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PubMed1977

"Thinking the unthinkable": the prospect of compulsory sterilization in India.

The National Population Policy Statement adopted by the Government of India in April 1976 gave states the mandate to adopt coercive and compulsory sterilization measures toward the end of bringing under control the nation's massive population growth. Many states have since adopted stringent measures which penalize couples having three or more children, and four states additionally have proposed legislation for compulsory sterilization. While the demographic impact of compulsory sterilization after the third child is undisputed, the administrative feasibility of such and undertaking has been widely questioned, particularly in light of the inadequacy of India's medical infrastructure in the rural areas. Critics further have raised questions concerning the social and ethical implications of compulsory sterilization and of measures which penalize the poor through means which may have adverse effects on their health and welfare. Finally, opponents of the new sterilization measures have suggested that they divert attention from the need for more basic changes in the nation's economic and social structure. While the need for bringing down India's continued high birth rate is widely recognized, alternative population measures-e.g. increased abortion facilities and an enforcement of the raised age at marriage-have been advocated in lieu of the compulsory sterilization measures currently being proposed.

Adolescent↗
PubMedDate not supplied

Damage of office supply, personal use items, and over-the-counter medical devices after sterilization by ethylene oxide gas, electron beam, and gamma radiation.

After letters containing Bacillus anthracis spores entered the U.S. mail in 2001, a problem emerged regarding how to decontaminate the letters, packages, and personal items in offices that received these letters. The effects of three sterilization methods (i.e. ethylene oxide gas [EO], electron beam [e-beam] radiation, and gamma radiation) were evaluated for a variety of office supply and equipment, personal use items, and over-the-counter medical devices. No single sterilization method was suitable for all items that could be mailed or found in an office. Damage or discoloration was evident for some items by each sterilization method. There were changes in the color of certain items, such as some of the packaging material, some pacifiers, some of the fabrics, and the nylon stockings after e-beam and gamma radiation. Both e-beam and gamma radiation damaged all film samples. Following EO sterilization and normal aeration, there were a number of samples with high (above 250 microg/g) levels of EO and samples with detectable ethylene chlorohydrin levels. The data would suggest that certain items exposed to EO sterilization must be further aerated prior to use, or discarded. Generic descriptions of products (such as plastics) or grouping of items (such as condoms) were not sufficient to predict what is safe in terms of EO residual levels remaining on an item. Successful decontamination of a wide variety of items will require careful selection of different sterilization methods.

Biosensing Techniques↗
PubMed1996

Novel technology for the preparation of sterile alginate-poly-l-lysine microcapsules in a bioreactor.

The purpose of this study was to develop a method that may be suitable for the commercial manufacture of sterile alginate-polylysine-alginate microcapsules in a bioreactor. A Turbotak atomizing device in conjunction with a Bellco Bioreactor was used to prepare sterile microcapsules. Aseptic procedures were followed using sterilized equipment and materials. Sodium alginate solution was sprayed into calcium chloride solution using the Turbotak, with nitrogen as the atomizing gas. The resultant gelled alginate microcapsules were coated with polylysine and alginate to produce alginate-poly-l-lysine microcapsules. In-process contamination of the atomizing gas and microcapsules was investigated using modified USP sterility tests. Microcapsule size was determined using a light blockage technique (Accusizer) which measures both number and volume weighted mean diameters. The microcapsules prepared passed a modified USP sterility test, and the Bellco Bioreactor was found to minimize the possibilities of environmental contamination and therefore enhanced operator safety. The flow rate of the atomizing gas was determined to significantly alter number and volume weighted mean microcapsule diameters. Statistical analysis indicated that the number weighted mean diameters in conjunction with the volume weighted mean diameters can be used to detect batch-to-batch changes in microcapsule diameters. In conclusion, the modified Bellco Bioreactor offers a novel approach for producing sterile alginate-polylysine microcapsules on a laboratory scale.

Alginates↗
PubMed1993

Flash sterilization and instrument tape--an experimental study.

A letter appearing in the AORN Journal questioned whether flash sterilization is appropriate for instruments coded with color identification tape. The reply stated that porous, colored tape required a longer time to penetrate and sterilize the area beneath, and thus if it should peel off, the zone beneath might not be sterile. This conclusion was, as far as we can determine, reached by intuitive reasoning and not by experimental evidence. Therefore, the following experimental approach was undertaken to test the hypothesis. Spores on discs were placed between the color-code tape and a metal instrument. Exposure to heat (135 degrees C) and time (3 min.) was in a gravity displacement sterilizer. We then determined whether spore kill has been achieved. The test organism was B. stearothermophilus. None of the discs that were in contact with the instruments while being sterilized showed any growth. Thus, it appears that sterility can be achieved on the instrument surfaces that are beneath color-code tape in three minutes.

Equipment Contamination↗
PubMed1994

Evaluation of the Plazlyte Sterilization System at the Richmond Hospital, Richmond, B.C.

Ethylene oxide mixed with chlorofluorocarbons has been the sterilant of choice for heat- and pressure-sensitive instruments and equipment in most Canadian and U.S. healthcare facilities. A pending July 1, 1994 ban on CFCs in British Columbia propelled the Greater Vancouver Regional Hospital District (GVRHD) to seek out any new available technologies to replace EtO sterilization. AbTox Plazlyte Sterilization System, which employs a proprietary, low-temperature gas plasma in conjunction with vaporized peracetic acid chemistry to provide terminal sterilization of instruments and devices, appeared very promising. A task force was formed at the Richmond Hospital to develop and implement a clinical isolate test protocol of the system. Following the three-month trial, the results showed the system to be effective in sterilizing all clinical isolates and compatible with the materials tested. There has also been improved product throughput. The Richmond Hospital now uses one Plazlyte sterilizer to process all items formerly processed using EtO.

British Columbia↗
PubMed1993

Low-temperature sterilization using gas plasmas.

A number of plasma-based techniques for sterilizing heat-sensitive medical equipment at low temperatures are being developed worldwide as alternatives to existing chemical and gaseous sterilization methods. The techniques involve the use of plasmas in controlled sterilization processes that increase operator safety and offer medical device manufacturers the option of using materials they cannot currently consider because of the incompatability of those materials with existing sterilization technologies. In this article, the author discusses three development programmes that are under way and assesses the potential applications of the technique as an alternative to ethylene oxide sterilization. The potential of the technique to meet in-house sterilization requirements of medical product manufacturers is also discussed.

Equipment Contamination↗
PubMedDate not supplied

Improving the ethylene oxide sterilization process.

Although ethylene oxide (EtO) sterilization is commonly used in the manufacture of sterile medical devices, concern about residues of the sterilant in the sterilized products has led to an increase in the use of alternative methods; however, these methods, in turn, have significant drawbacks. The authors have tackled the issue by looking into the possibility of reducing EtO residuals. After conducting a series of investigative experiments, it has been proved that EtO residuals may be reduced by decreasing the amount of EtO used in the sterilization process. This can be achieved without lowering the safe sterility level and there are additional benefits for safety, cost, and the environment.

Ethylene Oxide↗
PubMed1999

Choosing a low-temperature sterilization technology.

Low-temperature sterilization technologies are used instead of steam for sterilizing heat-sensitive or moisture-intolerant surgical equipment and supplies. In this Guidance Article, we describe several common alternatives, but we focus specifically on the two that have generated the most interest in recent years: ethylene oxide (EtO) and gas plasma sterilization. Ethylene oxide has been used as a low-temperature sterilization technology since the 1950s. Although EtO can be used safely, exposure to this gas is known to be a health hazard, and the emissions from certain EtO sterilizers are known to pollute the atmosphere. For these reasons, the use of EtO is regulated--more strictly in some regions than in others--and many healthcare facilities have decided to investigate alternative technologies. Gas plasma sterilization emerged in the 1990s as one promising alternative. This method appears to pose fewer health and environmental risks, and it offers faster turnaround times. However, this technology also has some limitations. We describe the advantages and disadvantages of both methods, along with the factors to consider when selecting from among these alternatives, in this Guidance Article.

Chemical Phenomena↗
PubMed1999

Problems associated with sterilization using ethylene oxide. Residues in treated materials.

The paper deals with problems associated with reduction of undesirable effects of ethylene oxide in polymers in medical devices on the patient's health. The authors explain the need of careful elaboration and validation of the sterilization and aeration process incl assessment of ethylene oxide (EO) residues. The authors investigated the effect of the type of material and conditions of sterilization and aeration on the assessed EO concentration. For research of the behaviour of different polymers in the sterilization process model sterilizations of actual items of medical devices with a known composition proved more suitable than assessment in medical devices from medical institutions. The main conclusions of the investigation were a classification of polymers into those suitable and unsuitable for sterilization or resterilization, and attention was also drawn to poor reproducibility of results in old sterilizers, in particular those lacking effective aeration in aerators.

Acrylates↗
PubMedDate not supplied

Use of Dacron as an alternative carrier for evaluating oxidizing sterilants in the AOAC sporicidal test.

The AOAC sporicidal method (966.04) recommends the use of porcelain penicylinders and black waxed silk sutures as carriers for demonstrating the sporicidal activity of sterilants. However, the silk carriers are not suitable for evaluating the sporicidal efficacy of oxidizing agents, and an inert polyester material (Dacron) is recommended as an alternative. Dacron provides an equivalent microbial and physical challenge to silk. Microbiologically, both materials demonstrated similar HCI resistance, which is required by the AOAC test, as well as equivalent spore loading and spore wash-off. Electron microscopy showed that both materials present the same braided microstructure, providing an equivalent physical challenge to the test sterilant. Dacron was more consistent than silk, and did not require extraction prior to spore loading. The extraction method for black waxed silk was variable and incomplete, which may compromise the activity of oxidizing sterilants and add to method variability. Silk was also structurally altered in the presence of oxidizing sterilants and increased sterilant degradation. Dacron did not affect the sterilant and was inert in the presence of oxidizing agents. Dacron sutures are proposed as inert alternatives to silk for evaluating the sporicidal efficacy of oxidizing agents.

Hydrochloric Acid↗
PubMedDate not supplied

[Progress in food technology: sterilization processes (author's transl)].

The results of the investigations on the behaviour of micro-organisms begun in about 1920 and deepened in more recent years, together with a better knowledge of the mechanism of heat, penetration, have been the basis for the conception and the realization of a large number of sterilization processes, sterilizers and containers allowing a quicker heat exchange to be obtained and higher sterilization temperatures to be used, with the manufacture of preserved food of better quality as a result. Aseptic filling processes, continuous sterilizers with the a can kept rotating or agitated by different means, heat exchangers with mixing of heating medium and food, scraped-surface heat exchangers and containers made of aluminium plastics laminates are being used more and more extensively. The improvement of heat sterilization processes has enabled the use of chemical preservatives to be reduced and to be limited to those surely fase for the health of the consumer. Sterilization by ionizing radiation, which seemed to be so promising at birth, has marked time in these last years and because of the doubts raised as to the harmlessness of radiation-treated foods and other drawbacks it has a present no prospects of application on a commercial scale.

Food Irradiation↗
PubMed2002

Assessment of performance of UV sterilizer for room air bacteria.

Paper presents a technique for performance of UV sterilizer for room air bacteria. Patterns of decay of room air bacteria concentration during sterilization and build-up there after as a function of time is studied. Decay process seems to follow exponential pattern. Half-lives during decay are estimated. For single sterilizer unit with a dose of 16 W the decay half-life is around 8.6 min. For the dose of 32 W (2 sterilizers), half-life is estimated to be 6.18 min. The removal rates of room air bacteria due to sterilizer are compared with the natural decay of aerosols at steady state. The importance of decay half-life in the assessment has been stated. The bacteria concentration buildup process after putting off the sterilizers seems to be sigmoidal in nature. The buildup half-life is estimated to be around 53 min for present experimental conditions.

Air Microbiology↗
PubMed1992

[Patient information prior to sterilization].

The law in Denmark prescribes that the patient and the general practitioner to whom the patient directs his or her request for sterilization are obliged to confirm by their signatures that the patient has received information about sterilization, its risk and consequences. We asked 97 men and 96 women, if they had received this information prior to their sterilization. They were also asked about their knowledge about sterilization. 54% of the women and 35% of the men indicated that they had not received information. Only few of these wished further information by the hospital doctor. Knowledge about sterilization was good. It is concluded that the information to the patient prior to sterilization is far from optimal. The patients' signature confirming verbal information is not a sufficient safeguard. We recommend, among other things, that the patient should receive written information and that both the general practitioner and the hospital responsible for the operation should ensure that optimal information is received by the patient.

Denmark↗
PubMedDate not supplied

Temperature profiles and sterilization within a dead-ended tube.

Use of steam-in-place (SIP) sterilization has increased as the complexity of biotechnology processing equipment has increased. Extensive biological testing is required prior to use of this equipment as no quantitative guidelines exist for the design of SIP sterilizable equipment. Dead-ended geometries present the most difficult challenge to SIP sterilization, but data are not available as to the effects of tube orientation, length and diameter on time required for sterilization. This study examines the effects on sterilization of location within a dead-ended tube and orientation of the tube with respect to the gravitational vector. Temperature profiles and biological kill of Bacillus stearothermophilus were determined for four tube orientations. Kill kinetics were characterized by time to start of kill and cycle log reduction (CLR) times. Both values increased with increasing distance up the tube and orientation of the tube in a more horizontal position. CLR values were as much as ten times greater than those resulting from saturated steam. Projected sterilization times were determined and found to be very dependent on tube orientation. Recommendations are given for sterilization and validation testing of dead-ended geometries.

Equipment Design↗
PubMedDate not supplied

Determination of conditions for the production scale sterilization of prefilled syringes.

External and internal differences in pressure of prefilled syringes can cause plunger movement during sterilization, which might cause drug product contamination. Consequently the pressure inside the autoclave during sterilization should be controlled carefully to prevent contamination of the drug product by microorganism and particulates. A previously determined theoretical relationship of temperature to pressure in sealed bottles was modified for prefilled syringes to take plunger movement into account. This modification yielded a correction factor that includes a coefficient of linear thermal expansion for the syringe, thermal expansion of the plunger, and friction between the plunger and the syringe wall. To confirm the accuracy of this modified relationship, 100 mL polypropylene prefilled syringes with butyl rubber plungers, some of which carried pressure and temperature sensors, were used to test various sterilization conditions at the experimental scale. The results showed that the major problem in establishing the pressure conditions for production scale sterilization is temperature distribution throughout the load. However, an over pressure sterilization cycle at 121 degrees C and 0.34 MPa showed the best results. Microbial challenge and light-obscuration particle count tests were performed on the syringes from the worst-case location predicted from modified relationship; the results show that these conditions preserved the sterility of the drug product and protected it from particulate contamination.

Disposable Equipment↗
PubMed1979

[Tubal sterilization with the tupla-clip per laparoscopiam (author's transl)].

This study refers about a newly developed plastic clip which has been used with good results for the past three years in tubal sterilization. By applying this method, heat or thermal injuries are avoided and a greater possibility of refertilization is indicated. This clinical evaluation consists of experimental data of 243 women who underwent sterilization in the local OB/GYN clinics at Fulda and at Bremerhaven. 59 women were sterilized during puerperium, and 184 were sterilized irrespective of pregnancy. As complications, 2 pregnancies were observed, further 3 hematomae within the broad ligament; 11 clips dropped into the free adbominal cavity while 5 clips broke during application. After the initial difficulties, the authors of this study recommend a sterilization with this tubal clip as an alternative to the usual methods of sterilization.

Adult↗
PubMed1979

Silicone band technique for laparoscopic tubal sterilization in the gravid and nongravid patient.

Laparoscopic tubal sterilization by the Falope ring technique was performed on 196 patients. Sixty-four patients underwent laparoscopic tubal sterilization at the time of gestation termination. One hundred thirty-two patients underwent interval laparoscopic sterilization. The complication and failure rates in the group that had both laparoscopic tubal sterilization and gestation termination was lower than in the group that had laparoscopic tubal sterilization alone. The Falope ring sterilization technique is a safe method when combined with gestation termination, and spares the patient the inconvenience and increased hazard of 2 separate procedures.

Abortion, Induced↗
PubMed2004

Sex and the sacred: sterilization and bodily integrity in English and Canadian law.

Through an examination of cases of non-consensual sterilization for learning disabled persons in Canada and England, this article considers the role that law plays in framing the thoughts, beliefs, and norms that fashion the ways we think about bodies, sex, gender, and sexuality. The author asks how it is that Canadian and English law, while both claiming to protect bodily integrity, have reached opposing conclusions about whether non-therapeutic sterilization can be in a person's best interests. She hypothesizes that the answer could lie in the manner in which courts have constructed the bodies of learning disabled men and women in the sphere of sexuality and reproduction. Where the overriding concern in the sterilization cases is the containment of the sexuality of a learning disabled person perceived as "out of control" or "vulnerable to seduction", sterilization is cast as a just and humane solution that will advance the welfare of the individual concerned. Conversely, where the overriding concern is the preservation of the integrity of a law committed to the principle of equality, sterilization is thought to be a violation of the bodily integrity of the person. The author shows that these two views engender very different legal and cultural discourses about best interests and bodily integrity. The debate highlighted by the sterilization cases and the commentary surrounding them reflect larger tension within legal discourse between the commitment to liberal values and the maintenance of a particular social order.

Canada↗