FDA UDI Easy Compliance with RFID Solutions

Recalls of medical devices can be time-sensitive. Hospitals must be aware of a faulty pacemaker, infusion pump, or surgical device lot, and know where it is and who the patients are that may have been impacted. RFID can enable that process to change from manually searching records to a quick and automated inventory.

The essential piece to the puzzle is to know how RFID fits into the Unique Device Identification (UDI) system developed by the Food and Drug Administration. Always choose the best RFID hospital inventory management to improve patient safety.

What does FDA UDI Compliance mean?

The UDI system created by the FDA is a system of identification for medical devices that is consistent throughout distribution and use. A UDI typically includes a device identifier (DI) that identifies the labeler and the specific version or model of the device, and production information (PI), such as a lot/batch number and/or a serial number or expiration date if applicable.

UDI information is meant for enhanced identification and support:

• Medical-device recalls
• Adverse-event reporting
• Inventory management
• Patient safety
• Tracking and documenting devices.

But a UDI on a label does not necessarily equal real-time visibility. However, hospitals must have systems that can capture and link that data with their inventory and clinical workflows.

Where RFID Makes a Difference

RFID works by sending radio waves to identify an object tagged with a chip that does not need to be scanned using a bar code reader, one per item.

If RFID tags have medical-device data attached to them, the hospital could gather medical data as the devices pass through certain areas.

In an RFID-based system, the following are the parameters that can be tracked:

• Device identity
• Lot numbers, Batch numbers
• Serial numbers
• Storage locations
• Movement between departments
• Inventory status

Staff can identify potentially affected devices much faster and without having to physically go through cabinets, shelves, spreadsheets, or paper records by using centralized RFID data.

Rapid Search is a Useful Skill to Have

Discuss the possibility of a pacemaker lot being faulty.

If inventory is not visible: Workers could have to:

1. Review purchasing records.
2. Search inventory databases.
3. Visually examine storage areas.
4. Compare lot numbers.
5. Contact multiple departments.
6. Identify the transfer of, or use of, devices.

It can be particularly challenging in large hospital systems.

If the device has been appropriately designed with RFID and inventory, authorized individuals can use the relevant information to search the device and find tagged inventory that is connected to the affected lot and quarantine or take further action on the devices.

RFID doesn’t replace the recall process; it simply makes identification and locating stages much quicker.

RFID and Barcodes can Work Together!

Hospitals don’t necessarily have to abandon barcode technology.

A viable UDI approach might involve:

• Unique serial numbers for identification and point-of-use scanning.
• Automated location and movement visibility with RFID tags.
• Software to manage inventories and store them in a central location.
• The use of electronic health records, if applicable,

The goal is NOT picking the right identification technology for each situation; it’s to develop a reliable chain of information. Consultation with an expert will surely help you install an RFID warehouse management system.

Important Implementation Considerations

RFID isn’t a magic compliance button. Hospitals must carefully define their systems based on FDA needs and in their operational reality.

Before implementation, consider:

• Which types of medical devices need to be tracked?
• What UDI data needs to be captured?
• What applications are there for radio frequency identification (RFID)?
• Will RFID interfere with existing workflows?
• How will data be assured?
• What departments are required to be able to access it?
• What will be the process for quarantining recalled products?
• How will the RFID records be integrated with current inventory systems?

Hospitals should also ensure that the use of RFID tagging and equipment placement are suitable for the particular medical-device operating environment.

The following are some tips for better UDI and RFID management:

1. Begin with expensive, critical, or easily lost equipment: Begin with expensive, critical, or frequently lost equipment.
2. Take data in correctly: Bad lot or serial number data can have a negative impact on recall effectiveness.
3. Establish clear workflows: Identify individuals responsible for receiving, tagging, moving, scanning, and retiring devices.
4. Test recall scenarios: Conduct a series of recall tests to see how fast inventory can be identified that’s been affected.
5. Protect data: Ensure access control and ensure proper cybersecurity has been put in place with connected systems.

While FDA UDI offers a standardized set of identifiers, RFID can offer automated traceability of where medical devices are located and how they flow through a hospital.

With proper integration with inventory and clinical systems, RFID can enable hospitals to act swiftly on recalls, lessen manual searching, enhance inventory accuracy, and support patient-safety efforts.

That difference can make a difference in the multi-department investigation at a hospital with thousands of medical devices becoming more controlled and much faster.