HICPAC Infection Prevention Product Assessment Algorithm
A
B
C
D
E
F
Is the product or device FDA approved / cleared or EPA registered ?
□ Yes ( Proceed to Node B )
□ No : FDA / EPA label is not required and marketing materials do not make medical or mitigation claims ( Proceed to Node B )
□ No : marketing materials make medical or mitigation claims : ( STOP - HICPAC will not review products or devices that are not approved and make these claims )
What is the FDA or EPA approval type ? ( Note : search the FDA or EPA databases for similar products )
For the purposes of this analysis , is the product or device being considered for used in accordance with FDA- or EPA-approved labels ? ( Note : review FDAor EPA-approved labels )
□ Yes
□ No
Key Question
What are the clinically relevant human outcomes ? Proxy outcomes ?
What are the indications for use ? Label claim ?
Is the product marketed for infection prevention ?
Describe : ________________________________________________
Describe ( e . g ., population , indicated use , setting , etc .): ________________________________________________
If off-label use is considered , is the product / device not approved due to possible safety concerns ?
□ No safety concerns on label ( Proceed to Node D )
□ Possible safety concerns ( STOP - HICPAC will not draft recommendations for products that are not approved due to possible safety concerns )
What to Include
List all outcomes reported in publications including metrics of how they are reported ( e . g ., catheter days , percent , etc .)
Indications for use and label claims as described by the manufacturer when submitting products for review to FDA , and detailed on the FDA-approved label .
Summary of manufacturer ’ s marketing material .
Dates / Timeframes for Data Source
Comments
G
What evidence of efficacy is available ?
• Pre-specified clinically relevant outcomes ?
• Supporting indications for use ?
• Supporting label claims ?
• Marketing data ?
Summarize the available evidence . Note :
• Follow guideline approach to evidence appraisal
• Source of evidence ( e . g ., was the evidence published in peer-reviewed journals or was it provided to FDA as premarket data ?)
• Type and quality of the evidence
• Funding source of the evidence
• Provide references for the evidence
• Does the evidence support the marketing ?
Premier ( 2020 ) suggests that evaluators gather information from a variety of sources , including :
• Key clinical and non-clinical stakeholders
• Clinical requirements , areas of use and current outcomes
• Product specifications , such as product and current utilization amounts and practices
• Associated policies , procedures and guidelines , including internal , professional associations and regulatory
• Evidence-based literature
• Annual spend and supplier proposed pricing , value adds and key terms and conditions
• Benchmarking data – price , cost , quality , safety , labor , and outcomes as applicable
• Reimbursement information
• Supplier capacity – historic , projected and disaster recovery plans
When information has been secured , Premier ( 2020 ) recommends that healthcare value analysis projects follow five key processes :
➊ Identify . Pinpoint the opportunities to address .
➋ Gather Information . Determine and gather the requisite data , content and information to evaluate the opportunity .
➌ Analyze . Weigh all the evidence gathered to make the right decision for your organization and the impacted stakeholders .
➍ Implement . Efficiently implement the decision .
➎ Monitor . Measure and report on decision sustainability and value over time .
Premier ( 2020 ) makes a critical observation , in that sometimes a process improvement is needed , rather than purchasing a new product or technology : “ It is not uncommon to gravitate toward a solution before thoroughly examining the problem that needs to be solved . Solutions can seem easy , obvious and speedy . Problems , on the other hand , are more difficult to discuss , can appear nebulous and can raise questions that challenge our assumptions . Although that solution-first mindset feels comfortable , it may not provide the best odds for success . It may set teams on a direction that might not deliver the value we expect , and we may miss other paths leading to a result that more accurately solves the problem . When evaluating new requests , value analysis teams can implement process steps to assist them in identifying or confirming the problem the requestor is trying to solve .”
As an example , the value analysis team at a multi-hospital healthcare system received a product request from a medical / surgical nursing unit that wanted silver-coated urinary catheters . Their rationale for securing this technology was that it could address an increase in catheter-associated urinary tract infections ( CAUTIs ). The healthcare system ’ s value analysis team noted that while some studies suggest that silver-coated urinary catheters may reduce the risk
When evaluating new requests , value analysis teams can implement process steps to assist them in identifying or confirming the problem the requestor is trying to solve .”