Healthcare Hygiene magazine September 2020 September 2020 | Page 38

patient safety & quality By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP Vetting Infection Control Technologies: Ensuring Safe and Efficacious Usage in Healthcare Settings Anytime there is a pandemic threat or large-scale outbreak of an infectious disease, there is a predictable entry of “novel” infection control products and technologies into the U.S. marketplace. Many of these technologies claim to solve the specific pandemic or outbreak-related threat yet may not hold the necessary product registrations from the government nor have independent efficacy validation to substantiate claims or safety instructions. Most infection prevention and control products will be regulated by either the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA). In most cases, products must first be approved by these agencies prior to being marketed to customers. Healthcare facilities should carefully review all product information prior to instituting product evaluations/ trials or implementing new products/technologies. Here are a few best practices to ensure that any products utilized meet the stringent requirements for safety and efficacy: 1 Review the product’s registration or approval classification. For products that are used on humans or given as medications, they will be regulated by the FDA or the EPA. To determine whether a product hold these regulatory approvals, healthcare providers can visit www.fda.gov or www.epa.gov. All product registration information indicating product approval or registration is available to the public. 2 Review the product’s technical data specific to efficacy, claims, and safety. It is imperative that healthcare users evaluate products to ensure that they are safe for the patient, healthcare team, and environment, and also are efficacious and deliver upon their clinical claims (e.g., microbe-kill claims, etc.). 3 It is important to note how long an infection control product takes to work such as an environmental surface disinfectant may take 5 minutes to fully inactive all microorganisms. While, in this example, that would be appropriate for disinfecting an animate surface, this timeframe would be far too long for healthcare professionals to wash their hands. Therefore, products must have reasonable contact times to achieve efficacy so that compliance with use remains as high as possible. 4 Ideally, utilize products that are broad spectrum and demonstrate validated efficacy against the following key microorganisms: a. Gram-positive bacteria b. Gram-negative bacteria c. Enveloped viruses d. Nonenveloped viruses e. Pathogenic fungi f. Bloodborne pathogens (minimum of hepatitis B virus and HIV) for environmental surface disinfection especially g. Bacterial spores as appropriate 5 Speak with colleagues in other healthcare institutions that are current users of the product to determine their experience with the product or technologies. This type of personal experience can be invaluable. 6 Review the product’s safety data sheet to conduct a risk assessment about potential risks that might be relevant to either the patient or the healthcare team. 7 Involve your facility infection preventionist (IP) upfront in the product evaluation checklist. The IP must be an integral partner in evaluating any new technology to ensure that it meets the current evidence-based standards and guidelines related to infection prevention and control. 8 In addition to vetting the safety and efficacy of infection control-related products, healthcare facilities should ensure the compatibility of certain products such as environmental disinfection agents with common surfaces specific to the facility (e.g., overbed tables, counter tile, stainless steel, etc.). Emerging infectious disease challenges and threats create a sense of urgency in the clinical practice arena, but also can create risks associated with non-vetted products that might endanger patients. Following a standardized process, involving the facility IP, and thoroughly vetting each product will significantly mitigate the risks associated with these new market entrants. IPs bring unique expertise to the table related to product evaluation and are an integral part of the value analysis process in both inpatient and outpatient settings. While we cannot stop every outbreak or pandemic, through a proactive and comprehensive approach to infection control, we certainly can be ready and able to respond to the next infectious disease threat that might land at our front doors. IPs bring unique expertise to the table related to product evaluation and are an integral part of the value analysis process in both inpatient and outpatient settings. J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is the president and CEO of Community Health Associates, LLC. He also is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Dr. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He can be reached at: [email protected] 38 september 2020 • www.healthcarehygienemagazine.com