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PubMed1999

Working conditions and health effects of ethylene oxide exposure at hospital sterilization sites.

Ethylene oxide (EtO) is a powerful disinfectant and sterilant for heat-sensitive surgical items and instruments. Its use in hospitals constitutes an important source of occupational exposure that is sometimes underestimated, such as in cases of EtO device malfunction when the safety rules of procedure are not strictly followed or when individual or collective protective equipment is lacking. We carried out a descriptive study of the health care workers who were assigned to EtO sterilization units of the Lille University Hospital Centre in Lille, France (n = 16). Before the modification of the sterilization units in the development of a single, central sterilization site, we studied the workplaces, occupational conditions, and work procedures of the health care workers exposed to EtO. The aim was to assess the risk of EtO overexposure of the workers in order to improve workers' health and security in the future sterilization center. The study was based on a physical examination, a questionnaire covering each subject's personal and occupational history, and a complete ocular examination. For occupational conditions, the studies of each workplace were also performed by the occupational physician. Area and personal breathing air samplings were performed at each exposure site. Fourteen of the 16 operators had posterior and anterior subcapsular lens opacities, three of which seemed to be directly and primarily related to occupational exposure; the other ten seemed to be rather common and compatible with age. High levels of EtO exposure were reported in the oldest site (90 parts per million [ppm] during the changing of the gas bottle), where exposure often exceeded French threshold limits (permissible exposure limit: 1 ppm 8-hour time-weighted average (TWA) in air; short-term excursion limit: 5 ppm 15-minute TWA in air), or the current US recommended and legal exposure limits for EtO advocated by the Occupational Safety and Health Administration and the American Conference of Governmental Industrial Hygienists (permissible exposure limit: 1 ppm 8-hour TWA in air; excursion limit: 5 ppm 15-minute TWA in air), and the National Institute for Occupational Safety and Health standard (recommended exposure limits: 0.1 ppm 8-hour TWA in air; 5 ppm 10-minute TWA in air). The faults in the work processes, such as interruption of the sterilization cycle and disregard for the use of protective devices, were very common.

Adult↗
PubMed2007

Autoclave sterilization of instruments used on women with cervical neoplasia is an effective method of eradicating residual human papillomavirus DNA: a polymerase chain reaction-based evaluation.

OBJECTIVE: To determine whether autoclave sterilization eradicates human papillomavirus (HPV) DNA on specula and instruments used to treat women with cervical neoplasia. METHODS: Specula and instruments used in two referral colposcopy clinics were evaluated to determine the PGMY9/11 primer system's ability to amplify residual HPV DNA. Each speculum and instrument was sampled with a Dacron swab and stored in PreservCyt solution (Cytyc Corporation, Marlborough, MA) at 4 degrees C. DNA amplification was performed under standard conditions with appropriate controls followed by HPV typing using the reverse line blot test (Roche Molecular Systems, Alameda, CA). Once validated, the same polymerase chain reaction method was used on autoclave-sterilized specula and biopsy instruments and heated glass bead- and Cidex bath (Johnson & Johnson, New Brunswick, NJ)-sterilized instruments. All results, with appropriate positive and negative controls, were confirmed in triplicate. RESULTS: A total of 140 instruments (70 used and 70 autoclaved) were sampled for residual HPV DNA. Five samples in the contaminated specula arm were excluded from analysis secondary to insufficient sampling. Of the remaining samples, 52.3% (34/65) of contaminated instruments-both specula and biopsy instruments-had detectable HPV DNA. Fifty-five percent of contaminated biopsy instruments (11/20) were positive and 51.1% of contaminated specula (23/45) were positive. All 70 autoclaved samples (50 specula and 20 biopsy instruments) were negative for residual HPV DNA or beta-globin. One instrument in the glass bead and Cidex group that was presumed sterile was positive for HPV 16 DNA. CONCLUSIONS: The PGMY9/11 primer system is an effective method to detect residual HPV DNA. Autoclave sterilization appears to eradicate HPV DNA to levels undetectable with this sensitive assay, whereas heated glass beads followed by Cidex bath appears to be inadequate methods. These results suggest that autoclave sterilization is effective when using nondisposable instruments and should be the method of choice in studies using polymerase chain reaction-based amplification of HPV DNA.

Adult↗
PubMed1994

Sterilization of the handengine. Is it a necessity?

BACKGROUND: The risk of interpatient infection through a dermabrasion handpiece is not known, nor is there a published standard of handpiece maintenance. OBJECTIVE: To investigate the possibility of transferring material through the handpiece and evaluate the methods used by dermatologists to disinfect and/or sterilize dermabrasion equipment. METHODS: Handengines run while immersed in fluorescein-dyed alcohol were observed for fluorescence. After dermabrasion of a fluorescein-basted pig's foot the instrument was inspected. A survey of handpiece disinfection/sterilization procedures was sent to 114 members of the American Society for Dermatologic Surgery. RESULTS: Although material can be transmitted to the motor/handpiece through the chuck and vice versa, contamination of the instrument did not occur in a dermabrasion simulation. 58.7% of respondents sterilize the chuck and only 38.1% sterilize the motor/handpiece. CONCLUSIONS: No absolute requirement to sterilize the handengine is warranted. It is prudent however to sterilize the chuck in a steam autoclave and gas sterilize the motor/handpiece to eliminate the rare possibility of cross-contamination.

1-Propanol↗
PubMed1999

In vitro evaluation of integrity and sterilization of single-use argon beam plasma coagulation probes.

OBJECTIVE: Argon plasma coagulation probes (APC) are currently marketed in the United States as single-use items, and may constitute a significant per-procedure expense. It is unknown whether these probes can be sterilized after endoscopic use and if electrical integrity can be maintained after reprocessing. METHODS: Ten probes (2.3 mm diameter, 220 cm length) manufactured by ERBE Inc., (Marietta, GA) were studied using the ERBE APC 300 at 60 watts. Baseline coagulation depth was measured by coagulating a piece of beefsteak for 60 s. Probes were contaminated with 10(6) Bacillus subtilis spores, cultured, and manually cleaned. Culturing involved introducing 10 cc sterile water through the probes; water was filtered, plated onto blood agar, and incubated for 48 h. After ethylene oxide (ETO), the probes were cultured to determine sterilization. Finally, the per-procedure cost of each probe was assessed. RESULTS: Ten of 10 probes completed 10 testing sessions. One probe split at the proximal end but remained functionally intact. Electrical integrity remained intact for all 10 sessions. All probes grew too numerous to count colonies of B. subtilis after inoculation and no B. subtilis was detected after ETO sterilization. Assuming 10 uses clinically, a total per-procedure equipment cost would approximate $24.00, whereas per-procedure probe cost would equal $42.66 if only five uses were obtained in vivo. CONCLUSIONS: The combination of manual cleaning and ETO sterilization consistently sterilized APC probes. Ninety percent of the probes showed no sign of physical deterioration and 100% maintained their electrical activity after 10 uses. APC probes can potentially be safely and effectively reused up to 10 times, and a significant procedural savings is possible with reuse.

Bacillus subtilis↗
PubMed2006

The sterility of dental burs directly from the manufacturer.

BACKGROUND: The purpose of this research was to assess the sterility of burs directly from manufacturers. The authors wished to determine the types of bacteria, if any, found on nonsterilized burs. METHODS: The authors used burs from a major manufacturer. Sterilized and nonsterilized burs were cultured for bacteria. Any burs found to be contaminated were further cultured on agar plates. The bacteria on the plates were identified by a commercial laboratory. RESULTS: Of the 100 sterilized and nonsterilized burs, the authors found none of the sterilized burs to be contaminated. Eight of the nonsterilized burs showed growth of bacteria after 24 hours. Seven of the eight bacteria identified on the burs belonged to the genus Bacillus. CONCLUSIONS: The Bacillus genus is encountered in daily living and is not considered to be pathogenic; however, there have been documented cases of infection in humans in which these bacteria dominate. They should never be introduced into the bloodstream. CLINICAL SIGNIFICANCE The dentist must consider that soft tissue exposure may be unavoidable with subgingival restorations or even those close to the gingiva. Therefore, it is imperative that the dentist use sterile burs during dental procedures. This article will prove the necessity for sterile burs and leave the rest to the manufacturers.

Bacillus↗
PubMed1999

Radiation sterilization of a bifunctional cement formulation of hydroxilapatite-plaster-polymers.

A sterilization method based on the use of gamma ionizing radiation was applied to a cement formulation of hydroxilapatite, plaster and polymers to be used in bone restorations in dental, aesthetic, and neurological surgery. After the cement was exposed to a dose of 21.5 kGy it reached the sterility assurance level which was necessary for its employment in surgical applications as specified by International Standard ISO ordinate 11137: Radiation Sterilization of Health Care Products. No variation in the initial cement composition or processing parameters, such as working or setting time and molding quality was observed due to sterilization. Its characteristics as a drug delivery system were also not affected. Therefore, radiation sterilization provides a feasible alternative to conventional sterilization methods such as dry/wet heat and ethylene oxide.

Biocompatible Materials↗
PubMedDate not supplied

Microbiological survey of dialysate: vantage of use of sterile bag concentrate.

Haemodialysed patients are exposed to nearly 400 litres of dialysis water weekly. The bacterial contamination of treated dialysate and water induces acute pyrogenic reactions or chronic damage and cytokine activation. The aim of this study was to value the microbiological parameters of dialysis water and dialysate of our monitors by bacterial culture (measured as colony forming units [CFU]) of water samples at 37 degrees C after 48 hours, at 22 degrees C after 72 hours and after seven days, and by measuring endotoxin levels (endotoxin units [EU]). In our centre, there are 16 monitors (6 monitors use sterile dialysate fluid and 10 monitors use non sterile dialysate fluid). The chemicals used for disinfection are chlorine and paracetic acid. Water samples were taken under sterile procedures every three months for a year. No bacteria were found in the samples of water of the dialysis ring; EU were lower than the limit value of 0.25 EU/ml fixed by the European Pharmacopoeia. The concentration of CFU and EU of the dialysate, taken from monitors with a sterile bag, were lower than those of other monitors (p < 0.05 t Student test). However, the levels of CFU/ml and EU/ml of dialysate samples, taken from monitors with a non-sterile bag, were lower than the guideline value of the European Pharmacopoeia (v.n. CFU < 50 CFU/ml and EU < 0.05 EU/ml). Frequent examination of CFU and EU is essential to reduce the damage caused by the use of contaminated water, therefore the goal of future dialytic techniques will be the use of "sterile dialysate".

Health Care Surveys↗
PubMed1988

Continuous-sterilization system that uses photosemiconductor powders.

We report a novel photochemical sterilization system in which Escherichia coli cells were sterilized with photosemiconductor powders (titanium oxide). For sterilization that could be used in practice, it was necessary to separate the TiO2 powders from the cell suspension. Therefore, semiconductor powders were immobilized on acetylcellulose membranes. We constructed a continuous-sterilization system consisting of a TiO2-immobilized acetylcellulose membrane reactor, a mercury lamp, and a masterflex pump. As a result, under the various sterilization conditions examined, E. coli (10(2) cells per ml) was sterilized to less than 1% survival when the cell suspension flowed in this system at a mean residence time of 16.0 min under irradiation (1,800 microeinsteins/m2 per s). We found that this system was reusable.

Escherichia coli↗
PubMed1962

Gamma-ray sterilization and residual toxicity studies of ground beef inoculated with spores of Clostridium botulinum.

Inoculated packs of cooked and raw ground beef were sterilized with gamma radiation from cobalt-60. With inocula of 5,000,000 Clostridium botulinum 213B spores per g of cooked ground beef, 3.8 megarad were required for sterilization; in raw ground beef, 3.72 megarad sterilized the meat when inocula of 1,700,000 C. botulinum 213B spores were used per g. Using C. botulinum 62A spores, cooked ground beef inoculated with 5,200,000 spores per g was sterilized with 3.85 megarad; raw ground beef, inoculated with 2,670,000 spores per g, was sterilized with 3.6 megarad. Cans of meat that were considered sterile by lack of culture growth after incubation for at least 6 months and, in some instances, as long as 5 years, were tested for the presence of botulinus toxin. No toxin was found in any meat taken from inoculated packs prepared from C. botulinum 213B spores; however, all cans of meat that had been inoculated with more than 2,670,000 C. botulinum 62A spores per g of meat, contained type A toxin. It was shown that these latter inocula of heat-shocked spores, by themselves, contained sufficient toxin to kill mice. However, more toxin appeared to be present than could be ascribed to the unirradiated spores alone. This finding is discussed.

Animals↗
PubMed1968

Microbial contamination on disposable hypodermic syringes prior to sterilization by ionizing radiation.

A large number of syringes were taken from the production lines of three independent manufacturers; the numbers and types of microorganisms contaminating these randomly sampled syringes were assessed in the laboratories maintained by each of these manufacturers for routine sterility testing, according to a standard protocol devised by the Research Committee of the UK Panel on Gamma and Electron Irradiation, which coordinated the investigation and analyzed the results. Items produced by a manufacturer were assessed for microbiological contamination both in their own laboratories and in the laboratories of the other manufacturers. The level of "false-positive" results was determined independently for each laboratory by the testing of "known sterile" items which had been subjected to the radiation-sterilization process. Both the percentage of syringes initially sterile and the average number of organisms per contaminated syringe differed among the three manufacturers. When corrected for interlaboratory differences, the number of syringes initially sterile ranged from 16 to 48%, and the mean number of organisms per contaminated syringe was 20 to 70. Of 964 syringes tested by all three laboratories, only one contained over 1,000 aerobic organisms (1,133). The most common organisms found were coagulase-negative, gram-positive cocci. Two manufacturers assessed contamination by anaerobic organisms; of 610 syringes, 1 contained 4,275 organisms and 3 more had 100 to 1,000 organisms, but 488 (80%) were uncontaminated by anaerobes. The results are discussed in the context of the choice of radiation dose necessary for the sterilization of medical products manufactured under controlled hygienic conditions.

Bacteria↗
PubMed2001

Effects of ethylene oxide gas sterilization on physical properties of poly(L-lactide)-poly(ethylene glycol)-poly(L-lactide) microspheres.

The aggregation of poly(alpha-hydroxy acid) microspheres during ethylene oxide (EO) gas sterilization makes it difficult for the microspheres to be used in clinical applications. In this study, six kinds of PLLA-PEG-PLLA triblock copolymers (TriPLE) were synthesized with various composition ratios of PEG/PLLA in the range of 0.012 to 0.103. TriPLE microspheres were prepared by the oil-in-water emulsion method. TriPLE microspheres were characterized by using 1H-NMR, gel permeation chromatography (GPC), and differential scanning calorimetry (DSC). After sterilization by EO gas at 55 degrees C, the microspheres were analyzed by scanning electron microscope (SEM), laser diffractometry, standard sieves, X-ray diffraction (XRD), GPC, and DSC. When the composition ratio of PEG/PLLA was above 0.02, the initial crystallinity of TriPLE in microspheres was as high as 50%, and the microspheres were suitable to be sterilized by EO gas. On the other hand, TriPLE microspheres, which had composition ratios of PEG/PLLA below 0.02, had low initial crystallinities of about 30%, and aggregated during EO gas sterilization. For these microspheres, crystallinity increased up to 50% during the sterilization, whereas other TriPLE microspheres did not show any changes in crystallinity. Therefore, the aggregation of TriPLE microspheres during EO gas sterilization was markedly reduced as the initial crystallinity of TriPLE in the microspheres was increased.

Calorimetry, Differential Scanning↗
PubMed1993

New technique for the sterile introduction of flexible nasopharyngolaryngoscopes.

Since the inception of flexible fiberoptic endoscopes, disinfection of these instruments has been a problem. Soaking in glutaraldehyde does not always achieve sterilization, and often damages the scopes. Ethylene oxide can sterilize endoscopes; however, it is economically impractical because of a required downtime of 24 hours. Thus, it is obvious, especially with respect to human immunodeficiency virus, hepatitis B virus, and Mycobacterium, that a new technique to attain sterility is necessary. This paper discusses a new method of sterile introduction of the flexible nasopharyngolaryngoscope. The technique employs disposable sterile sheaths that are prepackaged and made from a thermoplastic elastomer with a clear optical end. The sheaths can be applied in seconds and tightly adhere to the flexible insertion portion of the scope. Results to date indicate that the performance of the endoscope is unhindered by using the sheaths. Furthermore, there has been no break in the integrity of the sheaths or damage to instruments. It is our opinion that these devices will greatly improve the level of sterility while at the same time reducing costs and downtime.

Cross Infection↗
PubMedDate not supplied

The effects of freeze-drying and ethylene oxide sterilization on the mechanical properties of human patellar tendon.

Human patellar tendon allografts are used to replace injured anterior cruciate ligaments. They are often stored by freeze-drying or freezing before use and have been sterilized by gamma irradiation or ethylene oxide gas. Studies comparing the mechanical properties of tendons preserved by freeze-drying and sterilized by ethylene oxide have yielded conflicting results. This study examined the effects of freeze-drying and ethylene oxide sterilization on the mechanical properties of human patellar tendons obtained from 11 human cadavers; all were free of musculoskeletal disease. The 22 patellar tendons were halved longitudinally; 7 were frozen at -70 degrees C for 8 weeks and served as controls; 8 were freeze-dried; and 7 were freeze-dried and sterilized with ethylene oxide gas. Ultimate tensile stress and longitudinal strain were greater for frozen than for freeze-dried, but not greater than freeze-dried, ethylene oxide-sterilized tendons (P < 0.05). The modulus of elasticity was similar in all tendon groups. The study suggests that some in vitro mechanical properties of frozen tendons may be marginally superior to the properties of freeze-dried tendons, even after correction for size difference. Ethylene oxide gas sterilization had no adverse effect on tendon mechanical properties.

Aged↗
PubMed2002

Is steam sterilization really making any difference in dialysis-induced cytokine release?

Ethylene oxide (ETO) is presently the most commonly used sterilization method for medical devices. Although alternative sterilization modes such as steam sterilization have been suggested, the effect of steam on dialysis-induced cytokine release is unknown. We enrolled 9 patients on chronic hemodialysis and evaluated at different intervals IL-1beta production while treated with ETO (NC 1785-Bellco) and steam sterilized NC 1785S-Bellco) Synthetically Modified Cellulose (SMC). A basal test during treatment with NC 1785 was performed (A); the same test was set up 4 weeks after treatment with NC 1785S (B) and, lastly, 4 weeks after returning to NC 1785 (C). Peripheral blood mononuclear cells (PBMC) were purified before and after the dialysis session, were isolated on a Ficoll/Hypaque gradient and incubated for 24 h. Spontaneous IL-1beta release was evaluated in the supernatant and in the lysate. In A, IL-1beta levels were (in pg/ml/10(6) cells, in supematant and lysate, respectively): 5.8 +/- 4.8 and 7.6+/-5.2 in pre-HD and 4.68 +/- 3.6 and 9.7 +/- 6.65 in post-HD. These levels showed a clear reduction in B: 2.5 +/- 2.2 and 4.4 +/- 3.1 in pre-HD, and 4.35+/- 6.6 and 7.52 +/- 7.22 in post-HD. In the C test, 4 weeks after the return to the ETO membrane, IL-1beta levels remained unchanged: 2.9 +/- 1.8 and 4.5 +/- 3.1 in pre-HD; and 2.6 +/- 3 and 5.7 +/- 6.6 in post-HD. Statistical analysis showed significant changes in the pre-HD levels both in supematant (p < 0.04) and in lysate (p < 0.04). Steam sterilization of SMC induced a lower spontaneous IL-1beta release, but this effect was not statistically significant due to the large inter-individual variation. Hence, contrary to claims of better biocompatibility, steam sterilization does not result in a reduced production of pro-inflammatory IL-1beta.

Biocompatible Materials↗
PubMed1985

Long-term regret among 216 sterilized women. A six-year follow-up investigation.

Six years after tubal sterilization 16 of 208 women reported serious regret. The desire for another child in a new relationship was given as the main reason for later regret, although other causes were also reported. No association between age, parity, time or type of tubal sterilization and later regret was demonstrated. However, a greater proportion of regretters than of the remainder had been recommended the sterilization by a doctor at abortion application. The regretters had undergone more abortions before their sterilization, and the study revealed more unstable marriages with consequently less support from the spouse at sterilization in the regretting group. Post-sterilization regret is discussed within the framework of life events and social support.

Adult↗
PubMed2004

Provision of female sterilization in Ribeirao Preto, Sao Paulo, Brazil.

Forty percent of Brazilian married women from 15 to 49 years of age have undergone surgical sterilization. The 1988 Brazilian Constitution states that all scientifically proven contraceptive methods should be available to all citizens, but it was only in 1997 that specific family planning legislation was approved. This study examines physicians' perceptions and attitudes towards the current provision of female sterilization and its legal implications, as well as women's experience with obtaining and undergoing sterilization. The study design included: (1) an investigation of the hospitals and health professionals and (2) a survey of women sterilized in combination with cesarean delivery in 1998. The survey showed they had a median of 3 living children, 60.0% had been sterilized between 30 and 39 years of age, and 61.0% had paid for the procedure. Many women reported previous method failure and adverse effects with hormonal contraceptives. Women with less schooling and lower socioeconomic status had more children and had begun childbearing and had been sterilized at younger ages than women with more schooling and higher socioeconomic status. Inequalities related to reproduction were strongly associated with teenage pregnancy and inadequate knowledge about contraceptives.

Adult↗
PubMed1980

Demographic trends of tubal sterilization in the United States 1970-75.

An estimated 2,300,000 women in the United States underwent tubal sterilizations in 1970-1975. During this period the rate of tubal sterilizations per 1,000 women 15-44 years of age rose from 4.7 to 11.7. We studied the influence on sterilization trends of four demographic variables: age, region of residence, race, and marital status. Women 25-34 years of age were twice as likely to be sterilized as older or younger women. Rates were about 40 per cent lower in the West than in the rest of the country. In 1970 rates for non-white women were double those for Whites. Rates for Whites rose faster than those for non-Whites, however, and by 1975 the rates were similar for the 2 races. Non-Whites still tended to be sterilized about one year younger than Whites, and marked regional differences existed in the race-specific rate trends. Rates rose more sharply for previously married women than for currently married women; by 1975 rates for these two groups were similar. Never married women had rates about 1/7 of those of currently married and previously married women. Among the never married, tubal sterilization rates for non-Whites were nine times higher than those for Whites.

Adolescent↗
PubMed2004

The effect of gamma radiation sterilization on the fatigue crack propagation resistance of human cortical bone.

BACKGROUND: Clinical evidence has suggested that the rate of fracture in allografts sterilized with gamma radiation may be higher than that in controls. Gamma radiation sterilization has been shown to affect the post-yield properties of bone but not the elastic modulus. Since most allograft fractures occur with subcritical loads during activities of daily living, it may be that the fatigue properties of irradiated allografts are diminished. In this study, the fatigue crack propagation behavior of cortical bone sterilized with gamma radiation was compared with that of gender and age-matched controls. We hypothesized that gamma radiation significantly reduces the resistance of cortical bone to fatigue crack growth. METHODS: Specimens for fatigue crack propagation testing were machined from four pairs of fresh-frozen human femora obtained from four individuals (a younger male, younger female, older male, and older female donor). Half of the specimens were sterilized with 31.7 kGy of gamma radiation. The specimens were cyclically loaded to failure in a servohydraulic testing system, and crack growth was monitored. The cyclic stress intensity factor and the fatigue crack growth rate were calculated to examine the kinetics of fatigue crack growth. Following testing, the damage zone around the fracture plane was analyzed histologically. RESULTS: The morphology and kinetics of crack growth in irradiated specimens differed from the control data. Overall, the irradiated bone was significantly less resistant to fatigue crack growth than was control tissue (p < 0.05). There was less microdamage associated with fracture in the irradiated specimens than in the control specimens, with the exception of the bone from the older female donor. CONCLUSIONS: Gamma radiation sterilization significantly reduces the fatigue crack propagation resistance of cortical bone. Irradiated specimens also demonstrate a smaller amount of microdamage along the fracture plane. These findings may be due to ultrastructural alterations in the collagen matrix caused by radiation. CLINICAL RELEVANCE: This study suggests that, despite having pre-yield mechanical properties that are similar to those of nonirradiated bone, gamma-radiation-sterilized allograft may be more predisposed to fracture even under the subcritical loads that occur during the activities of daily living.

Adolescent↗