Considerations concerning the information to be provided by the manufacturer
The reprocessing of invasive neurosurgery Medical Devices involves significant risks such as cross-contamination and wear. The information on reprocessing to be provided by the manufacturer is key to the safety and functionality of reprocessed instruments. This article provides background information and summarises what manufacturers should take into account to ensure that the reprocessing information they provide is in conformity with the standard.
Single use or re-use?
The reprocessing of reusable Medical Devices is a complex and risky process. Even the smallest mistakes can ruin all efforts to deactivate pathogens. Despite the greatest care, the risk of transmitting prion diseases from patient to patient, but also from patient to users or staff reprocessing the devices, cannot be fully excluded. Scientific data indicate high transfection rates even after long storage periods of contaminated instruments. In view of these facts, many countries forbid the re-use of sterile neurosurgical instruments. Apart from the above, the re-use of these instruments may cause premature wear, compromising the function of the devices. However, in spite of these findings, the processing and re-use of sterile Medical Devices is still common practice in Germany and considered safe provided the relevant guidelines are being observed.
In Germany, Medical Devices are assumed to be reprocessed in conformity with the German Regulation on the Installation, Operation and Use of Medical Devices (Art. 4 (2)), if reprocessing follows the joint recommendations by the Commission for Hospital Hygiene and Infection Prevention (Kommission für Krankenhaushygiene und Infektionsprävention - KRINKO) at the Robert Koch-Institut (RKI) and the Federal German Institute for Drugs and Federal Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) on the "Hygiene requirements for the reprocessing of Medical Devices" (Federal Health Bulletin 55 (2012): 1244–1310). (This regulation replaces the relevant recommendation from 2001, published in the Federal Health Bulletin 44 (2001): 1115-1126.)
Requirements for manufacturer's information
The manufacturer's information on processing is an important part of the documentation of the Medical Device. It provides guidelines for the safe and effective cleaning and sterilisation. The requirements for the information to be provided by manufacturers are set forth in EN ISO 17664:2004 "Sterilisation of Medical Devices: Information to be provided by the manufacturer for the processing of resterilisable Medical Devices".
This European standard provides exact information for every processing step – from all work steps and equipment for the preparation at the point of use and at the instrument (e.g. separation from other objects) to cleaning, disinfection, drying, inspection, maintenance, testing, packaging, sterilisation and storage. Within the scope of the approval and registration of the Medical Device, the information to be provided by the manufacturer must be subjected to conformity assessment.
Look out for approved disinfectants
In addition to the content and structure of the reprocessing information, the selection of disinfecting agents included therein may also affect conformity assessment. The reason for this is that many active substances routinely applied in this area have not yet been proved in recognised studies on prion deactivation. Naming the approved chemical agents can facilitate conformity assessment.