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PubMed1996

A comparison of two methods of sterile urethral catheterisation in spinal cord injured adults.

The purpose of this study was to compare the incidence of urinary infection following sterile catheterisation after either (1) a handwash of 30 s and double gloving, (the shorter sterile technique) or (2) after a 3 minute wash from fingertips to elbows and the wearing of a sterile gown and one pair of gloves, (the longer sterile technique). Forty-six patients were randomly assigned to the two groups. No significant difference in urinary infection rates was found and as a result the more complicated technique has been discontinued.

Adult↗
PubMed2001

Efficacy of chemical sterilization and storage conditions of gutta-percha cones.

AIM: The objective of the present study was to assess the efficacy of 2.5% sodium hypochlorite and 2.2% glutaraldehyde ('Cidex') as sterilizing agents for gutta-percha cones. The efficacy of storage of gutta-percha cones in the presence or absence of paraformaldehyde was also evaluated. METHODOLOGY: Gutta-percha cones artificially contaminated with a suspension of Bacillus stearothermophilus (ATCC/7953) were treated with either 2.2% glutaraldehyde for 10, 15, 30 and 60 min and 10 and 12 h, or 2.5% sodium hypochlorite for 5, 10 and 15 min. The cones were then incubated in thioglycollate medium for the determination of microbial growth. In parallel, additional sterile gutta-percha cones were stored in sealed containers with or without paraformaldehyde tablets for 30 days. The containers were opened 30 min a day and exposed to the environment of a functioning dental clinic. Twelve cones were removed weekly from the containers to determine whether contamination had occurred. RESULTS: The results showed that 2.5% sodium hypochlorite was effective after 5, 10 and 15 min, whereas 10 and 12 h contact with 2.2% glutaraldehyde was necessary to obtain sterilization. There was no contamination of the gutta-percha cones when stored with or without paraformaldehyde. CONCLUSIONS: Sodium hypochlorite (2.5%) and 2.2% glutaraldehyde ('Cidex') proved to be effective as sterilizing agents for gutta-percha cones, with sodium hypochlorite requiring shorter periods of use. No difference was observed between the two methods of cone storage.

Anti-Infective Agents, Local↗
PubMedDate not supplied

Sterile connector.

Fabrication of a sterile connector for joining a supply source to an independent delivery location through a contaminated environment requires four design steps: 1) alignment of connector housings; 2) exclusion of the contaminated environment; 3) sterilization of the excluded region; and 4) penetration within the sterilized area followed by coupling of the protected internal conduits. Protective covers for connectors now in use may be modified to provide penetrable terminal barrier membranes that can be joined to exclude the environment. An adhesive containing an antimicrobiologic agent would set the stage for a controlled mechanical penetration of the decontaminated fused barriers. In another design concept, plastic barrier membranes without preliminary adhesions are simultaneously fused, sterilized, and penetrated by a nichrome wire heated to approximately 288 C. A system can be designed that is compatible, at the option of the user, with either of these methods. The more economical mechanical approach could then be used for parenteral fluid therapy while the nichrome wire technique would be reserved for more complex processing methods (frozen erythrocytes) or when storage of the resulting component is a factor.

Cell Separation↗
PubMed2000

Compodock, a new device for sterile docking.

BACKGROUND: A new device for sterile docking, the Compodock (Fresenius NPBI Transfusion Technology), was developed for connecting PVC tubing for medical use while maintaining sterility. STUDY DESIGN AND METHODS: Sterility of the connections was assessed by welding tubing with a heavy exterior contamination with Bacillus subtilis spores and also by welding in an environment contaminated with aerosols of B. subtilis. Tubing was either dry or liquid-filled ("wet") and had various diameters. Bacterial culture medium was flushed through the welded area and subsequently cultured. Tensile strength was measured, and, under semi-routine conditions, Compodock was tested for user friendliness and speed. RESULTS: None of the cultures of welded tubing with exterior contamination showed growth, neither the dry-dry (n = 434) nor the wet-wet connections (n = 622). Cultures were also negative for welds made in the contaminated environment (dry-dry, 67; wet-wet, 55). Tensile strength complied fully with ISO 3826 standards (that is, a force of 20 newtons [N] for 15 sec), with a mean maximal strength ranging from 73 to 100 N, depending on diameter and content of the tubing. The semi-routine handling was regarded as good: welds were easily opened; there were clear instructions and error warnings; and the processing time averaged 52 seconds. CONCLUSION: The Compodock is able to maintain a functionally closed system, with maintenance of sterility, despite heavy exterior bacterial contamination; tensile strength conformed to ISO standards. Compodock is suitable for routine implementation in the blood bank.

Bacillus subtilis↗
PubMed2001

An evaluation of complications following dental extractions using either sterile or clean gloves.

This randomized prospective study aims to evaluate any differences in the postoperative infection rate from dental extraction using either sterile or clean surgical gloves and to determine any predisposing factors that may complicate socket healing. A total of 609 patients were randomly assigned to two groups, with the operators wearing either sterile or clean gloves in performing forcep extractions. 551 patients, who had 811 extractions performed, returned for the postoperative assessment visit. There was no difference in the incidence of an acutely inflamed socket, acutely infected socket and dry socket and also no significant predisposing factors found between the sterile and clean glove groups. The pre-operative diagnosis of caries, periodontal disease or retained root had a higher tendency of producing an acute-inflamed socket, whereas an acutely infected socket only developed in the cases of retained root. On the pain intensity level, an acutely inflamed socket caused mild to moderate pain, on acutely infected socket caused moderate to severe pain; and a dry socket caused severe pain in the majority of cases. The study concluded that the use of sterile surgical gloves does not offer an advantage over clean gloves in minimizing socket inflammation, infection, as well as a dry socket following dental extraction.

Adolescent↗
PubMed1982

[Sterilization of mentally retarded women].

Seven mentally retarded women were sterilized in the Department of Obstetrics and Gynaecology of Medical School Hannover between 1.6.74 and 1.6.81. The decision to operate proceeded only after careful consideration by the director of the clinic. Each case was documented with proof that improvement of the mental situation was unprobable and that sterilization seemed highly desirable. In spite of strong reservation the sterilization of a mentally retarded may medically and ethically be justified in exceptional cases. The operation seems possible by the following: The sterilization may only be performed if the patient does not obviously refuse it. Diagnosis and prognosis of the mental handicap must undoubtedly be proven. If the patient cannot judge the consequence of the operation the legal guardian must decide for her. The court must consent in these cases. Regarding legal theory the decision by the guardian is an open question.

Adolescent↗
PubMedDate not supplied

Observation on retrieved Hylamer glenoids in shoulder arthroplasty: problems associated with sterilization by gamma irradiation in air.

Hylamer is an ultra-high molecular weight polyethylene that was used in the glenoid prosthesis of the Global Shoulder. It was developed from a joint venture with DePuy Orthopaedics, Inc, and E.I. DuPont Company. In presterilization evaluations it was noted to have improved mechanical strength with superior creep and wear resistance. However, after sterilization was performed with gamma irradiation in an air environment from 1990 to 1993, the Hylamer glenoids were affected by oxidation, which altered the mechanical properties, and they became brittle and eroded. From 1993 to 1995 Hylamer glenoids were sterilized by gamma irradiation in a nitrogen environment. From 1995 to 1998 sterilization was by gas plasma processes, which do not create the oxidation problem. Since 1998 the glenoid prosthesis of the Global Shoulder has been made exclusively of Enduron and is gas sterilized. The primary purpose of this article is to provide orthopaedic surgeons the best information available about Hylamer glenoids. We make suggestions concerning the diagnosis and treatment of the patients who had a Hylamer glenoid inserted between 1990 and 1993.

Arthroplasty, Replacement↗
PubMedDate not supplied

Medicalization, reproductive agency, and the desire for surgical sterilization among low-income women in urban Brazil.

This article draws on data from ethnographic fieldwork in an urban housing project to examine the social context and meanings of surgical sterilization for low-income women in Brazil. Low-income women resort to sterilization because they distrust or are unsatisfied with alternative methods and because it helps them to fulfill the requirements of modern, responsible motherhood. Although sterilization is an option among few alternatives, and one that has subjected women to greater medical management and intervention, I argue that sterilization also represents poor women's active struggle to improve their lives and to resist the burdens placed on them by unequal gender relations. This article contributes to a growing anthropological literature that demonstrates how reproduction has become a central site where social values are constituted and contested, and it details women's diverse responses to the process of medicalization.

Adult↗
PubMed2006

Non-voluntary sterilization.

We cannot easily condemn in principle a policy where people are non-voluntarily sterilized with their informed consent (where they accept sterilization, if they do, in order to avoid punishment). There are conceivable circumstances where such a policy would be morally acceptable. One such conceivable circumstance is the one (incorrectly, as it were) believed by most decent advocates of eugenics in the late nineteenth and early twentieth century to exist: to wit, a situation where the human race as such is facing a threat. Perhaps today's Chinese experience with a threat of over-population is a more realistic example? Finally, there is some room for a kind of non-voluntary (and coercive) sterilization without informed consent. I think of people who are severely mentally retarded, and who cannot understand how sexual intercourse relates to conception. If some of these persons are fertile and sexually active, it may very well be the morally right thing to do to sterilize these persons, in their own best interest, but without their consent--if necessary even through coercive means.

Eugenics↗
PubMedDate not supplied

Blood tubing and cytokine production: effect of sterilization.

Blood tubings commonly represent an integral component of hemodialysis circuits. Different factors may influence their biocompatibility, such as the type of material, the sterilization mode and the geometry. In vivo the final biocompatibility may be further complicated by the individual host response, the flow parameters, and the impact of mechanical trauma on blood's cellular components (i.e. erythrocytes). In this in vitro study we evaluated some commercially available blood tubings sterilized by different methods as to their interaction with normal leukocyte population and tested the response of these cells in terms of cytokines (IL-1beta, IL-1Ra, TNF-alpha). As a positive control, leukocytes were incubated with 0.5 ng/mL of bacterial lipopolysaccharide (LPS) or with Cuprophan of comparable surface. The results showed that cytokine production was markedly reduced, particularly in the case of gamma-ray-sterilized tubings. Of interest, it was not always related to the adherence. However in some cases, particularly of gamma-ray sterilization, adherence was none, despite the cytokine production.

Apoptosis↗
PubMed2002

Evaluation of rapid readout biological indicators for 132 degrees C gravity and 132 degrees C vacuum-assisted steam sterilization cycles using a new automated fluorescent reader.

OBJECTIVE: The primary objective of this study was to evaluate fluorescent readout results of Attest 1291 Biological Indicators (BIs) (3M Health Care, St. Paul, MN) and Attest 1296 BI test packs (containing Attest 1292 BIs) using full and fractional cycles compared with the growth data when prolonged incubation (7 days) was included. Gravity displacement and vacuum-assisted steam sterilization cycles were evaluated. A secondary objective of this study was to evaluate the new automated rapid fluorescent reader (Attest 290 Auto Reader). DESIGN: The rapid readout BIs for gravity displacement and vacuum-assisted steam autoclave cycles at 132 degrees C were processed using full (4 minutes) and four fractional cycles that provided 30% to 80% positive results for growth after 24 hours of incubation (48 hours of incubation for Attest 1292 BIs from the Attest 1296 test packs). Sixty of each type of BI were tested for each cycle (300 of each BI type in total). RESULTS: For all full steam sterilization cycles, results of the rapid fluorescent readout and the 24-hour, 48-hour, and 7-day growth tests were negative for all Attest 1291 and 1292 BIs tested. For all fractional cycles, the 24- and 48-hour growth results for the Attest 1291 and 1292 BIs, respectively, were the same as the 7-day growth results. The fractional cycle data indicated that fluorescent rapid readout was a more sensitive indicator than growth. There were rare (0.9%) false-negative results for BIs under fractional cycle conditions and these all correlated with short fractional cycle exposure times. CONCLUSIONS: The fluorescent rapid readout results of the 1291 BIs and 1296 BI test packs reliably predict both 24- and 48-hour and 7-day growth. These data support the value of rapid readout BIs for sterilizer monitoring for both the vacuum-assisted and the gravity displacement steam sterilization cycles. The new automated reader requires less manipulation of the BI and makes monitoring user friendly and less prone to user errors.

Biomarkers↗
PubMed2004

Preliminary results for a new final package test to assess the quality of sterile package systems.

OBJECTIVES: To develop a microbial test method to ascertain the passage of airborne bacteria through the medical device packaging system after sterilization, and to apply this test method to flexible packages under mechanical pressure changes. METHODS: Petri dishes filled with nutrient agar were integrated into the packaging unit prior to sterilization. We examined paper packaging consisting of 1 (single-paper packaging [P]), 2 (double-paper packaging [PP] and textile and paper double packaging [TP]), and 3 (double packaging with transport packaging [TPP]) layers. After sterilization, the test packages were pressed five times per minute for 1 or 3 hours by a mechanical device weighing 1 kg. This exposure took place in rooms with an average airborne bacterial count of 35 (room 1) or 440 (room 2) CFU/m3. The packaging was opened following culture at 37 degrees C for 48 hours to determine the number of colonies formed. RESULTS: The proportion of contaminated packages rose with the duration of mechanical stress and increased airborne bacteria concentration. Thus, mechanical pressure change for 3 hours resulted in the contamination of 60% (P), 15% (PP), 0% (TP), and 0% (TPP) of the packages in room 1, whereas 100% (P), 65% (PP), 73% (TP), and 0% (TPP) of the packages in room 2 were contaminated. CONCLUSIONS: This test method allows sterile packaging systems to be tested for contamination under practical conditions without extensive laboratory preparation. Contamination as a result of laboratory errors can be ruled out almost certainly.

Central Supply, Hospital↗
PubMed2006

Sterility and microbiological assessment of reused single-use cardiac electrophysiology catheters.

OBJECTIVE: To assess the performance and limitations of a reprocessing protocol for nonlumen electrophysiology catheters by testing the sterility of reprocessed devices and defining the maximum number of reprocessing cycles sustainable by the device in hygienically safe conditions. DESIGN: Simulated use, reprocessing, and testing of the catheters. SETTING: Microbiology and virology department of a public health diagnostic laboratory. INTERVENTIONS: Seventy-three catheters were collected after clinical use on patients. The first group of devices was tested for sterility after 1 cycle of reprocessing. By the repetition of simulated use (blood inoculated with bacteria) and reprocessing (decontamination, cleaning, and hydrogen peroxide gas plasma sterilization), we obtained 39 sample devices reprocessed 2 times, 26 reprocessed 3 times, 28 reprocessed 4 times, 36 reprocessed 5 times, and 22 reprocessed 6 times. Devices were cultured for 28 days in trypticase soy broth. RESULTS: We tested 208 catheters with 6 cycles of reprocessing and 4 inoculated bacteria species. No devices tested positive for the inoculated strains until the fourth cycle of reprocessing. One of 35 catheters showed the growth of the inoculated strain Bacillus subtilis after 5 cycles of reprocessing, and 1 of 22 catheters showed growth of this organism 6 cycles. After the second reprocessing, 7 of 36 devices showed growth of gram-negative bacteria other than the strain inoculated. CONCLUSIONS: Reprocessing according to the reprocessing protocol was insufficient to guarantee device sterility after 5 reuses. Cleaning with enzymatic solution revealed good cleaning properties with efficient bioburden reduction. Storage intervals of longer than 24 hours during reprocessing should be avoided to limit contamination or bacterial overgrowth. Technical considerations suggest the introduction of reprocessing procedures only in hospitals with considerable workloads.

Cross Infection↗
PubMed1996

Comparison of a rapid readout biological indicator for steam sterilization with four conventional biological indicators and five chemical indicators.

OBJECTIVE: In this study, we compare a new biological indicator that provides results within 3 hours with four conventional, 48-hour biological indicators and five chemical indicators. DESIGN: Biological indicators tested included the conventional Attest 1262, Proof Plus, Assert, and Biosign, and the new Attest 1292 Rapid Readout biological indicator. Chemical indicators tested included Comply, Propper, Chemdi, Sterigage, and Thermalog S. Spore survival following 121 degrees C in a gravity displacement sterilizer was measured by media color change after incubation for 24 and 48 hours at 56 degrees C for the conventional biological indicators, fluorescence at 3 hours for the Attest 1292 Rapid Readout biological indicator, and color change for the chemical indicators. Each exposure time was replicated 12 times with 5 samples of each indicator per run (ie, 60 replicates per indicator). RESULTS: At 48 hours, the conventional biological indicators Attest 1262, Proof Plus, Assert, and Biosign showed 100%, 95%, 88%, and 93% spore survival at 5 minutes' exposure 0%, 0%, 0% and 8% at 10 minutes; and all showed 0% survival at 15 minutes' exposure. Following a 3-hour incubation, the Attest 1292 Rapid Readout biological indicator showed fluorescence at 100%, 72%, and 0% at 5, 10, and 15 minutes, respectively. The chemical indicators Comply, Propper, Chemdi, Sterigage, and Thermalog S revealed sterilization failure rates of 100%, 100%, 100%, 100%, and 100% at 5 minutes' exposure; 0%, 0%, 0%, 92%, and 100% at 10 minutes; and 0%, 0%, 0%, 3%, and 27% at 15 minutes' exposure, respectively. CONCLUSIONS: The sensitivity of the Attest 1292 Rapid Readout biological indicator parallels that of conventional biological indicators. These data suggest that a 3-hour rapid readout biological indicator is equivalent to a standard 48-hour biological indicator. Some chemical indicators (eg, Thermalog S) failed to indicate adequate sterilization at 15 minutes' exposure. These chemical indicators have the potential of causing unnecessary recall of adequately sterilized items.

Equipment Contamination↗
PubMed1995

Gas plasma sterilization--application of space-age technology.

Gas plasma sterilization is new to the healthcare field. The first such sterilizer has been manufactured by Advanced Sterilization Products (J&J, Irvine, CA). The system uses hydrogen peroxide as the substrate gas and radio frequency emissions to generate plasma. This system is a low-temperature, quick-acting process with no toxic residues. It appears that this sterilizer system holds promise in the healthcare field and could help to reduce the use of ethylene oxide.

Hydrogen Peroxide↗
PubMed2003

National survey of quality assurance activities for pharmacy-compounded sterile preparations.

The compliance of hospitals' quality assurance practices for pharmacy-compounded sterile preparations with the American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products was studied. A survey based on the 2000 ASHP guidelines was developed to determine current practices for compounding sterile preparations in hospital pharmacies. Practices were compared with those identified in a 1995 ASHP survey. The survey was mailed in July 2002 to a stratified random sample of 600 hospital pharmacy directors. There were a total of 182 usable responses, for a net response rate of 30.3%. Quality assurance practices for some quality domains showed low compliance with the 2000 ASHP guidelines. Only 5.2% of pharmacies that compounded risk level 1 preparations were compliant with garb requirements. Only 4.7% of pharmacies compounding risk level 3 preparations were compliant with recommendations for documentation. Compliance with guidelines on the use of resources to determine expiration dates was high (95.5%). Hospitals were moderately compliant with guidelines related to personnel training (62.7%) and labeling (61.1%). Although some improvements were observed, hospital pharmacies in 2002 were still not fully compliant with the ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.

Data Collection↗
PubMed2001

A randomized controlled trial of direct access for laparoscopic sterilization.

OBJECTIVES: The aim of this study was to establish and evaluate a direct access service for laparoscopic sterilization. METHODS: A pragmatic randomized controlled trial was carried out on a total of 232 women referred to Aberdeen Royal Infirmary for sterilization between 1 June 1996 and 31 March 1997, from 57 general practices around Aberdeen, Scotland, comprising 75 from general practices that had received criteria for direct access, and 157 from control practices. The main outcome measures were: patients' waiting times to appointments and operation, satisfaction, short-term regret, operative complications and costs; conjoint analysis of patient preferences; GPs' adherence to referral criteria; GP and gynaecologist satisfaction; and NHS costs. RESULTS: Analysis was by intention to treat. There were no inappropriate direct referrals. Waiting time was lower in the intervention group, but there were more visits post-operatively to the GP. Patient and doctor satisfaction was equally high in both groups. There was no difference in operative complication rate, nor in total cost to patients or to the NHS. GPs and gynaecologists strongly supported direct access, but women preferred to meet both a gynaecologist and a GP before sterilization (routine referral). Other attributes of care important to patients included written information, although waiting time was not important. Of all women referred for sterilization during the study period, only 31% were suitable for direct referral. CONCLUSIONS: Patients preferred routine referral, and there were no differences in patient costs or satisfaction. There was, however, strong medical support for direct referral. Restrictive direct referral criteria may limit the uptake. These findings are important for future planning of direct referral services. Important methodological lessons were also learnt about the conduct of trials involving the primary-secondary care interface.

Adult↗
PubMedDate not supplied

Analysis of a carcinogen, 4,4'-methylenedianiline, from thermosetting polyurethane during sterilization.

Polyurethane (PU) is widely used in medical devices such as potting material in artificial dialysis devices, plasma separators, etc. Gamma-ray irradiation is frequently used for the sterilization of such devices. This paper reports that a carcinogen, 4,4'-methylenedianiline (MDA, p,p'-diaminodiphenylmethane), is produced from medical thermosetting PU by gamma-ray irradiation. Gamma-ray irradiated PU was immersed in methanol or equine serum. The serum was treated with a mixture of 5N HCIO4:acetonitrile (1:10) in order to deproteinate and recover MDA. It was found that MDA is formed from thermosetting PU at around a few ppm in the original sample. The production of MDA increased with increasing irradiation dose. The MDA amount formed was related to the irradiation dose by a second order equation. Results of methanol and serum extraction were similar. Pressurized steam (autoclave) sterilization in place of gamma-ray sterilization was also examined. MDA production was not found in autoclave sterilization procedures. Gel permeation chromatography (GPC) of methanol or N,N-dimethylformamide (DMF) extract of irradiated PU showed that the PU oligomers eluted. Time course of methanol extract of irradiated PU was detected at 245.5 nm. This showed an exponential decline regardless of doses of irradiation.

Aniline Compounds↗