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Making the best of Medical Device Recalls

Posted by Chris Richie on Nov 17, 2015 2:58:53 PM

In Compliance, Automation, RFID, Software Update

Most of us are familiar with automotive recalls like the ones that are frequently in the news, like Takata’s airbag recall that affected over 33 million vehicles. Those working in healthcare technology management (HTM) are also acutely aware of medical device recalls, which happen more frequently than most people realize. In the four years between 2005 and 2009, the FDA reports that manufacturers conducted 87 recalls on infusion pumps alone. It’s not news anyone likes hearing, but when a hospital is notified of a recall like the recent one on Alaris pumps, it can affect thousands of devices that are scattered across the hospital. Just finding these devices in a hospital can be a massive undertaking. After sending out emails to nursing staff, informing them of the recall, it’s not uncommon for HTM departments to have a dedicated staff member scouring the hospital in search of the devices.  Once they are taken out of service for repair, the nursing staff and operations teams immediately feel the squeeze of having less equipment on hand.  It is an arduous, time-consuming process, but there’s a way to turn that pain into gain.

Lean Approach  

This is the situation many HTM departments found themselves in when the latest round of recalls came down from CareFusion on their Alaris syringe pumps for a drive train issue, and point-of-care units (PCUs) for a keypad issue. A large children’s hospital (name withheld upon request) efficiently managed this recall and took advantage of the situation to improve equipment availability and regulatory compliance. In this instance, over two thousand devices at the hospital were under recall. A mandatory software update coinciding with the recall increased that number to three thousand devices, as the update would affect the manufacturer’s large-volume-pumps as well. The HTM leadership wanted to find an efficient (lean) and safe (six sigma) approach that would minimize the impact on clinical operations. Being a long-time partner of Mainspring, they came to us for help. 

After spending some time understanding the process that Carefusion intended to use to manage the physical repair of each of the three device types, Mainspring and the hospital’s HTM team decided to use a traditional lean work cell model. Individual work cells were set up for the software update, PCU repair, syringe pump repair and final safety inspection. This approach minimized cycle time and ensured that each device got the appropriate work done before being released to the next work cell and ultimately back into the hospital. 

With the physical workflow problem solved, attention was turned to automating the process of documenting the software update, repairs and safety inspections. This was not a small task, as the documentation would include over 8,000 corrective and preventative work orders that would be performed over the course of four to six weeks. To minimize the amount of time spent on data entry, Mainspring deployed an automated process that had the added benefit of reducing the possibility of errors. Barcodes were scanned as the equipment passed through the work cells. The unique asset control number, along with the time/date stamp from the scan was used to automatically create, notate and close: a corrective work order for the software update, a corrective work order for the recall repair, and a preventative maintenance work order for the safety inspection. The approach was low risk and effectively added no time to the process.

RFID Tagging 

Since each device was going to be physically touched and scanned, it would take very little additional work to place a passive RFID tag on each one. These tags cost a couple of dollars each, don’t have batteries and are nearly indestructible. For under $10,000 the entire fleet of 3,000 PCUs, LVPs and syringe pumps could be tagged, making them far easier to track down next time. The passive tracking technology would also be a big help in finding pumps for future preventative maintenance and could be used for loss prevention. This was a no-brainer. Mainspring added an additional work cell to the process to apply the tag, associate it to the asset and do a final quality check to ensure that all work was done.

Device recalls and software updates are painful, but they create a cost-effective opportunity for RFID implementation by leveraging the necessary evil of additional labor that is needed when dealing with a recall. With very little upfront investment a hospital can put a system in place that can be used to improve staff productivity and regulatory compliance, while reducing the loss of equipment. Beyond that, the platform can easily be extended to track other equipment, supplies and staff.

 

Tracking 20,000 Hospital Devices with RFID