Understanding the Difference Between Operation and Reprocessing Manuals

Published on:
June 9, 2026
Last updated on:
July 1, 2026

Question:

What’s the difference between the operation manual and the reprocessing manual for medical devices?

Answer:

Instructions for Use (IFUs) for medical devices are often divided into two key components: the operation manual and, for reusable devices, the reprocessing manual. While they apply to the same product, they serve different purposes and audiences.

The operation manual explains how to safely and effectively use the device prior and during patient care, including setup (e.g., functionality and visible cleanliness checks), operation, and handling best practices. It is primarily used by clinical staff.

The reprocessing manual applies to reusable devices and provides validated instructions for point of use treatment, manual cleaning, disinfection and/or sterilization, inspection, and storage after use. These instructions are critical for infection prevention and are typically followed by reprocessing technicians.

These instructions are interconnected. How a device is used can impact how well it can be cleaned, and failure to follow reprocessing steps may compromise safety, even if the device was used correctly.

Bottom line:

Operation manuals guide safe device use, while reprocessing manuals help ensure reusable devices are properly reprocessed and ready for reuse. Both are important for supporting patient safety and can support alignment with applicable standards, regulations, and guidance documents [1 - 4].

Access your local Olympus IFUs here: Manuals and IFUs for Olympus Endoscopes.

Sources and further readings

  1. Food and Drug Administration. Reprocessing of Reusable Medical Devices. U.S. Department of Health and Human Services, https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices. Accessed May 2026.

  2. Association for the Advancement of Medical Instrumentation. Standards and Publications. https://array.aami.org/standards-and-publications. Accessed May 2026.

  3. ISO 17664-1:2021, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices.

  4. Medical Device Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.