by Tracey Berkowitz on April 19, 2024
It’s after midnight on a weekend, but a hospital never sleeps. An OR nurse quickly removes some AlloDerm, MTF-DBM, and Lifelinks from an RFID enclosure in preparation for surgery. As the nurse hurries back to the operating room, the RFID enclosure, through an integration with UDI tracking software, automatically logs which items were removed, who took them, and adjusts inventory. As the surgery takes place the RFID enclosure periodically transmits temperature logs to the tracking software to document storage integrity and ensure the safety of the patient receiving the tissue.
What Could Go Wrong?
While UDI tracking systems and RFID enclosures are highly reliable, black swan events can still occur. What if the communication link between the RFID enclosure and the UDI tracking system temporarily fails? If this happens, it’s highly unlikely that anyone on the floor would notice. The OR nurse would still remove the tissue and hurry back to the operating room. The surgery would still take place and the patient would receive the implant. But the tracking data and temperature would not be logged automatically in the UDI tracking system. In fact, under some circumstances the logging data could be lost permanently.
Patient Safety Risk
If the hospital is unprepared, this will trigger unnecessary risks that increase over time. While communications are out, hospital staff would have to be in the same room as an RFID enclosure to monitor a temperature alarm. Any alarm that goes unnoticed long enough could result in unsafe tissue storage conditions that put patient safety at risk if the tissue is used.
Stockout Risk
If item counts in the UDI tracking system do not reflect recent usage, surprise stockouts could occur. Even as a patient is being prepped for scheduled surgery, staff may find that items shown as available are actually out of stock – resulting in the need to reschedule the surgery. This risks poor patient experience and creates unproductive time for the surgical team.
Compliance Risk
Loss of logging data has the potential to create exposure in an OIG audit, even if there is no direct evidence of unsafe storage. If a time period sampled by an auditor overlaps with any time period logging data was lost, the incident could result in fines and tarnish the hospital’s compliance reputation.
What Would Happen If the Hospital Were Unprepared?
If a hospital is unprepared for an incident like this, staff will lose precious time to take corrective action. They are unlikely to discover the problem quickly on their own. Someone would have to notice the absence of data being logged into the UDI tracking system. They would have to be specifically looking for it, and even then it may not be apparent for hours - if they find it at all.
The hospital is much more likely to be notified by the vendor that operates the communication network. That vendor would likely know about the problem immediately, but it would take time for them to identify affected hospitals and notify their designated contact person in each hospital. If the designated contact is not on duty at the time, it could be hours or days before the designated contact receives the message and takes action. And the longer the time between incident and action, the more the hospital puts itself at risk.
How to Shorten the Time from Incident to Action
Should an incident like this occur, hospitals with InVita’s RFID Device Manager will be highly prepared to prevent or mitigate their risk. Available with InVita’s UDITracker® and Implant360TM, RFID Device Manager supports remote monitoring and management of RFID enclosures within a hospital or across an entire IDN.
RFID Device Manager would notify hospital staff immediately if communications are lost between the UDI tracking software and any RFID enclosures. RFID Device Manager would also show the exact location of any affected RFID enclosures so hospital staff can get a corrective action plan in place without losing precious time.
For example, with proper notice of which RFID enclosures are affected, clinical staff could manually log their retrieval, usage, and replacement of tissue inventory into UDITracker at those locations, so logging is maintained during the communications outage. This would mitigate stockout risk without increasing staff burden at unaffected locations.
To mitigate patient safety and compliance risk, staff could periodically visit affected RFID enclosures to monitor temperatures and manually log them into UDITracker. If there is any concern about maintaining proper storage temperatures, staff could move inventory to alternative enclosures in time to protect against patient safety concerns or costly inventory losses.
It all comes down to shortening the time from incident to action. Be prepared with InVita’s RFID Device Manager.