Reprocessing medical devices – ASTM E1837 and ISO 17664:2017
Background
Manufacturers of reusable medical devices are responsible for having labelling that bears adequate directions for use, including instructions on preparing a medical device for use. Validated reprocessing instructions are required that ensure that the medical device can be used safely and for the purpose for which it is intended. Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. Reprocessing of reusable medical devices encompasses appropriate steps that begins in close proximity to the point of use of the medical device and, in general, involves the following three steps in sequence:
- Point-of-use processing, i.e. initial cleaning steps and/or measures to prevent drying of soil and contaminants in and on the medical device.
- Thorough cleaning
- Disinfection or sterilization depending on the intended use of the medical device.
Methods
Micans testing is performed in agreement with recommended procedures described in:
- ASTM E1837-96 Standard test method to determine efficacy of disinfection processes for reusable medical devices
- ISO 17664:2021 Processing of health care products – information to be provided by the medical device manufacturer for the processing of medical devices
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. Document issued on: March 17, 2015, Appendix E of this guidance was updated on June 9, 2017
- Procedures and requirements requested by the contracting sponsor
Micans can contaminate and analyse your reprocessing protocols with a variety of microbial species such as, but not only:
- Escherichia coli
- Geobacillus stearothermophilus
- Klebsiella pneumoniae
- Mycobacterium smegmatis
- Mycobacterium terrae
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Serratia marcescens
We can also soil and analyse the reprocessing efficiency of equipment with blood, slime, mucus and protein
Micans laboratory is:
ISO 17025:2018 (SS) accredited by Swedac (id 10351)
ISO 9001:2015 certified by A3 cert (id 1565)
ISO 14001:2015 certified by A3 cert (id 1565)
Micans laboratory comply with the OECD Principles on Good Laboratory Practice (GLP), ENV/MC/CHEM(98)17
Please contact us for questions, prices and more details.