According to the MDR, the manufacturer of a medical device must provide information on the reprocessing of his product. According to ISO 17664-1 and ISO 17664-2, this requirement applies to all reprocessable medical devices.
DIN EN ISO 17664-1 specifies requirements for the information to be provided by the manufacturer for the reprocessing of critical and semi-critical medical devices (i.e. a medical device that has contact with sterile body areas or a medical device that has contact with mucous membrane or pathologically altered skin) or medical devices that require sterilization.
This includes information on reprocessing prior to use or reuse of the medical device.
The requirements specified in DIN EN 17664-1 support manufacturers in providing detailed reprocessing instructions that include the following activities, where applicable:
- Pre-treatment at the point of use;
- Preparation before cleaning;
- Cleaning;
- Disinfection;
- Drying;
- Inspection and maintenance;
- Packaging;
- Sterilization;
- Storage;
- Transport.
A second part was added to DIN EN ISO 17664 of 2018, which now also specifies requirements for reprocessing instructions for non-critical medical devices, resulting in ISO 17664-2 Reprocessing of healthcare products - Information to be provided by the medical device manufacturer for the reprocessing of medical devices - Part 2: Non-critical medical devices. As a member of NA 063-04-10 AA "Sterilization and reprocessing of medical devices" at DIN, our expert Dr. Riebe was involved in drafting the second part in Working Group 7.
It is not always clear which formulations can be safely used in reprocessing instructions. Our expert can provide assistance and, if necessary, check existing instructions for conformity or create new ones.
Dr. Riebe can assist with his expertise in creating the "worst case" selection from your product range. Dr. Riebe has also been involved in the preparation of numerous reprocessing instructions for well-known medical device manufacturers. Dr. Riebe's hobbyhorse is the assessment and preparation of reprocessing instructions to ensure their conformity with the requirements of ISO 17664.
As a reprocessing specialist, his many years of experience in carrying out reprocessing validations in accordance with MDR and FDA requirements within the framework of 510(k) approvals are of great benefit.
About the consultant
Dr. rer. nat. Oliver Riebe received his PhD in 2009 in the Department of Microbiology of the Institute of Biosciences at the University of Rostock with the distinction "summa cum laude". The focus of the thesis was the investigation of defense mechanisms of anaerobic microorganisms against radical oxygen species.
This was followed by 3 years of research in collaboration with national and international scientists on the topic of genetic modification of surface proteins for use in nanosensors.
Since 2013, Dr. O. Riebe is employed at a medical device testing lab, where he manages the division for reprocessing of medical devices since 2014. The focus of the testing area is the validation of manual and mechanical reprocessing procedures for medical devices in accordance with the requirements of EN ISO 17664 and American and international standards.
Dr. Riebe has many years of experience in the validation of reprocessing instructions according to EN ISO 17664 and FDA guidelines, for example, for dental instruments, endoscopes, dialysis units, heater-cooler units (hypothermia devices), probes, sensors, catheters, etc.
Dr. Riebe is also a certified medical device consultant in accordance with Section 31 of the Medical Devices Act and Medical Device Law Implementation Act §83 (TÜV SÜD Academy) and participates in various standardization committees in the field of medical devices.
He is a member of the Method Development Working Group (Method Group 2.0) for the Guideline for the Validation of Manual Cleaning and Manual Chemical Disinfection Processes for the Reprocessing of Thermolabile Endoscopes and a member of NA 063 DIN-Normenausschuss Medizin (NAMed) NA 063-04-10 AA Working Committee Sterilization and Reprocessing of Medical Devices. He is also a member of the AG-RMT of the DGKH and participated in this working group in the development of methods for comparative detergent testing.
On ISO level, Dr. Riebe is one of the German experts of ISO/TC 330 "Surfaces with biocidal and antimicrobial properties" and is also involved in CEN/TC 204 for the revision of EN 556-1 in the field of sterilization of medical devices.
Dr. Riebe's work has been published in various journals at national and international level.