Generic filters
Exact matches only
Generic filters
Exact matches only
Header Artwork
Header Artwork





Reprocessing

February 1, 2023

Guidance on Combining Biocompatibility and Cleaning Validation Testing

Depending on the type and duration of contact for reusable devices, biocompatibility testing can involve more than ten endpoints that need to be addressed for first-time use and end-of-life use. This can be costly and time consuming. Read this whitepaper...

See Blog

November 30, 2021

Should all Steam Sterilization Cycle Parameter Sets Indicated in your IFU be Validated?

ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one validated sterilization method must be specified in the IFU. Consequently, if devices are intended to be steam sterilized, at least...

See Blog

September 28, 2021

Can you randomly choose analytes to use as end-points for the cleaning validation of a reusable device?

The FDA guidance on reprocessing medical devices in health care settings: validation methods and labeling states, that when performing cleaning validations, the artificial test soil that is chosen should allow for at least two clinically relevant soil components to be...

See Blog

September 15, 2021

Under what quality system should your reprocessing validation be performed?

ISO 17664[1] and ISO17664-2[2] clearly state that all reprocessing instructions provided in the Instructions For Use (IFU) document must be validated; and FDA[3] as well as other guidance documents provide information on how these validations should be performed. However, that...

See Blog

September 8, 2021

Are you required to perform reprocessing validations for all your devices?

It is important that all reprocessing instructions included in the Instructions For Use document are validated to ensure patient safety and minimize healthcare-acquired infections; however, validating the reprocessing instructions for every device is a costly affair. Luckily, when an array...

See Blog
of 5
Footer Artwork