Determination of Microbial Population in Medical Devices
This new service was developed with the specialized technicians of the sterilization central units. Therefore, MK is able to develop customized operational protocols based on sector regulations (eg: UNI EN ISO 11737).
MK analyses are based on culture techniques and enumeration of microorganisms before sanitization and sterilization of the surgical instrument (immediately after being used in operating rooms) as well as after the removal of the microorganisms with procedures used by hospital sterilization units and chosen according to the shape, size, and characteristics of the surgical instrument to be sterilized.
The final result should reveal complete hygiene of the surgical set with the absence of investigated microorganisms.
Analytical control of instruments is carried out through a periodic sampling plan that includes:
- Sonication on surgical instruments pre and post wash: Ultrasonic technique that causes the detachment of any microorganisms from the instrument without affecting their vitality and allowing them to be collected in the specific diluent (Buffer Peptone Water) that later will be analyzed in the laboratory.
- Surface swabs for hygiene testing on pre and post washing of surgical set transport containers and work surfaces: this technique, through the use of a swab dipped in a test tube containing transport liquid with neutralizing agents, allows to collect any microorganisms present in the sampled surfaces
In the workplaces of the sterilization plants, hygiene control is also provided through:
- Active air sampling and microbiological analysis of working environments: technique that through the aspiration of large volumes of air allows airborne bacteria to be captured and collected on a nutrient substrate for subsequent counting and identification of grown colonies.
- Sampling and analysis of water used for washing procedure: control of chemical and microbiological parameters of water used for washing and disinfection of surgical instruments at sterilization plants, according to Dlgs 31_2001
About MK Analysis Laboratory
The MK laboratory is a safe and reliable partner for chemical and microbiological analysis on food, feed, water, air, soil and surfaces. It offers consulting, auditing, and training services and specializes in thermal processes design. It also provides companies with a consultancy service on environmental prevention and compliance with the relative regulations in force. Please find further information at https://www.mkambiente.com
If you would like more information about this topic, please contact:
MK S.r.l.
Via Antoniucci, 2
06012 Città di Castello (PG)
T +39 758 512 150
info@mkambiente.com
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 90 locations worldwide. More than 4,000 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group
An der Industriebahn 5
13088 Berlin, Germany
www.tentamus.com
Tentamus Group GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
Business Development Manager MK Laboratory
E-Mail: marco@mkambiente.com