A Process for Assessing Products for Infection Prevention in Healthcare Settings: a framework from HICPAC

Background

The Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory committee that focuses on the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections (HAIs), antimicrobial resistance, and related events in United States healthcare settings. At the July 2017 HICPAC Meeting, the Centers for Disease Control and Prevention (CDC) asked HICPAC to develop a process for HICPAC and CDC to use when formulating product-specific recommendations. HICPAC formed a workgroup to achieve this goal. The workgroup provided updates and obtained HICPAC input at the July and November 2017 HICPAC meetings and the May and November 2018 HICPAC meetings. HICPAC voted to finalize the tool and workflow at the November 2018 meeting.

Introduction

Innovations in healthcare infection prevention are essential to improve patient safety and increase our ability to provide optimal care. During the last decade, numerous novel products have entered the healthcare market. CDC and HICPAC recognize the importance of being able to meaningfully and consistently assess these innovations, for which supporting evidence is often limited or of heterogeneous quality. To address these issues, CDC asked HICPAC to develop a transparent and rigorous process for the Committee to use when formulating product-specific recommendations, and to provide the rationale for the criteria proposed.

Methods

The process used by the workgroup to develop the workflow is described here: A Process for Assessing Products for Infection Prevention in Health Care Settings: A Framework From the Healthcare Infection Control Practices Advisory Committee of the Centers for Disease Control and Prevention [PDF – 6 pages]external icon

Summary

The workgroup developed a tool consisting of discrete elements for the review of product-specific evidence. This tool is intended to be used to assess the evidence for a novel product, compare and contrast two similar products, and serve as a workflow when guidelines are considering recommendations for a product.

HICPAC Infection Prevention Product Review Worksheet

Contributors

2018 HICPAC Members, ex officio Members, and Liaison Representatives

2017 HICPAC Members, ex officio Members, and Liaison Representatives

HICPAC Products and Practices Workgroup Members

Vineet Chopra, MBBS, MD, MSc, FACP, FHM, The University of Michigan Health System (Co-Chair); Lynn Janssen, MS, CIC, CPHQ, California Department of Public Health (Co-Chair); Hilary M. Babcock, MD, MPH, Washington University School of Medicine in St Louis; Kristina Bryant, MD, University of Louisville School of Medicine; Loretta L. Fauerbach, MS, CIC, Fauerbach & Associates, LLC; Tom Talbot, MD, MPH, Vanderbilt University Medical Center.

Acknowledgements

Michael Bell, MD, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Designated Federal Officer (DFO); Elizabeth Claverie-Williams, MS, US Food and Drug Administration; Kendra Cox, MA, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention; Koo-Whang Chung, MPH, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention; Jamesa Hogges, Northrup Grumman; Lauren Lilly, PhD, US Food and Drug Administration; Erin Stone, MA, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Committee Management Specials (CMS).

Declarations of Interest

None of the Workgroup members reported financial or intellectual interests related to the topics in this document.