patient safety & quality
By J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , BC- MSLcert™ , MSL-BC , CPPS , CPHQ , CPXP , CVAHP , FACDONA , FAAPM , FNAP , FSHEA , FIDSA , FACHE
Infection Prevention Perspectives for Healthcare Value Analysis
In today ’ s complex healthcare environment , the evaluation of infection prevention and control products can be a daunting task . As part of the clinical value analysis process , infection preventionists and value analysis leaders must objectively evaluate new products and technologies using a standardized methodology . The Institute for Healthcare Improvement ( IHI ) has defined three core elements to define overall healthcare value which includes the experience of care , population health , and per capita cost .
One of the first steps in product evaluation is centered around determining the appropriate regulatory body that is responsible for oversight of the product being evaluated . For example , hand sanitizers such as alcohol-based hand sanitizers are used on the hands and because they are used on the human body , they are regulated by the Food and Drug Administration ( FDA ). The FDA regulates :
● Medical devices
● Drugs ( OTC and Rx )
● Blood
● Biologics
● Vaccines
● Food
● Sterilization
● High-level disinfection
The Environmental Protection Agency ( EPA ), on the other hand , regulates :
● Low-level disinfectants
● Intermediate-level disinfectants
● Cleaning agents
Product evaluation for most infection control-related products can be reviewed through three unique lens :
Efficacy : Does it work ? Is it going to kill the relevant microorganisms ?
Safety : Is it safe for the patient , healthcare team and environment ?
Compatibility : Will the product work with my other medical items , technologies , etc .?
This approach can easily be leveraged with a variety of products including hand hygiene , disinfectants , cleaning agents , certain medical devices , and personal protective equipment . The product evaluation process should be multidisciplinary and may differ by product type to ensure the relevant expertise ( i . e ., pharmacy , vascular access , etc .) is an active part of the product evaluation process .
Many infection control products must demonstrate their ability to be “ broad spectrum ”, in that they must be effective against a wide range of pathogens including :
● Broad spectrum for bacteria
● Viruses ( non-enveloped and enveloped )
● Multi drug-resistant organisms ( drug-resistant strains )
● Pathogenic fungi ( Candida )
● Bloodborne pathogens ( HIV , HBV , HCV )
● Emerging pathogens ( novel viruses , etc .) as applicable
Evidence-based medicine remains an important part of infection control product evaluation , but there is a necessary prioritization in most situations . First , healthcare facilities must fall regulation as that is considered the law and is enforceable . Next , healthcare facilities should review and follow applicable national evidence-based guidelines and guidance from reputable governmental agencies such as the Centers for Disease Control and Prevention ( CDC ) or the Association of periOperative Registered Nurses ( AORN ). Third , there may be practice or specialty-specific professional society guidelines or recommendations which can be helpful to consider such as gastroenterology standards for a new disposable endoscope . Finally , the lowest level of consideration is that of expert opinion , as this is not considered to be evidence-based .
The CDC ’ s Healthcare Infection Control Practices Advisory Committee ( HICPAC ) has developed an Infection Prevention Product Review Worksheet that healthcare facilities , infection preventionists , and healthcare value analysis professionals with an objective methodology to evaluate any product related to infection prevention and control . Before introducing a new product into a healthcare , a complete and thorough review must be performed to ensure patient and healthcare team safety .
A comprehensive value analysis process that incorporates assessment of evidence-based practices , patient and healthcare worker safety , population health management , patient satisfaction , and cost of care delivery will mitigate many risks associated with infection control product introduction across the continuum of care .
J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , BC-MSLcert™ , MSL-BC , CPPS , CPHQ , CPXP , CVAHP , FACDONA , FAAPM , FNAP , FSHEA , FIDSA , FACHE , is president and CEO of Community Health Associates , LLC . He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine , is a fellow with the Institute for Healthcare Improvement , and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America . Garrett is a frequent lecturer globally on patient safety , infectious diseases , and medical device reprocessing and safety . He may be reached at :
Hudson . garrett @ chaassociates . com