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At least 19 recordsLinked to original sources
PubMed1989

[Studies on the method of sterilization with ethylene oxide gas. 1. Sterilization procedure and sterilizing effect].

Undertaken to ensure perfection of sterilization with ethylene oxide gas (EO gas) in routine clinical laboratory practice, an investigation was made of the relationship between sterilization procedure and sterilizing effect using the film bag delivery system and chamber system. Using a biological indicator as a monitor of sterilizing effect, the efficiency of sterilization was studied under various likely conditions and compared. The results led to the following conclusions: 1. Sterilization with EO gas by the film bag delivery system, because of this procedure being unable to be performed at a constant temperature, was shown to prove inadequate due to insufficient exposure to gas especially in winter season (when room temperature fell below 10 degrees C). 2. With the EO gas sterilization method using the film bag delivery system, which is believed to be effective within the ordinary range of humidity of the atmosphere, sterilizing effect was recognized to be affected by excess wetting of an object of sterilization that was caused by inadvertent manipulation or due to a predisposing attribute of the object, such as shape or outline. 3. All materials are sterilized upon being packaged. It is necessary therefore to make best choice of package material with respect of texture and size. Reuse influence to sterilizing effect. 4. The method of sterilization with EO gas using the chamber system has the advantage in that operating conditions are all automatically controlled. For this reason, there was not a single instance of failure to sterilize due to inappropriateness of temperature and humidity. From these results it is concluded that sterilising effect was affected by sterilization procedure and condition.(ABSTRACT TRUNCATED AT 250 WORDS)

Ethylene Oxide↗
PubMed1984

Tubal sterilization. A prospective long term investigation of 218 sterilized women.

The present study is a long-term investigation of 218 consecutively sterilized women in Akershus County, Norway. The operations were performed in 1973-74, when the access to sterilization was regulated by a legislation from 1934. The women were interviewed personally, and a clinical examination was performed before sterilization, at discharge from hospital, three months, one and six years later. At each occasion the participation was about 95%, and only one woman was lost to follow-up. The women in this series lived in stable social conditions, their average age was 33.7, their parity 2.8. They were not socially distinguishable from women of the same age in the county at large, but there were important socially and age related differences within the series. Their contraceptive usage was widespread, but inconsistent. Family planning was the all-dominant motive. Forty per cent of the women had been suggested the sterilization by a doctor, 30% at abortion application. The operations were performed as laparoscopic electrocoagulation of the tubes or as a Pomeroy resection. Five pregnancies were recognized in the study period, four of these in the laparoscopy group. There were few serious complications, but 20% had a diversity of complaints at the three month interview. At six years seven women had complaints attributed to the operation. The large majority of the series was satisfied with the sterilization. Almost half the women would have preferred an even earlier operation, and six years after the sterilization 85% of the women had told friends about it, and 71% of these had directly recommended sterilization to someone. Six years after the sterilization 74% said the operation should be more widespread, 69% believed postoperative regret was uncommon, and the impact on postoperative marital life was mainly positive. However, during the study period, 18% of the women had experienced regret, ambivalence or periodic depression because of their sterilization. The rate of, and reasons for regret varied with time. The rate increased; at six years 6% of the women would have preferred the sterilization undone, and in 10% of the couples at least one of the partners held that view. At one year, the primary reason for regret was a feeling of having been persuaded by the doctor at abortion application. Six years after the sterilization the desire for a child with a new spouse was the principle reason. There was no association between regret and age or parity at operation.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1984

The rationale and a computer evaluation of a gamma irradiation sterilization dose determination method for medical devices using a substerilization incremental dose sterility test protocol.

The experimental procedure described is designed to allow calculation of the radiation sterilization dose for medical devices to any desired standard of sterility assurance. The procedure makes use of the results of a series of sterility tests on device samples exposed to doses of radiation from 0.2 to 1.8 Mrad in 0.2 Mrad increments. From the sterility test data a 10(-2) sterility level dose is determined. A formula is described that allows a value called DS Mrad to be calculated. This is an estimate of the effective radiation resistance of the heterogeneous microbial population remaining in the tail portion of the inactivation curve at the 10(-2) dose and above. DS Mrad is used as a D10 value and is applied, in conjunction with the 10(-2) sterility level dose, to an extrapolation factor to estimate a sufficient radiation sterilization dose. A computer simulation of the substerilization process has been carried out. This has allowed an extensive evaluation of the procedure, and the sterilization dose obtained from calculation to be compared with the actual dose required. Good agreement was obtained with most microbial populations examined, but examples of both overdosing and underdosing were found with microbial populations containing a proportion of organisms displaying pronounced shoulder inactivation kinetics. The method allows the radiation sterilization dose to be derived from the natural resistance of the microbial population to gamma sterilization.

Computers↗
PubMed1983

[Dependency of a microbiological test of a formaldehyde gas sterilization procedure on the shape of objects to be sterilized].

During the last decade, a number of procedures have been developed by different firms for the sterilization of heat-sensitive instruments using a mixture of formaldehyde and water vapor at a temperature of approximately 60 degrees C as means of sterilization. Instruments to be sterilized by this technique as e.g. sounds and catheters normally have long narrow cavities. Therefore, the formaldehyde gas sterilization procedures have to be tested primarily for their capability of achieving a sufficient microbicidal effect within those cavities. For this purpose, the bioindicators are placed into special test pieces. The test pieces commonly in use differ widely in their construction, shape, and size. They mostly consist of some hollow cylinder with an attached capillary or a tube (see Table 1). The authors demonstrated by means of models that the variety of test pieces in use meant that the sterilization procedures had to meet quite different requirements. The models consisted of flexible tubes differing in diameter and length and were connected to short glass tubes. These glass tubes having identical or wider inner diameters than the flexible tubes served as receptacles containing the bioindicators. Spores of Bacillus stearothermophilus served as test organisms. The spores were suspended in defibrinated sheep blood and dried on filter paper. The efficiency of the sterilization technique was measured in terms of the relative number of indicator strips with surviving germs (i.e. non-sterilized indicators) after treatment of the test pieces with the formaldehyde gas. At first, the test results were examined as to their dependency on the length of the flexible tubes. These tubes were 3 mm wide and 5 to 100 cm long, each being sealed at one end and with the bioindicators placed near the sealed end. The percentage of indicators with surviving germs increased with the length of the tubes. After the sterilization process, nearly all indicators (92%) contained in the 1 m tubes proved to be non-sterile (see Table 2). The same results were obtained with tubes open at both ends, with the bioindicators located in the middle section of the tubes (see Table 3). Using tubes of 1 m length, the dependency of the test results on the inner diameter of the test pieces was demonstrated. While all indicators placed into tubes of 3 mm inner diameter still contained surviving germs, those in the tubes of 9 mm inner diameter were all sterile (see Table 4).(ABSTRACT TRUNCATED AT 400 WORDS)

Bacteriological Techniques↗
PubMedDate not supplied

Design and use of a novel peracetic acid sterilizer for absolute barrier sterility testing chambers.

Increasing use is being made of absolute barrier chambers in the pharmaceutical industry for sterility testing of sterile pharmaceuticals. Since these barriers are designed to form a microbial-tight enclosure to eliminate laboratory microbial contamination derived from the operator and the environment,it is important that the method used to sterilize these barriers, product containers, and articles used within, provide a high degree of sterility assurance. A major part of incorporating absolute barriers in the sterility testing laboratory at the Upjohn Company was to design an automated sterilization system to facilitate the spraying of a liquid sterilant, e.g., peracetic acid, inside these barriers. This article focuses on general design considerations, specific details of the apparatus, and the operational steps. The sterilization efficacy of this method is also described, with particular emphasis on validation criteria and results. Finally, operational sterility testing results are discussed.

Equipment Contamination↗
PubMed1987

[Sterilization of the female with special reference to laparoscopic tubal sterilization].

Within recent years female sterilization has gained a place of great importance as an effective contraceptive method. Nowadays sterilization is hardly subject to any formal restrictions, but is solely the responsibility of the woman concerned, the couple or the physician. The indications for sterilization may be divided into two main groups, namely for medical indications and family planning. Sterilization is carried out on the uterus or tubes. Today the method of choice is laparoscopic tubal sterilization. The most frequently used procedure and the safest way of tubal occlusion is bipolar electrocoagulation of the entire isthmic tubal portions without additional section of the tubes. The complication rate in laparoscopic tubal sterilization depends on the type of anaesthesia, on the skill of the operator and on patient risk factors such as obesity etc. Minor intraoperative complications are of little importance since they are easily remedied during laparoscopy. Severe complications are rare, but have to be corrected immediately by laparotomy. Pregnancies on account of failure in sterilization procedure may be due to the occlusion technique, the lack of experience of the operator, the timing of sterilization and the observation period. Altogether 2372 laparoscopic tubal sterilizations were performed at the University Department of Obstetrics and Gynaecology in Graz between January 1st, 1975 and December 31st, 1985. During these eleven years a specific technique has been developed, whereby standard methods were simplified and improved. No intrauterine cannula for mobilizing the uterus is applied to avoid infection or perforation. The preferred "single-puncture technique" offers many advantages over the older "double-puncture technique", since fewer instruments are needed and the operation is less time-consuming, eliminating the danger of a second puncture. Moreover, the procedure is easier to perform and the cosmetic result better. In high-risk patients, especially the extremely obese, the laparoscopic technique has been improved by a special method of introducing the trocar.

Female↗
PubMed1992

Sterilization needs in the 1990s: the case for quinacrine nonsurgical female sterilization.

Much evidence suggests that demand for sterilization is a function of supply of surgical sterilization services in less-developed countries. If such services were greatly expanded, the number of procedures performed would grow dramatically. While the prevalence of sterilization is estimated to increase from 23.5% to 28.8% of married women of reproductive age in the 1990s, there will actually be 106,432,000 more couples of reproductive age at the end of this decade than at its beginning who use either no method or a far less effective method with much lower continuation rates than sterilization--nearly a 20% increase. To achieve a mean sterilization prevalence of 47% of married women of reproductive age in the less-developed world, as now seen in the Republic of Korea and Puerto Rico, the number of sterilizations would need to be more than double the current projection for the 1990s: 328,429,000 rather than 159,000,000. The quinacrine pellet method for nonsurgical female sterilization offers hope that this enormous shortfall in sterilization services can be overcome in this decade.

Adult↗