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PubMed1988

Microsurgical reversal of female sterilization.

Between 1979 and 1985, 25 consecutive, unselected women (age 28-40 years, median 34) underwent microsurgical tubo-tubal anastomosis for reversal of sterilization. The overall pregnancy rate was 44%. The incidence of pregnancy was correlated to the tubal length after reversal. Of 12 women with tubal lengths exceeding 5.5 cm, 8 (67%) became pregnant. Of the 13 women with tubal lengths under 5.5 cm only 3 (23%) conceived (p less than 0.04). There was no significant correlation between pregnancy rate and age, interval since sterilization, or the sterilization procedure itself.

Adult↗
PubMed1980

Sterilization operations in Australia.

The proportion of males and females in Australia having privately performed sterilization operations has been estimated from 1976 operation rates for each age group and for each State. These figures indicate that 60% of Australian couples (maximum: 74% in Western Australia; minimum: 53% in Victoria) will choose this form of birth control during their fertile lifetime. A general practitioner survey in March, 1978, indicated this proportion would be an underestimate. If this rate of sterilization continues, we will challenge the United States as the country with the highest prevalence of sterilized couples.

Adult↗
PubMed1975

Injury to the ureter during laparoscopic tubal sterilization.

As the use of laparoscopy and laparoscopic tubal sterilization has increased, a number of serious complications have been reported. A case is described in which the ureter was damaged during laparoscopic sterilization. The majority of serious complications associated with laparoscopic sterilization have been burn injuries resulting from the use of cautery instruments. Thermal injuries are likely to occur when the operator is inexperienced, and when cautery instruments of the high-energy type are used. Meticulous technique is required in the performance of laparoscopic sterilization and low-energy "cold cautery" units should be used in this procedure.

Adult↗
PubMed2000

Effect of surface treatment and sterilization processes on the corrosion behavior of NiTi shape memory alloy.

Nickel-titanium (NiTi) alloy derives its biocompatibility and good corrosion resistance from a homogeneous oxide layer mainly composed of TiO(2), with a very low concentration of nickel. In this article, we described the corrosion behavior of NiTi alloys after mechanical polishing, electropolishing, and sterilization processes using cyclic polarization and atomic absorption. As a preparative surface treatment, electropolishing decreased the amount of nickel on the surface and remarkably improved the corrosion behavior of the alloy by increasing the mean breakdown potential value and the reproducibility of the results (0.99 +/- 0.05 V/SCE vs. 0.53 +/- 0. 42). Ethylene oxide and Sterrad(R) sterilization techniques did not modify the corrosion resistance of electropolished NiTi, whereas a steam autoclave and, to a lesser extent, peracetic acid sterilization produced scattered breakdown potential. In comparing the corrosion resistance of common biomaterials, NiTi ranked between 316L stainless steel and Ti6A14V even after sterilization. Electropolished NiTi and 316L stainless-steel alloys released similar amounts of nickel after a few days of immersion in Hank's solution. Measurements by atomic absorption have shown that the amount of released nickel from passive dissolution was below the expected toxic level in the human body. Auger electron spectroscopy analyses indicated surface contamination by Ca and P on NiTi during immersion, but no significant modification in oxide thickness was observed.

Alloys↗
PubMed1978

The cold sterilization of abortion cannulae.

The purpose of this study was to determine if cold sterilization is a feasible method for sterilizing abortion cannulae and, if so, to find the appropriate solutions and time intervals for this sterilization process. Study findings show that abortion cannulae can be cold sterilized by soaking them for a minimum of 10 minutes in a solution of Cidex or 95% ethanol. Soaking the cannulae for 20 minutes in a 2% tincture of iodine solution also appears to be useful for decontamination purposes.

Abortion, Induced↗
PubMed1989

Enhancement of the kinetics of the aeration of ethylene oxide sterilized polymers using microwave radiation.

Ethylene oxide (EO) is used extensively to sterilize medical supplies that are heat sensitive. EO residues in materials post sterilization can present a hazard to patients at the point of use. Protracted aeration (i.e. degassing) times are necessary post sterilization to reduce EO residues to an accepted level. The sorption of EO into polyvinylchloride was found to be an active process given that at sorption equilibrium (i.e. when the net flow of diffusant into the host material has reduced to zero) the number of molecules of EO per unit volume was greater in PVC than in its external environment. The diffusion coefficient (D) was concentration (c) dependent and the relationship which best describes this dependence was D(c) alpha ln c. The diffusion of EO was dramatically accelerated (as evidenced by a time saving in degassing of up to 400%) if microwave heating (2.45 GHz) was used instead of conventional heating for the same macroscopic temperature. The values of activation energy for diffusion were obtained from the respective Arrhenius plots of diffusion coefficient versus inverse temperature for each process. In general, even small reductions in activation energy can greatly increase the specific rate of reaction. The relative efficacy of microwaves in eliminating EO residues as evidenced by this data occurs as a result of microwaves reducing the activation energy for diffusion by almost a factor of two. The relative efficiency of microwave desorption compared to conventional aeration offers considerable gains in the cost-effectiveness of gas sterilization since it will permit a much greater throughput of material, thereby obviating the need for excessively large inventories of equipment.

Air↗
PubMed2004

Effects of different sterilization methods on the morphology, mechanical properties, and cytotoxicity of chitosan membranes used as wound dressings.

The aim of this work was to compare the effects induced by two different sterilization methods (exposure to gamma radiation or ethylene oxide) and an antiseptic technique (immersion in 70% ethanol aqueous solution) on the morphology, tensile strength, percentage of strain at break, and in vitro cytotoxicity to Vero cells on chitosan membranes designed for wound healing. Four distinct membrane compositions were evaluated, with chitosan, glycerol, and chitin used as components. Gamma radiation, in spite of being one of the most commonly employed sterilizing agents, negatively affected the morphology of membranes composed solely by chitosan as well as the percentage of strain at break of the chitosan-membranes containing glycerol on their composition. Moreover, its use affected the color of the chitosan membranes. The use of 70% ethanol aqueous solution did not change the chitosan-membrane characteristics significantly, but its use has limitations concerning the process scale up. With ethylene oxide (EtO), chitosan-membrane morphology, percentage of strain at break, and in vitro cytotoxicity to Vero cells were not significantly affected. The tensile strength of the membranes containing chitin were reduced after the treatment with ethylene oxide; however, the obtained values were comprised in the range verified for normal human skin. Therefore, because the final characteristics of the membranes treated with ethylene oxide are appropriate when considering their use as wound healing devices, and because this sterilization process is easily adjusted to use on an industrial scale, EtO can be considered the most adequate sterilizing agent for chitosan membranes. However, it should be considered that this chemical is associated with toxicity, flammability, and environmental risks, as well as with possible material contamination with ethylene oxide residues.

Animals↗
PubMed1999

Effect of molecular weight, calcium stearate, and sterilization methods on the wear of ultra high molecular weight polyethylene acetabular cups in a hip joint simulator.

Orthopaedic surgeons must currently choose from several types of ultra high molecular weight polyethylene acetabular cups that differ in their material properties and in the methods used for their sterilization. Information on the wear resistance of these different cups may help in the selection process. This study included two separate tests for wear run on a hip simulator to investigate the effect of molecular weight, calcium stearate, and sterilization methods on the wear resistance of ultra high molecular weight polyethylene acetabular cups. Test 1 revealed nearly identical wear rates for acetabular cups with molecular weights in two distinct ranges, as well as for cups with molecular weights in the same range but with or without calcium stearate added. In Test 2, cups that were sterilized in air with gamma irradiation exhibited lower rates of wear than those sterilized with ethylene oxide, presumably due to the crosslinking induced by the irradiation. In addition, cups that were irradiated while packed in a partial vacuum to minimize oxygen absorbed in the surface layer initially showed lower rates of wear than those irradiated in air, with the wear rates becoming similar as wear penetrated the more oxidized surface layer and the more crosslinked subsurface region. Because these tests were run a few months after the irradiation, the potential effects of long-term oxidation of any residual free radicals in the irradiated materials could not be taken into account. After artificial aging to accelerate oxidative degradation of the materials, the wear rates could be markedly different. Analyses performed after wear indicated that the irradiated (i.e., crosslinked) cups exhibited a smaller proportion of, as well as shorter, fibrils in the wear debris and an increased crystallinity and melting temperature and that gamma irradiation in the low-oxygen environment reduced the level of oxidation and increased the level of crosslinking in the surface region of the cups.

Acetabulum↗
PubMed1985

Sterility test systems for product recovery.

When presterilized, closed canister, membrane filter units for sterility testing are validated for process, large volumes of therapeutic products for injection can be tested for sterility, recovered, and added to a subsequent bulk prior to sterile filtration. Intermittent positive pressure, applied to the canisters through the vent filters, makes possible the relatively rapid filtration, with minimal foaming, of viscous solutions such as 25% (w/v) normal serum albumin (human). Canister systems appear to be at least as effective as the standard membrane filter method, and the canisters are particularly suited to the sterility testing of bulks.

Bacteria↗
PubMed1994

Derivation of a rigorous equation for the calculation of the F-value in isothermal sterilization processes.

The use of simplified equations utilizing the Z- and F-values to calculate the level of sterilization achieved in isothermal processes is very common in industry. This method assumes that the Z-value is independent of temperature. This is a simplifying assumption that is not based on a physically realistic microbial inactivation model. In the present work the appropriate equations for the Z- and F-values were derived with kinetic theory and utilized to predict the level of sterility obtained during isothermal sterilization. The F-value obtained with the proposed equation was always higher than the F-value obtained when the simplifying assumption was made. Therefore, the use of the equation proposed here for the F-value results in more realistic and generous estimates of the lethal effect on microorganisms produced by isothermal sterilization processes. Tables of the F-values so obtained are provided.

Biotechnology↗
PubMed2002

Fundamentals of thermal sterilization processes.

Information has been provided in this chapter on the fundamentals of thermal sterilization processing. The derivation of various equations presented in the text was not discussed; the reader is referred to the references cited for this information. Emphasis was placed on the need for good manufacturing practice and for control of presterilization bioburden. These considerations will have the greatest impact on product quality in the long run. An attempt was also made to dispel the notion that sterilization processes always require the most rigorous biological challenge for validation. Finally, parametric or process control release of terminally sterilized products was discussed. Parametric release is a concept that will find greater application in areas other than most heat sterilization as the industry continues to derive full benefit from validated processes.

Cell Death↗
PubMed1980

Suture loosening and gamma sterilization of 10-0 nylon.

The tissue reaction to 10-0 nylon sutures sterilized with gamma-rays was compared to the reaction caused by 10-0 nylon thread sterilized with ethylene oxide. In a vascularized cornea more tissue reaction was seen to 10-0 nylon thread sterilized with gamma-rays than to sutures sterilized with ethylene oxide gas.

Aged↗
PubMed1989

Potential acceptors of Norplant implants in comparison with recently sterilized women in Sri Lanka.

This paper analyzes data from a population-based survey fielded in Sri Lanka, which showed that almost half of the women interested in using Norplant contraceptive subdermal implants were actually those who wanted to limit childbearing, a pattern also found in international Norplant clinical studies. A comparison between recently sterilized women and professed limiters of potential Norplant users showed the limiters to be socio-economically and demographically a significantly different group of women from those sterilized. Among several variables analyzed, the most important factor distinguishing the two groups was their relative economic status. Further comparison of the limiters with professed spacers interested in using Norplant showed that the spacers were yet another distinct category of women, the most important characteristic distinguishing between the two groups being the total number of living children. The preliminary results suggest that the Norplant implants system is not necessarily a substitute for sterilization; it appears potentially a popular method among those who want no more children but are not ready to accept sterilization. These findings that the potential Norplant implant users represent different gradients of women in the population have implications for provider counseling and user satisfaction as well as continuation.

Adolescent↗
PubMed1995

The sterilization of honey with cobalt 60 gamma radiation: a study of honey spiked with spores of Clostridium botulinum and Bacillus subtilis.

Unprocessed honey is a recognized wound-healing remedy. However, to make clinical use of honey acceptable, it should be sterile. To find the lowest dose of irradiation needed for sterilization, six batches of honey (a-f) were gamma irradiated with 6, 12, 18, 22 and 25 kGy Cobalt-60. After a dose of 25 kGy the antibacterial activity was not altered. Presumably glucose oxidase (EC 1.1.3.4), which produces hydrogen peroxide, is not easily damaged by irradiation. Amylase activity on the other hand was significantly reduced to 19%, 19%, 21%, 22%, 43% in batches a), b), c), d) and f) respectively, whereas no decrease was observed in batch e). All batches spiked with approximately 10(6) spores from Cl. botulinum or B. subtilis per 50 g honey proved to be sterile after irradiation with a dose of 25 kGy. Honey was also spiked with Cl. botulinum at up to 5000 spores per 50 g honey, which is the upper limit of natural contamination. The sterilizing dose in this case was 18 kGy.

Anti-Bacterial Agents↗
PubMed1991

Microbiological aspects of heat sterilization of drugs. III. Heat resistance of spore-forming bacteria, isolated from large-volume parenterals.

In order to calculate the minimum sterilization process conditions to obtain the generally accepted sterility level (less than 1.10(-6) probability of microbial survival), we determined the bioburden and its heat resistance of 500 ml large-volume parenteral bottles over a period of 5 years. For the bioburden determination 1,832 bottles were examined by the membrane filtration method. Mean bioburden was 9.36 colony-forming units/bottle. Of the colony-forming units isolated 118 were heat resistant (0.69%). These were spore-forming Bacillus species. Of the isolated Bacillus species heat resistance was determined in 5% glucose, 0.9% sodium chloride and 8% amino acids solution. D values greater than 1 min at 105 degrees C were found for 2, 5 and 4 different Bacillus species in glucose 5%, sodium chloride 0.9% and amino acids 8%, respectively. 2 Bacillus species showed a D value over 2 min at 105 degrees C in all three media. D values at 110 degrees C in sodium chloride 0.9% for these 2 Bacillus species were 1.8 and 2.6 min and in amino acids 8% 0.9 and 1.7 min, respectively. The minimum sterilization process time at 110 degrees C, calculated with the experimentally determined bioburden and D values is less than 25 min. When introducing reduced exposure times/temperatures, each individual manufacturer should assess the bioburden. The time-consuming determination of the heat resistance of bioburden isolates is not always necessary. By dividing the isolated colony-forming units in a 'heat-resistant' group and a 'not-heat-resistant' group, changing from standard overkill sterilization procedures to processes with lower F0 values is possible.

Bacillus↗
PubMed1994

Association for Voluntary Surgical Contraception: a technical statement on quinacrine pellets for nonsurgical female sterilization.

For many years, researchers have been seeking nonsurgical methods for female sterilization because these methods may be safer, simpler, cheaper, and quicker than conventional techniques, and may require a lower level of skill to deliver. Various investigators have explored using intrauterine instillation of quinacrine for tubal occlusion. Until recently, reports of quinacrine use for nonsurgical sterilization have been scarce and limited to data sets involving small numbers with very short-term follow-up. The July 24, 1993 issue of the Lancet reports on 31,781 cases of nonsurgical sterilization with quinacrine in a field trial from Vietnam. The present paper is written as a background review to assist family planning providers in the dialogue regarding the introduction and use of quinacrine. It attempts to answer questions regarding what is currently known about the safety and efficacy of quinacrine, and what the recent article published in the Lancet adds to our knowledge. It also raises the question of how quinacrine sterilization affects free and informed choice and the other interests of family planning clients.

Female↗
PubMed1978

Influence of sterilization and temperature changes on the in vitro characteristics of the pH electrode.

1. When chemical sterilization (with Korsolin, Cidex) is performed, a minimal duration of sterilization of 3 h is required for asepsis. 2. Duration of Korsolin sterilization up to 3 h does not influence the in vitro characteristics of the pH-electrode. 3. Sterilization with formaldehyde (24 h, 40 degrees C) is safe, but needs another 24 h restabilization time of the electrode. 4. The temperature dependence of the pH-electrode is minimal. With increasing temperature a slight decrease of pH measurement can be found (-0.02 pH units from 20--40 degrees C).

Disinfectants↗
PubMed2003

A new sterilization technique with balloon-tube thoracostomy for thoracic empyema.

OBJECTIVE: Failure or prolongation of treatment for refractory thoracic empyema by the current chest-tube drainage technique is often due to sterilization difficulties. Insufficient sterilization prolongs hospitalization, and is often associated with life-threatening complications and/or additional invasive surgical procedures. A new chest-tube sterilization technique aimed at making it less invasive and shortening the therapy is proposed. METHODS: Following pretreatment for complications including loculation, bronchopleural fistula, or corticated lung, a double-lumen trocar catheter was introduced at the bottom of the empyemic cavity through the lateral chest wall. Then, a Foley balloon urethra-catheter was inserted and attached just inside the anterior chest wall at the top of the cavity for the evacuation of intrathoracic air. After irrigation of the cavity with distilled water once or twice, the cavity was completely filled with a bactericidal solution which was left in place for 30-60 minutes, followed by an antibiotic solution for more than 20 hours. RESULTS: Among the five treated post-lobectomy or pneumonectomy cases, sterilization was obtained after only one treatment in four cases and after two courses in the other. Catheterization duration from the initial treatment was 2-13 days. Neither recurrence nor treatment-related major complications were observed. CONCLUSIONS: This balloon-tube thoracostomy technique is simple, minimally invasive and cost-effective, due to shortening of the treatment time with minimal manpower and equipment requirements. It is thus a promising therapeutic approach to thoracic empyema and has the potential for application to other intrathoracic disorders.

Aged↗