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PubMed1999

Biomechanical properties of sterilized human auditory ossicles.

Bone allograft material is treated with sterilization methods to prevent the transmission of diseases from the donor to the recipient. The effect of some of these treatments on the integrity of the bone is unknown. This study was performed to evaluate the effect of several sterilization methods on the mechanical behaviour of human middle ear bones. Due to the size and composition of the bones (approximately 1.5 mm diameter by 4 mm long), mechanical testing options were limited to the traditional platens compression test. Experiments were first performed with synthetic bone to evaluate the precision of this test applied to small specimens. Following this, fresh frozen human ossicles were thawed and sterilized with (i) 1 N NaOH (n = 12); (ii) 0.9% LpH, a phenolic solution (n = 12); or (iii) steam at 134 degrees C (n = 18). A group of 26 control specimens did not receive any sterilization treatment. Material and structural properties were determined from axial compression testing. Results from the synthetic bone showed that the test was reproducible, with standard deviations less than 20% of the means. Significant differences occurred in stiffness and ultimate force values between NaOH-treated and autoclaved bones when compared to normals (p<0.05), but not for LpH-treated bones. LpH is not approved for medical use, so NaOH is the most appropriate of the treatments studied for the sterilization of ossicle allografts.

Analysis of Variance↗
PubMed1980

Non-sterile intermittent catheterization with antibiotic prophylaxis in the acute spinal cord injured male patient.

The efficacy of antibiotic prophylaxis by the oral and intravesical routes was studied in acute spinal cord injury patients maintained on a non-sterile intermittent catheterization program. There were 25 male patients investigated and monitored with daily urine cultures. Significant bacteriuria occurred at a rate of 0.83 per cent. This infection rate was greater than that determined previously using a sterile catheterization technique (0.28 per cent), p less than 0.05). Control patients catheterized with a sterile technique and no antibiotic prophylaxis had an infection rate of 0.96 per cent. Establishment of significant bacteriuria was more prominent when patients were catheterized every 8 hours as opposed to every 4 hours. Despite antibiotic prophylaxis the non-sterile procedure results in unacceptable rates of significant bacteriuria. The sterile technique may be preferred in the acute spinal cord center.

Anti-Bacterial Agents↗
PubMed2001

Safety and efficacy of levonorgestrel implant, intrauterine device, and sterilization.

OBJECTIVE: To evaluate safety and efficacy of levonorgestrel-releasing contraceptive implants (Norplant; Leiras Oy, Turku, Finland) in developing countries. METHODS: We used controlled cohort methodology. Women attending family planning clinics in eight developing countries selecting Norplant were enrolled, together with women of similar age choosing intrauterine devices (IUDs) or surgical sterilization. Participants were interviewed and examined at semi-annual visits and followed-up for 5 years regardless of change of contraceptive methods. Incidence rate ratios of health events were estimated for initial and current method use. RESULTS: Altogether, 7977 women initiated Norplant, 6625 IUD, and 1419 sterilization. The overall follow-up rate was 94.6% and 78,323 woman-years of observation were accumulated. Pregnancy rates for Norplant, copper IUDs, and sterilization each averaged less than 1 per 100 woman-years. With two exceptions, no significant excess risk of serious morbidity was detected for Norplant users compared with controls. The incidence of gallbladder disease was higher in women who initiated Norplant use than in controls (rate ratio 1.52, 95% confidence interval [CI] 1.02, 2.27), as was the incidence of hypertension and borderline hypertension in current implant users (rate ratio 1.81; CI 1.12, 2.92). Other new findings were increased risks of respiratory diseases and decreased risks of inflammatory disease of the genital tract in Norplant users compared with IUD users and sterilized women. CONCLUSION: The study confirms the safety with respect to serious disease and the high contraceptive efficacy of Norplant, copper IUDs, and sterilization.

Adult↗
PubMed1997

Sterilization of instruments in general practice: what does it entail?

There is increasing interest amongst general practitioners in carrying out minor surgical procedures but it is unclear what resources are available for this. We decided to assess the level of knowledge of sterilization and the use of benchtop sterilisers in general practice by circulating a postal questionnaire to the 883 general practices in the Trent Regional Health Authority. The response rate was 49%. Minor surgical procedures were performed in 86% of practices but less than half of respondents understood what was meant by sterilization, 28% considered that the floor of the surgery should be disinfected or sterilised and 13% believed that immersion in 2% glutaraldehyde for 10 min constituted sterilization. 93% had a benchtop steriliser, only a quarter kept a log book, and approximately a third had it serviced at intervals of one year or longer. Less than 50% understood the correct position in which a bowl or kidney dish should be placed and 41% had used or had access to a local sterile services department. The concept of sterilization is not clearly understood and the use of benchtop sterilisers in Trent is suboptimal. On-going education of staff in primary care is required and consideration should be given to a system of accreditation.

England↗
PubMed2002

Impact of sterilization on the porous design and cell behavior in collagen sponges prepared for tissue engineering.

This study investigates the impact of different sterilization processes on structural integrity and stability of collagen sponges designed for tissue engineering. Collagen sponges with uniform pore size (20 microm) were sterilized either with ethylene oxide (EO) or gamma irradiation (2.5 Mrad). Gamma-sterilized sponges showed a dramatic decrease of resistance against enzyme degradation and severe shrinkage after cell seeding. Collapsed porosity inhibited fibroblasts and barred completely the human umbilical vein endothelial cell ingrowth into the sponges. On the contrary, the porous structure and stability of EO-sterilized sponges remained almost unaltered. Fibroblasts and endothelial cells exhibited favorable proliferation and migration within sponges with normal morphology. Tubular formation by seeded endothelial cells occurred early in the first week. Therefore, we emphasize that the impact of sterilization of biomaterials is substantial and any new procedure has to be evaluated by correlating the impact of the procedure on the porous structure with cell proliferation behavior.

Biocompatible Materials↗
PubMed2003

Influence of sterilization on the mineralization of titanium implants induced by incubation in various biological model fluids.

The aim of this work was to investigate the effect of the sterilization processes on the mineralization of titanium implants induced by incubation in various biological model fluids. Titanium samples were submitted to the following sterilization processes used for implant materials: steam autoclaving, glow discharge Ar plasma treatment and gamma-irradiation. The modification of the treated surfaces was evaluated by contact angle determinations, X-ray photoelectron spectroscopy (XPS), laser profilometry and X-ray diffraction. The most significant modifications were detected on the wettability: while the samples treated with Ar plasma became highly hydrophilic (water contact angle approximately 0 degrees), gamma-irradiation and steam sterilization induced an increase in the hydrophobicity. After being sterilized, the samples were incubated for one week in three biological model fluids: Hanks' Balanced Salt Solution, Kokubo's simulated body fluid (SBF) and a fluid, designated by SBF0, with the same composition of SBF but without buffer TRIS. The level of mineralization of the incubated Ti samples, assessed by dynamic contact angle analysis, scanning electron microscopy, electron dispersive spectroscopy and XPS, indicated that the early stages of mineralization are essentially independent of the sterilization method. In contrast, the incubating fluid plays a determinant role, SBFO being the most efficient medium for biomineralization of titanium.

Biocompatible Materials↗
PubMedDate not supplied

Oxidation in orthopaedic UHMWPE sterilized by gamma-radiation and ethylene oxide.

Ten new polyethylene prosthetic components (PEs), ethylene oxide (EtO)- and gamma-sterilized, were studied by means of infrared (IR) analysis in order to evaluate oxidation. Using attenuate total reflection infrared spectroscopy the authors demonstrate that all samples show surface oxidation, formed during processing and shaping, related to mechano-degradation. By means of Fourier transform infrared (FTIR) microscopy and derivatization techniques, the EtO-sterilized PEs present different behaviour in comparison to the gamma-radiated. The former show low levels of depth oxidation that could be related to the degradation which occurred during preparation of slices for IR analysis. The gamma-sterilized PEs show higher oxidation levels, variable from sample to sample, on the surface and in the bulk. The authors demonstrate that oxidation is described both by carbonyl species distribution and by hydroperoxide concentration. The hydroperoxides could be responsible for oxidative PEs ageing in in vivo service. The different oxidation levels and distribution could depend on the conditions of gamma-sterilization, in particular on the rate of the dose absorbed, not previously reported for ready-to-implant PEs. Chain scission of gamma-radiated UHMWPE, estimated by IR analysis, results in reduction of molecular weight and consequently in less abrasive resistance. The scheme of UHMWPE oxidation due to gamma-sterilization demonstrates the inhomogeneous distribution of reactive species in PEs responsible for the unpredictable performance in vivo.

Biocompatible Materials↗
PubMed1984

Sterilization and care of surgical instruments and supplies.

Adequate instrument handling and sterilization are important aspects of office surgery. Heat sterilization is the most reliable choice. The steam autoclave is highly recommended. Dry heat is effective but can pose some storage problems. Gas sterilization is useful for heat-sensitive materials but not practical for the private office. Cold "sterilization" is not reliable for incisional surgery. In addition to proper sterilization modality selection, the surgeon must observe important standards of instrument care, packing, and storage.

Ambulatory Surgical Procedures↗
PubMed2003

Evaluation of a low-temperature steam and formaldehyde sterilizer.

We evaluated a low-temperature steam and formaldehyde (LTSF) sterilizer based on the draft European Standard prEN 14180. Microbiological tests were conducted on small and full loads using process challenge devices in five programs (P1-P5). With small loads all tests showed no growth of Bacillus stearothermophilus (ATCC7953) spores. However, positive cultures were observed with full-load tests using P5 (sterilization temperature, 50 degrees C). Our data indicated that the load influenced the efficacy of the LTSF sterilizer. Desorption tests were conducted to determine residual formaldehyde in indicator strips. The mean concentrations of formaldehyde in P1-P5 were 31.9, 56.3, 54.9, 82.2 and 180.6 microg, respectively, which are below the limits allowed by the draft Standard. Our results indicate that the LTSF sterilizer is useful for sterilization because of its excellent efficacy, short handling time, and safety.

Disinfectants↗
PubMed1996

Dental instrument and device sterilization and disinfection practices.

Dental instruments and devices require sterilization or high-level disinfection. An evaluation of the implementation of such processes was undertaken. Eleven thousand questionnaires on methods used to sterilize and disinfect dental instruments were sent to dental practices and 1391 (13%) were returned for evaluation. Sixty-eight percent of respondents believed they were sterilizing their instruments, however, some of the liquid chemical products used were not suitable for sterilizing instruments, and 12% of respondents used incorrect contact times. Forty-nine percent of respondents did not challenge autoclaves with biological spores to check their function at an acceptable frequency. There were similar product and timing problems when a high-level liquid chemical disinfection was attempted. Although the return sample was small, problems were identified that can and should be corrected. This study demonstrates that the potential for person-to-person transmission of infectious agents such as the human immunodeficiency virus (HIV) and hepatitis B and C viruses via inadequately sterilized dental instrument exists depending on the prevalence of HIV in the dental practice area.

Dental Equipment↗
PubMed1980

The use of indicators for quality control of sterilizing processes in hospital practice: a review.

The development over the last 100 years of spore preparations to challenge sterilization processes using steam is reviewed briefly, and efforts to standardize such biological indicators (BIs) in the last 30 years are reviewed in more detail. A similar review of BIs for the ethylene oxide processes is presented with discussion of spore test resistances compared to the potential resistances of organisms commonly found as contaminants in the materials being sterilized. The development and need for quick-reading chemical indicators (CIs) that produce color changes only when exposed to moist heat or ethylene oxide plus moisture, as planned, are discussed. It is emphasized that BIs and CIs can only indicate that the sterilization process has worked as planned. They do not indicate that the materials being sterilized are completely sterile.

Cross Infection↗
PubMed1998

Inactivation of human immunodeficiency virus type 1, hepatitis A virus, respiratory syncytial virus, vaccinia virus, herpes simplex virus type 1, and poliovirus type 2 by hydrogen peroxide gas plasma sterilization.

BACKGROUND: Studies were conducted to determine the capability of a hydrogen peroxide gas plasma sterilization process to inactivate several types of viruses. Six test agents were used: HIV type 1, human hepatitis A virus, respiratory syncytial virus, vaccinia, herpes simplex virus type 1, and poliovirus type 2. METHODS: The test viruses were suspended in cell culture medium and dried on the bottom of sterile glass petri dishes. The inoculated dishes were processed in the hydrogen peroxide gas plasma system for half the normal sterilization cycle time. Four inoculated carriers for each virus were used in two separate half cycles. Infectivity of the test viruses and cytotoxicity to the indicator cell lines were assayed. RESULTS: The hydrogen peroxide gas plasma sterilization process produced inactivation of the six viral test agents under these experimental conditions. The reduction in viral titers ranged from 2.5 log10 to 5.5 log10, a 99.68% to 99.999% decrease. CONCLUSIONS: These results clearly demonstrate the virucidal effectiveness of the hydrogen peroxide gas plasma sterilization process against both lipid and nonlipid viruses.

Cells, Cultured↗
PubMed2001

The changes in ovarian hormone levels and ovarian artery blood flow rate after laparoscopic tubal sterilization.

OBJECTIVE: To investigate the changes in serum ovarian hormone levels and ovarian artery blood flow rate by Doppler ultrasonography following laparoscopic tubal sterilization. METHODS: Laparoscopic tubal sterilization have been performed on 13 voluntary subjects between the sixth and eighth days of the menstrual cycle. Serum ovarian hormone levels and ovarian artery blood flow rate, by Doppler ultrasonography, were determined 3 days before the operation, on the post-operative third day and on the post-operative third month. The results of 10 participants who finished the follow-up period were analyzed. RESULTS: There were no statistically significant changes in serum levels of ovarian hormones after laparoscopic tubal ligation. The end-diastolic blood flow in ovarian artery was found to be decreased following tubal sterilization (8.7+/-2.8 and 7.4+/-1.8m/sec, respectively, P>0.05), while resistivity index (RI) increased after the operation (0.7+/-0.1 and 0.8+/-0.03, respectively, P>0.05). CONCLUSION: There was no change in ovarian hormone levels after laparoscopic tubal sterilization. There is slight but statistically non-significant decrease in ovarian artery blood flow rate following tubal sterilization, signifying a local increase in vascular resistance.

Adult↗
PubMed2002

Preparation and characterization of sterile and freeze-dried sub-200 nm nanoparticles.

The feasibility of producing sterile and freeze-dried polyester nanoparticles was investigated. Various poly(D,L-lactide-co-glycolide) and poly(D,L-lactide) were selected as biodegradable polymers. Using the salting-out procedure, process parameters were optimized to obtain sub-200 nm particles. After purification, the nanoparticle suspensions containing different lyoprotectants were sterilized by filtration. Freeze-drying was performed using vials covered with 0.22 microm membrane filters in order to preserve the suspensions from bacterial contamination. Sterility was assessed on the final product according to pharmacopoeial requirements using the membrane filtration method. With all polymers tested, sub-200 nm particles could be obtained. Nanoparticles with a size as low as 102 nm were prepared with good reproducibility and narrow size distribution. Upon freeze-drying, it appeared that complete redispersion of all types of polyester nanoparticles could be obtained in presence of the lyoprotectants tested such as saccharides while aggregation was observed without lyoprotectant. Sterility testing showed no microbial contamination indicating that sterile nanoparticulate formulations have been achieved.

Capsules↗
PubMed1999

Evaluation of disinfection and sterilization of reusable angioscopes with the duck hepatitis B model.

PURPOSE: Nosocomial transmission of viral hepatitis and retrovirus infection has been reported. The expected risk is greatest for the hepatitis B virus (HBV). The duck HBV (DHBV) has similar biologic and structural characteristics to HBV and has been adopted as a suitable model for disinfectant testing. METHODS: Angioscopic examination of the external jugular vein was performed on DHBV-infected ducks. After use, the instrument was air dried for 3 minutes. Samples were obtained by flushing the channel with 5 mL of phosphate buffered saline solution. The samples were collected immediately after drying (control), after flushing with 5 mL of water, after glutaraldehyde disinfection for 5, 10, and 20 minutes, and after ethylene oxide gas sterilization. Angioscopes were either precleaned or uncleaned before disinfection/sterilization. Residual infectivity was assessed with inoculation of samples into the peritoneal cavity of day-old ducks (n = 231). RESULTS: DNA analysis results of liver samples showed that all 38 control ducks became infected. The frequency of DHBV infection was reduced to 93% (14 of 15) by flushing the angioscope with 5 mL of sterile water. No transmission occurred after the use of any of the properly precleaned and disinfected/sterilized angioscopes. However, after the use of the uncleaned angioscopes, the transmission rate was 90% (9 of 10) and 70% (7 of 10) after 5 and 10 minutes of contact time, respectively, in 2% glutaraldehyde. Even after the recommended 20 minutes of contact time, there was still 6% (2 of 35) transmission. After ethylene oxide sterilization, two of the recipient ducklings (2 of 35) were infected with DHBV. CONCLUSION: There was no disease transmission after reuse of disposable angioscopes adequately cleaned before disinfection or sterilization. However, if the angioscopes are inadequately cleaned, DHBV can survive despite glutaraldehyde disinfection or ethylene oxide sterilization. This contrasts with previous in vitro and in vivo data with solid surgical instruments. It is postulated that the presence of a narrow lumen or residual protein shielding within the lumen may compromise effective inactivation of hepadnaviruses on angioscopes, with the potential risk for patient-to-patient transmission.

Angioscopes↗
PubMed1991

Comparison of convection heat sterilization units for the orthodontic office.

Convection heat has become a popular means of sterilization for orthodontic practices. Several commercial brands are currently being marketed. This investigation compares the Cox sterilizer, the Dentronix DDS 5000, and a Farberware convection oven by means of thermal and bacteriologic testing. Thermal testing was conducted with a thermocouple in well-defined areas of each oven, while bacterologic evaluation involved Bacillus subtilis spore strips placed in specific sectors. The results showed that specific areas of the Cox sterilizer dropped below 375 degrees F during the sterilization cycle, while the DDS 5000 maintained temperatures above 375 degrees F. The Farberware oven reached a mean temperature (including 1 standard deviation) above 375 degrees F when set at 400 degrees F after the oven was allowed to warm up for 13 minutes. Spore growth was detected in several sectors of both the Cox sterilizer and the DDS 5000. No growth was seen in the Farberware oven.

Dental Offices↗
PubMed2001

Comparison of microlaparoscopy and conventional laparoscopy for tubal sterilization under local anesthesia with mild sedation.

STUDY OBJECTIVE: To compare tubal sterilization performed by microlaparoscopy and conventional laparoscopy. DESIGN: Prospective, randomized trial (Canadian Task Force classification I). SETTING: Gazi University School of Medicine. PATIENTS: Twenty women undergoing surgical sterilization. INTERVENTION: Ten sterilizations by conventional laparoscopy and 10 by microlaparoscopy. MEASUREMENTS AND MAIN RESULTS: The techniques were comparable in quality of visualization, operating time, amount of drugs used for sedation and local anesthesia, and intraoperative pain scores. However, the postoperative analgesic requirement was significantly less in women treated by by microlaparoscopy. CONCLUSION: Tubal sterilization by microlaparoscopy does not differ greatly from conventional laparoscopic sterilization.

Adult↗
PubMed2004

Female sterilization in Latin America: cross-national perspectives.

Fertility levels have dropped substantially in Latin America in recent decades, fuelled by increased contraceptive use and notably a method mix skewed towards female sterilization. This study examined choice of female sterilization in four Latin American countries: Brazil, Colombia, the Dominican Republic and Peru. Data were drawn from national Demographic and Health Surveys conducted in 1995--1996. Discrete-time hazard models were used on the five-year calendar modules of women's reproductive histories to consider the effects of a number of sociodemographic and contextual determinants as they pertained to status at the moment of the event. The results revealed that the likelihood of a woman's having undergone contraceptive sterilization was increasing over time in Brazil and Peru, suggesting that the potential for future growth of this method remains strong. A consistent pattern of increased probability of sterilization with higher education was seen across all countries, seemingly dispelling certain controversial claims that the procedure may have been disproportionately performed on the poor. At the same time, the multilevel analytical approach pointed to significant cluster-level random effects, suggesting that there were additional unmeasured contextual influences on women's propensity to choose sterilization.

Adolescent↗