Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff,” was issued on March 17, 2025. It superseded the previous guidance from 1996.
The FDA has six criteria for reprocessing instructions:
➊ Labeling should reflect the intended use of the device
➋ Reprocessing instructions for reusable devices should advise users to thoroughly clean the device
➌ Reprocessing instructions should indicate the appropriate microbicidal process for the device
➍ Reprocessing instructions should be technically feasible and include only device and accessories that are legally marketed
➎ Reprocessing instructions should be comprehensive
➏ Reprocessing instructions should be understandable
( Source: Reprocessing Medical Devices in Healthcare settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, 2017)
One of the issues that I believe has contributed to the problem is that in Section X, FDA Review of Reprocessing Instructions and Documentation of Reprocessing Method Validation in Submissions,( page 28) it states that all cleaning, disinfection and sterilization methods should be validated and reprocessing instructions included in the labeling when the FDA reviews premarket submissions yet, as noted above, there is no guidance regarding testing each of the disinfectant categories. In addition, AAMI provides guidance for the reprocessing of reusable medical devices that predominantly come under the categories of semi-critical and critical devices— thus lending to greater confusion and conflict.
Today, there are thousands of non-critical medical devices in more than 100 different categories in an average hospital that require low to intermediate level cleaning and disinfection.( Exact numbers were not able to be identified.) Cleaning and disinfecting of reuseable medical devices is performed by many healthcare professionals, including EVS technicians, nurses, certified nursing assistants( CNAs), radiology staff, occupational and physical therapy staff, and others. Technology has advanced over the past 30 years, and some non-critical medical devices are complex medical devices that require more time for cleaning and disinfecting and may require that a healthcare worker have more advanced training to perform the task.
The FDA does recognize that many medical devices are older and“ may not be consistent with state-of-the-art science and therefore may not ensure that devices is clean, disinfected, or sterile.”
Incremental steps to address the cleaning and disinfecting concerns started as early as 2013, according to Carling, et al.( 2013) who indicated that standardization should be studied to support the use of a single EPA-approved agent for cleaning and disinfection of common patient care items.( Source: Carling, P, Improving Healthcare Environmental Cleaning and Disinfection: Current and Evolving Issues, Infection Control and Hospital Epi, May 2013, Vol. 34, No. 5.) However, it took almost another 10 years before the topic was addressed again.
In 2022 the FDA released additional information highlighting the importance of device design and composition of the materials used in the manufacturing of new products.
Around the same time, APIC conducted a focus group related to this issue and shared feedback at the 2023 National APIC
Click to View Working Together to Improve Reusable Medical Device Reprocessing conference. The association then conducted a survey of infection preventionists to gain further insight as to the issues with which IPs are confronted.
In 2023, TJC released its Guide to Reprocessing Reusable Medical Devices. Chapter 1 of this document focuses on the Spaulding classification system, single-use devices, and manufacturer instructions. Chapter 2 addresses high-level disinfection of semi-critical devices and chapter 3 addresses Sterilization. The authors review what they have called a hierarchical approach to cleaning, disinfection and sterilization. In essence, this document addresses what principles and practices must be followed to review and develop policies and procedures within the healthcare organization; however, I wasn’ t able to evaluate the impact on this guidance to ease the conflict over IFU.
In May 2025, APIC announced that it sent a letter to TJC asking the agency to modernize the compliance with IFU evaluated during the survey process. APIC recommended that TJC:
• Differentiate between simple non-compliance with policies / stated practices and situations in which facilities have conducted risk assessments and determined that alternative cleaning, disinfection, and / or sterilization method is appropriate.
• Reassign IFU findings from the“ Infection Prevention and Control” chapter to“ Environment of Care” or“ Leadership” to better reflect responsibility and workflow.
( Source: https:// apic. org / modernizing-medical-device-instructions-for-use-ifus /)
Taking things one step further, maybe it is time to revise the Spaulding classification or to consider changing the risk levels to the concept proposed by Kremer, et al.
Some hospitals have been proactive
Click to View A by implementing policies and procedures proposed cleaning that state a new medical device will not classification be approved for purchase unless the system for reusable disinfectant they use for low- to intermediate-level disinfection is approved or a to complement
medical devices
risk analysis can be performed.( Contact the Spaulding the author for an example.) classification
Addressing the conflict will require more than TJC to“ modernize compliance.” It will take a village of the FDA, AAMI, APIC, EPA, CDC, device manufacturers as well as disinfectant manufactures to come to the table for in-depth conversations as to the issues and possible resolutions.
The time for action now. Let’ s not wait another decade to resolve this.
Carol Calabrese, RN, BS, CHESP, CIC, is an independent consultant and principal of Calabrese Consulting Services, LLC.
Additional references:
It will take a village of the FDA, AAMI, APIC, EPA, CDC, device manufacturers as well as disinfectant manufactures to come to the table for in-depth conversations as to the issues and possible resolutions.”
https:// www. ecfr. gov / current / title-21 / chapter-I / subchapter-H / part-860 https:// www. beckershospitalreview. com / quality / fda-publishes-list-of-reusablemedical-devices-with-greatest-infection-risk /
jul-aug 2025 • www. healthcarehygienemagazine. com •
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