What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part II)

In the first part of this blog (Elmed blog #41) it was pointed out that the FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). The FDA’s concern with the content and the “validity” of manufacturers’ IFUs was codified on March 17, 2015 when the FDA issued “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

A key element of this publication was the FDA’s new requirement that:

“Manufacturers must also establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b). FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.”

As part of this requirement, the FDA has established six criteria for reprocessing instructions. In Part I of this blog we covered the first two criteria. In Part II we will cover criteria number three. Future installments of this blog will cover the remaining FDA criteria.

  1. Reprocessing instructions should indicate the appropriate microbicidal process for the device.

To comply with this requirement, a manufacturer’s cleaning instructions should be consistent with current infection control principles. The microbicidal process recommended should be sterilization or disinfection (high, intermediate, or low level), depending on the intended use of the device. The FDA further requires that:

“Whichever reprocessing method(s) is/are recommended the compatibility of the device with the method(s) and the ability of the method(s) to successfully reprocess the device features should be validated and then stated in the instructions for use. The validation should demonstrate that soil and contaminants have been effectively removed and that the device is free of viable microorganisms.”

The FDA uses the Spaulding Classification System1 for critical, semi-critical and non-critical devices to describe the potential risk of infection caused by the device and the appropriate microbicidal processes. Because the Spaulding Classification System does not address all clinical device uses and reprocessing needs in detail, the FDA has modified it as described below:

Critical devices are devices that are introduced directly into the bloodstream or which contact a normally sterile tissue or body-space during use. There is a likelihood of microbial transmission and risk of infection (subclinical or clinical) if the device is not clean and sterile. Users should be instructed to disassemble (if applicable), thoroughly clean, and sterilize critical devices after each use.  

Examples of critical devices include surgical instruments, irrigation systems for sterile instruments in sterile tissues, endoscopes used in sterile body cavities (such as laparoscopes, arthroscopes, intravascular endoscopes) and all endoscope biopsy accessories.”2

According to the Spaulding Classification System, semi-critical devices are devices that contact intact mucous membranes or non-intact skin.3 In the course of normal use they usually do not penetrate tissues or enter normally sterile areas of the body. Intact mucosal surfaces are relatively resistant to small numbers of spores and as such, are typically not harmed by contact with semi-critical devices.

Semi-critical devices should, however, be thoroughly reprocessed so as to be free of all microorganisms. If the design and/or components of the device does not permit sterilization (e.g., the device materials cannot withstand the heat of the sterilization process), then high level disinfection should be used.

The FDA’s list of semi-critical devices include “Duodenoscopes, endotracheal tubes, bronchoscopes, laryngoscope blades and other respiratory equipment, esophageal manometry probes, diaphragm fitting rings, and gastrointestinal endoscopes.” 4

Semi-critical, heat-stable devices (e.g., rigid endoscopes) should be reprocessed using steam sterilization. For semi-critical devices that cannot withstand the heat generated during the steam sterilization process, you must utilize “low temperature” reprocessing options. These options include hydrogen peroxide (H2O2) sterilization, ozone (O3) sterilization, ethylene oxide (EO) sterilization (including device aeration) and liquid chemical sterilant/high level disinfectant chemical systems used to provide either liquid chemical sterilization or high level disinfection.

High-level disinfection methods used in health care settings include liquid chemical sterilants used at high level disinfection conditions and hot water pasteurization (most frequently used for respiratory and anesthesia equipment reprocessing). There are a number of commercially available disinfectors designed to kill or inactivate many microorganisms from instruments, containers, and other clinical utensils by immersion in hot water, automatically or semi-automatically. These disinfectors are typically devices with a tank resembling a hot water bath that reaches temperatures of less than 100 degrees Celsius.  Hot water pasteurization disinfectors are used to disinfect devices when complete sterilization is not needed or justified.


  1. Spaulding, EH The role of chemical disinfection in the prevention of nosocomial infections. In: Brachman PS, Eickoff TC, eds Proceedings of the International Conference on Nosocomial Infections, 1970. Chicago: American Hospital Association, 1971:254-274
  2. FDA Report “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015


  1. “Spaulding”


  1. FDA”
© 2021  ELMED Incorporated    Site by curtis