So , what we ’ ve heard from our members focuses on the struggles that they and their facilities ’ sterile processing departments are having around the amount of time and energy that the IFU compliance issue is taking out of the healthcare system .” — Devin Jopp

Stallard ( 2021 ) reports that several years ago , medical device manufacturers , regulators , and healthcare technology management ( HTM ) experts came together to address complex and confusing IFUs , and the resulting updated technical information report , TIR12:2020 , Designing , testing , and labeling medical devices intended for processing by healthcare facilities : A guide for device manufacturers , standardizes manufacturer IFUs for the processing of clinically used medical devices . It also helps manufacturers understand how well the end users comprehend a device ’ s instructions and labeling .

The healthcare facility ’ s infection preventionist ( IP ) should be a strong partner in supporting the SPD and can lend his or her expertise in the fight against device-related infections . They can also be a champion for improved IFUs . To this end , last month , the Association for Professionals in Infection Control and Epidemiology

( APIC ) launched a surveyreceiving more than 1,300 responses , to help the organization quantify IP challenges with IFUs . Devin Jopp , chief executive officer of APIC , shared his hopes for what the survey can help accomplish .

“ Ultimately , the whitepaper that we produce will serve as roadmap for how we agree across stakeholders to address the challenges with IFUs ,” Jopp says . “ The report will provide suggestions to the FDA on reforming the IFU process through means of regulation , recommendations for standards organizations to consider as they evaluate protocols for standards compliance , reporting requirements on IFUs from manufacturers , and recommendations for the creation of a centralized national system to electronically access IFU . Addressing IFUs is challenging because of the sheer number of moving parts , however , this new report will serve as a blueprint for collective action in hopes to create a

The Infection Prevention Exchange

By MD-Medical Data Quality & Safety Advisors , LLC

The IPEX Bundle

• Data

• Process Improvement

• Technology • Artificial Intelligence

Patient & Staff Safety

Patient Satisfaction Scores improved LeapFrog Scores improved

Financial & Operational Efficiencies 50-75 % Reductions in cost of infection

HEALTHCARE-ASSOCIATED INFECTIONS

Contact Tracing

50-75 % Reductions in infections

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