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Endoscopy water source: tap or sterile water?

The purpose of this study was to determine whether the endoscopic water source holds potential for transmission of pathogens. Phase I of the study used tap water and clean water bottles; Phase II used sterile water and steam-sterilized water bottles. In both phases, a control bottle filled with water from the appropriate source was set up. Cultures were taken from both the controls and endoscopy water sources before the day's procedures were started and at the end of the day. Each phase contained 100 to 106 sets of samples. Many of the tap water samples were positive for normal flora found in city water sources. No clinically significant complications were identified during either phase of the study. The use of tap water and clean water bottles was found to carry no greater risk than using sterile water and sterile bottles. The practice of using tap water will result in significant cost savings. Further study will be needed to look at the integrity of the endoscope and water bottle design in preventing transmission of pathogens.

Bacterial Infections↗

Ethylene oxide gas sterilization does not reduce the osteoinductive potential of demineralized bone in rats.

It has been shown that different sterilization procedures of demineralized bone may influence its osteoinductive properties. The aim of this study was to evaluate the effect of ethylene oxide sterilization for 1, 3, and 6 hours on the osteoinductive potential of allogeneic demineralized bone implanted heterotopically in rats. Sixty male Wistar rats were randomly assigned to one of four groups, A through D, and four demineralized bone chips (2.8 mg) were implanted in a pouch created between the right oblique abdominal muscles in each animal. In Group A, the demineralized bone was implanted without prior sterilization of the material, whereas the demineralized bone implanted in Groups B, C, and D had been sterilized in ethylene oxide gas for 1, 3, or 6 hours, respectively, and aerated for 48 hours. At 4 weeks postoperatively, bone formation was evaluated quantitatively by strontium 85 uptake and qualitatively by light microscopy of histological sections. One-way analyses of variance at the 0.05 level revealed no significant difference in strontium 85 uptake of the different groups, and no qualitative differences in osteoinduction could be detected by light microscopy. Ossicles consisting of bone and bone marrow were seen in the recovered implants of all groups.

Analysis of Variance↗

Sterilization of bacteria by means of microwave heating.

Despite the simplicity and convenience of microwave heating, descriptions in the current literature of attempts to provide a thorough sterilization process have not been encouraging nor has any manufacturer of sterilization equipment introduced such a device to the market. Trials conducted at Providence Hospital using a commercial microwave oven operating at 2450 MHz resulted in a satisfactory sterilization process, that is, the destruction of heat-resisting spore forms (B. stearothermophilus), provided that the materials undergoing sterilization were placed in sealed containers with sufficient water present to provide steam during the heating process. Suggestions are made for further investigation involving the microwave spectrum of the molecule of dipicolinic acid as well as the possibilities of practical applications which could result in reducing hospital costs.

Bacteria↗

Torsional properties of stainless-steel and nickel-titanium files after multiple autoclave sterilizations.

This study tested the hypothesis that multiple sterilizations of endodontic stainless-steel and nickel-titanium files will lead to a continuous decrease in the resistance of files to separation by torsion. One hundred stainless-steel and 100 nickel-titanium #30 K-type files were divided into 20 groups of 10 and sterilized in increments of 10 cycles, using a full cycle and a fast cycle autoclave. These files were tested by twisting each of them in a clockwise direction until fracture (torque g-cm). Samples of the fractured files were embedded in an epoxy resin and polished for Knoop hardness tests. In addition, the samples were chemically etched to reveal changes in microstructure. The findings of this study indicate that neither the number of sterilization cycles nor the type of autoclave sterilization used affects the torsional properties, hardness, and microstructure of stainless-steel and nickel-titanium files.

Acid Etching, Dental↗

The crystallization of sodium hypochlorite on gutta-percha cones after the rapid-sterilization technique: an SEM study.

The purpose of this study was to identify the presence, crystallization, and subsequent removal of sodium hypochlorite crystals on gutta-percha cones after rapid sterilization. Seventy-two, fresh, standardized, gutta-percha cones were randomly selected. Each cone was observed under the scanning electron microscope and the elemental analysis machine before and after rapid sterilization using 5.25% and 2.5% sodium hypochlorite. Gutta-percha cones were rinsed after sterilization with 96% ethyl alcohol, 70% isopropyl alcohol, and distilled water independently to determine which of these agents removed the sodium-chloride crystals. There were no crystals present on the gutta-percha cones directly from the box. All gutta-percha cones had sodium-chloride crystals present after the rapid-sterilization technique using 5.25% and 2.5% sodium hypochlorite. However, the sodium-chloride crystals were removed by 96% ethyl alcohol, 70% isopropyl alcohol, and distilled water.

Alcohols↗

Sterility in unsterilized surgical adhesive tape.

Providing a barrier to infectious organisms, sterile surgical adhesive tape has been used to close wounds for almost 20 years. The possibility that prepackaged unsterilized tape could be used for similar purposes is suggested by this study. Samples (480) were taken from 120 rolls that had been left in plastic surgical suite cabinets for 2 weeks. Aerobes and anaerobes were evaluated using tryptic soy agar with 5% sheep blood, while yeast and fungi were checked with Sabouraud dextrose agar. Sterility of sticky and smooth inner surfaces is shown to be a significant finding (p less than 0.01). It is concluded that prepackaged unsterilized surgical adhesive tape can be used to approximate wound edges without being a source of contamination (the sterile tape is 5600 percent more expensive). Wound closure in this manner would benefit the patient in the field, in the emergency room, or in third world countries where the supply of sterile tape is limited.

Bandages↗

Spring clip sterilization: long-term follow-up.

Between 1978 and 1984, 186 women had interval laparoscopic and postpartum Hulka clip sterilization at the University of Missouri Health Sciences Center. We reached 109 (58%) of these women for follow-up. All had had their sterilization procedures at least one year earlier, and the average duration of follow-up was 3 1/2 years. The procedure failed in four patients, for a failure rate of 3.7%; three of these failures occurred more than 12 months after sterilization. These data suggest that long-term (more than 12 months) follow-up studies may be necessary to document more accurately the failure rate of Hulka clip sterilization.

Adolescent↗

Physical effects of reuse and repeated ethylene oxide sterilization on transscleral cyclophotocoagulation laser G-probes.

PURPOSE: The authors documented the physical effects of reuse and repeated ethylene oxide sterilization on transscleral cyclophotocoagulation laser G-probes. METHODS: Transscleral cyclophotocoagulation was performed using G-probes on fresh porcine eyes. Each of two G-probes was used for four transscleral cyclophotocoagulation procedures, with three cycles of ethylene oxide sterilization in between. The power output from the G-probes was measured by a laser output meter before and after each transscleral cyclophotocoagulation procedure. The G-probes were also examined under a slit lamp for signs of physical damage. RESULTS: Repeated use of the G-probe in transscleral cyclophotocoagulation, with ethylene oxide sterilization in between, resulted in an average decrease of 3% in laser energy delivered per repeated cycle of use up to the fourth cycle. No signs of physical damage were found. CONCLUSIONS: Laser G-probes remain functional after repeated use and ethylene oxide resterilization for up to four cycles. No visible physical damage to the probes was identified. It is safe and cost-effective to reuse G-probe for transscleral cyclophotocoagulation with ethylene oxide sterilization, provided the surgeon stays alert for signs of probe damage. This alertness should be retained regardless of whether new or old G-probes are used.

Animals↗

The pros and cons of polyethylene sterilization with gamma irradiation.

This retrospective study evaluated the implant, patient and surgical factors associated with polyethylene wear for one type of porous-coated hemispheric total hip arthroplasty cup. Radiographic wear measurements among 567 Duraloc cups (512 patients) revealed that liners sterilized by gamma-irradiation wore 0.085 mm/year less than those that were sterilized by gas-plasma, a noncross-linking chemical surface treatment. The substantially decreased wear rate associated with gamma-irradiation was attributed to sterilization-induced polyethylene cross-linking. Shelf-aging adversely affected liners that were gamma irradiated in air. On average, highly crystalline Hylamer liners showed a 0.064 mm/year increase in wear rates for each year of shelf storage after terminal sterilization with gamma-irradiation in air. Among conventional Enduron liners, the effect of shelf aging after gamma-irradiation in air was more modest, increasing wear rates by 0.014 mm/year for each year of shelf storage. Because Hylamer's wear performance degraded at about five times the rate of Enduron's, the improved wear resistance associated with gamma-irradiation in air would be lost after 1.3 years of shelf aging for Hylamer compared with 6.1 years for Enduron. For every additional year of age at the time of surgery, the wear rate decreased by 0.003 mm/year. Increased body mass index, a preoperative diagnosis of inflammatory arthritis, and a ceramic femoral head also were associated with decreased wear rates.

Aged↗

Effect of high-power microwave on indicator bacteria for sterilization.

According to the superiority sterilization, a specially-designed microwave disinfector using high-power microwave energy was made. A series of sterilizing experiments have been made to determine the effect of microwave energy on several typical indicator bacteria such as Bacillus subtilis var. niger, Bacillus stearothermophilus, Bacillus pumilus E601, Staphylococcus aureus, Bacillus cereus. Under the conditions of different sterilization duration and unequal intensity of microwave power irradiation onto the bacteria, a useful result of killing bacteria has been observed, i.e., the Bacillus subtilis can be considered as an optimum indicator bacterium for microwave sterilization.

Bacillus↗

Effects of FLONLIZER, ultraviolet sterilizer, on Legionella species inhabiting cooling tower water.

Legionella pneumophila in sterile distilled water was not detected after ultraviolet irradiation by FLONLIZER, a new-type sterilizer, at a flow rate of 82.5 to 364.8 liters/hr. When irradiated by FLONLIZER at a flow rate of under 324.0 liters/hr, no viable cells of legionellae, other heterotrophic bacteria and bacterivorous protozoa were detected in the cooling tower water, which was found to contain L. pneumophila. No viable cells of L. pneumophila and L. bozemanii suspended in sterile distilled water were detected after the irradiation with UV-doses of over 6.16 X 10(3) micro W.sec/cm2. At the irradiation of low UV-doses under 1.06 X 10(4) micro W.sec/cm2, the viable count of legionellae recuperated by photoreactivation from UV-damage increased with the exposure time under a white fluorescent lamp. However, in the samples irradiated with UV-doses of over 3.52 X 10(4) micro W.sec/cm2, equal to the FLONLIZER, legionellae did not recuperate even after 18 hr illumination with a white fluorescent lamp. FLONLIZER is thus expected to act as a sterilizer which can control the legionellae inhabiting cooling tower systems placed in outdoor space.

Legionella↗

The stability of adrenaline ophthalmic solutions on sterilization and storage.

The stability of adrenaline ophthalmic solutions, at pH 5.8 and 7.4, to sterilization and storage conditions has been studied. Solutions sterilized by filtration or heating at 98 degrees C for 30 min showed no detectable degradation at either pH value, whilst sterilization at higher temperatures resulted in losses of up to 30%. Total degradation increased with increasing sterilization temperature at both pH values.

Drug Stability↗

Thioethers in urine of sterilization personnel exposed to ethylene oxide.

Biological monitoring of exposure to ethylene oxide (EO) was carried out in 31 hospital workers in the sterilization facilities of five hospitals. The excretion of total thioethers was determined in the urine of sterilization workers. An occupational nonexposed group served as a control (n = 31). The air EO level was not monitored routinely, however, peak concentrations of EO up to 200 p.p.m. were detected mainly when the sterilization chambers were open. Our results show a significant difference in urinary thioether excretion between the exposed and control groups (P less than 0.001). Sterilization workers seem to absorb significant quantities of EO. We feel that other alternative and more sensitive methods for detecting thioether metabolites of EO should be carried out to confirm our results.

Adult↗

A total of 250,136 laparoscopic sterilizations by a single operator.

A total of 250,136 women were sterilized as outpatients by a single operator working with a team in ad hoc sterilization 'camps'. Falope rings were applied by the laparocator under local anaesthesia, with premedication but without vaginal manipulation (in all but the first 10,100). Volunteers were recruited and the operation discussed in nearby villages. The women were numbered at registration and arranged in groups, each comprised of two rows (odd or even numbers) of 15 women, leading to two improvised operating tables or benches in a steep Trendelenburg position. With good teamwork the number of women sterilized was generally 40 to 50/h. There were 12 associated deaths, not all attributable to the procedure, a mortality rate of 4.8 per 100,000; 8 major complications (3.2 per 100,000) required laparotomy or admission to hospital. In a follow-up survey of 84,940 responders to a questionnaire only 90 pregnancies (0.1%) were reported to have been conceived after the cycle of surgery. The results suggest that the rapid 'no exposure' technique as used in this series is safe and acceptable in an Indian context. If others could acquire this skill it could with appropriate adaptation make appreciable inroads into the unmet need for female sterilization in many other developing countries.

Adult↗

Subcutaneous sterile water injection for labour pain: a randomised controlled trial.

BACKGROUND: About 30% of women experience severe continuous low-back pain in labour, but limited options are available to reduce this pain especially in developing countries and remote areas. AIMS: To evaluate the efficacy of subcutaneous sterile water injection in reduction of labour pain compared with placebo. METHODS: One hundred (100) consecutive patients were enrolled in a double-blind randomised controlled trial. During the first stage of labour with planned normal vaginal delivery, the intervention group (n = 50) received 0.5 mL sterile water injected subcutaneously and the control group (n = 50) received normal saline as a placebo. Pain score was measured before and 10 and 45 min after the injection, using the faces rating scale. MAIN OUTCOME MEASURE: Low-back labour pain. RESULTS: The two groups were not significantly different regarding maternal age and weight, gestational age, parity and gravidity and degree of effacement. The median pain score was equal in both groups prior to the injection. Pain severity was reduced in both groups after the injection. However, the median pain score in the sterile water group was significantly lower than the placebo group 10 min (P < 0.01), as well as 45 min, after the injection (P < 0.01). CONCLUSION: Administering one subcutaneous injection of sterile water in a painful point of the lumbosacral area is effective in reducing low-back pain during labour.

Adult↗

Sterile versus nonsterile gloves during Mohs micrographic surgery: infection rate is not affected.

BACKGROUND: Mohs micrographic surgery (MMS) is an outpatient procedure that has become the treatment of choice for certain cutaneous malignancies. Although the major steps in this procedure are relatively standardized, one difference involves the use of sterile or nonsterile, clean gloves during the tumor removal phase. OBJECTIVE: This retrospective chart review study was performed to evaluate whether infection rates are affected by the use of sterile versus nonsterile gloves in the tumor extirpation phase of MMS. METHODS: This study evaluated the surgical records of 1,810 consecutive Mohs patients, of which 1,239 Mohs patients (1,400 Mohs procedures) met inclusion criteria. Age, sex, tumor diagnosis, anatomic location, number of Mohs stages, area of the defect, closure type, cartilage exposure, and sterile versus nonsterile glove use were recorded and evaluated. RESULTS: Twenty-five infections were identified. Statistically significant infection rates were discovered for patients with cartilage fenestration with secondary healing and malignant melanoma diagnosis only. There was no statistical difference in infection rates with all other measured variables to include the use of sterile or clean, nonsterile gloves. CONCLUSION: Our study lends support to the contention that clean, nonsterile gloves are safe and effective for use in the tumor extirpation phase of MMS, at a significant cost savings.

Adult↗

Sterility testing of cell therapy products: parallel comparison of automated methods with a CFR-compliant method.

BACKGROUND: Automated blood culture systems are not FDA-approved for sterility testing of human cells, tissues, or cellular- or tissue-based products. It was previously demonstrated that BacT/ALERT (bioMérieux) and Bactec (Becton Dickinson) were superior to the manual CFR method described in the general biologics regulations, in rates of detection and time to detection of organisms seeded into mock mononuclear cell products with a variety of background media and antibiotics. In this study, the two automated systems were compared to the CFR method for sterility testing of actual cell therapy products manufactured in our facility. STUDY DESIGN AND METHODS: Over a 36-month period, in-process and final product samples from all cell therapy products manufactured in our facility were tested for sterility both by the CFR method and by either BacT/ALERT or Bactec. Products were categorized according to collection and processing variables for analysis of results. RESULTS: For 1617 samples of a broad range of cell therapy products, rates of true-positive tests were comparable for the automated and CFR methods (2.3% vs. 2.1%), but the CFR method had higher rates of false-positive results (7.3% vs. 0.2%). For automated systems, time to detection of organisms was equivalent to, or faster than, the CFR method. CONCLUSION: Compared to the CFR method, both BacT/ALERT and Bactec are more sensitive, faster in time to detection, less prone to false-positive results, and less labor-intensive. Both of these automated systems are suitable for sterility testing of cell therapy products after site-specific validation has been performed.

Automation↗

Influence of the sterilization process on alginate dispersions.

The influence of different sterilization procedures on alginate dispersions was studied by measuring viscosity and molecular weight changes. Autoclaving caused a 64% decrease in viscosity. Heating at a low temperature over several cycles was less efficient in sterilizing alginates and there was a progressive breakdown of the alginate chain over the succeeding cycles. Heating during ethylene oxide sterilization also resulted in reduced viscosity and breakdown. Membrane filtration yielded a sterile product with no significant reduction in viscosity or mol. wt.

Alginates↗