Since 2011, TÜV SÜD has offered support for medical device manufacturers in the preparation of the technical documentation for reprocessing according to EN ISO 17664, and also supplies a submission form (reprocessing according to EN ISO 17664:2004 requirements). Official documents are now confirming the international hygiene drive in the healthcare sector, where the focus of interest is increasingly turning to instructions for use (IFU) for the reprocessing of medical devices. Unfortunately, during surveillance the authorities repeatedly identify nonconformities in reprocessing, which can quite often be traced to the fact that the manufacturers’ IFUs provide inadequate information. This particularly applies to Class I medical devices which must be sterilized before use and which have not yet been subject to inspection by a Notified Body prior to market approval. However, in cases where there is no third-party surveillance, the parties involved tend to be somewhat liberal about implementing the requirements of the EN ISO 17664, which defines the information that manufacturers need to provide. The new EU Medical Device Regulation (MDR) will bring some changes in this respect.
The two following documents can be interpreted as a clear indication that authorities intend to step up surveillance.
IFU checklist of the COEN group
In 2014, in a move to assist authorities, Notified Bodies, and manufacturers, the “Medical Devices Compliance and Enforcement Group” (COEN) developed a checklist (available in German only) which can be used to check the manufacturers’ IFUs against the criteria of the EN ISO 17664. The checklist covers the EU-wide requirements for IFUs and can be downloaded free of charge from the website of the Swiss agency for therapeutic products, SWISSMEDIC.
SOP of the Working Group Medical Devices
On November 23, 2016, the Working Group Medical Devices (Arbeitsgruppe Medizinprodukte, AGMP) at the Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG), published a documented procedure on hygiene requirements for the reprocessing of medical devices (available in German only), including the pertinent forms. The documented procedure and the associated forms specifically address manufacturers’ IFUs.
“1.3.2 Has the manufacturer provided any specifications for the reprocessing of the medical device? Are these specifications in line with the requirements [editor’s note: of EN ISO 17664]?”
“1.3.3 Are there any regulations for the owner of the medical device on how to proceed in case of inadequate information according to DIN 17664 (e.g. ceasing to use the medical device, notification of the responsible national authority, inquiry to the manufacturers, incident reporting)?“
Both documents are landmarks in terms of implementation of the requirements regarding manufacturer surveillance.
New requirements according to the MDR
In the future, the MDR will demand conformity assessment carried out by a Notified Body for all sterile Class I medical devices that can be reprocessed. This corresponds to the previous method for sterile devices (Class Is) or medical devices with measuring function (Class Im) set forth in the Medical Device Directive (MDD). Should you want to make sure today that your reprocessed medical devices are in compliance with present and future regulatory requirements, TÜV SÜD can provide the following services: