Case Studies
Advancing IFU Compliance in Response to ECRI’s 2024 Health Technology Hazards
Introduction:
The ECRI Institute's 2024 Health Technology Hazards Executive Brief casts a spotlight on a critical issue within the healthcare sector: "Inadequate or Onerous Device Cleaning Instructions Endanger Patients." This alert mandates that manufacturers of reusable medical devices and healthcare items deliver practical, validated reprocessing instructions that align with FDA guidelines and ISO 13485 requirements. During a recent Joint Commission Survey, the healthcare organization grappled with significant challenges, further compounded by the limitations of their existing IFU Vendor and the need to incorporate a VAR process throughout the medical device lifecycle.
Challenge:
The Joint Commission Survey unveiled three significant compliance risks within the organization, and affecting multiple hospitals, directly tied to miss-association and missing Instructions for Use (IFU) for key medical devices: an infant warmer mattress, a radiation ring, and a sterilized pouch. These discrepancies not only amplified the urgency to address the hazards identified by ECRI but also demanded an extensive collaborative effort:
· Incorrect Association of IFUs: The infant warmer mattress IFU was incorrectly linked for a different product, a grave error that risked an increase in staff training and safety hazards imposed by the potential requirement of an HLD practice as shown in the incorrect IFU.
· Absence of IFUs: No IFU existed for the radiation ring, a device employed in medical settings but not classified as a medical device by the manufacturer. This absence raised significant concerns for incorrect cleaning procedures. Similarly, an instrument pouch—crucial for maintaining the sterility of items during procedures had no manufacturer-provided IFU, with a description implying it was used for sterilized instruments but contained no sterilization method.
These issues necessitated over a month of dedicated efforts from leadership, infection control teams, and staff to rectify, thereby emphasizing the inefficiencies in our IFU Vendor’s library.
Strategic Solution with Xcelrate UDI:
To resolve the critical needs for IFUs to avoid the Joint Commission citations, Xcelrate UDI's (XUDI) processes were utilized:
· Immediate and Accurate IFU Access through IFUVitals: XUDI promptly delivered the accurate manufacturers IFU for the GE warmer mattress within 24 hours, ensuring continuation of the correct LLD process. Furthermore, XUDI’s initiative working with the manufacturer to simplify GE’s complex poster instructions into a user-friendly format underscored their dedication to practicality and compliance.
· Efficient Closure of Documentation Gaps: XUDI's direct engagement with the manufacturer to address the lack of reprocessing instructions for the radiation ring resulted in the creation of essential documentation from the manufacturer within 72 hours, demonstrating XUDIs capability to swiftly bridge critical IFU gaps.
· Proactive Instruction Development: In the absence of a manufacturer IFUs for the pouch sterilization, XUDI spearheaded the development of a Standard Operating Procedure (SOP), ensuring compliance while awaiting the development of the IFU by the manufacturer (in consultation with the FDA for the final IFU version).
Outcome and Future Direction:
The engagement with XUDI and implementing a VAR process for existing medical devices not only addressed the immediate compliance challenges but also positioned us to preempt similar issues in the future with the integration of IFUVitals. This strategic alliance is anticipated to substantially reduce the extensive time and resources previously allocated by the hospital’s leadership, infection control, supply management, and sterile processing teams for IFU discrepancy management, and eliminating the inefficiencies (outdated, miss-associated, missing, and manufacturer removed IFUs) encountered by staff with our existing IFU Vendor.
Conclusion:
The proactive collaboration with XUDI, in the wake of ECRI’s 2024 health technology hazards, accentuates the critical need for selecting partners that offer innovative solutions and comprehensive support. Through the expertise and resources provided by XUDI, particularly with IFUVitals, we have significantly enhanced our operational efficiency, ensured compliance, and upheld the highest standards of patient care and safety. Moving forward with XUDI and the deployment of IFUVitals, we are confident in our enhanced ability to manage IFU complexities and reprocessing requirements, reaffirming our commitment to excellence in healthcare delivery and patient safety.
IMPROVED LABOR TIME & COSTS (case study)
Xcelrate UDI uses workflow optimization paired with UDI-assisted barcode scanning technology to improve labor costs associated with the handling and administration of medical devices and biologics.
Prior to implementing our technology, our client relied on manual processes to perform inventory maintenance and manual data entry of medical supplies into the patient health record. We conducted time studies over a period of one month to assess the time spent on inventory management tasks and patient record documentation of medical device / biologic data.
For inventory management, staff would spend between 6-8 hours manually validating the medical devices and biologic supplies across multiple storage locations in one facility using printed spreadsheets. This often resulted in erroneous item counts and the failure to identify and remove supplies that were expired, recalled, counterfeit or were truck stock items that weren’t not hospital-approved.
For patient record documentation, staff would spend between 3-6 minutes to manually type in the full product and device information into the appropriate fields within the clinical record for each medical device type or biologic item used during surgeries. Surgeries included an average of 5 Class 1 and Class II medical devices used with patients, which took an average 20 minutes to manually type into the clinical record. This manual entry often resulted in typing errors and many of the data elements that are required to document were omitted, mirroring the results of the 2015 study conducted by the CDC on the benefits of barcode scanning over manual data entry.
After implementing our technology, the client was able to significantly reduce the amount of time it took to complete the inventory management and patient record documentation by 95%, allowing the staff to reallocate the time savings to complete more productive tasks.
For inventory management, Xcelrate UDI’s barcode scanning technology allowed staff to complete the same inventory tasks in 18 minutes compared to the 6-8 hours when conducted manually. It also allowed the staff to efficiently identify and remove items that should not be used with patients.
For patient record documentation, Xcelrate UDIs barcode scanning technology allowed the product and device data to be parsed into the appropriate fields within health record with precision accuracy and in 6 seconds per item compared to 3-6 minutes when typed manually
IMPROVED BILLING ACCURACY (case study)
In addition to improving labor costs by reducing non-productive time spent on manual processes, another financial pain point Xcelrate UDI addresses for hospitals and surgery centers is over and under billing of medical devices and biologics.
Prior to implementing our technology, one of our clients relied on manual data entry to capture the supplies used with patient and initiate the billing / reimbursement process. We conducted a billing audit with just one screw over the course of one month. This audit uncovered that the nurses were documenting the use of screws that were not on contract, were listed in client’s the item master.
Although we can assume the correct screws were used during surgery, relying on manual entry often yields inaccuracies that can be costly when added up. In this case, the items in red are non-contract screws that were incorrectly documented as being used with patients – identified in red in Exhibit A below.
Exhibit A
In one month in 2021, over $8,000 was over billed to patients and more than $1,200 under billed per the audit finding.
In addition to the cost impact of incorrect billing, this also contributed to inventory waste - as incorrect items continued to show up as depleting faster and were replenished unnecessarily, while other supplies used were not replenished timely.
