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PubMed1998

The impact of sterilization method on wear in knee arthroplasty.

Sterilization by gamma irradiation in air has been shown to have the potential to accelerate the oxidation of polyethylene components resulting in reduced mechanical properties. In the hip, it has been reported that the occurrence of delamination and cracking in retrieved bearings is significantly different when comparing components sterilized with gamma irradiation in air with components sterilized with ethylene oxide. Using a collection of 1635 retrieved polyethylene knee bearings, this study pursues a similar comparison of sterilization method with clinical wear in the knee. It confirms that retrieved polyethylene knee components that were gamma irradiated in air have a high incidence of delamination and cracking, leading at times to complete wear through of the bearing. Knee components sterilized with ethylene oxide showed no evidence of fatigue damage even after in vivo durations in excess of 15 years.

Biomechanical Phenomena↗
PubMed1989

The failure of ethylene oxide gas-sterilized freeze-dried bone graft for thoracic and lumbar spinal fusion.

Thirty-seven patients underwent posterior and/or posterolateral spinal fusion using ethylene oxide gas-sterilized freeze-dried bank bone graft. Thirteen patients had discogenic back pain, eight with prior failed laminectomy procedures, and five undergoing initial spinal surgery. Six patients had isthmic spondylolisthesis, three with associated radicular complaints, and two patients had degenerative spondylolisthesis. Seven patients with spinal fractures and nine patients with scoliosis underwent spinal fusion with associated instrumentation. Pseudarthroses were detected in 28 patients (76%), and 18 patients (49%) underwent pseudarthrosis repair procedures using autogenous iliac bone graft. At surgery, the prior gas-sterilized freeze-dried bone graft was noted to have been almost completely resorbed. Ethylene oxide sterilization has been found experimentally in animal models to damage the osteoinductive ability of bone grafts. Ethylene oxide gas-sterilized freeze-dried bank bone graft is inferior to autogenous bone graft or bank bone graft preserved and/or sterilized by other methods. Its use in thoracic or lumbar posterior or posterolateral fusion cannot be recommended.

Adolescent↗
PubMed1998

A sterile syringe for every drug user injection: how many injections take place annually, and how might pharmacists contribute to syringe distribution?

Our objectives were to estimate the annual number of injections by injection drug users (IDUs) in the United States of America, and to describe the potential role of pharmacists in providing IDUs with a sterile syringe for every injection. We estimated the number of annual injections by IDUs for the United States, selected U.S. states, and selected U.S. cities according to the following formula: number of injections per year = (number of IDUs) x (average number of injections per IDU per day) x 365. Data were obtained from published articles, personal communications with local experts, and selected national databases. We also reviewed published and unpublished studies of pharmacy kits, pharmacist attitudes, and pharmacist practices in the United States and abroad. Between 920 million and 1.7 billion injections by IDUs take place each year in the United States. We estimated 12 million injections per year in San Francisco and >80 million in New York City. A similar number of syringes would be needed to satisfy the goal of a sterile syringe for every injection. Pharmacy-based strategies, including the sale of kits for injection drug use, have provided sterile syringes to IDUs in Europe, Australia, and New Zealand. Modification of laws restricting syringe purchase and possession has led to marked increases in purchase of syringes from pharmacies and reductions in needle-sharing. In conclusion, large numbers of syringes would be required to provide a sterile syringe for every injection, but significant numbers of pharmacists seem to be willing to play a central role in syringe sale and distribution. Outreach programs should emphasize that using a sterile syringe for every injection is the optimal HIV prevention practice for IDUs who cannot or will not stop injecting. Pharmacy-based syringe sale or distribution has the potential to augment current efforts to prevent HIV infection in IDUs, their sex partners, and their children.

Australia↗
PubMed1998

Cost and cost-effectiveness of increasing access to sterile syringes and needles as an HIV prevention intervention in the United States.

We determined the cost of increasing access of injection drug users (IDUs) to sterile syringes and needles as an HIV prevention intervention in the United States and the cost per HIV infection averted by such a program. We considered a hypothetical cohort of 1 million active IDUs in the United States. Standard methods were used to estimate the cost and cost-effectiveness of policies to increase access to sterile syringes and syringe disposal at various levels of coverage (e.g., a 100% coverage level would ensure access to a sterile syringe for each injection given current levels of illicit drug injection in the United States; a 50% coverage level would ensure access to one half of the required syringes). A mathematical model of HIV transmission was employed to link programmatic coverage levels with estimates of numbers of HIV infections averted. A policy of funding syringe exchange programs, pharmacy sales, and syringe disposal to cover all illicit drug injections would cost just over $423 million U.S. for 1 year. One third of these costs would be paid for as out-of-pocket expenditures by IDUs purchasing syringes in pharmacies. Compared with the status quo, this policy would cost an estimated $34,278 U.S. per HIV infection averted, a figure well under the estimated lifetime costs of medical care for a person with HIV infection. At very high levels of coverage (>88%), the marginal cost-effectiveness of increased program coverage becomes less favorable. Although the total costs of funding large-scale IDU access to sterile syringes and disposal seem high, the economic benefits are substantial. Even at high levels of coverage, such funding would save society money. As part of a comprehensive program of HIV prevention, policies to increase IDUs access to sterile syringes urgently need further consideration by public health decision makers.

Cost-Benefit Analysis↗
PubMed1984

Normal sister chromatid exchange levels in hospital sterilization employees exposed to ethylene oxide.

This study was undertaken to determine whether a specific group of hospital workers exposed to ethylene oxide (ETO) in sterilizing areas showed evidence of increased levels of sister chromatid exchange (SCE) formation. SCE frequencies were determined for 14 sterilizer workers and 14 matched controls. Time-weighted average (TWA) and peak ambient levels of ETO were measured in the sterilizing areas. Results indicated that all sterilizer workers were exposed to less than 5 parts per million TWA of ETO and that there were no statistically significant differences in SCE levels between sterilizer workers and controls. Smoking habits did appear to be associated with increased SCE levels. In this particular hospital setting no evidence of genetic effects stemming from employees' exposure to low levels of ETO was found.

Adult↗
PubMed1994

Efficacy of sterilization of endodontic files after autoclaving in a synthetic sponge.

A common way of sterilizing endodontic files for clinical use is to insert them into synthetic sponges. The files are sterilized in the sponge, and the sponge is then used on the patient tray for ease of file retrieval. The ability to sterilize the files in a sponge has been questioned. The purpose of the present investigation was to evaluate the sterility of files and spore strips following autoclaving in a sponge. Commercial spore strips and contaminated endodontic files were inserted into sponges, sealed in sterilization pouches and autoclaved. The spore strips and the files were removed from the sponge and cultured for growth of microorganisms. Results show that no microbes were cultured from spore strips or contaminated files after autoclaving them in the sponges sealed in autoclave pouches. These results indicate that the insertion of files into the sponges used in this study does not obstruct the autoclaving process.

Colony Count, Microbial↗
PubMed1993

Peracetic acid and its application to medical instrument sterilization.

Peracetic acid is recognized as a powerful germicidal agent. However, heretofore its corrosive nature has prevented its direct use for medical instrument sterilization. A specially formulated buffered peracetic acid sterilant with anticorrosives has been developed for use in the STERIS PROCESS. The STERIS SYSTEM 1 Processor and the STERIS 20 Sterilant Concentrate have met or exceed the rigorous requirements of the Environmental Protection Agency and Food and Drug Administration for making claims related to sterilization. With this system, medical devices including endoscopes are sterilized and ready for use in less than 30 min.

Animals↗
PubMed1988

Outcome of sterilization by steam autoclaves in Danish dental offices.

The aims of this study were to evaluate the performance of autoclaves and the use of biologic indicators for sterilization control, and to look for predictor variables for improperly functioning autoclaves in Danish dental offices. The study population comprised 314 Danish dental offices (participation rate 94%); 177 from the public Child Dental Service (CDS) and 137 from private practice. A minor questionnaire and five biologic indicators (Attest Biological Indicator for Steam Sterilization, 3M) were sent to the participants. CDS offices were found more inclined to use biologic indicators than PP offices (P less than 0.00001). Among CDS autoclaves 2.3% (95% confidence limit: 0.9-5.7%) failed to sterilize compared to 7.3% (95% confidence limit: 4.0-12.9) of the PP autoclaves. This difference is not statistically significant, but the confidence intervals indicate a possible true difference in favor of a better outcome in the CDS offices. Looking at the whole sample no other predictor variable for inadequate sterilization could be determined as differences were statistically insignificant with regard to years of professional experience, age and brand of autoclave, and use of biological control. Recommendations from an official body stating the approved types of sterilization control in dental offices would be of value.

Denmark↗
PubMed1979

Biological indicators for the control of ethylene oxide sterilization.

A new biological indicator has been developed for the control of ethylene oxide sterilization, particularly for large scale sterilization of disposable medical equipment. The aim has been to provide the new indicator with the same resistance to the combined effect of ethylene oxide and water vapour as the biological indicator referred to by the health authorities in Scandinavia. The reference indicator contains spores of a Danish test strain, Bacillus subtilis, in sand. The new one contains spores of a test strain used extensively for biological indicators, viz. B. subtilis var. niger (B. globigii). The spores in the new preparation are dried in pieces of cotton yarn. The two indicators were exposed to ethylene oxide and water vapour in five different series of experiments and almost the same resistance was found. In simulated routine sterilization procedures, the new indicator was placed at locations not easily accessible for the gas and water vapour, and the results reflected the blockage of diffusion. The experiments included samples of household dust. The resistance of the microorganisms in the dust was compared with that of the biological indicators. Based on these comparisons, it is concluded that the resistance of the two biological indicators to ethylene oxide is in accordance with the official Scandinavian standard for sterilized medical equipment when used in the control of sterilization of products with low microbial contamination.

Bacillus subtilis↗
PubMed2005

Mechanical properties of laser cut poly(L-lactide) micro-specimens: implications for stent design, manufacture, and sterilization.

BACKGROUND: The development of endoluminal stents from polymeric materials requires an understanding of the basic mechanical properties of the polymer and the effects of manufacturing and sterilization on those properties. METHODS: Pure poly(L-lactide) (PLLA) and PLLA containing varying amounts of triethylcitrate (TEC) as a plasticizer (5-10-15%) were studied. The specimens were solution-cast and CO2 laser-cut. Specimen dimensions were adapted to the strut size of polymeric vascular stents. The properties of the PLLA micro-specimens were assessed before and after sterilization (EtO cold gas, H2O2-plasma, beta- and gamma-irradiation). Tensile tests, and creep and recovery tests were carried out at 37 degrees C. Additionally the thermal and thermo-mechanical characteristics were investigated using dynamic-mechanical analysis (DMA) and differential scanning calorimetry (DSC). RESULTS: The results showed the dramatic influence of the plasticizer content and sterilization procedure on the mechanical properties of the material. Laser cutting had a lesser effect. Hence the effects of processing and sterilization must not be overlooked in the material selection and design phases of the development process leading to clinical use. Altogether, the results of these studies provide a clearer understanding of the complex interaction between the laser machining process and terminal sterilization on the primary mechanical properties of PLLA and PLLA plasticized with TEC.

Biocompatible Materials↗
PubMed1967

Certification of probability of sterilization of liquid by filtration.

Four types of hydrosol filters, two reusable (diatomaceous cylinder and fritted-glass funnel) and two disposable (asbestos pad and membrane filter) were challenged with a heavy bacterial suspension to assess their ability to produce sterile filtrates. Two of the four diatomaceous earth filters, the four fritted-glass funnels, and all of the asbestos pads tested generally gave sterile filtrates. However, only one type of filter, one of the membranes in its manufacturer's own holder, consistently gave sterile filtrates. The two other types of membranes usually gave sterile filtrates if tested in one manufacturer's holder, but all types invariably gave contaminated filtrates when tested in another manufacturer's holder. Contaminated filtrates were generally attributed to a poor reusable filter or to a faulty holder used with a disposable filter. If a high degree of certainty is required for sterile heat-labile filtrate, it is suggested that the liquid be passed through two or more filters in a previously tested and proven system.

Filtration↗
PubMed1969

Elimination of toxicity from polyvinyl trays after sterilization with ethylene oxide.

Ethylene oxide (ETO) sterilization of polyvinyl trays used in an antiviral screening program was initiated to overcome seasonal outbreaks of bacterial and mycotic contamination of tissue culture cells. Trays sterilized by 100% ETO for 5 hr after 48 hr of prehumidification, or by 12% ETO plus 88% Freon 12 for 1, 3, 5 or 18 hr, followed by various methods of aeration, were seeded with several types of tissue culture cells and examined for contamination, toxicity, and monolayer quality. A 1-hr exposure in 12% ETO plus 88% Freon 12 was adequate for sterilization, although residual toxicity for tissue cultures remained. A 7-day aeration period at 37 C was sufficient to eliminate toxicity and allow the growth of good monolayers of WI-38, HEp-2 and primary bovine kidney cells. Sterilization with 100% ETO required 14 days of aeration at 37 C to eliminate cytotoxicity. Increased residual toxicity resulting from longer ETO sterilization periods required longer aeration times at 37 C or higher aeration temperatures for detoxification.

Air↗
PubMed1971

Microbial penetration of muslin- and paper-wrapped sterile packs stored on open shelves and in closed cabinets.

Microbial penetration of sterile packs was studied using single-wrap (two layers) muslin, double-wrap (four layers) muslin, and two-way crepe paper (single layer) to wrap 20 gauze sponges (2 by 2 inch). These packs were stored in the central sterile supply departments of two hospitals and processed for sterility at predetermined intervals. Microorganisms penetrated single-wrap muslin as early as 3 days and double-wrap muslin and single-wrap two-way crepe paper in 21 to 28 days stored in open shelves. The time required for microbial penetration was at least twice as long when closed cabinets were used. Single-wrap muslin packs stored in sealed, impervious plastic bags remained sterile for at least 9 months. All sterile materials in pervious wrappers should be handled as little as possible and then only with extreme care and caution. Closed cabinets offer more protection than open shelves, and single wrappers are not recommended.

Bacteria↗
PubMed1996

Amplification of residual DNA sequences in sterile bronchoscopes leading to false-positive PCR results.

PCR has been used successfully for the direct detection of Mycobacterium tuberculosis in uncultured patient samples. Its potential is hindered by the risk of false-positive results as a result of either amplicon carryover of cross-contamination between patient samples. In the present study, we investigated whether residual amplifiable human or M. tuberculosis DNA could remain in sterile bronchoscopes and potentially be a cause of false-positive PCR results in subsequent patient samples. Sterilized bronchoscopes were flushed with sterile saline, and the collected eluate was submitted for PCR amplification of IS6110 sequences and exon 8 of the human p53 gene. Of a total of 55 washes of sterile bronchoscopes from two institutions, 2 (3.6%) contained amplifiable M. tuberculosis DNA and 11 (20%) contained residual human DNA. These findings indicate that residual DNA can remain in sterilized bronchoscopes and can be a source of false-positive PCR results.

Bronchoscopes↗
PubMedDate not supplied

In vitro fluoride dose-response study of sterilized enamel lesions.

Currently our intra-oral model uses enamel specimens that have been disinfected by soaking in buffered formalin (pH 6.8). However, because of increasing emphasis on infection control, it is important to identify a way to sterilize these specimens. The aim of this study was to determine if autoclaved, or gas sterilized, lesioned enamel responds to fluoride (F) in the same way alcohol-disinfected enamel lesions do. Seventy-two formalin-disinfected, human enamel specimens (3 mm) were lesioned in demineralizing solution for 96 h and were then divided into three groups. One group was autoclaved; one group was gas sterilized (ethylene oxide), and the remaining 24 specimens were further disinfected in 70% ethanol for 10 min. Specimens in each group were then treated 4 times/day for 4 weeks with 0, 250 or 1,100 ppm F dentifrice slurries in an in vitro cycling, remin/demin model. Following treatment, fluoride uptake was analyzed by microdrill biopsy, and lesion depth and mineral content changes (DeltaM) were determined by transverse microradiography. Data were analyzed by one-way ANOVA analysis. In all three groups of specimens there were significant (p<0.05) differences in fluoride uptake in response to different fluoride treatments. Autoclaved lesions failed to provide dose- response data with regard to changes in lesion mineral content. Because formalin and 70% alcohol are only disinfectants, and autoclaving altered the responsiveness of enamel lesions, results from this study suggest that, of the methods tested, gas sterilization is the preferred method for sterilizing enamel specimens that will be used in intra-oral studies.

Analysis of Variance↗
PubMed2006

The impact of vacuum freeze-drying on collagen sponges after gas plasma sterilization.

The sterilization of porous collagen sponges remains a challenging procedure. Gamma irradiation denatures collagen, resulting in dramatic changes to its structure. Ethylene oxide leaves toxic residues requiring weeks to evaporate. This study investigated the impact on cell behavior of gas plasma treatment when combined with vacuum freeze-drying. The goal of this procedure is to eliminate the molecules of hydrogen peroxide remaining after the sterilization process, together with their decomposition products, from the scaffolds. These molecules hinder the immediate use of the porous designs. Collagen and EDC/NHS-heparinized collagen scaffolds were sterilized with gas plasma. H2O2 released by the collagen specimens was measured by peroxidase test both immediately and also 1 week after the plasma treatment. Further measurements were done 24, 36, 48 and 72 h after vacuum freeze-drying. The activity of these scaffolds was further evaluated in relation to the proliferation, migration and differentiation of human umbilical vein endothelial cells (HUVECs). Both immediately after exposure to gas plasma and also 1 week later, the collagen designs contained significantly higher concentrations of H2O2 than scaffolds having also undergone vacuum freeze-drying. This procedure achieved faster decontamination of the remaining H2O2. Following vacuum freeze-drying, sponges already allowed HUVEC proliferation after 48 h, but in non-lyophilized specimens after gas plasma treatment alone, cell death occurred as early as only 1 week later. These data highlight the advantages of carrying out vacuum freeze-drying following gas plasma sterilization. The results show the substantial impact of sterilization of porous materials made for tissue engineering.

Animals↗
PubMedDate not supplied

Menopausal symptoms and psychological distress in women with and without tubal sterilization.

Data from self-administered mailed questionnaires were used to examine the relationship between menopausal and psychological/psychiatric factors in women age 45-50 years with and without tubal sterilization. In multivariate logistic regression analysis, tubal sterilization was associated with current flushing (odds ratio = 8.78, 95% confidence interval [CI] = 1.58-48.67) and current symptoms of psychological distress (odds ratio = 3.37, 95% CI = 1.27-8.95); psychological distress was associated with tubal sterilization (odds ratio = 3.28, 95% CI = 1.28-8.42) and with being perimenopausal (odds ratio = 3.93, 95% CI = 1.08-14.34). Sterilization was marginally associated with a history of physician-diagnosed depression (univariate age-adjusted odds ratio = 2.24, 95% CI = 0.90-5.60). The menopausal and psychological symptoms of women with tubal sterilization should be taken seriously and treated appropriately.

Adult↗
PubMed1994

Sterilization of teeth by gamma radiation.

Clinical simulations and restorative materials research and development conducted in vitro require the use of large numbers of extracted teeth. The simultaneous need for infection control procedures and minimal alterations of structure and properties of the tissue prompted this study of gamma irradiation as a method to eliminate microbes associated with extracted teeth and their storage solutions. Evaluations of potential change in structure of dentin were conducted in terms of permeability, Fourier transform infrared spectroscopy (FTIR), and optical properties. The dose required for sterilization by gamma irradiation was established by means of a tooth model inoculated with Bacillus subtilis (10(8) organisms/mL). Sterilization occurred at a dose above 173 krad with use of a Cesium (Cs137) radiation source. Gamma irradiation did not affect permeability of crown segments of dentin. A comparative evaluation of the effects of four sterilization methods on dentin disks was based on FTIR and ultraviolet-visible-near infrared (UV/VIS/NIR) spectra before and after sterilization by (1) gamma irradiation; (2) ethylene oxide; (3) dry heat; and (4) autoclaving. No detectable changes were found with gamma irradiation, but all other methods introduced some detectable change in the spectra. This suggests that common methods of sterilization alter the structure of the dentin, but gamma irradiation shows promise as a method which both is effective and introduces no detectable changes as measured by FTIR, UV/VIS/NIR, or permeability.

Bacteria↗