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Sterilization update 2003.

Instrument processing is a key part of the office infection control program. Each step in the process must be performed correctly to help ensure patient safety. The instrument processing area must be organized so that contaminated items are not confused with sterilized items, and so that sterilized items do not accidentally become recontaminated. Instruments need to be cleaned completely of visible debris using an ultrasonic cleaner or instrument washer. The cleaned instruments are packaged before sterilization to protect them from recontamination until they are opened for use for the next patient. Processing the packaged instruments through a heat sterilizer (steam, dry heat, or unsaturated chemical vapor) kills any microbes that remain on the instruments. The sterile packages are handled and stored in a manner that preserves the integrity of the packaging material. The use and functioning of the sterilizer is monitored by mechanical, chemical, and biological means, and records are kept to document these evaluations. Sterilization failures are addressed carefully so that patient safety can be maintained.

Dental Instruments↗

[Glass bead sterilization of orthodontic pliers].

The study on sterilization of orthodontic pliers by using glass bead sterilizer at 450 F was performed. Microorganisms used in this experiment were Staphylococcus aureus ATCC 25933, Bacillus subtilis ATCC 6633, Candida albicans ATCC 10231 and mixed microorganisms in human saliva. The result showed that after the pliers were scrubbed with alcohol and sterilized for 3 minutes with glass bead sterilizer, all vegetative cells and bacterial spores were killed in every test. This study indicated that glass bead sterilizer is capable of sterilizing orthodontic pliers and can be a useful adjunct when rapid chairside sterilization is desired.

Hot Temperature↗

[Dependence of microbiologic test results of formaldehyde gas sterilization methods on the nature of the test material].

The efficiency of a formaldehyde gas sterilization procedure was evaluated with the aid of test pieces consisting of various materials. Both rigid and flexible tubes served as test pieces. The tubes were 75 cm long with an inner diameter of 1 mm and were sealed at one end. The bioindicators were placed inside the tubes close to the sealed end. Dried spores of Bacillus stearothermophilus adhering to linen threads served as test organisms. The test results varied according to the material of the test pieces and the thickness of their walls (see Table 1). In flexible tubes made of silicon rubber, all bioindicators became sterile, in tubes of stainless steel, all bioindicators exhibited test organisms that had survived. The findings for materials such as polyvinyl chloride, polyethylene, polyamide and polytetrafluorethylene ranged between these two extremes; the frequencies of bioindicators containing viable germs were 10, 55, 68 and 85%, respectively. Rigid and flexible tubes which had been sealed at both ends served to demonstrate that silicon rubber and polyvinyl chloride were highly permeable for formaldehyde and water vapour. Also the other plastic materials tested were permeable for formaldehyde and water vapour but longer exposure periods were needed to create conditions in the interior of the tubes that would result in a killing of the test organisms (see Fig 2). In this respect, polyamide exhibited a peculiar behaviour. The number of viable spores remained at the initial level for a long period before a decline took place. From the results of testing, it is concluded that test pieces must conform to the objects to be sterilized not only in their dimensions (length, inner diameter) but also in the characteristics of their material. The walls of the test pieces should not have a higher permeability for formaldehyde and water vapour than the material to be sterilized. The highest demands on the efficiency of formaldehyde gas sterilization procedures are those created by mental tubes and thick-walled flexible polytetrafluorethylene. Instruments and devices to be sterilized by a formaldehyde gas procedure should be preferentially made of materials which are sufficiently permeable for formaldehyde and water vapour as e.g. silicon rubber. Such gas-permeable components may considerably facilitate the sterilization of cavities which have a small lumen and are difficult to reach.

Chromium↗

Luteal phase pregnancy and tubal sterilization.

The effectiveness of several measures that may reduce the risk of luteal phase pregnancies after interval tubal sterilization was analyzed. Using data from the Collaborative Review of Sterilization on 5495 women, 18 luteal phase pregnancies were identified. Women who underwent sterilization after their estimated date of ovulation had a low risk of having a luteal phase pregnancy if they used oral contraceptives or an intrauterine device in the month before sterilization. Of the 18 luteal phase pregnancies, 14 (78%) occurred among the 16.8% of the women who were sterilized after their estimated date of ovulation and who had used barrier, rhythm, or withdrawal methods of contraception in the month before sterilization. The use of concurrent dilatation and curettage in these women at increased risk of luteal phase pregnancy did not lower their risk to that of women who were sterilized before their estimated date of ovulation.

Adult↗

Social and clinical correlates of postpartum sterilization in the United States, 1972 and 1980.

This analysis is based on the 1972 and 1980 National Natality Surveys, conducted by the National Center for Health Statistics. About 10.6 percent (381,000) of women in the United States who delivered live infants in 1980 were sterilized postpartum. About 93 percent of these postpartum sterilizations were tubal operations; only 1.4 percent were hysterectomies. Because the literature on the health correlates of sterilization is sparse, this analysis was exploratory. In both 1972 and 1980, married mothers were more likely to be sterilized postpartum if they had previous fetal losses, underlying medical conditions, complications of pregnancy, or a cesarean delivery. Inspection of more detailed tabulations reveals that repeat cesarean delivery, multiparity, diabetes and at the higher birth orders, excess weight gain, and toxemia preeclampsia were associated with postpartum sterilization. An apparent association with varicosity may be due to misreporting. The degree to which each of these associations is causal or spurious awaits further research, but preliminary analysis suggests that some maternal health factors may influence some sterilization decisions. Beyond these specific maternal health conditions and complications, the evidence for a connection between poor maternal health and sterilization is equivocal.

Adult↗

Sixteen years of experience with sterilization monitoring.

Sterilization in the dental office should be monitored to ascertain proper sterilizer function. Biologic monitoring with calibrated preparations of bacterial spores is the preferred, as well as the only method that actually measures sterilization. A dental school-based sterilization monitoring service for dental practices was established in 1978 at the University of Detroit. This service has grown from 20 participating dental offices to more than 1,500. In 1993, 18,137 biologic monitoring tests were performed. The participants in the service primarily use autoclaves (70%) for heat sterilization, while unsaturated chemical-vapor sterilizers (20%) and dry-heat units (10%) are less common. This article describes the history of sterilization monitoring in dental practices from 1978 to the present through a dental school-based service.

Bacillus subtilis↗

Parameters governing steam sterilization of deadlegs.

Use of saturated steam for sterilization-in-place (SIP) is limited by factors effecting displacement of air from deadlegs. Effects of tube diameter, length, orientation and position within a deadleg were quantitatively studied by examining temperature profiles and rates of kill of Bacillus stearothermophilus spores. Tube diameter had the greatest effect on sterilization. For small diameter tubes, 0.4 cm inside diameter (ID), air displacement was minimal and due mainly to diffusion. 8.8 cm long tubes with 0.4 cm IDs could not be sterilized at 121 degrees C. As tube diameter was increased and buoyant driven convective flow became dominant over viscous forces, sterilization was achieved and tube orientation became critical. Sterilization time, as defined by a twelve log reduction in spore population, was 75 minutes in a 19.0 cm long vertical tube with 1.7 cm ID, whereas 167 minutes were required for an 8.8 cm long tube with 1.0 cm ID. For 8.8 cm long tubes, only the 1.7 cm ID tube could be sterilized when orientated 5 degrees above horizontal. Data show that length to diameter ratios, L/Ds, do not provide a general guideline which can be used to predict sterilization. In the absence of steam bleeders, equipment should be designed to assure strong buoyancy driven convective flow to assure adequate air removal. This requires elimination of small diameter deadlegs (0.4 cm ID and less) and vertical positioning of deadlegs.

Biotechnology↗

Reliability of biologic indicators in a mail-return sterilization-monitoring service: a review of 3 years.

Most mail-return sterilization-monitoring services use spore strips to test sterilizers in dental clinics, but factors such as delay caused by mailing to the laboratory could cause false negatives. The aims of this study were to determine the influence of poststerilization time and temperature on the biologic indicator recovery system and to evaluate sterilization failure and its possible causes in dental clinics subscribing to a mail-return sterilization-monitoring service. Spore strips used in independent tests revealed the poststerilization time and temperature after a 7-day delay to have no significant influence. Sixty-six dental clinics that received quarterly biologic indicators to evaluate the effectiveness of their sterilizers had sterilization failure rates of 28.7% in 1992, 18.1% in 1993, and 9.1% in 1994, a statistically significant decrease in sterilization failure during the 3-year period. The usual causes of failure were operator error in wrapping of instruments, loading, operating temperature, or exposure time.

Bacillus subtilis↗

Fatigue strength of polyethylene after sterilization by gamma irradiation or ethylene oxide.

The oxidation level of ultrahigh molecular weight polyethylene specimens sterilized by gamma irradiation in either air or Ar gas was compared with that of unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene. The fatigue strength of ultrahigh molecular weight polyethylene specimens sterilized by gamma irradiation in air was compared with that of unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene. At the specimen surface, oxidation was highest for ultrahigh molecular weight polyethylene gamma irradiated in air, lower for ultrahigh molecular weight polyethylene gamma irradiated in Ar gas, and absent in unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene. At a depth of 3.5 mm below the specimen surface, oxidation levels were equivalent for ultrahigh molecular weight polyethylene gamma irradiated in either air or Ar gas whereas unsterilized and ethylene oxide sterilized specimens were again unoxidized. Thus, even in an inert atmosphere, oxidative degradation of gamma irradiated ultrahigh molecular weight polyethylene occurs. The 10 million cycle fatigue strength was similar for unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene whereas the fatigue strength of gamma irradiated in air ultrahigh molecular weight polyethylene was lower. Results of this study show that ethylene oxide gas does not degrade ultrahigh molecular weight polyethylene whereas gamma radiation in air causes changes in the polymer that adversely affect its mechanical properties. Ethylene oxide gas is a viable alternative to gamma radiation in air that avoids oxidation and fatigue strength degradation known to accompany irradiation of ultrahigh molecular weight polyethylene polymer bearing surfaces in total joint implants.

Biophysical Phenomena↗

An evaluation of the AbTox Plazlyte Sterilization System.

OBJECTIVE: To evaluate the efficacy of the AbTox Plazlyte Sterilization System against selected microbial species using inoculated carriers and surgical instruments. SETTING: The microbiology laboratory of a 700-bed adult tertiary-care hospital. DESIGN: The study was conducted in two phases. In phase 1, microorganisms were inoculated to various metal, paper, plastic, and glass carriers, as well as surgical equipment, and processed in cycle II of the AbTox sterilizer. Phase 2 compared AbTox cycle III with ethylene oxide sterilization using stainless steel washers, penicylinders, and surgical equipment. In both phases, cultures of equipment and carriers were obtained after processing. The phenotypic profiles and antibiograms of positive cultures were compared to the original inoculate to rule out the possibility of contamination. RESULTS: Of a total of 350 paper carriers, 375 metal washers, and 234 pieces of equipment processed in cycle II and using trypticase soy broth as the inoculating medium, 123 metal washers (32%) and 8 instruments (3%) failed to be sterilized. Similar failures were noted with cycle III. The presence of either salt or protein adversely affected the system's ability to sterilize in either cycle. CONCLUSION: Further studies are needed to evaluate the extent to which salt or organic material compromise low-temperature gas-plasma sterilization. Meanwhile, users should exercise caution and use care in the cleaning of instruments that will be processed in the plasma-based sterilization technologies.

Adult↗

[Crystalline structure of endoprosthetic UHMWPE in relation to sterilization and mechanical processing].

We analysed the changes in crystallinity in sterilized and machined UHMWPE products used in the manufacture of total joint components. For this purpose, so-called DC measurements of absolute crystallinity and infrared spectroscopy for determining the relevant crystallinity were carried out. The DSC measurements are based on a further development of differential thermo-analysis (DTA), and a comparison of the melting enthalpy of an unknown material in comparison with known material. The results show particularly high values for gamma sterilized products, and the lowest values, i.e. the least brittleness, after sterilization with ETO. The crystallinity of the original material was 55%, that after gamma sterilized 56.5%, and after steam autoclaving 57.9%; after gamma sterilized in argon 56%, and after ETO sterilized 57.7%. During the period prior to the manufacture of the end product, a wide range of values is determinable. The average crystallinity of the end products varies between 55.4% and 61.6%. Among other things, changes in crystallinity during storage and after implantation must be taken into account. To summarize, we recommended ethylene oxide sterilization, after which the best values of crystallinity were seen in both semi-finished and finished products (prostheses).

Biocompatible Materials↗

[Sterile packaging].

After decontamination, cleaning, maintenance and functional testing, sterilized items must be packed suitably. The package must protect sterilized items against microbial contamination during removal from the sterilising chamber, and during storage or transport until use. The sterilized material must be packaged in suitable packaging material in accordance with the sterilising method. Sterilization packaging must conform to standards. There are not Polish standards for sterile packaging of medical devices. The article give general guidelines about: properties of sterile packaging, various national standards and European Standard, the packaging materials, general compatibility with the sterilization process which is intended to be used, general compatibility with the package forming process, and shelf life considerations.

Guidelines as Topic↗

Color change and fracture resistance of two preveneered stainless-steel crowns after sterilization.

PURPOSE: This study compared the fracture resistance and color stability of two commercially available, preveneered stainless-steel crowns before and after four sterilization techniques. METHODS: Thirty-five crowns from each of two manufacturers were divided into five groups. Four groups were sterilized twice using one of the following techniques: steam autoclave at both 121 degrees C (15 PSI) for 20 min and 132 degrees C (30 PSI) for 8 min; Chemiclave with formaldehyde at 132 degrees C for 20 min; and 2% gluteraldehyde for 10 h. The fifth group from each manufacturer was the control. Color of facings was measured before and after each sterilization in triplicate using a colorimeter, and the variance of each color parameter was analyzed for significance. Fracture resistance was measured for each group and differences between the control and experimental groups analyzed for significance. RESULTS: The results of this study show that high heat and chemical sterilizations have little effect on color and fracture resistance of the preveneered stainless-steel crowns. Student's t test analysis revealed a significantly decreased resistance to fracture with Kinder Krowns sterilized in 2% gluteraldehyde. Chemiclave sterilization caused the most negative color change in all three color parameters measured for both types of crowns. CONCLUSIONS: As neither steam technique produced significant changes in fracture resistance or color changes that were clinically detectable, the results of this study indicate that the two steam techniques tested can be used by clinicians to sterilize either Kinder Krowns or Nu Smile preveneered stainless-steel crowns.

Color↗

Mortality risk associated with tubal sterilization in United States hospitals.

Despite the millions of women who have undergone tubal sterilization in United States hospitals, little has been published about the risk of death from these procedures. To estimate a case-fatality rate of tubal sterilization, we combined data from the Commission on Professional and Hospital Activities and the National Center for Health Statistics with a review of the clinical circumstances for each woman whose death was identified as being potentially sterilization attributable. Considering all deaths temporally associated with tubal sterilization, we estimate that the case-fatality rate is nearly 8/100,000 procedures. When only deaths determined to be attributable to the sterilization operation per se are considered, the case-fatality rate is approximately 4/100,000 procedures, making death attributable to tubal sterilization a rear event.

Epidemiologic Methods↗

Menstrual pattern changes following laparoscopic sterilization with different occlusion techniques: a review of 10,004 cases.

A comparison is made of menstrual pattern changes reported by 10,004 women undergoing interval and postabortion sterilization by the laparoscopic occlusive techniques of unipolar electrocoagulation, the tubal ring, the prototype spring-loaded clip, and the Rocket clip. Controlling for prior contraceptive use, the menstrual patterns in these women sterilized by the four techniques were compared with respect to six parameters: cycle regularity, cycle length, menstrual flow duration, amount of flow, dysmenorrhea, and intermenstrual bleeding. The majority of women reported no menstrual changes subsequent to sterilization. When changes were experienced, they occurred in equal proportions in opposite directions. Depending on the parameter, from 15% to 79% of the menstrual pattern changes seen within 6 months after sterilization in women who were using oral contraceptives or intrauterine contraceptive devices at the time of sterilization could be attributed to the discontinuation of those methods of contraception. There were no significant differences between the several occlusion technique groups with respect to the proportion of women who reported changes in their menstrual patterns after sterilization.

Adult↗

Hysteroscopic sterilization with the use of formed-in-place silicone plugs.

Hysteroscopic sterilization with the use of a formed-in-place silicone plug is an office procedure which can be done with paracervical block anesthesia. It appears to be an effective method of sterilization. The present study is a review of 206 of the author's patients who chose this procedure. Thirty-four patients (16.5%) had more than one procedure for a total of 244 cases. Sterilizations were achieved in 188 patients (91.3%). The sterilization was accomplished in 166 patients (80.6%) at the time of the first procedure, in 20 of 40 patients (9.7%) at the second procedure, and in two of four patients (1.0%) at the third procedure. The primary reason for failure to achieve sterilization was tubal spasm. Of the 18 patients (8.7%) who were not sterilized, 16 were considered as failures and dropped from the study and two are awaiting a repeat procedure. No patients have become pregnant and there have been no significant complications.

Adult↗

Female sterilization failure after bipolar electrocoagulation: a 6 year retrospective study.

A 6 year retrospective study was conducted from January 1983 till December 1988. During this period there were 13,014 births, 1,776 registered spontaneous abortions and 200 tubal pregnancies. 1,437 sterilizations were performed in the same period via bipolar electrocoagulation. 11.5% of the ectopic pregnancies were in patients who had previously undergone a tubal sterilization. The failure ratio following bipolar coagulation was 1.18%, and all failures were extra-uterine pregnancies, with an average interval between sterilization and ectopic pregnancy of 28.8 months. This reflects the importance of previous sterilizations as an etiologic agent in ectopic gestations. We will discuss the possible etiological factors for our sterilization failures and how these failures can be avoided or minimized. Also diagnostic difficulties and management of an extra-uterine pregnancy (EUP) following sterilization will be presented.

Electrocoagulation↗

Development of endosalpingoblastosis and tuboperitoneal fistulas following tubal sterilization: relation with uterine adenomyosis.

A total of 25 consecutive patients who had undergone a tubal sterilization and who were referred for a hysterectomy, were examined by a peroperative methylene blue test of the tubal stumps, and extensive microscopic examination of the uterine wall, cornua and tubal stumps. Eighteen patients had been sterilized by electrocoagulation and 7 by mechanical methods (clips or rings). Tubo- or uteroperitoneal fistulas and endosalpingoblastosis were only observed in the group of patients sterilized by electrocoagulation. The development of tubo- or uteroperitoneal fistulas was correlated with the presence of endosalpingoblastosis and of uterine adenomyosis (P = 0.002 and P = 0.038, respectively). All patients with bilateral fistulas had bilateral endosalpingoblastosis and the only patient with a unilateral fistula had endosalpingoblastosis on the same side. The development of endosalpingoblastosis in patients sterilized by electrocoagulation was correlated with the presence of uterine adenomyosis (P = 0.008). In the same group of patients, a correlation between the length of the proximal tubal stump and the development of utero- or tuboperitoneal fistulas was observed (Wilcoxon test, P = 0.033). Two patients developed an ectopic pregnancy following sterilization. Both patients were sterilized by electrocoagulation, and had endosalpingoblastosis and bilateral fistulas. Our results suggest that the presence of uterine adenomyosis might predispose to the development of endosalpingoblastosis when performing tubal electrocoagulation close to the uterine cornum. We therefore suggest that when performing tubal coagulation, the intact proximal stump should be at least 2 cm.

Adult↗