Prepare and reuse medical devices after use

HYBETA GmbH VDI 5700 Sheet 1 describes measures for risk control in the processing of medical devices.

Contaminated medical devices with pathogens pose a risk not only to users but especially to patients. During a medical procedure, they can be a possible cause of infections. To avoid these risks, proper reprocessing of reusable medical devices is of great importance.

The revised guideline VDI 5700 Part 1, updated according to new regulations, provides developers, manufacturers, users, and operators of medical devices with detailed recommendations for applying risk management according to DIN EN ISO 14971 and ISO/TR 24971. The VDI 5700 Part 1 guideline addresses risk analysis, risk assessment, and risk control, which can arise from the reprocessing of medical devices for patients, users, and third parties. Both potential hazards and sources of damage as well as hazardous situations are considered within the framework of risk management and are demonstrated in the guideline. Furthermore, measures for risk control are presented.

The VDI 5700 Part 1 guideline supports making processes involved in the reprocessing of medical devices transparent and ensures that the health and safety of patients are not endangered. The intended functions of the medical device should be fully preserved.

The publisher of VDI 5700 Part 1 "Risk Management of Reprocessing Medical Devices – Measures for Risk Control" is the VDI Society for Technologies of Life Sciences (VDI-TLS). The guideline was published in January 2022 as a white paper and replaces the April 2015 edition. It can be ordered for EUR 165.60 from Beuth Verlag (Phone +49 30 2601-2260). Online orders are possible at www.vdi.de/5700-1 and www.beuth.de. VDI members receive a 10 percent discount on all VDI guidelines. VDI guidelines can be viewed free of charge at many public distribution points.

Technical contact at VDI:
Dr. Andreas Herrmann
VDI Society for Technologies of Life Sciences
Department of Medical Technology
Phone: +49 211 6214-634
Email: medizintechnik@vdi.de