2024-17935. Supplemental Evidence and Data Request on Environmental, Clinical and Economic Outcomes of Hospital Resources To Prevent Hospital-Acquired Infections

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting) Inclusion and Exclusion Criteria

Category	Inclusion criteria	Exclusion criteria
Population	Primary: Individuals receiving acute medical care Secondary: Healthcare workers using or caring for devices used in patient care	Individuals receiving ambulatory care.
Interventions	Primary interest: Devices/items that are intended to prevent infection or are used for general bedside care, including but not limited to PPE, drapes, linens, laryngoscopes, blood pressure cuffs, pulse oximeters Secondary interest: Other devices/items used during hospital care, including but not limited to: surgical devices, other scopes Regulatory status: All devices/items must be either	Devices/items with minimal or no pathogen transmission risk. Devices/items primarily used in an ambulatory or non-acute-care setting. Devices/items that have been reprocessed under emergency use authorization only. Implantable devices other than catheters.
	• FDA approved as reusable, and reprocessed per specifications
	OR
	• Designated as single-use, FDA authorized for reprocessing, and reprocessed per specifications
Comparators	Devices/items that are approved as single-use and are discarded after one use	Single-use devices/items for which no reusable or authorized reprocessed alternatives are available in the US.
Outcomes	Health outcomes (Patient-level or aggregated patient data) Outcomes include but are not limited to: HAI, SSI, or pathogen transmission (including MDRO; Sepsis; ICU stay related to HAI; Length of stay; Mortality; Adverse effects; Healthcare worker infection or injury	Quality of reprocessing. Usability by healthcare workers or patients. Device/item preferences of healthcare workers or patients. Device/item availability. Bacterial colonization of device/item.
	Economic outcomes (Hospital/health system perspective) Outcomes include but are not limited to: Procurement cost; Cost per procedure/use; Costs for: reprocessing, transportation, storage, functionality testing, maintenance, repair, disposal, replacement; Supply chain implications
	Environmental outcomes
	a. Environmental impact
	(Global, national, or regional perspective)
	Outcomes include but are not limited to: Greenhouse gas emissions; Air pollution; Water use; Water contamination; Energy use; Chemical use and toxicity; Recycling volume; Landfill use; Carcinogenic exposure; Climate change; Raw material extraction and processing
	b. Environmental health
	(Population health perspective)
	Outcomes include but are not limited to: Respiratory illness; Cardiovascular disease; Cancer risk; Infectious disease outbreaks
Timing	Any	NA.
Setting	Acute care hospitals in countries rated “very high” on the 2021 Human Development Index (as defined by the United Nations Development Programme) *	Non-hospital settings. Other countries.
Publication type	English language For primary interest interventions (devices/items used to prevent infections or for general bedside care): SRs, randomized controlled trials, nonrandomized controlled studies	Non-English-language, abstracts, case reports, non-comparative studies, narrative reviews, commentaries, guidelines.
	For secondary interest interventions (other devices/items used for hospital care): SRs
FDA: Food and Drug Administration; HAI: Healthcare-associated infection; ICU: Intensive care unit; MDRO: Multi-drug resistant organism; NA: Not applicable; PPE: Personal protective equipment; SR: Systematic review; SSI: Surgical site infection; US: United States.
* Human development index. United Nations Development Programme. Accessed April 16, 2024. https://hdr.undp.org/​data-center/​human-development-index#/​indicies/​HDI.