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The effects of ethylene oxide and gas-plasma sterilization on failure strength and failure mode of pre-tied monofilament ligature loops.

OBJECTIVE: To evaluate the effects of ethylene oxide and gas-plasma sterilization on the failure strength and failure mode of pre-tied monofilament ligature loops. STUDY DESIGN: A randomized block design was used by blocking for suture (size 1 polyglyconate, size 2 polydioxanone) and sterilization technique (control, ethylene oxide, gas plasma). SAMPLE POPULATION: Twenty replicates of each suture-sterilization technique combination. METHODS: Ligature loops were pre-tied using a 4S-modified Roeder knot then exposed to 1 of 3 treatments (control, ethylene oxide, or gas-plasma sterilization). Ligature loops were mounted onto a mechanical testing machine to evaluate the effects of sterilization on failure strength and failure mode (disruption, untying). RESULTS: There were no differences between polydioxanone and polyglyconate suture materials in failure strength or mode within sterilization methods. Both sterilization methods significantly increased the likelihood that suture loops would untie compared with controls subjects. Ligature loops that disrupted had a greater breaking strength than those that untied, regardless of sterilization method or suture type. CONCLUSIONS/CLINICAL RELEVANCE: Sterilization with either ethylene oxide or gas plasma of pre-tied, polyglyconate, or polydioxanone ligature loops significantly increases the in vitro likelihood of a modified Roeder knot untying. Further studies need to be conducted to determine the in vivo requirements for ligature loops.

Animals↗

Evaluation of a novel, rapid-acting, sterilizing solution at room temperature.

Test data are presented for a novel chemical germicide formulation capable of sterilizing reusable medical devices in 30 minutes at 20 degrees C in an open tray. The tests conducted with this rapid-acting sterilizing solution (RSS) included sporicidal, mycobactericidal, and virucidal studies performed in accordance with Association of Official Analytical Chemist International or Environmental Protection Agency published guidelines, by using RSS stressed for as long as 7 days. Sporicidal assays were performed at 20 degrees C with a 30-minute exposure time by using both Clostridium sporogenes and Bacillus subtilis spores dried on porcelain penicylinders or suture loops (n = 60 carriers per treatment). For comparison, identical carriers were exposed to a commercial glutaraldehyde-based sterilizing solution stressed to a maximum-use time of 14 days and exposed per manufacturer's requirements (10 hours at 25 degrees C). The RSS sterilized 100% of the carriers of both spore types. The glutaraldehyde solution demonstrated 100% sterilization of C sporogenes -treated carriers but had difficulty sterilizing B subtilis spore-laden carriers (ie, no sterilization of suture loops and only 57% sterilization of porcelain penicylinders). Similarly, Mycobacteria bovis and selected fungal and viral agents were exposed to stressed solution for 5 minutes or less at 20 degrees C. In each case, the resulting log decrease in viable microorganisms significantly supported a claim for rapid high-level disinfection. Based on these data, RSS demonstrates high-level disinfection in 5 minutes and sterilization in 30 minutes at 20 degrees C.

Bacteria↗

Ethylene oxide dispersion from gas sterilizers.

Ethylene oxide (EtO) is widely used by the health industry for sterilizing heat-sensitive devices. About 100 000 workers are regularly exposed to this chemical, used in an estimated 10 000 sterilizing units in U.S. health care facilities. Based on recent findings. NIOSh has recommended that EtO be regarded as a potential carcinogen and has urged OSHA to reexamine its present standard of 50 ppm. The ACGIH Notice of Intended Changes for 1982 has proposed reducing the recommended limit from 10 ppm TWA to 1 ppm and considers EtO a suspect carcinogen for man. Because of this increasing concern for its toxicity, it is imperative that the exposures to EtO be assessed, and that all reasonable steps to reduce these exposures be taken. This study demonstrates the effects of local exhaust ventilation, sterilizer chamber temperature, and sterilizer relative humidity in relation to their influence on EtO plume directionality, concentration and duration. Using two Foxboro/Wilks Miran 1A General Purpose Gas Analyzers, EtO concentrations were simultaneously monitored both immediately above and below the sterilizer door during various process runs, at three different types of sterilizers. Sterilizer operating conditions were representative of temperatures (38-54 degrees C (100-130 degrees F)), and relative humidities (30-50%) commonly employed in the sterilization process. The effects of varying local exhaust parameters were observed. Results clearly demonstrated that EtO tends to flow upward when the sterilizer door is opened. In all cases, the highest concentrations were observed at the upper location. Local exhaust ventilation significantly reduced the concentration of EtO observed and lessened the duration for which these levels persisted. Changes in temperature and relative humidity, within the range cited, have not shown any significant differences in EtO evolution patterns, concentrations or duration.

Ethylene Oxide↗

Current sterilization and packaging methods for polyethylene.

Gamma sterilization in an air environment can induce oxidation in polyethylene. Oxidation can lead to polyethylene embrittlement, compromising mechanical integrity and clinical performance of polyethylene bearings. For these reasons, orthopaedic manufacturers have modified their methods of sterilizing and packaging polyethylene. Two alternative approaches have emerged: sterilization by non-radiation methods and sterilization by gamma irradiation in inert environments. The current study presents a prognosis for clinical performance of polyethylene sterilized with new methods, based on material property analyses (oxidation levels, mechanical properties, crosslink density) of never implanted and retrieved bearings. Data from bearings that were never implanted which were sterilized with the new methods and shelf aged as many as 3 years, show negligible oxidation, ductility above 400%, and ultimate tensile strength near 50 MPa, all exceeding specifications of the American Society for Testing and Materials. There are significant differences in crosslink density (swell ratio) depending on the sterilization method. Retrievals indicate that bearings sterilized with these new methods are performing well clinically and that the majority are not changing with time. The current study suggests that the shelf oxidation problem has been addressed by these new sterilization techniques and that clinical performance at short followup is acceptable. However, long-term clinical performance must be evaluated in the future.

Drug Packaging↗

Condom use among sterilized and nonsterilized Hispanic women.

BACKGROUND: Women who use sterilization for contraception are at risk for various sexually transmitted diseases, unless they use a barrier method. Use of condoms is significantly lower among sterilized women than among hormonal-contraceptive users. Among Hispanics, women's perception of risk and the influence of male partners are strong correlates of dual-method use. Limited data are available concerning use of condoms among sterilized women, in particular among Hispanics. GOALS: Past and future use of condoms was examined and compared among 224 sterilized women and 104 hormonal-contraceptive users of Hispanic origin, and the reasons for use or nonuse of condoms were examined. STUDY DESIGN: Cross-sectional survey. RESULTS: As compared with hormonal-contraceptive users, sterilized women were significantly less likely to have used condoms in the 3 months before the study or to have plans to use them in the future (P < 0.001). Despite similarities between various HIV-related characteristics of sterilized and nonsterilized women, the former group had significantly lower perceptions of being at risk for both HIV and other sexually transmitted diseases. Sterilized women were also more likely to have used condoms for the purposes of dual protection from pregnancy. The strongest correlates of consistent condom use by both sterilized and nonsterilized Hispanic women were their perceived susceptibility to disease, male partners' positive opinion about condoms, and the women's ability to use condoms in long-term relationships. Furthermore, the practice of concealing the use of a contraceptive from a male partner was not uncommon, although this characteristic was not related to increased dual-method use. CONCLUSIONS: Sterilized women may be at a higher risk of disease than hormonal-contraceptive users. Among Hispanics, women's perception of risk and male partners' influences predict whether the women protect themselves from pregnancy and disease simultaneously.

Condoms↗

Use of peracetic acid to sterilize human donor skin for production of acellular dermal matrices for clinical use.

We previously reported methods for sterilizing human skin for clinical use. In a comparison of gamma-irradiation, glycerol, and ethylene oxide, sterilization with ethylene oxide after treatment with glycerol provided the most satisfactory dermis in terms of structure and its ability to produce reconstructed skin with many of the characteristics of normal skin. However, the use of ethylene oxide is becoming less common in the United Kingdom due to concerns about its possible genotoxicity. The aim of this study was to evaluate peracetic acid as an alternative sterilizing agent. Skin sterilized with peracetic acid was compared with skin sterilized using glycerol alone or glycerol with ethylene oxide. The effect of subsequently storing peracetic acid sterilized skin in glycerol or propylene glycol was also examined. Acellular dermal matrices were produced after removal of the epidermis and cells in the dermis, processed for histological and ultrastructural analysis, and the biological function was evaluated by reconstitution with keratinocytes and fibroblasts. Results showed that sterilized acellular matrices retained the integrity of dermal structure and major components of the basement membrane. There were no overall significant differences in the ability of these matrices to form reconstructed skin, but peracetic acid alone gave a lower histologic score than when combined with glycerol or propylene glycol. We conclude that peracetic acid sterilization followed by preservation in glycerol or propylene glycol offers a convenient alternative protocol for processing of human skin. It is suggested that this sterile acellular dermis may be suitable for clinical use.

Dermis↗

Safety issue of re-sterilization of polyurethane electrophysiology catheters: a cytotoxicity study.

The reuse of electrophysiology catheters could result in significant cost savings. However, re-sterilization of catheters could lead to several adverse consequences, including toxicity related to potential chemical reactions that occur during sterilization due to toxic residues remaining on the surface of catheters. The objective of this study was to investigate in vitro cytotoxicity of polyurethane (PU)-based catheter extracts on macrophages after their re-sterilization. We have compared three sterilization methods: steam autoclave, ethylene oxide (EtO) and hydrogen peroxide plasma (Sterrad system). Our results showed that the viability of cells varied from 90% to 99% as a function of incubation time and number of sterilization cycle. While there was no statistical difference based on the sterilization procedure, the number of sterilization cycles (up to 10 cycles) presents a statistically significant effect on the viability of J774 macrophages. However, extract obtained after resterilization of PU-based catheters had a low cytotoxic effect on J774 macrophages, since the overall cell mortality remained under 10%. An inhibitory effect on cell growth was also observed, which was not significant either as a function of incubation time, sterilization technique or the number of sterilization cycles. Finally, extracts of PU-based catheters had no statistically significant effect on TNF-alpha release by J774 macrophage. Even though there were some statistically significant differences between the control and processed samples, and among processed samples, our data suggest that one single reprocessing of PU-based catheters may not induce clinically significant changes in their cytotoxicity behaviour.

Animals↗

Formation and elution of toxic compounds from sterilized medical products: methylenedianiline formation in polyurethane.

The formation of a toxic and carcinogenic compound, methylenedianiline (MDA), in sterilized medical use polyurethane (PU) is discussed. Due to good biocompatibility and biostability, PU is widely used for blood-containing devices. There are two types of PU currently available for medical use. One is chain-extended thermoplastic PU, the other is thermosetting PU used for potting material connecting fibers and modules in artificial dialyzers and plasma separators. Both gamma-ray irradiation and autoclave sterilization are predominantly used for the sterilization of these devices. MDA formation in sterilized PUs by gamma-ray irradiation and by autoclave treatment is compared. The Delany clause in the USA prohibits the manufacture of medical devices producing any toxic compound during fabrication and sterilization, therefore, the formation and elution of MDA and other toxic compounds should be seriously considered. Although MDA formation at a concentration of a few to a few hundred ppb in autoclaved chain-extended thermoplastic PU has been reported, there have been no papers describing MDA formation in autoclaved thermosetting PU potting material, or describing MDA formation in gamma-ray irradiated chain-extended thermoplastic PU and thermosetting PU. We elected to determine whether MDA was in fact produced in Pus sterilized by gamma-ray irradiation or by autoclave sterilization. Our objective was to estimate the risk factor to the human patients or recipient. Our conclusion is to confirm which sterilization of gamma-ray or autoclave is more appropriate. No formation of MDA was observed in autoclaved thermosetting PU potting material at 121 degrees C for 60 min. A few ppm of MDA was formed in irradiated potting material. MDA formation increased with increasing irradiation doses. MDA formed in irradiated potting material at 2.5 Mrad (less than one ppm) is not a significant risk to the recipient. The estimated cancer causing risk factor when absorbing one mg MDA/kg body weight/day is 0.29. Twenty-nine persons per 100 persons exhibit a cancer potential. More importantly, our experimental evidence indicated that serum extracts from irradiated potting material contained unknown compounds other than MDA. The presence of these compounds is considerably more significant and toxic. When tested, these compounds proved to be mutagenic in the absence of metabolic activity, thus promoting a need to identify and study further. Compounds indicating mutagenicity increased with increasing irradiation. Small amounts of mutagenic compounds were determined in extract from autoclaved potting material, smaller than that by gamma-ray irradiation. Therefore, autoclave sterilization is more appropriate, providing materials can withstand the process.(ABSTRACT TRUNCATED AT 400 WORDS)

Aniline Compounds↗

Ethylene oxide sterilization of bone, dura mater, and fascia lata for human transplantation.

The use of allogeneic human bone, dura, and fascia has achieved an enduring and accelerating role in the augmentation of spinal fusions and the repair of skeletal and dural defects. Primary sterilization of these nonviable cadaveric tissues magnifies the potential sources and ensures the microbiological sterility of the implant. Subsequent lyophilization facilitates preservation and distribution and reduces the immunogenicity of the graft. The evaluation of gaseous ethylene oxide (EO) as a sterilant was suggested by the delerious effects of alternative methods. Through a series of experiments, the following properties of EO sterilization were studied: (a) surface and interstitial sterilization; (b) the diffusion of EO into tissue, the formation of the reaction products ethylene chlorohydrin (EC) and ethylene glycol (EG), and the desorption of all three from tissues; (c) lyophilization and aeration in the removal of residues; and (d) minimization of residues through pretreatment. Gaseous EO is a very effective surface sterilant of wet bone, dura, and fascia and does not grossly alter these tissues. Its partial penetration through compact bone renders it less reliable for an interstitial antimicrobial effect, unless access to the interior is provided by serial openings. The toxicity of EO, EC, and EG mandates the desorption through lyophilization of these compounds (EC and EG are formed during sterilization with EO). Before sterilization, bone must be rid of marrow by vigorous irrigation with deionized water. The resultant reduction of the number of cells and of the available chloride decreases antigenicity and the formation of EC. Freeze-drying for more than 72 hours, in some cases augmented by prolonged aeration at room temperature, reduces EO, EC, and EG to acceptable levels. The accurate assay of residues in tissue requires acetone extraction for gas chromatography on rehydrated tissues because extraction of dry tissues gives falsely low results. Rigorous adherence to a protocol incorporating these findings justifies the acceptance of gaseous EO as a safe, relatively rapid, and inexpensive sterilant of bone and soft tissues.

Adult↗

Reproducibility of sterilized rubber impressions.

Impressions, dentures and other dental appliances may be contaminated with oral micro-flora or other organisms of varying pathogenicity from patient's saliva and blood. Several approaches have been tried to control the transmission of infectious organisms via dental impressions and because disinfection is less effective and has several drawbacks for impression characterization, several sterilization methods have been suggested. This study evaluated the reproducibility of rubber impressions after sterilization by different methods. Dimensional accuracy and wettability of two rubber impression materials (vinyl polysiloxane and polyether) were evaluated after sterilization by each of three well-known methods (immersion in 2% glutaraldehyde for 10 h, autoclaving and microwave radiation). Non-sterilized impressions served as control. The effect of the tray material on impression accuracy and the effect of topical surfactant on the wettability were also evaluated. One-way ANOVA with Dunnett's method was used for statistical analysis. All sterilizing methods reduced the reproducibility of rubber impressions, although not always significantly. Microwave sterilization had a small effect on both accuracy and wettability. The greater effects of the other methods could usually be overcome by using ceramic trays and by spraying impression surfaces with surfactant before pouring the gypsum mix. There was one exception: glutaraldehyde still degraded dimensional accuracy even with ceramic trays and surfactant. We conclude that a) sterilization of rubber impressions made on acrylic trays was usually associated with a degree of dimensional change; b) microwave energy seems to be a suitable technique for sterilizing rubber impressions; c) topical surfactant application helped restore wettability of sterilized impressions.

Ceramics↗

Capture of Mediterranean fruit flies (Diptera: Tephritidae) in dry traps baited with a food-based attractant and Jackson traps baited with trimedlure during sterile male release in Guatemala.

Captures of the Mediterranean fruit fly, Ceratitis capitata (Wiedemann), in Jackson traps baited with trimedlure were compared with captures in cylindrical open-bottom dry traps baited with a food-based synthetic attractant (ammonium acetate, putrescine, and trimethylamine). Tests were conducted in Guatemala during a sterile male release program in an area where wild flies were present in low numbers. More wild and sterile females were captured in food-based traps, and more wild and sterile males were captured in trimedlure traps. The food-based traps captured almost twice as many total (male plus female) wild flies as the trimedlure traps, but the difference was not significant. Females made up approximately 60% of the wild flies caught in the food-based attractant traps; the trimedlure traps caught no females. The ratio of capture of males in trimedlure traps to food-based traps was 6.5:1 for sterile and 1.7:1 for wild flies. Because fewer sterile males are captured in the food-based traps, there is a reduction in the labor-intensive process of examining flies for sterility. The results indicate that traps baited with food-based attractants could be used in place of the Jackson/trimedlure traps for C. capitata sterile release programs because they can monitor distributions of sterile releases and detect wild fly populations effectively; both critical components of fruit fly eradication programs by using the sterile insect technique.

Animals↗

Sterility testing: how appropriate for the hospital.

In the hospital the need to test for sterility is as vital as in industry. However, the means of accomplishing this are quite different. The sterile "products" produced are used prior to a final sterility certification and this time-honored concept presents interesting challenges. Associated with the techniques of monitoring sterility are numerous problems. The difficulty of the hospital attempting to sterility-test sterile disposable devices they have purchased and shortcomings involved in culturing techniques used to evaluate the hospital's internal sterilization program are reviewed, A program for assurance of sterility based on proper monitoring ot the sterilizer and adequate preparation of the goods being processed are given.

Cross Infection↗

[Use of and verification with biological indicators in sterilizers belonging to dentistry surgeons from San Luis Potosi, Mexico].

OBJECTIVE: To assess the utilization of sterilizing equipment used by dentists, and verification of sterilization using biological indicators. MATERIAL AND METHODS: A cross-sectional study was conducted in 1999-2000, among 130 (65%) dentists having sterilizing equipment, at Facultad de Estomatología, Universidad Autónoma de San Luis Potosí and Colegio Dental Potosino. Biological indicators for sterilization containing Bacillus subtilis and Bacillus stearothermophilus were used. RESULTS: Thirty autoclaves and 100 dry-heat sterilizers were evaluated: 23 (17.7%) of them showed bacterial growth. Twenty-one (16.1%) dentists already were using biological indicators to verify their sterilizing equipment. Both sterilization methods were found to allow bacterial growth with similar frequencies (p = > 0.66). CONCLUSIONS: Few dentists verify the quality of sterilization process through biological indicators; bacterial growth and failure of sterilization were evidenced.

Bacillus subtilis↗

Sterilization of mentally retarded individuals: informed consent in Guidelines in the Netherlands.

The purpose of this paper is to describe and discuss the Guidelines of the Dutch Health Care Inspectorate' with respect to sterilization of mentally retarded individuals. In 1998, the Minister of Health had the 1989 Guidelines replaced by new ones. Two new laws were integrated into these new Guidelines: the Medical Treatment Agreement Act (hereinafter referred to as WGBO, being the Dutch abbreviation) and the Mentorship Act. The minister was also inspired to draw up new Guidelines by the revelation in the media of involuntary sterilizations still taking place in several European countries. She is adamant that the Guidelines should be a 'guarantee against involuntary sterilizations'. This issue requires special guidelines because of judicial questions connected with the sterilization of individuals who are more or less incapable of giving informed consent. Involuntary sterilization is a violation of basic human rights, such as the right of physical integrity and protection of privacy. The Guidelines describe how the decision-making process between doctor, patient, representatives, proxies or guardians should proceed and what to do when parties do not reach consensus. A distinction has been made between competent and incompetent patients. The Guidelines and the WGBO give answers to questions like the following: will the informed consent of representatives and proxies be sufficient to perform sterilization? Do doctors have to follow representatives and proxies? Can sterilization take place in spite of a patient's resistance? The Guidelines focus on the process of decision-making, in order to guarantee an appropriate procedure, with the best possible outcome for the mentally retarded individual. The Guidelines do not answer the question of what legitimate reasons doctors may have for performing sterilization on such a person. Given the substantial questions involved the Minister of Health has asked the Health Council to add possible grounds to the Guidelines that should be taken into account when deciding on sterilization.

Human Rights↗

Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy.

The need for sterility testing of antimicrobial-containing injectable solutions is discussed and specific testing methods are described. Despite their antimicrobial activity, antimicrobial-containing injectable drug products are not necessarily self-sterilizing and can become contaminated. In addition to practicing aseptic technique, pharmacists must perform end-product sterility testing on intravenous solutions to ensure their sterility. The United States Pharmacopeia provides guidelines for the performance and validation of two sterility test methods: membrane filtration and direct transfer to culture media. Membrane filtration is the method of choice for sterility testing of many antimicrobial-containing injectable solutions. After the test article is filtered, the membrane is rinsed with sterile fluid to remove residual antimicrobial agent, cut into two portions, and immersed in two types of culture medium. Visible turbidity of a sample within the appropriate incubation period indicates the presence of a contaminating microorganism. Closed filtration systems minimize false-positive results. In the direct transfer method, samples of the test article are directly inoculated into vessels of culture media, and antimicrobial activity is eliminated by dilution or by deactivation with chemical or enzymatic agents. Sterility testing as well as aseptic technique is needed to ensure the sterility of antimicrobial-containing injectable solutions.

Anti-Infective Agents↗

Gas and steam sterilization of assembled versus disassembled laparoscopic equipment. Microbiologic studies.

Current recommendations specify disassembly of most laparoscopic equipment prior to sterilization. Surgical technicians, however, are often unfamiliar with the proper assembly of laparoscopic instruments, resulting in possible patient injury from equipment malfunction. Therefore, we tested the hypothesis that disassembled laparoscopic equipment is sterilized more thoroughly than assembled equipment. We inoculated internal sites on laparoscopic instruments prior to assembly with bacterial spores resistant to ethylene oxide and steam sterilization. We also manually cleaned the equipment after inoculation prior to steam sterilization of both the assembled and disassembled instruments. The control instruments were stored at room temperature during test sterilization runs. No vegetative bacteria survived ethylene oxide or steam sterilization in assembled equipment, but despite a significant reduction, spore-forming bacteria could be cultured from the assembled equipment. If the instruments were washed before steam sterilization, there was similar spore clearance in the assembled and disassembled instruments, with both groups attaining a high level of disinfection. Our data suggest that disassembly, cleaning and proper assembly of equipment prior to sterilization present no more risk of infection transmission than does disassembly during prevacuum steam sterilization. The method provides properly assembled and functioning equipment at the time of surgery.

Clinical Protocols↗

Tubal sterilization and subsequent ectopic pregnancy. A case-control study.

OBJECTIVE: To assess the relative risk of ectopic pregnancy associated with postpartum or interval tubal sterilization. DESIGN: Case-control study using a comparison group of women of reproductive age at risk of pregnancy. SETTING: Group Health Cooperative of Puget Sound, a health maintenance organization based in Seattle, Wash. organization based in Seattle, Wash. PARTICIPANTS: Cases were 249 enrollees diagnosed as having an ectopic pregnancy between October 1, 1981, and September 30, 1986. Controls were 835 randomly selected enrollees matched to cases on age and county of residence. MEASUREMENTS: Information on interval sterilization history was obtained from interviews, examination of medical records, automated hospitalization files and a previously validated algorithm. A logistic regression model was used to estimate relative risks (RRs) for sterilized women compared with women using other types of or no contraception at the reference date. RESULTS: Controlling for age, county, race, smoking, income, gravidity, and prior use of a Dalkon Shield intrauterine device, the risk of ectopic pregnancy in women who had undergone interval sterilization was 3.7 (95% confidence interval [CI], 1.7 to 8.0) times that of women currently using oral contraception and 2.8 (95% CI, 1.5 to 5.5) times that of women currently using barrier contraceptive methods. Use of interval sterilization was associated with a risk of ectopic pregnancy similar to that of women using intrauterine devices (RR, 0.8; 95% CI, 0.4 to 1.7) and a risk lower than that of women who were not using contraception (RR, 0.2; 95% CI, 0.1 to 0.3). The corresponding RRs associated with postpartum sterilization were lower: 1.2 (95% CI, 0.3 to 3.9), 0.9 (95% CI, 0.3 to 2.8), 0.3 (95% CI, 0.1 to 0.8), and 0.1 (95% CI, 0.0 to 0.2), respectively. CONCLUSION: Tubal sterilization provides some protection against extrauterine as well as intrauterine pregnancy. It is likely that postpartum sterilization can be a safe alternative to all types of temporary contraception in terms of risk of ectopic pregnancy, while some types of interval sterilization may lead to an increased risk, in comparison with use of oral contraceptives or barrier methods.

Adolescent↗

Legal trends and issues in voluntary sterilization.

Legal barriers to voluntary sterilization are falling. In both developing and developed countries, new legislation, court decisions, government policy statements, and ministerial regulations increasingly leave the decision whether to be sterilized to the individuals involved rather than to medical experts or government officials. These legal changes confirm that voluntary sterilization is an acceptable means of fertility regulation and a legitimate medical procedure; it is no longer seen as physical mutilation to be condemned in the criminal codes. Nevertheless, barriers still exist in some countries that make it difficult for poor and rural populations to obtain voluntary sterilization. These obstacles arise when voluntary sterilization is excluded from national health and family planning programs and from private insurance plans. Changes in voluntary sterilization law reflect increasing choice of this method of fertility control. Over the last decade voluntary sterilization has become the most widely used means of family planning in the world. Approximately 100 million couples now are protected from unwanted pregnancy by voluntary sterilization. This amounts to one-eighth of the world's couples and one-third of all those practicing contraception. Almost half of these couples are in China. Voluntary sterilization is most prevalent in countries where the procedure has been clearly legal for a number of years. But now it is also becoming more common in countries like Brazil, where the legal status has been less clear.

Adolescent↗