Important Questions to Ask When Purchasing New Medical Devices

The instructions of the manufacturer of the respective medical device are needed to ensure proper reprocessing. Here it must be borne in mind that in different countries, different requirements, directives and laws exist, hence corresponding procedural steps are common and must be taken into account in the recommendations for processing. Before buying new or innovative instruments and other reprocessable devices, it must absolutely be carefully checked whether and how reprocessing can be properly conducted without having to effect fundamental and expensive changes to the processing procedure. The following is intended as a basis for compiling an internal checklist with which the most important questions can be clarified. The following questions must absolutely be clarified before purchasing new medical devices (incl. loaned instruments and their accessories): ◆ Is a similar medical device already available or is the device in question being newly introduced? (If similar devices are already available, the following questions should already have been clarified). ◆ Does the instrument have a CE mark? ◆ Can it be easily recognised whether the instrument has been designed for single or multiple use? ◆ Is the number of incidences of processing limited? ◆ Is the instrument unambiguously labelled in order to assure its assignment later to the corresponding operating manual? ◆ Is an operating manual that is easy to understand available and in the national language? ◆ Does the operating manual contain, in addition to the medical indication, also detailed information on processing? ◆ Is each separate processing step explained clearly: ◆ cleaning (manual, automated, ultrasonic) ◆ disinfection and ◆ sterilisation (chemical, thermal)? ◆ Is information given on checking, or the test results for, the individual steps, and if required the validation results for the particular device ◆ If so, are the various parameters affecting processing (chemical parameters, machines, water, etc) specified? ◆ Are alternative cleaning (alkaline, acidic, neutral), disinfection and sterilisation procedures mentioned? ◆ Are certain processing methods and modalities excluded? ◆ Does the operating manual give information on potential logistic problems (transportation times, wet transportation, use at weekends, etc)? ◆ Are the methods referred to available in the hospital? ◆ Can the new instrument be processed with a routine process in use in the establishment or is separate processing needed? (As regards the last two questions, the facilities available in the establishment should be communicated to the administration) (Source: www.wfhss.com)Highsnobiety Sneakers