Instructions for Use – Confusion and Chaos for Healthcare Professionals

Author: Joanna Mills, RN, MSN, CNS, CIC
December 3, 2021
I became involved with HSI as a board member when I was introduced to the purpose and mission of the institute, which are aligned with my role as an Infection Preventionist. I also work with the Instructions for Use (IFUs) Initiative Team, which is focused on addressing the common confusion between manufacturer IFUs and healthcare professionals. This confusion can result in surface disinfection compatibility issues and patient risk.

HSI’s recent case study illustrated some of the issues encountered when there are conflicts with specific processes in IFUs related to cleaning/disinfection of products that are not compatible with hospital-approved cleaning products. The case study also identified a critical miscommunication concerning IP guidelines and the manufacturer IFU for a medical device that resulted in significant costs for both the hospital and the manufacturer.

Throughout my career in IP, I have been frequently frustrated when the IFUs for new or newly acquired products are:

  • Lacking IFUs for cleaning and disinfection
  • Old or not updated
  • In conflict with CDC and/or other recommendations and guidelines

The Expanding Role of IP

The Covid-19 pandemic has brought into clear view the importance of infection control and prevention and the role of the infection prevention practitioners (IP). The expanding role for IP has been evolving for many years. As organizations have expanded and healthcare technology has progressed, so has the responsibilities of the IP. The Association for Professionals in Infection Control and Epidemiology (APIC) was established in 1972. Independent certification was established by Certification Board of Infection Control and Epidemiology (CBIC) in 1981. The CDC and HHS/CMS have mandated surveillance and HAI reduction further expanding the scope and activities of the IP.

The eight IP core competency activities identified by APIC include[i]

  1. Identification of infectious disease processes
  2. Surveillance and epidemiologic investigation
  3. Preventing/controlling the transmission of infectious agents/HAIs
  4. Employee/occupational health 
  5. Management and communication 
  6. Education and research 
  7. Environment of care
  8. Cleaning, sterilization, disinfection, and asepsis 

[i] Taken from APIC Text 2021 Chapter 1 Overview of Infection Prevention Programs

The IP Role in Product Selection

“Environment of care” and “cleaning, sterilization, disinfection, and asepsis” are the core competencies related to product selection, clinical application, and use. IPs are essential guarantors of patient safety related to the selection of devices and products. IP are dependent on the experts in SPD, EVS, and Biomedical engineers to assist with product evaluations. As has been identified by HSI, the communication, regulation, and terminology gaps in this process cause confusion and chaos for healthcare professionals, particularly for the IPs who are generally responsible for ensuring that products used can be effectively cleaned, sterilized, and disinfected.

The Need for Testing and Certification Standards for Surfaces

Without industry or regulatory mandates for testing and cleaning product compatibility standards, IPs are left with a daunting task. Organizational purchases are guided by manufacturers who identify cleaning products in their IFUs that may or may not be approved by the healthcare facility. In addition, healthcare facilities may use alternate cleaning products that could jeopardize product warranties.

Organizations have varying degrees of implementation of value analysis programs (VAP). IPs may be left to their own efforts in determining if IFUs and/or manufacturers’ recommendations are adequate.

This is a critical area in which HSI can provide support and guidance with the development of testing and certification standards by filling the gaps left by manufacturers and regulatory agencies. IPs and healthcare organizations need to recognize and promote the programs that can make a real difference in patient safety and HAI reduction.

The HSI Instructions for Use Initiative Group is focused on:

  • Bridging the gap between IP cleaning and disinfection guidelines within a healthcare facility and manufacturer IFUs.
  • Creating a guiding document that provides consistency in the information presented by manufacturers in their IFUs.
  • Educating manufacturers about IP cleaning and disinfection guidelines and opening a dialogue between manufacturers and healthcare professionals to support their common goals – a safe environment for patients, healthcare professionals, and the general public.

Read more about the HSI Surface Certification Program.

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