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At least 685 records · Page 38Linked to original sources
PubMed2004

Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the emergency department: a randomized controlled trial.

STUDY OBJECTIVE: Although sterile technique for laceration management continues to be recommended, studies supporting this practice are lacking. Using clean nonsterile gloves rather than individually packaged sterile gloves for uncomplicated wound repair in the emergency department may result in cost and time savings. This study is designed to determine whether the rate of infection after repair of uncomplicated lacerations in immunocompetent patients is comparable using clean nonsterile gloves versus sterile gloves. METHODS: A prospective multicenter trial enrolled 816 individuals who were randomized to have their wounds repaired by using sterile or clean nonsterile gloves. The attending physician or resident completed a checklist describing patient, wound, and management characteristics. The patients were provided with a questionnaire to be completed by the physician who removed their sutures at the prescribed time and indicated the presence or absence of infection. When follow-up forms were not returned, a telephone call was made to the patient to determine whether he or she had experienced any wound complications. RESULTS: Follow-up was obtained for 98% of the sterile gloves group and 96.6% of the clean gloves group. There was no statistically significant difference in the incidence of infection between the 2 groups. The infection rate in the sterile gloves group was 6.1% (95% confidence interval [CI] 3.8% to 8.4%) and was 4.4% in the clean gloves group (95% CI 2.4% to 6.4%). The relative risk of infection was 1.37 (95% CI 0.75 to 2.52). CONCLUSION: This study demonstrated that there is no clinically important difference in infection rates between using clean nonsterile gloves and sterile gloves during the repair of uncomplicated traumatic lacerations.

Adult↗
PubMed2004

Randomized trial to compare perioperative outcomes of Filshie clip vs. Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study.

OBJECTIVE: To compare, by conducting a randomized trial, Filshie clip and Pomeroy techniques for postpartum and intrapartum cesarean sterilizations in a United States teaching hospital with respect to surgeon preference and perioperative outcomes. METHOD: Thirty-two obstetric patients consented for sterilization were randomized to Pomeroy technique or Filshie clip placement. Following the surgical procedure, surgeons and operating room technicians completed a survey regarding their experience with the procedures and preference. Patient demographic data, time for procedure and follow-up visits were obtained by chart review. RESULTS: For most postpartum sterilizations, the mean duration of the procedure was almost 7 min faster for the Filshie clip technique (p = 0.08); perioperative outcomes were equivalent (p = 0.05). Application of the Filshie clip was rated easier than Pomeroy suture application and, overall, the Filshie clip sterilization procedure was rated less difficult (p = 0.03). Seventy percent of surgeons preferred the Filshie clip technique and would choose it if only one postpartum sterilization method was available. CONCLUSION: For obstetric sterilization, surgeons preferred the Filshie clip over the Pomeroy technique. In addition, operating time was shorter for the Filshie clip. This pilot study suggests that use of the Filshie clip technique has the potential to establish a new standard of care for postpartum and intrapartum cesarean sterilization.

Adult↗
PubMed2006

Sterile, injectable cyclodextrin nanoparticles: effects of gamma irradiation and autoclaving.

Sterility is required as stated by compendial requirements and registration authorities worldwide for an injectable drug carrier system. In this study, injectable nanospheres and nanocapsules prepared from amphiphilic beta-cyclodextrin, beta-CDC6, were assessed for their in vitro properties such as particle size distribution, zeta potential, nanoparticle yield (%), drug entrapment efficiency and in vitro drug release profiles. Different sterilization techniques such as gamma irradiation and autoclaving were evaluated for their feasibility regarding the maintenance of the above mentioned nanoparticle properties after sterilization. It was found that amount these techniques, sterilization with gamma irradiation seemed to be the most appropriate technique with no effect on particle size, drug loading and drug release properties. Gamma irradiation causes some chemical changes on beta-CDC6 observed as changes in zeta potential but this does not lead to any significant changes for nanoparticle properties. Autoclaving caused massive aggregation for the nanoparticles followed by precipitation, which led to the conclusion that excessive heat disrupted nanoparticle integrity. Sterile filtration was not feasible since nanoparticle sizes were larger than the filter pore size and the yield after sterilization was very low. Thus, it can be concluded that blank and drug loaded beta-CDC6 nanospheres and nanocapsules are capable of being sterilized by gamma irradiation.

Antineoplastic Agents, Hormonal↗
PubMed2006

Effects of sterilizing-grade filters on the physico-chemical properties of onion-like vesicles.

Spherulites are new promising multilamellar vesicles that we study in a drug delivery context. The sterilization of spherulites suspensions is a necessary step before biological tests and later, before pharmaceutical applications (for example, parenteral or local injections). Among all sterilizing operations, the filtration through 0.22 microm sterilizing-grade filters (of the type Millex (Ø 4 mm) by Millipore) is easy and rapid, and we decided to study it as a mean to obtain sterile suspensions. The spherulites diameter is usually comprised between 0.2 and 0.5 microm but bigger vesicles occur and reach Ø 1 microm. The effects of such filters on vesicles' size and lipids' concentration were then compromised. After examination of this challenging operation, results proved that the sterilizing filtration had no effect on these two parameters whatever the formulation chosen. Then, the possible release of amaranth, an encapsulated hydrophilic dye was followed. With the formulations and in spite of a filter diameter inferior to that of the vesicles, the encapsulation yields were not significantly different before and after the filtration and no leakage could be detected. Finally, the spherulites' functionality after sterilizing filtration was studied under the chemical angle: vesicles containing an amphiphilic reactive anchor (CholE3ONH2) were still able to bind covalently a peptidic molecular recognition pattern. The ligation was quantified by fluorimetry as high as for non-filtrated suspensions. Thus, though spherulites can present a diameter superior to that of the sterilizing filters, their passage through them do not alter the physico-chemical properties of these vesicles.

Amaranth Dye↗
PubMed2005

A validation survey of 197 hospital steam sterilizers in The Netherlands in 2001 and 2002.

Steam sterilization is the most common method of sterilization used in hospitals and by companies sterilizing for hospitals. This study validated 197 steam sterilizers with respect to technical condition, various production processes and routine control tests, according to the European norms and standards for steam sterilization. Overall, only 40% of the validated steam sterilizers met the norms and standards. We recommend that adequate measures need to be taken, based on the comments in the validation reports, in order to guarantee the sterility of processed medical items.

Europe↗
PubMedDate not supplied

Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation.

STUDY OBJECTIVE: To compare the institutional cost of permanent female sterilization by Essure hysteroscopic sterilization and laparoscopic bilateral coagulation. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Midwestern academic medical center. PATIENTS: Women of reproductive age who elected for permanent contraception by the Essure method (n = 43) or by laparoscopic tubal coagulation (n = 44) during the time frame studied. INTERVENTIONS: Placement of the Essure inserts according to the manufacturer's instructions or laparoscopic tubal sterilization using bipolar forceps according to standard techniques of open or closed laparoscopy. MEASUREMENTS AND MAIN RESULTS: Cost-center data for the institutional cost of the procedure was abstracted for each patient included in the study. In addition, demographic data and procedural information were obtained and compared for the patient populations. The Essure system of hysteroscopic sterilization had a significantly decreased cost compared with laparoscopic tubal sterilization when both procedures were performed in an operating room setting. The decrease per patient in institutional cost was 180 dollars (p = .038). This included the cost of the confirmatory hysterosalpingogram 3 months after Essure placement and the cost of laparoscopic tubal occlusion by Filshie clip if the Essure micro-inserts could not be placed. The majority of the cost was related to hospital costs as opposed to physician costs. The Essure procedure had higher costs for disposable equipment (p <.0001), but this was offset by higher charges for operating room costs, which included the recovery room (p <.0001) and pharmacy costs (p <.0001) in the patients in the laparoscopy group. CONCLUSION: In our setting, the Essure hysteroscopic sterilization had significant cost savings compared with laparoscopic tubal sterilization (p = .038). We believe that our data represent the minimum of potential savings using this approach, and future developments will only increase the cost difference found in our study.

Adult↗
PubMed1984

Product sterilization. Why industry uses radiation.

Industry uses gamma radiation sterilization because of its superior reliability, safety, and cost savings over the EO fumigation method. EO has many processing variables and is toxic and expensive. The Environmental Protection Agency has recently declared EO to be both mutagenic and carcinogenic. The residual EO in hospital products has been reported to adversely affect hospital workers. Unlike EO fumigation, radiation sterilization imparts no toxic residuals. The coloration and embrittlement problems experienced earlier with some products sterilized by gamma radiation are being overcome with the introduction of new manufacturing materials and lower radiation dosages. Other benefits of radiation sterilization include the option of sterilizing some materials that could not otherwise be sterilized and using new types of packaging to better protect the products and increase shelf-life. The emphasis now being placed on cost containment for health care products will be another significant part of the answer to why industry uses gamma radiation sterilization.

Bacteria↗
PubMed1987

Interhospital transportation. Monitoring sterility of instrument packs.

The Minneapolis-St Paul area is currently experiencing an increase in health care mergers among hospitals. As new facilities are acquired, whether through merger or the building of satellite hospitals, economic considerations often instigate the consolidation of certain departments and services. Thus, hospitals are confronted with a new set of management problems. One such problem might be determining if the probability of contamination increases when a sterile pack is transported from the central sterile supply department of one hospital to the operating room of another hospital. This study indicates that interhospital transport of surgical packs, using a specially designed transfer system, can be accomplished without compromising the sterile status to a significantly greater degree than that associated with transport within a hospital. Many more samples would have to be assayed before these results could be considered conclusive. This study proposes a simple, reproducible, microbiologically sensitive and statistically satisfactory test to monitor the sterile integrity of surgical packs. In the past, different sterility monitoring methods proposed have required either special equipment, specially trained personnel, or complicated procedures. The assay method described here can be easily used by central sterile supply department personnel to monitor the sterile status of transported or stored surgical packs.

Asepsis↗
PubMed1984

Characteristics of women requesting reversal of sterilization.

For a definition of the characteristics of women who request reversal of sterilization, 180 such women were compared with 180 women apparently satisfied with sterilization. Women who requested tubal reversal were younger at the time of sterilization, began and completed their families at an earlier age, and were of lower socioeconomic status than those who did not request reversal of sterilization. Women requesting reversal of sterilization had a significantly higher incidence of gynecologic clinic visits after and mental health clinic visits before and after sterilization. Thirty-five women requesting reversal of sterilization were compared with 35 control women by administration of the Minnesota Multiphasic Personality Inventory (MMPI). Higher MMPI scores on the hysteria and psychasthenia scales were noted in women requesting tubal reversal.

Adult↗
PubMed1993

Effect of sterilization on contaminated sponges.

Sponges are routinely used as a storage medium for endodontic files during clinical practice; however, very little research has been done to determine the effectiveness of sterilization procedures for these contaminated sponges. The purpose of this in vitro study was to determine the efficacy of chemical vapor sterilizers (chemiclaves), steam pressure sterilizers (autoclaves), and dry heat sterilizers on laboratory contaminated sponges. Four different types of sponges were used in this study: a black, relatively nonporous sponge; a red, semiporous stationary sponge; a blue, endodontic sponge, and a yellow, common household sponge. Natural sponges were eliminated from the study, because their large pore size made them unsuitable as a storage medium for endodontic instruments. The sponges were divided into three groups: chemiclave, autoclave, and dry heat. Five samples of each sponge type were impregnated with biological indicating strips containing spores of Bacillus stearothermophilus. Each sponge was subjected to 25 cycles of sterilization. The spore strip indicator was inserted into the sponges at 1, 5, 10, 15, 20, and 25 cycles. The spore strip was cultivated in trypticase soy broth medium solution at 55 +/- 1 degree C for 7 days. At 7 days the culture vials were read for turbidity; its presence indicating a positive culture. The samples that were subjected to chemiclaving demonstrated positive cultures of 0.00%, 0.00%, and 30.00% and those to autoclaving 3.33%, 0.00%, and 0.00% positive cultures for the black, red, and blue sponge types, respectively. None of the sponges survived dry heat sterilization. The O-Cell-O sponges become unusable when subjected to all of the sterilization methods used in this study.

Equipment Contamination↗
PubMed2001

Poly(ethylene glycol)-poly(L-lactide) diblock copolymer prevents aggregation of poly(L-lactide) microspheres during ethylene oxide gas sterilization.

Sterilization procedure is one of the most important obstacles in the clinical applications of biodegradable microspheres. The microspheres prepared with poly(alpha-hydroxy acid) were severely aggregated during ethylene oxide (EO) gas sterilization, and could not be used in clinical applications. In this study, the effects of EO gas sterilization on the poly(L-lactide) (PLLA) microspheres were analyzed by nuclear magnetic resonance spectroscopy (1H-NMR), differential scanning calorimetry (DSC), gel permeation chromatography (GPC), scanning electron microscope (SEM) and size fractionation. The aggregation between the microspheres might be stimulated by high mobility of amorphous regions of PLLA on the microsphere surfaces since both water vapor and gas mixture can reduce glass transition temperature (Tg) of PLLA below the sterilization temperature. During EO gas sterilization, there were no changes in the molecular structure and the molecular weight of PLLA in microspheres, but there were changes in the crystallinity of PLLA in microspheres. In this study, poly(L-lactide)-poly(ethylene glycol) diblock copolymers (PLE) were blended with PLLA homopolymers in various ratios to design the microsphere suitable for EO gas sterilization. Aggregation of PLLA microspheres was markedly prevented when more than 4wt% of PLE was blended in the microspheres. This inhibition effect on aggregation may be due to the increased initial crystallinity of the microspheres, which help to maintain the microsphere morphology during EO gas sterilization.

Calorimetry, Differential Scanning↗
PubMed1999

Infection control: the role of disinfection and sterilization.

Many articles that document infections after improper decontamination of patient-care items have emphasized the necessity for appropriate disinfection and sterilization procedures. This paper provides recommendations on the preferred method for disinfection and sterilization of patient-care items based on the intended use of the item (i.e., critical, semicritical, noncritical). The chemical disinfectants recommended for patient-care items and instruments include glutaraldehyde, hydrogen peroxide, peracetic acid, sodium hypochlorite, alcohol, iodophors, phenolics, and quaternary ammonium compounds. The choice of disinfectant, concentration, and exposure time is based on the risk of infection associated with the use of the item. The sterilization methods briefly discussed include steam sterilization, ethylene oxide, new low-temperature sterilization technologies and dry heat. When properly used, these disinfection and sterilization processes can ensure the safe use of invasive and noninvasive medical devices. However, this requires strict adherence to current cleaning, disinfection, and sterilization guidelines.

Cold Temperature↗
PubMed2000

Sterilization of poly(dimethylamino) ethyl methacrylate-based gene transfer complexes.

Parental administration of polyplex formulations for gene therapy or genetic vaccination requires sterile preparations. The possibilities and limitations of autoclaving, filtration and a combination of both methods for sterilization of poly(2-(dimethylamino) ethyl methacrylate) (pDMAEMA) based gene transfer complexes were assessed. Agarose gel electrophoresis and circular dichroism spectroscopy showed that sterile filtration of polyplexes did not change the topology and integrity of the DNA. The transfection potential was fully retained in COS-7 and OVCAR-3 cells, although the concentration of DNA was slightly decreased by the filtration process. Pre-coating of the filter with polyplexes reduced the material loss. In contrast, autoclaving dramatically affected physical characteristics of polyplexes, resulting in complete loss of transfection potential. Sterile filtration or autoclaving of polymer alone did not result in material loss, or in decreased transfection potential after complexation with plasmid DNA. 'Naked' DNA could easily be sterilized by filtration as well. In conclusion, sterilization of complexes between pDMAEMA-based cationic polymeric gene transfer agents and DNA plasmid is feasible by filtration. Depending on the filter type used, the filtered volume should be high enough, to prevent substantial material loss. Separate sterilization of the polymer by autoclaving or filtration and DNA by filtration offers a good alternative to filtration of formed polyplexes.

Animals↗
PubMed1998

Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters.

OBJECTIVES: The purpose of this study was to evaluate a new technique for sterilizing nonlumen electrophysiology catheters that uses hydrogen peroxide gas plasma. BACKGROUND: The reuse of electrophysiology catheters may potentially result in a significant cost savings. While ethylene oxide sterilization appears to be safe and effective from a clinical standpoint, toxic ethylene oxide residuals, which exceed Food and Drug Administration standards, have been reported. METHODS: Ten nonlumen electrophysiology catheters were extensively evaluated. Each catheter was used five times and resterilized after each use with hydrogen peroxide gas plasma. Tests for sterility, mechanical and electrical integrity, chemical residuals and standard and electron microscopic inspection were performed. RESULTS: Loss of electrical integrity or mechanical integrity was not observed in any catheter. No evidence of microbial contamination was found. Surface integrity was preserved except for one ablation catheter that exhibited fraying of the insulation at the insulation-electrode interface. Surface inspection using standard magnification and electron microscopy revealed no significant change in surface characteristics associated with the sterilization process. Hydrogen peroxide was the only chemical residual noted, with an average concentration of 0.22% by weight, which is within accepted American Association for the Advancement of Medical Instrumentation limits. The cost for a standard electrophysiology catheter ranges from $200 to $800, and one sterilization cycle costs $10. If electrophysiology catheters are used five times, resterilization could potentially result in a savings of $2,000 per catheter, or $9,000 for five ablation procedures. CONCLUSIONS: Hydrogen peroxide gas plasma sterilization may provide a cost-effective means of sterilizing nonlumen electrophysiology catheters without the problem of potentially harmful chemical residuals. However, careful visual inspection of catheters, particularly at the insulation-electrode interface, is required if catheter reuse is performed.

Anti-Infective Agents, Local↗
PubMed2003

Effects of sterilization on the Tekscan digital pressure sensor.

Investigations into the effects of sterilization on a new biomechanical pressure sensor are necessary before contemplating in vivo use. Ten, designated Experimental, "K-Scan" digital pressure sensor arrays were sterilized with ethylene oxide gas (EtO), and their ability to accurately and reproducibly measure an applied load of 2225 N (500 lb) was assessed. Simultaneously, 10 un-sterilized sensor arrays, designated Control, were assessed. Each array was loaded 10 times inside a two-dimensional curved surface, and all arrays exhibited high reproducibility (coefficients of variation<2.0%). Following sterilization, the Experimental sensors showed a 22.2% average decrease in recorded force, a statistically significant difference from the pre-sterile data (p<0.002). However, when the Experimental sensors were re-calibrated post-sterilization, they showed only a 0.1% average decrease in recorded force, not a statistically significant difference (p>0.05, beta<0.05). Following 1-week storage, trial 2 data of the Control sensors showed a less dramatic yet significant 3.4% average decrease in recorded force when compared to trial 1 data (p<0.02). Control trial 2, once re-calibrated, showed a 0.5% average decrease in recorded force, not a statistically significant difference (p>0.05, beta<0.05). Results suggest that, following EtO sterilization, accurate and reproducible pressure measurements can be obtained from K-Scan sensors when calibration is performed at time of use.

Calibration↗
PubMed2001

Tubal sterilization and risk of breast cancer mortality in US women.

OBJECTIVE: To investigate the hypothesis that tubal sterilization is associated with a reduced risk of breast cancer. METHODS: We examined this hypothesis in a large prospective study of US adults. After 14 years of mortality follow-up, 3837 deaths from breast cancer were observed in a cohort of 619,199 women who were cancer-free at study entry in 1982. RESULTS: Cox proportional hazards models (adjusted for multiple breast cancer risk factors) showed a significant inverse association between tubal sterilization and breast cancer mortality (adjusted rate ratio (RR) = 0.82, 95% confidence interval (CI) 0.70-0.96). Women who were sterilized before age 35 had a lower risk (adjusted RR = 0.69, 95% CI 0.53-0.88) than women who were sterilized at 35 years of age or older (adjusted RR = 0.92, 95% CI 0.75-1.13). Also, sterilizations performed before 1975 resulted in a lower risk (RR = 0.75, 95% CI 0.62-0.91) than those performed during or after 1975 (RR = 0.98, 95% CI 0.74-1.29), possibly reflecting the likelihood of greater tissue damage with earlier procedures. CONCLUSIONS: These results suggest that tubal sterilization may lower subsequent risk of breast cancer, especially among women who are sterilized at a relatively young age. Additional studies are needed to confirm or refute these findings.

Adult↗
PubMed1994

Gamma sterilization of a semi-solid poly(ortho ester) designed for controlled drug delivery--validation and radiation effects.

Radiation sterilization is becoming increasingly popular for the sterilization of many pharmaceutical products. Although this technique is not limited to the sterilization of polymers, it is probably the most suitable method for such materials. This method however suffers several drawbacks. The sterilization of a product must lead to a safety level of 10(-6), i.e. one chance in a million to find a contaminated sample. In many cases, this assurance of sterility can be achieved by using a uniform treatment dose of 2.5 Mrad, recommended by the pharmacopeia. We investigated the possibility of using doses of radiation inferior to 2.5 Mrad to sterilize a semi-solid poly(ortho ester) (POE) developed for use as carrier in controlled drug delivery. After determination of the initial bioburden, the polymer was intentionally contaminated with the bioindicator Bacillus pumilus E 601. Following exposure to gamma irradiation, the D10 value of the radio resistant bioindicator was determined. Using the initial contamination value, the reduction factor D10 and the safety level, it is possible to calculate an optimal sterilizing dose for POE. All polymers are affected by ionizing radiation and the amount of radiation which produces a significant change in properties may vary from one polymer to the other. A molecular weight and dynamic viscosity decrease resulting from backbone cleavage was observed for this POE at a dose lower than 2.0 Mrad. Evaluation of the structure using 1H-NMR, 13C-NMR and IR analysis shows that for doses higher than 2.0 Mrad, another degredation process takes place.(ABSTRACT TRUNCATED AT 250 WORDS)

Chemical Phenomena↗
PubMed2003

Effects of autoclave sterilization on properties of dental rubber dam as related to its use as barrier membrane in guided tissue regeneration.

BACKGROUND AND OBJECTIVE: Dental rubber dams (RDs) were used as barrier membranes in guided tissue regeneration for the treatment of periodontal intraosseous defects with acceptable clinical results. The aim of the present study was to investigate the effects of autoclave sterilization on properties of RD as related to its use as a barrier membrane in guided tissue regeneration. METHODS: RDs were sterilized by either an autoclave, gamma irradiation, or chemical agents and then co-cultured with human gingival fibroblasts. The cell responses to sterilized RDs were investigated by inverted phase contrast microscopy, scanning electron microscopy (SEM) and 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) technique. The surface alterations of the autoclaved RDs were observed under SEM. The tensile strength, tear strength and elongation at break of the autoclaved RDs were tested by a universal testing machine. RESULTS: The results from cell culture, microscopic and MTT studies showed that RDs sterilized by autoclave and gamma irradiation did not deteriorate gingival fibroblasts and provided surfaces suitable for cell attachment, whereas chemical-sterilized RDs were toxic to these cells. Ultrastructurally, surface changes from the non-autoclaved RDs, including some melted areas, small pores and folds were observed on the autoclaved RD surface. The tensile strength and tear strength of the autoclaved RDs were significantly lower than those of the non-autoclaved RDs (p = 0.042, p < 0.001, respectively). In contrast, the elongation at break of the autoclaved RDs was higher than that of the non-autoclaved RDs (p < 0.001). CONCLUSION: These results suggest that the autoclave sterilization deteriorated the physical properties of RDs even though they seemed to be compatible to the cultured human cells. Therefore, the sterilization method should be taken into consideration when RDs are utilized as barrier membranes.

Analysis of Variance↗