The Challenge
Reston Hospital was writing off approximately $200,000 worth of missing tissue grafts annually and relying on manual and labor-intensive inventory processes. As a result of the FDA and Joint Commission’s updated UDI regulations, their current inventory tracking and management processes posed even more challenges. The rising costs associated with missing tissues along with ever-evolving regulatory standards made it necessary for Reston to find a method for managing and tracking its tissue inventory that was both efficient and cost-effective.
The Unique Identification (UDI) Rule
Joint Commission standards apply to hospitals that store or issue tissue. This includes any areas outside of the clinical laboratory; for example, surgery and outpatient centers or tissue banks. On September 27, 2007, the Unique Device Identification (UDI) rule was signed into law. This was created to assign a unique identifier to medical devices, such as heart valves, implants, and stents. The purpose of the UDI rule is to improve the quality of information in medical device event reports. In turn, this will help to quickly identify recalled or compromised products. The FDA is using a phased implementation of the rule’s requirements. Class III devices went into effect on September 24, 2014. Implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the PHS Act went into effect on September 24, 2015.
The Solution
Reston Hospital determined that the implementation of Terso Solutions’ RFID-enabled enclosures integrated with InVita Health Technologies’ UDITracker® software would be the most effective solution to their critical issue. In 2013, Reston installed an Ultra-Low Temperature RFID Freezer that stores 57 pieces of inventory. In addition, a Large RFID Cabinet was installed, and stores 188 items, such as tissue and implants. The efficiency of these solutions led Reston Hospital to install an additional RFID freezer and RFID cabinet in 2015. Together, these enclosures store 192 pieces of inventory. When combined with the RFID-enabled enclosures, InVita’s UDITracker software identifies when all items are entered and removed, enabling them to see who took what, and when. For Reston, this automates what was once a time-consuming and error-prone process. The software allows nurses and hospital staff to track any medical device item with a lot, serial, or UDI number within seconds. Reston Hospital found UDITracker’s QuickReceipt feature to be an important piece to their overall workflow. With this feature, the hospital’s supply chain managers can access real-time shipment statuses while improving data accuracy at the same time. This ensures they only purchase what they need. By knowing what they have on hand, they can prevent overstocking. The information needed about the product and its sizes is right at staff’s fingertips.
Inventory Cost Savings
Between expiring and missing inventory, hospitals lose thousands of dollars every year. This was no different for Reston Hospital. Argenis Mendoza, Business Manager, Operating Room at Reston Hospital Center, has been using this automated inventory management system since its implementation. As a result of UDITracker, Argenis receives alerts when items are close to expiring, enabling him to take proactive measures before it’s too late, reducing waste and manual inventory reconciliation time. With data flowing into UDITracker software from the RFID enclosures, the analytics available for reporting have improved the hospitals implant usage records, from the loading dock to patient entry. Any tissue items removed from the RFID-enabled cabinets is automatically recorded through UDITracker, and this data is immediately accessible in real-time.
Faster Recall Management
In addition to cost savings and increased patient care, Reston Hospital is now able to provide a much quicker response time to recalled products. When exposed to a product recall, most hospitals take weeks or more to investigate. Now having real-time visibility of inventory across the product lifecycle, Reston Hospital can respond to a recall in approximately 24 hours. Data from the FDA Recall Database, EHR systems, and manufacturers is consolidated into UDITracker software. This enables data to be captured and automated for connecting recalls to patients and inventory, eliminating the manual cross-checking. With this automated process, Reston can now match recalls with affected patients and inventory storage locations and address recall notices promptly and efficiently to enhance patient safety and decrease liability.
The Benefits Continue
By combining Terso Solutions’ RFID-enabled enclosures with InVita’s UDITracker® software, Reston Hospital can manage and track its tissue and implant inventory from entry, storage, patient use, to recalls within one data-integrated solution. Further, this integration automates Reston’s clinical processes, giving Reston end-to-end control and visibility to ensure operational efficiency, comply with regulatory compliance guidelines, reduce costs, and enhance patient safety. Staff can focus on the work they do best – providing superior patient care – instead of manually managing inventory.
About InVita Healthcare Technologies
InVita Healthcare Technologies is a leading provider of specialized software for regulated industries, supporting the advancement of public health and safety. Our Implant Management division specializes in implant and explant lifecycle software, offering streamlined solutions with built-in compliance safeguards for handling tissue, non-biologic medical devices, product recalls, explants, and warranty claims. Our solutions improve operational efficiency, ensure compliance, and deliver cost-saving benefits to hospitals and health systems. Visit www.invitahealth.com for more information.
