[Processing of medical products in the urological practice]. / Aufbereitung von Medizinprodukten in der urologischen Praxis.

The reprocessing of medical products is an important topic both in urological practices and in hospitals. The complexity is caused by the increasing variety of medical instruments and also by the increasing demands on the legally required quality of the reprocessing. The Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) have published recommendations for the processing of MD and last updated them in 2012. This article summarizes the legal framework for the reprocessing of medical devices, how medical devices are categorized before the appropriate procedure for reprocessing can be selected and the various steps in the reprocessing. A special focus is placed on medical products that are typically found in urological practices or outpatient departments and are processed there. Furthermore, the necessity of validating the processing method and the required training (expertise) of the personnel are discussed.

Experimental contamination of a closed endotracheal suction system: 24 h vs 72 h.

OBJECTIVE: To ascertain the desirability of replacing closed suction systems after 72 h rather than after 24 h (manufacturer's recommendations) because it is possible that a reduction in the frequency of manipulations might reduce the risk of exogenous nosocomial pneumonia. We investigated the presence of time-dependent differences (after 24 h and 72 h) in pathogen survival/growth in artificially contaminated closed suction catheters (OptiFlo). DESIGN: The trial simulated bacterial contamination of the airways using a suspension of 2 x 10(3) CFU/ml of Staphylococcus aureus or Pseudomonas aeruginosa. Contamination was performed on a total of 80 catheters. Forty were contaminated a total of eight times every 45-60 min. Another 40 catheters underwent the same procedure 24 times over three consecutive days. Microbiological analysis of the catheters took place after 24 h and 72 h, respectively. RESULTS: The mean S. aureus load was 9.4 CFU/catheter after eight suction procedures and 6.2 CFU/catheter after 24 suction procedures (3 days). Mean growth of P. aeruginosa was 5.3 CFU/catheter, and 8.2 CFU/catheter after 3 days. There was no statistically significant difference between day 1 and 3 for S. aureus (p = 0.474), but there was for P. aeruginosa (p = 0.004). CONCLUSION: Our findings show that, from an experimental point of view, it remains controversial whether routine change of closed suction catheters can be extended from 24 h to 72 h. However, clinical evidence suggests that prolonged use of a closed suctioning system is safe.

Heater-cooler units: contamination of crucial devices in cardiothoracic surgery.

BACKGROUND: Several cases of Mycobacterium chimaera infection have recently been reported in cardiosurgical patients. So-called heater-cooler units (HCUs) used in cardiosurgical procedures are suspected to be the reservoir for pathogen growth and dissemination. AIM: To assess the contamination status of HCUs at our facility. METHODS: Air sampling for mycobacteria was conducted at different distances from the machines and in the area around the operating table. Air sampling was also conducted for non-fermenters as a surrogate parameter for water-associated pathogens. FINDINGS: Mycobacterium chimaera was detected in the water tanks of the HCUs. When the devices were operating, M. chimaera was also found in their exhaust air, as well as in the area around the operating table. Non-fermenters were identified at different distances from the running HCU and the area around the operating table. Cultures remained negative when the devices were switched off. CONCLUSIONS: Exhaust air from HCUs may be a pathway of pathogen transmission to patients undergoing open chest heart surgery. Although, for technical reasons, relocation of HCUs is difficult to achieve, only strict separation of the HCU from the operating room appears to enhance patient safety. Using non-fermenters as a surrogate parameter may be considered a viable option for a timely risk assessment. The design of HCUs should be modified to keep susceptibility to contamination at a minimum.

Surveillance of nosocomial sepsis and pneumonia in patients with a bone marrow or peripheral blood stem cell transplant: a multicenter project.

BACKGROUND: For surveillance of nosocomial bloodstream infections (BSIs) and pneumonia during neutropenia in adult patients who have undergone bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT), a multicenter study--the Hospital Infection Surveillance System for Patients with Hematologic/Oncologic Malignancies (ONKO-KISS)--was initiated in Germany in 2000. METHODS: Nosocomial infections were identified in neutropenic patients by means of Centers for Disease Control and Prevention definitions for laboratory-confirmed BSI and modified criteria for pneumonia. RESULTS: During the first 38-month period of the study (i.e., through December 2003), a total of 1899 patients associated with 28,273 neutropenic days were investigated. Of these, 1173 (62%) had undergone allogeneic and 726 (38%) had undergone autologous BMT or PBSCT. The mean duration of neutropenia was 14.9 days (9.6 and 18.1 days after autologous and allogeneic transplantation, respectively). Overall, 395 BSIs and 168 cases of pneumonia were identified. The pooled mean site-specific incidence density per 1000 neutropenic days was 14.0 for BSI (12.4 and 18.9 for the allogeneic and autologous transplantation groups, respectively) and 5.9 for pneumonia (6.1 and 5.6 in the allogeneic and autologous transplantation groups, respectively). After allogeneic transplantation, 22.4 BSIs per 100 patients and 11.0 cases of pneumonia per 100 patients occurred, whereas 18.2 BSIs per 100 patients and 5.4 cases of pneumonia per 100 patients occurred after autologous transplantation. The majority (57%) of pathogens associated with BSI were coagulase-negative staphylococci. CONCLUSIONS: The ongoing ONKO-KISS project provides unprecedented reference data about the incidence of pneumonia and sepsis among BMT recipients and PBSCT recipients in Germany. These data will be used for further evaluation of the impact of hygiene measures and therapeutic regimens for these patients.

Surveillance of nosocomial infections in adult recipients of allogeneic and autologous bone marrow and peripheral blood stem-cell transplantation.

To identify overall and site-specific rates of nosocomial infections (NIs) during the neutropenic, as compared to the non-neutropenic stage of treatment in adult recipients of allogeneic and autologous bone marrow transplantation (BMT) and peripheral blood stem-cell transplantation (PBSCT), a prospective, 54-month study was started at the Haematological Stem Cell Transplantation Unit of the University Hospital of Freiburg, Germany. NI types were identified using modified CDC definitions. A total of 351 patients (14 256 in-patient days, 5026 neutropenic days) were investigated (316/90% allogeneic, 35/10% autologous; BMT: 119 patients, PBSCT: 234 patients). The mean length of neutropenia was 14.3 days (range: 0-66). Antimicrobial prophylaxis for allogeneic transplantation consisted of ciprofloxacin, trimethoprim/sulpha-methoxazole, fluconazole, and metronidazole. In total, 239 NIs were identified in 169 patients (48.1%), and of these 171 (71.5%) occurred during neutropenia (34.0 NIs per 1000 days at risk). The main pathogens were coagulase-negative staphylococci (36.3%), Clostridium difficile (20.4%), and enterococci (10.0%). Site-specific incidence densities during neutropenia vs non-neutropenia were: 13.9 vs 1.6 bloodstream infections (all central line-associated), 11.9 vs 1.8 pneumonias, 3.0 vs 2.9 gastroenteritis, and 1.6 vs 0.3 urinary tract infections. The greatest number of NI in BMT and PBSCT recipients is acquired during neutropenia, and multicentre surveillance programmes should focus on this.

Surveillance of nosocomial infections in a neurology intensive care unit.

To identify overall and site-specific nosocomial infection (NI) rates in patients receiving neurological intensive care therapy, a prospective study was started in 1997 in the ten-bed neurological intensive-care unit (NICU) of the University Hospital of Freiburg, Germany. Case records and microbiology reports were reviewed twice a week, and ward staff were consulted. NI were defined according to the Center for Disease Control and Prevention (CDC) criteria and were categorised by specific infection site. Within 30 months, 505 patients with a total of 4,873 patient days were studied (mean length of stay: 9.6 days). 122 NI were identified in 96 patients (74 patients with one, 18 with two and 4 with three infections. An incidence of 24.2/100 patients and incidence density of 25.0/1,000 patient days of NI in the neurological ICU were documented. Site-specific incidence rates and incidence densities were: 1.4 bloodstream infections per 100 patients (1.9 central line-associated BSIs per 1,000 central line-days), 11.7 pneumonias per 100 patients (20.4 ventilator-associated pneumonias per 1,000 ventilator-days), 8.7 urinary tract infections per 100 patients (10.0 urinary catheter-associated urinary track infections (UTIs) per 1,000 urinary catheter-days). Additionally, 0.4 cases of meningitis, 0.8 ventriculitis, and 1.2 other infections (catheter-related local infection, diarrhea) were documented per 1,000 patient days. 15% of nosocomial pathogens were A. baumannii (due to a outbreak of an nosocomial pneumonia with A. baumannii), 13% S. aureus, 10% E. coli, 7% CNS,7% Bacteroides spp., 7% Enterobacter spp., 6,5% Klebsiella spp.,5.9% enterococci, 5.9% streptococci, and 4.7% Pseudomonas spp. In eight cases of NI no pathogen could be isolated. In future, data on NI in NICUs should be assessed in greater detail, both to improve the quality of care and serve as a basis for identification and implementation of the most effective measures by which to prevent these infections in patients receiving intensive neurological care.

Can household dishwashers be used to disinfect medical equipment?

In hospitals, medical instruments are usually cleaned and disinfected in a washer/disinfector. However, it is not efficient for small hospitals or general practitioners to purchase such machines as they would not be working to capacity. We investigated the possibility of cleaning and disinfecting medical equipment in a conventional household dishwasher modified to achieve a temperature of 71 degrees C. For this purpose we contaminated screws with different test soils containing either bacterial (100 screws) or viral (106 screws) suspensions. Test organisms were re-isolated from 2% of the screws after bacterial contamination and 4.7% of those with viral contamination. In both cases we found dishwasher-processing to be a suitable means of disinfecting medical instruments.

Nosocomial outbreak of norovirus gastroenteritis and investigation of ABO histo-blood group type in infected staff and patients.

The blood groups were analysed of staff and patients (N=45) infected during two nosocomial outbreaks of norovirus gastroenteritis at a German University hospital. Persons with O phenotype were significantly less affected than was expected from the normal distribution of blood group types in Southwest Germany (OR 2.45; 95% CI 1.22-4.95; P=0.01).

Can quality circles improve hospital-acquired infection control?

It is a fundamental principle of continuous quality improvement (CQI) that processes should be the objects of quality improvement. The objective of this study was to improve process quality concerning the prevention of hospital-acquired infections in surgical departments and intensive care units by a continuous quality improvement (CQI) approach based mainly on quality circles. This approach was evaluated in a prospective controlled intervention study in medium-size acute care hospitals (four intervention and four control hospitals). During two intervention periods (each 10 months) four external physicians with training in hospital epidemiology and infection control introduced and supervised quality circles in the intervention hospitals. Process quality was assessed by interviewing senior staff members before the first and after the second intervention period using standardized questionnaires. The gold standard process quality was defined on the basis of the CDC/HICPAC-guidelines for the prevention of hospital-acquired infections. Most of the evaluated aspects of process quality belonged to the HICPAC-categories IA and IB respectively, the CDC category I. Fifty quality circle sessions were performed in the four intervention hospitals of which 28 were dealing directly with key subjects in infection control. In the intervention hospitals, 19.8% of evaluated aspects of process quality which concerned the prevention of hospital-acquired infections were improved compared to only 6.9% in the control hospitals (P<0.05). Sixty-six point seven percent of positive changes in process quality were initiated by the results of the quality circles. Our study demonstrates that a CQI approach based on infection control quality circles can lead to a substantial improvement of process quality regarding the prevention of hospital-acquired infections.

Cost efficacy of tazobactam/piperacillin versus imipenem/cilastatin in the treatment of intra-abdominal infection.

OBJECTIVE: To compare the cost, efficacy and cost efficacy of tazobactam/piperacillin and imipenem/cilastatin in the treatment of intra-abdominal infection. DESIGN: The analysis was retrospective and based on a decision tree. Effectiveness data were obtained from 19 published clinical trials. Direct costs were quantified per patient from the time the decision was made to administer the antibacterial to the end of the first course of treatment or the end of a subsequent course of treatment, if required. The primary end-point was the cost per successfully treated patient. The cost per life saved was also analysed. Various follow-up times were taken into account. PERSPECTIVE: German National Health Insurance funds. STUDY POPULATION: 1744 patients with intra-abdominal infection. INTERVENTIONS: Tazobactam/piperacillin (total daily dosage of 13.5 g/day) and imipenem/cilastatin (total daily dosage of 1.5 to 4 g/day). The mean duration of treatment varied from 5.5 to 8.2 days for tazobactam/piperacillin and 5 to 9.4 days for imipenem/cilastatin. MAIN OUTCOME MEASURE AND RESULTS: Compared with imipenem/cilastatin, treatment with tazobactam/piperacillin was more effective and the overall treatment costs were lower. In the base-case analysis, the cost-efficacy ratio (cost per successfully treated patient) was 7881 German deutschmarks (DM) for tazobactam/piperacillin and DM11,390 for imipenem/cilastatin. The incremental cost-efficacy ratio (per life saved) varied between -DM72,567 and -DM350,738 for tazobactam/piperacillin. Sensitivity analyses revealed that the results were robust against various assumptions on cost parameters, clinical outcomes and length of treatment. All costs reflect 1998 values; $US1 = DM1.85. CONCLUSIONS: This study suggests that compared with imipenem/cilastatin, tazobactam/piperacillin is more cost efficacious in the treatment of intra-abdominal infections and that it offers a cost advantage through fewer relapses and lower daily therapeutic costs.

Concepts of diffusion theory and a graphic approach to the description of the epidemic flow of contagious disease.

Concepts used to analyze sociological, geographic, and economic processes were adapted to an examination of the diffusion of contagious disease. The example used in applying these concepts was an epidemic of variola minor which continued for 12 months in an area of 1,006 square kilometers centered on the city of Bragança Paulista, Sao Paulo State (Brazil). A graphic procedure is proposed that depicts aspects of the epidemic flow of person-to-person transmission. Spatial, temporal, and sociological characteristics of the epidemic flow are disclosed in sequential diagrams. They represent geographic areas as well as schools and agglomerates of households affected by the epidemic at a given time, the mode of diffusion, and the source of the infection. The procedure yielded indirect evidence of the role of school pupils as introducers of variola minor into households and school classes. All subdivisions of the city, six of the seven rural districts, and four of the five elementary schools were affected through hierarchical (between-areas) diffusion. Subsequently, there was neighborhood (within-area) diffusion, and this resulted in new interactions between areas.

[Whipple's disease--a case study]. / Morbus Whipple--Eine Fallstudie.

Whipple's disease is rare. The majority of patients are men. Before the advent of antibiotics the disease was almost invariably fatal. Now fewer deaths are recorded. We report about a typical case with the additional signs of sacro-iliitis, so that at first the false diagnosis of ankylosing spondylitis was made.

[Evidence-based recommendations for perioperative antibiotic prophylaxis]. / Evidenzbasierte Empfehlungen zur perioperativen Antibioticaprophylaxe.

The aim of perioperative antibiotic prophylaxis (PAP) is to reduce postoperative complications. In 1994 specialist American companies developed a PAP quality standard, whereby individual recommendations were divided into categories according to the degree of evidence. These recommendations have been tabulated and supplemented with the results of new, randomized, controlled studies.

[Ankylosing spondylitis in Central and Eastern Europe. Cross-sectional study on treatment modalities, disease activity and quality of life]. / Ankylosierende Spondylitis in Mittel- und Osteuropa. Querschnittsstudie zu Behandlungsmustern, Krankheitsaktivität und Lebensqualität.

OBJECTIVES: To obtain information on the profile of patients with ankylosing spondylitis (AS), disease activity, previous and current treatments, and the proportion and profile of patients treated with conventional medications but considered eligible for anti-tumour necrosis factor (TNF) therapy. METHODS: Participants were rheumatologists from seven Central and Eastern European countries who were considered experts in the treatment of AS and were to include 3-5 patients who had never received anti-TNF therapy. Rheumatologists were asked to decide whether they considered their patients candidates for anti-TNF therapy. RESULTS: A total of 1506 patients were analysed. Overall, 61% of AS patients who had never received anti-TNF therapy until the time of the survey were considered candidates for anti-TNF therapy based on the clinical judgement of their rheumatologists. This proportion ranged from 40% in Slovakia to 84% in Romania. Candidates had higher levels of disease activity and functional impairment, and they were more likely to report a lower quality of life. Only 38% of candidates fulfilled the Assessment in Ankylosing Spondylitis (ASAS) recommendations with respect to a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 combined with previous use of at least two non-steroidal anti-inflammatory drugs, ranging from 18% in Poland to 57% in Hungary. CONCLUSION: More than half of AS patients currently treated with other medications may be eligible for anti-TNF therapy. Also, rheumatologists regarded disease activity as the determining factor for starting anti-TNF drugs, but their decision did not always fully comply with the ASAS recommendations, confirming the need for continued exchange among the medical community to increase awareness of the ASAS recommendations.

Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial.

OBJECTIVES: To assess the effect of sulfasalazine (SSZ) on inflammatory back pain (IBP) due to active undifferentiated spondyloarthritis (uSpA) or ankylosing spondylitis in patients with symptom duration <5 years. METHODS: Patients with IBP and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >3 from 12 centres were randomly assigned to 24 weeks' treatment with SSZ 2 g/day or placebo. The primary outcome variable was the change in BASDAI over 6 months. Secondary outcomes included measures of spinal pain, physical function and inflammation. RESULTS: 230 patients (50% men, age range 18-64 years, 67% human leucocyte antigen B27 positive) were treated with either SSZ 2x1 g/day or placebo for 6 months. Enthesitis was found in 50%, and peripheral arthritis in 47% of the patients. The mean (SD) BASDAI dropped markedly in both groups: by 3.7 (2.7) and 3.8 (2.4), respectively, as did most secondary outcome measures. No noticeable difference in treatment was observed between groups. Patients with IBP and no peripheral arthritis had significantly (p = 0.03) more benefit with SSZ (BASDAI 5.1 (1.3) to 2.8 (2.3)) than with placebo (5.2 (1.6) to 3.8 (2.4)). Spinal pain (p = 0.03) and morning stiffness (p = 0.05) improved with SSZ in these patients, but other secondary outcomes were not markedly different. CONCLUSION: SSZ was no better than placebo for the treatment of the signs and symptoms of uSpA; however, SSZ was more effective than placebo in the subgroup of patients with IBP and no peripheral arthritis.

Pseudocontamination of blood components with Burkholderia cepacia during quality controls.

We report on a pseudooutbreak of Burkholderia cepacia because of the use of a contaminated disinfectant during quality controls in a university blood bank. No septic reactions associated with transfusions had been reported in patients over the last 6 months. Analysis of the individual quality control procedures showed that a disinfectant based on a quaternary ammonium compound (QAC) had been used in order to disinfect the rubber stopper of the blood culture bottle. B. cepacia was found in a sample taken from this disinfectant, which was prepared with concentrate and tap water according to the manufacturer's instructions. The four isolates (one in disinfectant and three in blood components) were found to be identical in their biochemical reactions and resistance patterns. QAC-based disinfectants are not efficacious against a part of the spectrum of gram-negatives and are therefore inadequate. After introduction of an alcohol-based preparation, no more cases of B. cepacia contamination have been identified.