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Schwerin, Germany

Werner S.,HygCen Germany GmbH | Werner S.,Ruhr University Bochum | Werner S.,Universitatsstr 136 | Lemm F.,Ruhr University Bochum | Von Rheinbaben F.,HygCen Germany GmbH
Hygiene + Medizin | Year: 2014

Respiratory equipment is considered as medical devices and preferably exposed to the intact mucous membranes of the respiratory tract. Accordingly, after the joint recommendations of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch-Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) they are classified as semicritical medical devices of category A and B. Therefore, they only need to be cleaned and disinfected. The sterilization is optional only, but not obligatory because of its intended use. However, the cleaning and disinfection must also be secure and in accordance to a validated reprocessing procedure.

Riebe O.,HygCen Germany GmbH | Riebe O.,Universitatsstrasse 136 | Beilenhoff U.,DEGEA Deutsche Gesellschaft fur Endoskopie Assistenzpersonal E. V. | Von Rheinbaben F.,HygCen Germany GmbH | And 5 more authors.
Hygiene + Medizin | Year: 2015

Background: The difficulty and complexity of reprocessing of flexible endoscopes have been known for more than 20 years and have been already discussed after publication of the HYGEA study in 2002. More than ten years later, we now have re-evaluated this investigation using a comparable methodology. Method: The quality of the reprocessing procedure of colonoscopes, gastroscopes and duodenoscopes was tested under routine conditions in 16 endoscopy hospital facilities as well as in seven practices. In our investigation we included different types of endoscopes from different manufacturers as well as the associated water bottle systems and the air/water and suction valves. In addition, data about the performance of the reprocessing procedure were collected using a questionnaire. Results: Of 30 biopsy channels of the endoscopes tested, eight sampled by taking swabs and seven sampled by investigating the rinse fluid (in total 13 of 30 tested endoscopes) showed bacterial contamination at low levels (< 10 Colony Forming Units (CFU) per endoscope). In addition five of 30 water samples drawn from rinsing water of the optical rinsing systems and six of 30 samples of the rinsing bottles showed weak microbial contaminations (> 1 CFU per ml or per tube). The tube of one optical rinsing system had a bacterial load of 52 CFU per ml. Although unacceptable results were not observed for the endoscopes themselves, the air/water and suction valves were often found to be microbially contaminated. Samples taken from the valves showed contamination in case of 24 air/water valves and 24 suction valves, five of them having mor e than 100 CFU per valve. Conclusion: The results presented here of the endoscope tests (reprocessing with washer-disinfectors (WD) and validated processes) and the flushing bottles of the optics tests show that lessons were learned from the HYGEA study and improvements in everyday endoscopy facilities have been achieved. However, the consistent annual average complaint rates of about 4 % as part of the quality review for colonoscopies conducted by the German Associations of Statutory Health Insurance Physicians BfArMshould prompt further efforts in endoscope reprocessing.

von Rheinbaben F.,HygCen Germany GmbH | Riebe O.,HygCen Germany GmbH | Koehnlein J.,HygCen Germany GmbH | Werner S.,HygCen Germany GmbH | Werner S.,Ruhr University Bochum
Parasitology Research | Year: 2014

The virological safety of medicinal leeches has to be ensured prior to their use on patients. While leeches can be kept and bred under standardized conditions, feeding them horse blood adds a non-standardized component, which poses some risk of infection of the treated patients. Here, we investigated the speed at which blood-borne viruses are degraded by the microbial flora in the leech intestine, in order to define the safety of the product and the length of the necessary quarantine period prior to its administration to patients. Feeding blood was spiked with bovine viral diarrhea virus (BVDV), reovirus, and murine parvovirus (107 ID50 ml-1). The virus titer in the intestinal contents of the leeches was determined using permissive cell cultures and compared to that of the original virus titer at the following time points: immediately after feeding; after 3, 14, and 30 days; and monthly thereafter until the 7th month. The BVDV titer was below the detection limit of 101 TCID50 ml-1 after 3 months, while reovirus and murine parvovirus titers were undetectable after 4 months. No positive virus findings were obtained at later time points. Thus, when fed the blood of vertebrates, the finished product "Medicinal leech, Hirudo verbana" can be considered virologically safe if the animals are maintained at 20 °C, which corresponds to their natural habitat conditions and ensures a high metabolic rate. Therefore, after the last feeding, a quarantine period of 4-6 months and appropriate care at room temperature, which supports microbial degradation and digestive processes, are recommended. © 2014 Springer-Verlag Berlin Heidelberg.

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