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PubMed1999

Drastic performance improvement of hand-operated sterilizers.

In a great number of low-income countries, hand-operated sterilizers are commonly used for the sterilization of medical supplies, including porous loads and hollow instruments. Due to the socio-economic situation in these countries the introduction of fully automatic sterilizers is not (yet) feasible. During a course on sterilization technology for hospital technicians at the Polytechnic in Mombasa, Kenya, some performance tests have been done with locally used sterilizers with standard test loads and loads as are common in the hospitals that were visited. The results for porous loads were alarming due to poor air-removal. Immediately, a number of modifications in the processes were made and tested, based on a method of steam pulsing. This resulted in a significant improvement of performance and can be introduced at a very low cost.

Developing Countries↗
PubMedDate not supplied

The use of sterile and low microbial diets in ultraisolation environments.

The evidence for the use of sterile and low microbial diets in ultraisolation environments is reviewed. Studies have suggested that sterile food is not required for gut sterilization when oral nonabsorbable antibiotics are used, but if a low microbial food contains an antibiotic-resistant organism, colonization can occur. There may be a beneficial effect on the incidence of infection by serving pathogen-free foods, either sterile or low microbial, to the immunosuppressed patient regardless of type of environment, yet the comparative effectiveness of sterile and low microbial diets in preventing introduction of new pathogens accessing the host via the mouth, oropharynx, and esophagus has not been systematically evaluated.

Anemia, Aplastic↗
PubMed2005

Effects of sterilization on implant mechanical property and biocompatibility.

This article concisely reviews the effects of sterilization on the mechanical properties and surface chemistries of implantable biomaterials. This article also summarizes the biological effects of the sterilization-related changes in the implant. Because there are so many different types of implant materials currently in use (including metals, polymers, and diverse biological materials), the response of tissue to these different materials varies dramatically. This review further discusses the effects of sterilization on in vivo and in vitro tissue response specifically to implantable metals and polyethylene, with the possibility of future biocompatibility testing of the implants sterilized with supercritical phase carbon dioxide sterilization.

Biocompatible Materials↗
PubMed1996

Sterility of filgrastim (G-CSF) in syringes.

OBJECTIVE: To determine if the sterility of filgrastim (G-CSF) is maintained for up to 7 days when aseptically transferred from the vial to tuberculin syringes in a laminar air flow environment. DESIGN: The study was conducted in two phases: a validation and an experimental phase. The method was validated by inoculating samples of sterile filgrastim solution with common bacterial and fungal skin contaminants. Samples were aseptically drawn into syringes in a class 100 horizontal laminar air flow hood and refrigerated. The samples were equally divided and transferred to microbiology culture media at times 0, 24 hours, 48 hours, and 7 days; incubated; and the organisms identified and quantitated. In the experimental phase, samples of filgrastim were aseptically drawn into syringes, separated into three groups, and refrigerated. At 24 hours, 48 hours, and 7 days, the samples were transferred to broth, incubated, and observed for the development of turbidity. SETTING: A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room. MAIN OUTCOME MEASURES: The sterility of filgrastim in syringes was determined by comparing experimental broth culture tubes to a control tube and observing for the development of turbidity. RESULTS: Filgrastim demonstrated the ability to support the growth of intentionally inoculated skin contaminants, both qualitatively and quantitatively. However, when aseptically transferred to syringes and refrigerated, all tested filgrastim samples remained sterile for at least 7 days. CONCLUSIONS: Syringes of filgrastim remain sterile for 7 days when prepared in a class 100 laminar air flow hood, using aseptic technique, and stored under refrigeration. This change in practice can result in significant cost savings.

Drug Contamination↗
PubMed1984

The social and gynaecological background of 218 sterilized women.

This is the first part of a longitudinal follow-up study of 218 consecutively sterilized women. The operations were performed at the Gynaecological Department of Akershus Central Hospital during the period May 22nd 1973 to February 1, 1974. The mean age of the women was 33.5 years, their mean parity 2.8. They could not be distinguished from the women of the same age in the county at large with regard to incomes, education or housing conditions. The usage of contraception was widespread, but not consistent. Fifty-eight per cent of the operations were performed postabortion, 69% of the women had at least one, 21% at least two induced abortions before the sterilization. Family planning was the predominant stated motive for sterilization, and the present study indicates that the sterilization legislation of 1934 was outdated some years before it was succeeded by a new law. Sterilization was suggested by the doctor in 40%, at abortion application in 30%.

Abortion, Induced↗
PubMed1993

Success rates of osseointegration for implants placed under sterile versus clean conditions.

A retrospective analysis was done comparing the success rate of osseointegration at stage 2 of implants placed under "sterile" versus "clean" conditions. "Sterile" surgery took place in an operating room setting with strict sterile protocol. "Clean" surgery took place in a clinic setting with the critical factor that nothing touched the surface of the implant until it contacted the prepared bone site. A total of 273 implants in 61 cases were placed under sterile conditions with a fixture success rate of 98.9% and a case success rate of 95.1%; 113 implants were placed under clean conditions in 31 cases with a fixture and case success rate of 98.2% and 93.5%, respectively as judged clinically at stage 2. The difference in the success rates was not statistically significant. The results of this analysis indicate that implant surgery can be performed under both "sterile" and "clean" conditions to achieve the same high rate of clinical osseointegration.

Chi-Square Distribution↗
PubMed1982

Demographic trends in tubal sterilization: United States, 1970-1978.

In the period 1970-1977, an estimated 4,236,000 women 15-44 years of age had tubal sterilization operations in United States hospitals. Both the number and the rate of tubal sterilizations increased each year from 1970-1977, but in 1978 both declined. Tubal sterilization rates for Black women were higher than for White women. Black women also tended to be younger at the time of tubal sterilization. For the nation as a whole, the mean age at the time of tubal sterilization remained constant at about 30 with the youngest age group having the highest proportion of never-married women.

Adolescent↗
PubMed1984

Tubal sterilization in women 15-24 years of age: demographic trends in the United States, 1970-1980.

Between 1970-1980, approximately 942,000 women 15-24 years of age underwent tubal sterilization in the United States. These women represented about 17 per cent of all women ages 15-44 years who underwent tubal sterilization in the United States during this 11-year period. During 1970-1980, sterilization rates rose steadily from three per 1,000 to 11 per 1,000 for women in the 20- to 24-year age group, but remained stable at less than one per 1,000 for women in the 15- to 19-year age group. For each year, rates for Black women were greater than those for White women. Sterilization rates increased over the time period for both currently and previously married women, but remained low for never-married women. Most tubal sterilizations were performed after delivery of an infant.

Adolescent↗
PubMed1983

Laparoscopic sterilization with the Falope-ring. Peroperative and late complications, method safety and a randomized investigation of immediate postoperative abdominal pain.

Following 189 laparoscopic sterilizations with the Falope-ring, 33 cases of peroperative complications were registered. Laparotomy was required in one case. Sterilization undertaken in connection with termination of pregnancy was not associated with more peroperative complications than sterilization performed during an interval phase. In a randomized trial comprising 100 women it was not possible to demonstrate that application of lidocaine to the tube reduced the incidence of immediate postoperative abdominal pain which occurred in 18% of the women in the control group. A follow-up investigation of 91 women revealed change in bleeding pattern in 32% and low abdominal pain de novo in 40%. The frequencies of changes in bleeding pattern and of low abdominal pain were greater in women who had previously employed oral contraception than in women who had not done so. A questionnaire investigation comprising 169 women revealed that 38% had developed one or more of the following symptoms: hot flushes, tendency to depression and irritability, and tachycardia. Alterations in libido were found in 26%. 2% regretted the sterilization. One pregnancy occurred in 172 sterilized women after an average observation period of 13 months.

Abdomen↗
PubMed1984

The social and gynecological long-term consequences of tubal sterilization. A personal six-year follow-up investigation.

The long-term consequences and complications of tubal sterilization were studied. Six years after surgery, information was obtained from 208 of 216 women. Five had been pregnant. Eight had been bothered by their scars for 2 years or more. The majority reported improved conjugal relations and a positive impact on marriage. Eighty-five percent had told others about the sterilization; the frankness was more common in the younger age groups. Although most women were satisfied, 6% would have preferred the sterilization undone. In 10% of the couples, at least one of the partners held that view. The most common cause for regret was the desire for more children, in most cases with a new spouse. Regret was not correlated to the woman's age, parity or social group. Regret was recorded with significant predominance when the sterilization had been suggested by a doctor at abortion application. In a controlled comparison between Pomeroy laparotomy and laparoscopic electrocoagulation, no differences in postoperative bleeding patterns were found. The present study indicates that tubal sterilization is not a major cause of subsequent menstrual irregularities.

Abortion, Induced↗
PubMedDate not supplied

A gas monitoring system for ethylene oxide sterilizers with constant sample flow through a microwave cavity spectrometer.

This paper reports a measurement system for monitoring the gas concentrations of ethylene oxide (EO) within sterilizers. It samples gas from the sterilizer chamber at a constant flow into a microwave cavity spectrometer. The pressure in the cavity of the spectrometer is linearly proportional to that in the sterilizer chamber, hence the partial pressure (i.e. gas concentration) of the EO gas is linearly proportional to that in the chamber. Measurement of the gas concentration in the chamber can therefore take place without the need to monitor and interpret the chamber pressure. As a consequence the reliability of the sterilization process may be improved, thus enabling a reduction in the in-chamber concentration of EO during sterilization and, hence, EO residues. The microwave cavity spectrometer operates under conditions of power saturation, and there is a good linear correlation between the output signal and the concentration of EO in the gas cell (to within a standard error of 4%).

Equipment Design↗
PubMed1990

A modified apparatus for dual, sterilized, isolated perfusion of the rat liver.

The isolated perfused rat liver (IPRL) has proven to be a useful model for the study of physiology and pathology of the liver. For research in nonparenchymal cell (NPC) function that includes measurement of cytokine production (eg, TNF), it is necessary to have a sterilized perfusion system. We have modified the IPRL apparatus so as to be able to perform sterile perfusions of two livers simultaneously. The perfusion apparatus is a recirculating closed system in which the oxygenator is a plastic container separated into two chambers by a fenestrated plastic wall. A disposable macropore filter functions as both a bubble trap and perfusate filter. The sterilization process is done by immersing the various components in Benz-All solution. The tubing is disinfected by irrigation with 10% Clorox followed by 0.9% sodium chloride solution. The perfusate used is filter-sterilized Krebs buffer solution containing 0.5 g Mandol/250 mL perfusate. Not only can two organs be conveniently perfused simultaneously, but the entire system can be reliably sterilized for up to 20 consecutive perfusions. Bile production is higher and more stable with less leakage of intracellular enzymes. Many of the components are disposable and can be altered to suit the needs of a particular experiment.

Animals↗
PubMed1988

Effect of sterilization on osteoinduction. Comparison of five methods in demineralized rat bone.

The aim of this study was to find a safe, effective sterilization method that does not destroy the bone-inductive capacity of demineralized bone implants. Five sterilizing agents were tested in rats. Implants procured and processed under sterile conditions served as controls. New bone formation was evaluated by determining dry weight, calcium content, and Sr-85 incorporation of the induced ossicles. Glutaraldehyde solution, formaldehyde gas, and ethylene oxide destroyed almost all the bone-inductive capacity. Irradiation by 2.5 Mrads Co-60 resulted in a loss of about half of the inductive capacity. Merthiolate (0.18 per cent) was the only sterilizing agent that did not reduce the bone-inductive capacity of the demineralized implants. Because merthiolate is not sporicidal, gamma irradiation appears to be the most appropriate sterilizing agent for demineralized bone in clinical use.

Animals↗
PubMed1994

Ethylene oxide sterilization of bone grafts. Residual gas concentration and fibroblast toxicity.

We examined the concentration of ethylene oxide in bone allografts after gas sterilization. Chips of the human femoral head were investigated. Residual gas concentration was determined by gas chromatography after the bone chips had been subjected to defatting and freeze-drying, followed by ethylene oxide gas sterilization. Bones were prepared in various ways in an attempt to reduce the concentration of residual ethylene oxide. The concentration was higher when gas sterilization was performed before freeze-drying than when it was done afterwards. An experiment performed with fibroblasts showed the high toxicity of residual ethylene oxide in bone chips, even when the concentration was very low. The growth of fibroblast was reduced more in medium which had been shaken with bones sterilized with ethylene oxide before freeze-drying than in medium which had been shaken with bones sterilized after freeze-drying. The higher residual ethylene oxide concentrations resulted in a decrease in fibroblastic culture activity. Our experiment showed the importance of reducing the residual ethylene oxide gas concentration. Defatting and freeze-drying result in lower residual ethylene oxide concentrations.

Bone Transplantation↗
PubMed2002

Immobilized bacterial spores for use as bioindicators in the validation of thermal sterilization processes.

Spores of Bacillus subtilis ATCC 6051 and Bacillus stearothermophilus NCTC 10003 were immobilized in monodisperse alginate beads (diameter, 550 microm +/- 5%), and the capacity of the immobilized bioindicators to provide accurate and reliable F-values for sterilization processes was studied. The resistance of the beads to abrasion and heat was strong enough to ensure total retention of the bioindicators in the beads in a sterilization cycle. D- and z-values for free spores were identical to those for immobilized spores, which shows that immobilization does not modify the thermal resistance of the bioindicators. A D(100 degrees C) value of 1.5 min was found for free and immobilized B. subtilis spores heated in demineralized water, skimmed milk, and milk containing 4% fat, suggesting that a lipid concentration as low as 4% does not alter the thermal resistance of B. subtilis spores. Providing that the pH range is kept between 3.4 to 10 and that sufficiently low concentrations of Ca2+ competitors or complexants are present in the medium, immobilized bioindicators may serve as an efficient, accurate, and reliable tool with which to validate the efficiency of any sterilization process. The environmental factors (pH, media composition) affecting the thermoresistance of native contaminants are intrinsically reflected in the F-value, allowing for a sharper adjustment of the sterilization process. Immobilized spores of B. stearothermophilus were successfully used to validate a resonance and interference microwave system that is believed to offer a convenient alternative for the sterilization of temperature-sensitive products and medical wastes.

Bacillus subtilis↗
PubMed1996

Reuse in sterile sites of single-use medical devices: how common is this in Australia?

OBJECTIVE: To determine to what extent Australian hospitals reuse in sterile sites medical devices labelled "single use only"; to assess the adequacy of cleaning and sterilising procedures before reuse; and to estimate the possible incidence of cross-infection and the costs of not reusing these devices. DESIGN: A self-administered questionnaire survey. SETTING: All Australian hospitals (419) with more than 45 beds and undertaking medical and surgical procedures. METHODS: Questionnaires were sent to hospital infection control practitioners in 1994 requesting information about reuse in sterile sites of single-use medical devices, the extent of reuse, the cleaning and sterilising processes involved, and the reasons for reuse. RESULTS: Responses were received from 168 hospitals (40%). Reuse occurred in 64 (38%), and another 33 hospitals had been reusing medical devices 12 months before our survey (i.e., 97/168 hospitals [58%] were either reusing them at the time of our survey or had been doing so 12 months previously). More large (> 300 beds) metropolitan public hospitals (9/14; 64%) reported reusing than did smaller (50/143; 41%) or private hospitals (15/47; 32%). At six of the 64 hospitals where reuse occurred, the process of cleaning and/or sterilization of these devices was not satisfactory; from the information we received, both cleaning and sterilization were satisfactory in only 38 hospitals (59%). Examination of the 14 most commonly reuse devices showed that the structure of 13 of these may compromise cleaning (and therefore sterilization). The main reason given for reuse was cost saving. Assuming a 2% prevalence of transmissible infections in blood, and an infection transmission risk of 1/500, we estimate that each year in Australia there may be 40 cases of cross-infection for every one million procedures performed with reused devices (0.004%). CONCLUSIONS: Reuse of medical devices labelled "single use only" is common in Australian hospitals. Most devices appear to be unsuitable for reuse. Complete cessation of this practice of reusing single-use medical devices would stop potential cross-infection, but this would cost and estimated $2.5 million or more per case prevented

Australia↗
PubMed1999

[Function of the central sterilization office at the Semmelweis Clinic of Conservative Dentistry and Prosthodontics].

In order to prevent cross-infection by blood borne and other pathogens central sterilization department has been constructed in the common building of the Depts. of Conservative Dentistry and Prosthodontics. Instrument sterilization is accomplished in six steps: (1) consolidation and transport of instruments, (2) cleaning, (3) packaging, (4) sterilization, (5) storage, (6) sterilizer monitoring. This process is performed by trained sterilization technicians to ensure that attending faculty, student dentists, clinical staff and patients are protected from cross-infection caused by contaminated dental instruments.

Cross Infection↗
PubMed1997

Extracorporeal circuit sterility after 168 hours.

One of the most important tasks of the perfusionist is the proper assembly of the extracorporeal circuit (ECC) prior to the initiation of cardiopulmonary bypass (CPB). The ECC is usually assembled, primed and debubbled 30 minutes to one hour prior to the patient entering the operating room. But there are occasions when the ECC may have been set up and the previously scheduled procedure cancelled. Perfusionists in this situation have found themselves in a quandary; dispose of the ECC because of required nursing compliance and the sterility question, or keep it and use it later because of the economic impact on the "bottom line". Some hospitals may have satisfactorily answered the question of ECC sterility after 24 hours without observation, but the few reported papers regarding this issue, and our desire to save these circuits, inspired us to find out if they were in fact sterile after having been open for a long period of time. The purpose of this study was to evaluate ECC sterility using an open reservoir oxygenator, over a time period of seven days. After obtaining 792 bacterial cultures from three sites within the ECC, the study was terminated. There were no positive bacterial cultures during the study period. Assuming there is no deliberate contamination, pump circuits assembled in an unused operating room can be maintained sterile for a period of seven days.

Bacteria↗