ACIG

ENGLISH 25 Validation of class Ir instruments The MDR has brought the professional reprocessing of medical devices, such as surgical instruments, for single or repeated use to the attention of regulatory and supervisory authorities as well as notified bodies. According to ISO 17664, manufacturers of instruments that fall under device class Ir must provide the user, e.g. in a clinic, with validated reconditioning methods. Typical content of a validation plan (plan for worst-case validation) - Designate the organisation, responsibilities and competencies for carrying out the validation process and the accompanying risk assessment. - Define the person/team responsible for assessing the results protocols. - Set out what device contamination / degree of device contamination is to be expected - Justify and compare with worst-case devices • Take into account the aspects mentioned above • Identify the areas that are most difficult to clean • Identify critical influences The validation plan covers all stages of the reprocessing process, including de- scriptions of the respective procedures: • Cleaning • Disinfection • Drying • Functional testing and maintenance • Packaging • Sterilisation • Functional testing - Establish terms of acceptance / acceptance criteria and the basic methodology Validation involves the devices being contaminated for test purposes in manner based on their use, subjected to the reprocessing step under investigation and subsequently tested for the presence of any residual contamination. Cleaning pro- cesses can normally be tested by contaminating with protein and blood (sheep’s blood) that contains two detectable markers (protein and haemoglobin - as re- quired by the FDA). The disinfection process can be validated by adding test microbes and then ascertaining the number of remaining microbes after cleaning. Steam sterilisation is validated by adding highly resistant microbes that ought to no longer be detectable following half a treatment cycle (half the normal duration of the sterilisation process). Further validation procedures range from particle analyses, cytotoxicity and accumulation tests, to examining the number of permissible reconditioning cycles.