutathione S-transferase-ORF138 fusion protein were raised to establish that this 19 kDa polypeptide is the product of orf138. The anti-ORF138 serum was used to demonstrate that the orf138 translation product occurs only in sterile cybrids and co-purifies with the mitochondrial membrane fraction.

Blotting, Western↗

Molecular mapping of the male-sterile, female-sterile mutant gene (st8) in soybean.

Soybean male-sterile, female-sterile mutant genes have been identified by genetic and cytological studies. The St8 gene has been identified as an asynaptic mutation resulting in male and female sterility. This mutant gene was derived from a gene-tagging study using the soybean w4-mutable line. In this report we identified the genetic map position of st8 via restriction fragment length polymorphism (RFLP) and simple sequence repeat (SSR) markers. The St8 gene mutation was located between RFLP marker E107 and SSR markers Satt132, Sct_065, and Satt414 on molecular linkage group J and linked to each by 7.8 cM and 3.4 cM, respectively.

Chromosome Mapping↗

Towards male sterility in Pinus radiata--a stilbene synthase approach to genetically engineer nuclear male sterility.

A male cone-specific promoter from Pinus radiata D. Don (radiata pine) was used to express a stilbene synthase gene (STS) in anthers of transgenic Nicotiana tabacum plants, resulting in complete male sterility in 70% of transformed plants. Three plants were 98%-99.9% male sterile, as evidenced by pollen germination. To identify the stage at which transgenic pollen first developed abnormally, tobacco anthers from six different developmental stages were assayed microscopically. Following the release of pollen grains from tetrads, transgenic pollen displayed an increasingly flake-like structure, which gradually rounded up during the maturation process. We further investigated whether STS expression may have resulted in an impaired flavonol or sporopollenin formation. A specific flavonol aglycone stain was used to demonstrate that significant amounts of these substances were produced only in late stages of normal pollen development, therefore excluding a diminished flavonol aglycone production as a reason for pollen ablation. A detailed analysis of the exine layer by transmission electron microscopy revealed minor structural changes in the exine layer of ablated pollen, and pyrolysis-gas chromatography-mass spectroscopy indicated that the biochemistry of sporopollenin production was unaffected. The promoter-STS construct may be useful for the ablation of pollen formation in coniferous gymnosperms and male sterility may potentially be viewed as a prerequisite for the commercial use of transgenic conifers.

Acyltransferases↗

[Diagnosis and therapy of sterile marriages. Retrospective studies on the sterility of 500 childless couples].

In the retrospective analysis of 500 involuntarily childless couples the following results were observed: The pregnancy rate was 37.2%. The age of the women did not influence the conception rate significantly. Women with a sterility of less than 5 years duration had a statistically higher conception rate than those with longer lasting sterility. Patients with oligomenorrhea had a significantly higher pregnancy rate than those with normal menstrual cycle. Cyclofenil therapy resulted in a significantly higher conception rate than treatment without ovulation inducing compounds. Homologeous insemination had a pregnancy rate of 25,4%. The additional therapy with ovulation inducers did not influence the results significantly. Patients with uterine hypoplasia had a significantly higher conception rate than women with normal uterine size. Women who showed uterine hypoplasia before sterility treatment had taken oral contraceptives less often than women with normal uterine size. There was a significant correlation between uterine hypoplasia and cyclic disorders. Women with cyclic disorders had hirsutism more often than those with a normal cycle. In cases with normal sperm count (40 mill./ml) there was a significantly better pregnancy rate than in those with oligozoospermia (40 mill./ml). In cases of sperm motility of over 70% a significantly higher pregnancy rate was observed than in those with a motility below 70%. In spermiograms with more than 70% of normally configurated sperms the results were significantly better than in those with less than 70% normal sperms.

Contraception↗

A comparison of quinacrine sterilization (QS) and surgical sterilization (TL) in 600 women in Guizhou Province, China.

OBJECTIVES: Compare the safety and efficacy of quinacrine sterilization (QS) and surgical sterilization, also known as tubal ligation (TL). METHODS: 300 women accepted QS in Guiyang, China during the period from July 1995 to September 1997. Each patient was scheduled for follow-up at 3, 6, 12 and 24 months. In March 1998, a comparison group of 300 women electing TL during the same time period was systematically chosen. Researchers visited the village of every woman and conducted a structured interview. Each candidate was given a general health and pelvic exam at a clinic in her village. All interviews and exams were completed in August 1998. RESULTS: Of the 289 QS patients interviewed (a follow-up rate of 96.3%), 265 had had 2 insertions. There were 3 pregnancy failures for a cumulative life table failure rate of 1.2 per 100 women at 24 months. The 299 TL patients (a follow-up rate of 99.7%) had a similar rate of 0.7. There were no life-threatening side effects or deaths in either groups. QS was less disruptive, more easily tolerated, required fewer resources and was viewed more favorably than TL by women and their spouses. CONCLUSIONS: Both methods were found safe and very effective. However, QS was considered to be more acceptable than TL.

Adult↗

Development of a novel method of female sterilization: I. The development of a novel method of hysteroscopic sterilization.

BACKGROUND AND OBJECTIVES: For more than 100 years, gynecologists have attempted to effect sterilization via a transuterine approach. Our aim was to develop a safe, simple, rapid method of sterilization that could be performed in the outpatient clinic. The authors felt that a tubal screw based on a "self-tapping" screw would be less likely to become dislodged from the uterine cornu with time because multiple backward-pointing threads prevent it from being displaced. METHODS: During the development of the technique, many changes had to be made to deliver the tubal screw effectively to the uterine cornu. These involved overcoming problems of poor cornual distension before screw application, effecting the requisite deflection toward the uterine cornu, performing the screwing action with a deflected applicator, and finally disimpacting the screw. Changes were made to the tubal screw, hysteroscope, method of uterine distension, method of deflection, screw applicator, and method of disimpaction. RESULTS AND CONCLUSIONS: The system that appears to be the most efficient consists of a 25F cystoscope with a variable bridge, a 4-mm 30-degree endoscope, and an unsealed spring applicator with bayonet mounting on the screw applied with the use of a pressure bag for uterine distension with saline solution.

Female↗

Carrying out biological qualification, the control operation of moist-heat (steam sterilization) processes for producing sterile pharmaceuticals and medical devices.

In this report we will first discuss the principles behind the practices that are used today in the design and qualification of moist-heat (steam sterilization) microbial-control processes used to produce sterile pharmaceutical products and medical devices. Secondly, we will work through example applications of how to design and qualify processes of three levels of complexity which we call Empirical Overkill, Empirical, and Product Specific. Empirical Overkill is specifically for the microbial-control processes for indirect items, such as tanks, pipes, pumps and other hardware. Empirical is for pharmaceutical and medical-device products that are produced under good manufacturing conditions and, therefore, there is control of the level of the microbial bioburden. Product Specific is for microbial-control processes designed and qualified for a specific product on the basis of the numbers and resistance of the bioburden of that product. We will treat design in this report; however, the major thrust is in setting up and carrying out the biological qualification of the process, which is the mode of control used to assure the adequacy of these microbial-control processes.

Biological Products↗

Development of quality indicators for sterilization practices of the central sterile supply department.

OBJECTIVE: To develop quality indicators for assessing the performance of central sterile supply department. (CSSD). MATERIAL AND METHOD: Quality indicators for sterilization in CSSD were searched by literature review and by current situation analysis by 79 infection control nurses (ICNs) and 83 heads of CSSD. Quality indicators were drafted and subsequently validated by 5 experts. The feasibility and applicability of the quality indicators were tested in 37 ICNs and 34 heads of CSSD. The quality indicators were finally refined by a forum of 5 experts and 5 representatives from CSSD. RESULTS: A total of 30 quality indicators were developed. These include 9 indicators for structure, 12 for process and 9 for output of CSSD. The quality indicators were deemed appropriate for the assessment of the quality of CSSD in Thailand. CONCLUSION: Thirty indicators were developed for assessing the quality of CSSD.

Central Supply, Hospital↗

Physicochemical, toxicological and hygienic aspects of ethylene oxide application for the sterilization of medical products. III. Setting hygienic norms in sterilized medical products.

Some of the drawbacks are discussed associated with hygienic norms for gaseous sterilizing agents in polymeric products for medical applications. A new approach is proposed for regulating ethylene oxide (EO) in such products. To this end, limiting types of biological effect and its pathways have been determined and substantiated as well as the reliability factor for establishing hygienic norms for EO in medical products. Daily threshold EO limit values were calculated for momentary and repeated exposure of humans. The duration of long-term and short-term exposure of the patient to sterilized products was evaluated on the basis of EO extraction kinetics from a variety of materials. Using daily threshold limit values, threshold residual values (TRV) of EO were calculated for different groups of polymeric products for medical applications.

Animals↗

[Correlation between endometriosis and fallopian tube patency in sterility patients especially after microsurgical sterility operations].

In 130 sterile women undergoing first look laparoscopy we found in 86.9% patent tubes. In this group in 34.5% an endometriosis was discovered. All patients with closed tubes had no signs of endometriosis. In a second look laparoscopy we found in 50% an endometriosis after microsurgery if the tubes were open. In this group we didn't also find an endometriosis if the tubes were closed. The frequency of endometriosis in women with laparoscopic sterilisation is 3.3%. After microsurgery in sterile women a second look laparoscopy seems to be very necessary to check the operation success and to exclude an endometriosis.

Adult↗

Minilaparotomy or laparoscopy for sterilization: a multicenter, multinational randomized study. World Health Organization, Task Force on Female Sterilization, Special Programme of Research, Development and Research Training in Human Reproduction.

A multicenter, multinational randomized comparison of minilaparotomy and modified Pomeroy tubal ligation and laparoscopy with tubal electrocoagulation for interval sterilization of women was conducted in eight centers. Results were analyzed for 791 women in the minilaparotomy group and 819 in the laparoscopy group. Major complications occurred in 1.5% of women in the former group and 0.9% in the latter. Technical problems or major anesthetic complications occurred in 0.5% of subjects undergoing minilaparotomy and 0.9% of subjects undergoing laparoscopy. For minor complications the figures were 11.6% and 6.0%, respectively, while for minor complaints the rates were 34.1% and 26.5%, respectively. It is concluded that the two methods of approach to the fallopian tubes are similar in their complication rates. Because of its more simple requirements in terms of equipment and training, minilaparotomy is the preferred approach for services provided away from a major institution.

Adult↗

[Aerodynamic analysis of a new sterile operating enclosure, and comparative bacteriologic testing between a conventional operating theatre and a sterile enclosure during sham operations (author's transl)].

An aerodynamic and bacteriological evaluation of a new sterile operating enclosure has been undertaken, comparing it with a conventional operating theatre under sham operating conditions with or without coincident use of either a surgical helmet or surgical face mask. Statistical analysis of these studies show the bacterial level in the sterile enclosure at the wound site is significantly lower than in ordinary operating theatre conditions whereas the use of a helmet with evacuating ducts effects these findings insignificantly.

Air Microbiology↗

An axonemal dynein at the Hybrid Sterility 6 locus: implications for t haplotype-specific male sterility and the evolution of species barriers.

Poor sperm motility characterized by a distinct aberration in flagellar waveform known as "curlicue" is a hallmark of t haplotype (t) homozygous male sterility. Previous studies have localized "curlicue" and a flagellar developmental defect, "whipless", to the Hybrid Sterility 6 locus (Hst6), between the markers Pim1 and Crya1. More recent heterospecific breeding experiments between Mus spretus (Spretus) and Mus musculus domesticus (Domesticus) have mapped the primary source(s) of both "curlicue" and "whipless" to a small sub-locus of Hst6, Curlicue a (Ccua). Here we report the complete physical isolation of the Ccua locus and the identification of a candidate gene for expression of both "whipless" and "curlicue" at its proximal end, an axonemal dynein heavy chain gene, Dnahc8, formerly mapped by interspecific backcross analysis near Pim1. Dnahc8 mRNA expression commences in the Domesticus wild-type testis just prior to flagellar assembly and is testis-specific in the adult male. However, expression of Dnahc8 is not readily evident in the testis of either Spretus or "whipless" animals (Domesticus males homozygous for the Spretus allele of Dnahc8). Our results argue that Dnahc8 is fundamental to flagellar organization and function in Domesticus, but not Spretus, and suggest that Dnahc8 is integral to both Hst6- and t-specific male infertility.

Animals↗