At the latest since the entry into force of the European Medical Devices Directive (93/42/EEC) on June 14, 1993, medical devices must undergo a series of application-specific tests. Medical devices are first divided into active (operation is directly dependent on a power source such as electricity) and non-active medical devices. Active medical devices or other medical equipment can be used for the production or processing of medical devices themselves or for use during diagnosis or therapy in humans.
The safety of the overall processes can only be ensured by the safety of the sub-processes. The essential process steps of cleaning and disinfecting therefore have to be qualitatively and quantitatively characterized and be analyzed in their mutual dependence with all the other steps of the entire processing procedure. The results of validation of the substeps (washer-disinfectors, sterilizers, sealing machines) must be understood as links in a chain.
The entire "safety" of the processing utilizes this elements and combines them with transportation, packaging, storage, and documentation (medical reprocessing cycle). In addition, the other substeps of the medical device cycle, from use on the patient to reuse, can also be checked (pre-cleaning, packaging, transport/logistics, storage, disposal). In addition to the process steps themselves, the quality of the media supply is of great importance for the overall outcome of processing (e.g. chemical and microbiological contamination in drinking and industrial water). HygCen verifies using the respective coordinated procedures also in the course of type tests including relevant risk analysis, whether the manufacturer's processing instructions reproducibly result in a hygienically correct re-usable medical device and the requirements of the Medical Device Directive are met. HygCen supports you in securing the reprocessing of medical devices as well as the validation and revalidation of all technical reprocessing procedures of washer-disinfectors:
- Endoscope washer-disinfectors
- Container washers
- Bedpan washer-disinfectors
- Waste disinfection systems
- Dishwashers and washer-extractors
- Steam processes
- Plasma/H2O2 processes
- Low-temperature steam processes
- Formaldehyde (NTDF) processes
- Ethylene oxide (EO) processes
- Sealing machines
- Endoscope drying and storage cabinets
HygCen offers decades of experience in the field of type testing of devices
The term "type test" was coined in Europe. Such tests serve to prove that a device meets the requirements of the relevant product standards and is therefore suitable for the intended field of application. Therefore, only type-tested devices should be considered for new acquisitions and tenders; in the case of washer-disinfectors for endoscopes, for example, only type-tested devices in accordance with EN ISO 15883 should be considered. In contrast to validation, a device or a machine is tested for general suitability during a type test, while their safety is checked during a validation of the individual specific processes.
The type test is the responsibility of the manufacturer and is divided into a technical and a hygienic part. Besides the active medical devices, there is also other equipment both in health and from other sectors that may be of indirect hygienic relevance. Large-scale systems are of importance in the production as well as in the environment of all living organisms. This foremost involves securing the function, as well as the safety and the prevention of unwanted side effects. This includes also ecological safety as well as safety for operators and users. Among other things, we test the emission in order to detect a potential influence on the ecological system. We also test the operation on spreading of germs respectively chemical discharge, whether into the atmosphere or into the outgoing water. Conformity with relevant standards tests, routine monitoring, and actual state analyses as prophylaxis as well as tests for specific and non-specific problems are conducted. It must be ensured during operation that no hygiene risks can arise.
Air conditioning systems, recooling systems on buildings in hospitals, public buildings, production facilities
No area with high requirements to indoor climate can work without appropriate air-conditioning systems. The normal "user" only knows the openings where air blows out. Behind them often hides a complex conditioning system with ducts, fans, dampers, filters, drying units, humidifiers, cooling units, heating equipment, and heat recovery systems or heat exchangers. At some points of this complex system improper construction, maintenance or operation management can lead to hygienically questionable growth of microorganisms that are then blown into the room and can even cause serious diseases. The cooling of the air in the air conditioning systems begins condensation of the moisture - an ideal growth factor for many microorganisms. Our inspectors will help, to take the right actions at the right times.
Cooling towers of power plants
When planning power plants, which are equipped with cooling towers and used with pass through modes , the heat dissipated may at elevated water temperature of the surrounding waters, may not be discharged directly into surface waters. This heat must be dissipated into the atmosphere via the cooling tower. This means that the cooling tower thereby serves to discharge the water.