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PubMed1989

[Does the ideal dental sterilizer exist].

Heat sterilization is still the best known method to sterilize all dental instruments. No compromise is acceptable. The use of the so-called cold sterilizing solutions is only palliative. Glutaraldehyde and chlorine compounds seem to possess some sterilizing properties, but these solutions are recognized as being toxic, allergenic and probably carcinogenic. The use of two (2) or more sterilizers may be the ideal method to sterilize the metal, plastic and rubber materials... There are many practical sterilization systems on the market today. An intensive evaluation of these systems is necessary before one is used in a dental office and subsequently an annual reevaluation is suggested. The regular use of physical, chemical and especially biological indicators is the only sure way to control the many failures associated with sterilizers. The choice of equipment is directly related to the total aseptic protocol to be implemented. The objective of this article is to review and clarify certain ideas and controversies associated with this subject matter.

Dental Equipment↗
PubMedDate not supplied

The impact of national policies on the acceptance of sterilization in Colombia and Costa Rica.

Using data that cover the period 1978 to 1986, this article assesses the effect of policies concerning the provision of female sterilization during the early 1980s. The annual rate of sterilization among ever-married women aged 20-39 in Costa Rica was approximately one-fifth lower in 1985 than in 1982, when sterilization became illegal. Medical committees continued to review each case individually, and sterilizations were still available, especially to less educated women, among whom prevalence increased slightly between 1981 and 1986. However, sterilization prevalence decreased modestly among women aged 35-39 and among the better educated. As of 1986, 16.7 percent of all women who were currently in union relied on sterilization, compared with 17.3 percent in 1981. In Colombia, annual rates of sterilization rose by less than 4 percent from 16.9 in 1977 to 17.5 in 1979, and prevalence increased among women at all educational levels, in rural and urban areas, and especially among women aged 30-44. As a result of the adoption of flexible eligibility criteria, minimal cost, and accessibility in both rural and urban areas in Colombia since 1984, sterilization is now the most preferred contraceptive method there, used by approximately 18.3 percent of all women currently in union as of 1986.

Adult↗
PubMed1989

[Sterilization and quality control].

The dental profession has always considered the sterilization of surgical instruments as an important element in the prevention of infection. During the last decade the concern with blood and to a lesser degree with saliva in the transmission of infection, due primarily to the hepatitis and HIV viruses, has resulted in many corporate organizations releasing recommendations to reinforce the use of sterilization techniques and disinfection techniques when sterilization is not applicable or justifiable. As a result of the fact that the two terms are often intermingled, the authors review the fact that each one pursues different objectives and put the emphasis on sterilization by briefly reviewing the principal advantages and disadvantages of each method of sterilization presently available for use in dental offices. Subsequently, they stress the importance of introducing quality control in any infection prevention program, in order to assure that the sterilization process is not at the mercy of human error or mechanical failure. The pharmaceutical industry, food chains and hospital centres have for more than 40 years realized the importance of using chemical indicators and especially biological testing. Only biological testing can put one's mind at ease, for the professional in a dental office and the patient receiving care, that the instruments or objects that one comes in contact with are truly sterile. The dental profession did not wait for the discovery of the hepatitis B and HIV viruses to become preoccupied with the spread of disease and have sterilized their surgical instruments for many years.(ABSTRACT TRUNCATED AT 250 WORDS)

Communicable Disease Control↗
PubMed1987

[Determination of formaldehyde concentration in a low-pressure sterilizer].

Two methods are described in determining the concentration of Formaldehyde in the sterilisation chamber of a regular commercial sterilizer. The measurement and flow of the concentration is ascertained during a routine sterilization procedure. With regard to the biological efficiency test of the examined apparatus the stability of the active Formaldehyde concentration is controlled. The difficulty in the determination of the Formaldehyde in such sterilizers is due to the fact that samples must be taken at a reduced pressure of 200 mbar. We have developed two different sampling methods. By employing the first continual collection method Formaldehyde gas is drawn out of the sterilization chamber with a high vacuum pump and conveyed with hydrogen into a nickel catalysator, whereby Methane is formed. The determination of Methane is carried out with a flame ionisation detector (F.I.D.). The results of the F.I.D. method are between 10.1-10.8 mg Formaldehyde per litre of gas. It is possible to detect a slight, even reduction in the Formaldehyde concentration throughout a period of 90 min. With the second discontinual method of determination vacuum tubes are employed which are furnished with external magnetic valves for control. By opening the magnetic valves briefly during the pre-vacuum therewith causing loss of pressure, Formaldehyde gas can be collected in the vacuum tubes throughout the sterilization procedure. The determination of the samples extracted by the discontinual method is carried out spectrophotometrically using the p-Rosanilin method after Miksch et al. The second method of determination shows values of 9.0-9.8 mg/l (Sx = 0.8 mg/l). These results lie somewhat lower than those of the F.I.D. determination. The flow of the concentration during 90 min. shows an average reduction of 7.4% and matches exactly the curve which was obtained by the F.I.D. method. By measuring the Formaldehyde concentrations which goods are subjected to in normal sterilization procedure it is possible to examine the efficacy of Formaldehyde sterilizers under regular conditions. Only by quotation of the Formaldehyde concentration present is it possible to reproduce details on sterilization times of treated articles.

Calibration↗
PubMed1988

Efficacy of various methods of sterilization of acupuncture needles.

The iatrogenic transmission of hepatitis B virus by inadequately sterilized acupuncture needles recently has been reported. Because some licensed chiropractors use acupuncture as a therapeutic modality, we have evaluated sterilization methods for these needles, which would be adaptable for use in a chiropractic office. Dry heat, boiling water, pressurized steam, sodium hypochlorite, and 70% alcohol were compared with a glass bead dry heat sterilizer originally developed for dental instruments. Presterilized acupuncture needles were contaminated with Bacillus stearothermophilus, Escherichia coli or Staphylococcus epidermidis and sterilized for intervals ranging from 5 sec to 30 min. The needles were then cultured to determine the efficacy of the sterilization regimen. Seventy percent alcohol was ineffective as a sterilization method. In terms of both time and convenience, the glass bead apparatus was the most efficient of the remaining methods tested. B. stearothermophilus-contaminated acupuncture needles were sterilized within 10 sec of exposure to preheated glass beads. Less than 10 sec exposure killed E. coli and S. epidermidis. A significant advantage of the glass bead sterilizer over the other methods was the absence of physical damage to the needles.

Acupuncture Therapy↗
PubMed1984

Tubal sterilizations performed in freestanding, ambulatory-care surgical facilities in the United States in 1980.

In 1981 the American Association of Gynecologic Laparoscopists and the Division of Reproductive Health, Centers for Disease Control, jointly conducted a study of tubal sterilizations performed in 141 freestanding, ambulatory-care surgical facilities in 1980 in the United States. Information was collected through mailed questionnaires and telephone interviews. Of 330 potential responding facilities, 141 we identified as freestanding, ambulatory-care surgical facilities. About 16,500 tubal sterilizations were performed in these facilities in 1980. The mean number of tubal sterilizations per freestanding, ambulatory-care surgical facility was 212. Sixty-seven percent of tubal sterilizations were performed in the south and west. General anesthesia was the anesthetic method used in 97% of the procedures. Nearly 91% of tubal sterilizations were done via laparoscopy, with bipolar electrocoagulation the tubal-occlusion method used most frequently. After tubal sterilization the patients were observed for an average of 2.4 hours before discharge. The average cost of laparoscopic tubal sterilization was $801; for nonlaparoscopic tubal sterilization it was $850.

Adult↗
PubMed1982

Deaths from contraceptive sterilization in bangladesh: rates, causes, and prevention.

This report summarizes the second of 2 epidemiologic investigations of deaths attributable to sterilization in Bangladesh. All deaths resulting from sterilizations performed nationwide between September 16, 1980, and April 15, 1981, were investigated and analyzed. Nineteen deaths from tubal sterilization were attributed to 153,032 sterilization operations (both tubal sterilization and vasectomy), for an overall death-to-case rate of 12.4 deaths per 100,000 operations. This rate is lower than that (21.3) for operations performed in Dacca and Rajshahi Divisions from January 1, 1979, to March 31, 1980, although this difference is not statistically significant. Anesthesia overdosage, tetanus, and hemorrhage were the leading causes of death. Improvements in anesthesia management, surgical asepsis, and postoperative monitoring of vital signs should make sterilization operations even safer. Although tubal sterilizations performed in Bangladesh cost some lives, they avert far more maternal deaths. The net health impact is strongly favorable: For every 100,00 tubal sterilizations performed, approximately 100 deaths are prevented.

Anesthesia↗
PubMed1994

Effectiveness of two types of sterilizers on the contents of sharps containers.

The purpose of this study was to evaluate the killing effect that a gravity steam autoclave (GSA), a high-vacuum steam sterilizer (HVA) or an unsaturated chemical vapor sterilizer (UCV) had on endospores present on strips or applied to dental needles within three sizes of sharps containers. Commercial spore strips containing 1.7 x 10(5) Bacillus stearothermophilus endospores were used, while the needles were soiled with an equal number of spores or with spores mixed with blood. Needles were tested capped and uncapped. Initial operating conditions were for the: (1) GSA were 129 kPa at 124 degrees C for 30 minutes; (2) HVA were 214 kPa at 131 degrees C for 10 minutes and (3) UCV, 172 kPa at 134 degrees C for 20 minutes. Strips and needles were placed within 3/4 filled containers. Fill materials consisted of needles, syringes, plastic sheaths and scalpel blades. Containers were processed upward or on their sides. Twenty-five strips or needles comprised a test group for each operational parameter. Processed strips and needles were aerobically cultured at 56 degrees C for 7 days. If sterilization was not accomplished after the initial period, additional exposure time was added. Results included: (1) soiled needles are more difficult than strips to sterilize; (2) capping or the presence of blood did not affect sterilization efficiency; (3) container positioning was important only for the smallest container; (4) additional exposure time was usually required when sterilizing soiled needles; (5) the HVA killed all spore challenges in a single sterilization cycle and (6) GSA and UCV were approximately equal in sterilization efficiency.(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesia, Dental↗
PubMed1993

Long-term effect of tubal sterilization on menstrual indices and pelvic pain.

OBJECTIVE: To evaluate the long-term effect of tubal sterilization on menstrual indices and pelvic pain. METHODS: Five hundred women undergoing sterilization were interviewed before sterilization, 6-10 months after surgery, and 3-4.5 years later. Four hundred sixty-six non-sterilized comparison women were interviewed in parallel. The study population consisted of low-income, ethnically and regionally diverse women from three participating institutions. RESULTS: When women who were taking oral contraceptives were excluded, no long-term differences was found between sterilized and nonsterilized women in terms of menstrual cycles, bleeding between periods, prolonged or heavy flow, dysmenorrhea, or noncyclic pelvic pain. Hysterectomy was uncommon (3.2%), but statistically more prevalent among sterilized women (4.55%) than nonsterilized women (2.17%) (P = .019). CONCLUSIONS: Tubal sterilization has no long-term effect on menstrual indices or pelvic pain. An increase in severe dysmenorrhea, which emerged as a disturbing but nonsignificant trend at 6-10 months, did not progress over the next 3-4.5 years. Reasons for an increased rate of hysterectomy are not clear, but may be related to a lower threshold for choosing hysterectomy as a treatment option once a woman has been sterilized.

Adult↗
PubMedDate not supplied

The relative safety of gamma-ray, autoclave, and ethylene oxide gas sterilization of thermosetting polyurethane.

Sterilization of polyurethane (PU) produces 4,4'-methylenedianiline (MDA), a known carcinogen, and various other compounds. The relationships of the components of PU to the formation of these compounds by sterilization were studied. Specimens of PU fabricated from different combinations of isocyanates and polyols were obtained from dialyzers. The molecular weight of the particular polyol was found to influence the production of MDA by sterilization. Sterilization also produced many unidentified compounds. MDA production was not always associated with the production of the other compounds. Compared with gamma-ray irradiation and ethylene oxide gas (EOG) sterilization, autoclave sterilization eluted more hydrophilic compounds. This phenomenon was significant for PUs produced from smaller-molecular-weight polyols. The combination of autoclave sterilization and a PU produced from a larger-molecular-weight polyol is recommended to minimize the production of potentially toxic compounds. Of the techniques studied, EOG sterilization produced the least amounts of MDA and the other compounds, but the residue of EOG is itself problematic. The risk posed by the amounts of MDA extracted was not significant, but the biological safety of the other compounds remains to be determined.

Aniline Compounds↗
PubMed1996

Heat-sterilized PD fluid blocks leukocyte adhesion and increases flow velocity in rat peritoneal venules.

Data from cell culture experiments indicate that heat sterilization of peritoneal dialysis (PD) fluids produces cytotoxic glucose degradation products. The present vital microscopic study investigated the effects of different sterilization methods on the biocompatibility of PD fluids. Thus, heat-sterilized (commercially obtained and experimentally produced) and filter-sterilized PD fluids (pH = 5.30-5.40; 1.5% glucose) were compared with Tyrode buffer, with respect to the effects on microvascular blood flow velocity and leukocyte adhesion in the rat mesentery. Exteriorization of the mesentery produced a mild inflammation, known from the literature and characterized by the adhesive rolling of leukocytes along venular walls. Superfusion of the mesentery with filter-sterilized PD fluid had no significant effects on leukocyte rolling or flow velocity in venules 25-40 microns in diameter compared with buffer superfusion. Heat-sterilized PD fluid decreased the concentration of rolling leukocytes and increased flow velocity significantly, as compared with buffer and filter-sterilized PD fluid. The results indicate that heat sterilization of PD fluids produces substances that interact with microvascular tone and leukocyte-endothelial adhesion, which hypothetically could impair the acute, granulocyte-mediated defense against bacterial infections.

Animals↗
PubMed1997

[Evaluation of medical supplies sterilization at health care institutions in Poland].

The assessment of the condition of sterilization of medical supplies in health care settings in Poland was done. The following issues were taken into consideration: preparation of medical supplies for sterilization, methods of sterilization, including used apparatus, and the control systems for monitoring the quality of sterilization process. It was shown that the system of sterilization of medical supplies in Poland is not satisfactory. There is the need for improvement actions, especially including: the change for dry-heat sterilizers to autoclaves; the organization of the centers for sterilization services; the installation of washer-disinfectors, and the wide introduction of monitoring of the quality of sterilization processes with the use of chemical indicators and the periodic control with biological indicators.

Cross Infection↗
PubMedDate not supplied

Selection of biological indicator for validating microwave heating sterilization.

For the purpose of selecting an appropriate biological indicator for evaluation of the effects of microwave heating sterilization, we examined aerobic bacterial spores to determine whether microwaves have non-thermal sterilization effects. After microwave irradiation on dry bacterial spores (three species), none of the bacterial spores were killed. The survival rate of the spores after microwave irradiation of spore suspensions (twelve species) was compared with that after heating by a conventional method. The order of heat resistance in the bacterial species was similar between the two heating methods. Bacillus stearothermophilus spores were the most heat-resistant. These results suggest that microwaves have no non-thermal sterilization effects on bacterial spores, the specific resistant spores to microwave heating, and microwave heating sterilization can be evaluated in the same way as for conventional heating sterilization. As a biological indicator for evaluation of overkill sterilization, B. stearothermophilus spores may be appropriate for microwave heating sterilization as well as steam sterilization.

Bacteria↗
PubMed1998

Ectopic pregnancy in sterilized and nonsterilized women. A comparison.

OBJECTIVE: To assess whether differences occurred in the presentation, treatment and postoperative outcomes of ectopic pregnancy in sterilized and nonsterilized women. STUDY DESIGN: All cases of ectopic pregnancy admitted over five years at two hospitals were reviewed. Using a case-control method, patients with ectopic pregnancy and prior tubal sterilization were compared with the next nonsterilized patient with ectopic pregnancy admitted within 30 days. Statistical comparison, utilizing t tests, chi 2 tests of Fisher's exact test, when appropriate, was performed. RESULTS: Thirty-eight (18%) of 208 patients with ectopics during the study period had undergone prior sterilization. This group, when compared with the 38 nonsterilized patients with ectopics, was similar for gestational age at diagnosis, frequency of pelvic inflammatory and sexually transmitted diseases, and mean human chorionic gonadotropin (hCG) level; the preoperative sonographic findings were also similar in the two groups. Sterilized patients were less likely than controls to have had serial hCG levels, while their mean duration of symptoms at admission was shorter. Although both groups had a similar distribution of surgical management (laparoscopy, laparotomy or both) and postoperative complications, there were trends toward a higher risk of ectopic rupture and hemoperitoneum in sterilized patients. CONCLUSION: Ectopic pregnancies following tubal sterilization have clinical manifestations and surgical outcomes similar to those occurring without prior sterilization, except for less frequent determination of serial hCGs, probably related to a shorter duration of reported preceding symptoms. The trend toward more frequent rupture and hemoperitoneum in this group suggests that sterilized patients are less likely to heed the early warnings of this complication.

Case-Control Studies↗
PubMedDate not supplied

Industrial manufacture of parenteral products in The Netherlands. A survey of eight years of media fills and sterility testing.

Sterility testing and media fills are essential requirements in the pharmaceutical industry. With the results obtained the manufacturer must ensure that the aseptic filling process is under control. In an eight year (1988-1995) retrospective survey of three major Dutch pharmaceutical companies the performance of the sterility test, of media fills and their relationship have been statistically evaluated. The products included human and veterinary pharmaceuticals and biologicals, and were divided into six different groups according to their production process and primary containers. A distinction was made between the results from the period 1985-1991 and the period 1992-1995, because this made the statistical analyses of a number of types of products possible, and because some significant changes in the production process were made in 1991 at some of the production sites. The results of the evaluation of the sterility test show that the frequency of false positives has not changed significantly. The overall rate of false positives of 0.17% is a factor ten better than considered acceptable by USP XXIII. For all product groups the frequency of positive sterility tests has decreased during the period of investigation. During the period 1992-1995 there was no significant difference between the results of product sterility tests and the negative controls for any of the product groups. This indicates that given the present state-of-the-art production the sterility test offers little or no additional security. The overall contamination of the media fills done in the more recent period is a factor twenty better than the limit given in the PDA Technical Monograph No. 2. In the more recent period there is a good agreement between the observed positive rate of the sterility tests and the positive rate that had been estimated from the results of the media fills. This indicates that despite some shortcomings, media fills are an adequate simulation of the production process and can be used to give an estimate of the rejection rate for the various product groups. The overall conclusion is that the production conditions of the participating Dutch pharmaceutical companies comply with the current international guidelines for aseptic production and sterility testing.

Drug Contamination↗
PubMed1976

[Biological and chemical indicators of thermal sterilization and their possible effect on its general concept].

Regarding to ignorance of germ thermoresistance occurring in hospital environment, the effect of sterilization in medicine is determined occasionally on samples of medium with high number of germs or tests are performed to determine the sterilization success (in pharmacy) by examining samples of sterile badges, although their degrees of contamination (mostly low) before sterilization are not known. Instead of fixed sterilization parameters, the new second Pharmacopoeia of the German Democratic Republic (1976 seqq.) allows a free choise of sterilization parameters ingeniously spaced (110 degrees C--140 degrees C vapour, 160 degrees C--200 degrees C hot air) according to diagrams. The mentioned methods both imperfect and expensive ones should be replaced by introducing sterilization indicators whose changes might render the designation "sterile" possible. Substantial differencies between biological and chemical indicators are shown.

Chromium↗
PubMed1976

[Biological and chemical indicators of thermal sterilization and their possible influence on its total conception].

Regarding to ignorance of germ thermoresistance occurring in hospotal environment, the effect of sterilization in medicine is determined occasionally on samples of medium with high number of germs or tests are performed to determine the sterilization success (in pharmacy) by examining samples of sterile badges, although their degrees of contamination (mostly low) before sterilization are not known. Instead of fixed sterilization parameters, the new second Pharmacopoeia of the German Democratic Republic (1976 seqq.) allows a free choise of sterilization parameters ingeniously spaced (110 degrees C--140 degrees C vapour, 160 degrees C--200 degrees C hot air) according to diagrams. The mentioned methods both imperfect and expensive ones should be replaced by introducing sterilization indicators whose changes might render the designation "sterile" possible. Substantial differencies between biological and chemical indicators are shown.

Cross Infection↗
PubMed1980

An epidemiologic study of risk factors associated with pregnancy following female sterilization.

Data on 14,700 female sterilization patients were collected by the International Fertility Research Program (IFRP) from 1972 to 1978 and analyzed to determine risk factors associated with the incidence of pregnancy following sterilization. With a case-control approach, it was found that younger patients (less than or equal to 34 years old) and those who did not lactate after sterilization had a higher risk of becoming pregnant. Patients who were sterilized in the early phases of a service program had a higher risk of pregnancy than those sterilized later. In the laparoscopic series, the relative risk of pregnancy was four times greater in patients who had the prototype spring clip than in patients who had the Falope ring. The relative risk increased to 7.0 when patients who had the prototype spring clip were compared to those who had the Falope ring, electrocoagulation, or the Rocket clip. Patients sterilized by electrocoagulation had a low pregnancy risk, but the risk of an ectopic pregnancy was significantly higher than for those sterilized with mechanical devices. In the culdoscopic series, the tantalum clip had an unacceptable pregnancy risk.

Adult↗