The clinician or IP should consider using the Healthcare
Infection Control Practices Advisory Committee ( HICPAC ) Infection Prevention
Product Assessment Algorithm . This tool can assist when formulating product-specific recommendations . By doing this , it eliminates bias .”
— Lisa Kilgore , MBA-HCM , BSBM , CIC
with technology that rapidly replaces mechanical or manual ways of providing care . And although innovation provides an essential health benefit , the healthcare system is challenged to select and evaluate emerging technologies to ensure their cost benefit . These factors underscore the importance and need for robust product evaluation programs and collaboration across all hospital disciplines .”
Infection preventionists ( IPs ) are no longer on the sidelines of product evaluation and purchasing decisions , as more IPs are joining their facilities ’ committees for the purpose of representing the interests of HAI prevention . And as Miller and Kelly ( 2009 ) observe , “ Product evaluation remains an essential function in healthcare facilities . As the healthcare environment is increasingly dominated by managed care and capitated reimbursement , constraints are placed on the amount of funding available to hospitals . At the same time , quality of care and outcome measures are beginning to be used as a basis for reimbursement . Therefore , hospitals have tremendous incentive to control costs and improve outcomes . Healthcare-associated infections ( HAIs ) are becoming a focus in the product market , as manufacturers develop high-cost products claiming to decrease infections . Infection preventionists must take an active part in the evaluation of products that may affect infection rates to determine whether they are efficacious and thus worth the added cost .”
Lisa Kilgore , MBA-HCM , BSBM , CIC , director of epidemiology and infection control for Scripps Health in San Diego , reminds clinicians that product / technology purchase decisions impact patient-care outcomes , and when considering a product choice , to ask themselves :
• What are the infection-related risks ?
• Is there a potential for errors ?
• What is the potential compatibility of devices ?
• Are there special population needs ?
• Are there unintended side effector complications ?
Halvorson and Chinnes ( 2007 ) have suggested the goals of a product evaluation program are to select products that meet specific performance criteria , including clinical and financial criteria ; are safe for patients and healthcare personnel ; contribute to positive patient outcomes , such as fewer infections and injuries , and are cost-effective for the healthcare institution as well as patients .
However , some categories of products pose a greater challenge than others in terms of evaluation , and require discernment on the part of clinicians .
Kilgore says it is important for clinicians and infection preventionists to have informed opinions to assist their institutions in effectively evaluating products and devices , “ The clinician or IP should consider using the Healthcare Infection Control Practices Advisory Committee ( HICPAC ) Infection Prevention Product Assessment Algorithm ,” she suggests . “ This tool can assist when formulating product-specific recommendations . By doing this , it eliminates bias .”
The CDC ’ s product assessment guide walks clinicians through critical considerations when evaluating medical devices , products and technologies . Important product considerations include :
• Does the product have the necessary regulatory approvals if required ?
• Does the product have the specific indications for the intended clinical usage ?
• Is the product compliant with established evidence-based clinical guidelines or regulatory requirements ?
• Is the product on your GPO contract ?
• What is the overall cost per usage of the product ?
• What product implementation product is available from the supplier ?
In terms of assessing a product or technology ’ s claims , experts suggest the following considerations :
• Review the product / technology ’ s full regulatory approval document
• Assess the product / technology ’ s technical data bulletin if available
• Review published product reports or clinical studies in peer-reviewed literature
• Review the FDA ’ s MAUDE Reports to assess potential risk for adverse events , especially for medical devices
• Validate supplier materials with independent sources
• Assess for compliance with appropriate clinical guidelines and recommendations