As hospitals across the country look for ways to become more efficient with the use of technology, a significant area of need is the digitization of medical device tracking – an issue that currently costs the system as a whole some $5 billion a year.
To address this, the FDA is mandating a unique device identification by 2020, with the initiative having begun in September. It’s essentially a bar code that can be scanned, tracked, and more easily recalled if need be while keeping the patient informed and up to date on what’s been implanted in their bodies.
Champion Medical Technologies outlined the issue recently, calling attention to the antiquated, costly and often dangerous process used for tracking certain devices implanted in patients, particularly in the case of a product recall.
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“Product recall is expensive,” said Peter Casaday, CEO and president of Chicago-based Champion. “It takes months, and during those months, patient safety is at risk. This has become a major issue for hospitals.”
Currently, 99 percent of all product recalls are handled manually, Casady said, meaning a hospital employee has to physically type down a number into a system. That often leads to human error and a prolonged search process more prone to oversights and lost devices.
“Manual data entry creates inefficiencies from the minute a medical device arrives at the hospital,” Champion notes in a white paper. “Someone receives the package, documents information in a paper logbook, and then enters the same information into a computer. That third step doubles the chances for input error; studies at Ohio University’s Automatic Identification and Data Capture Lab have found the typical error rate for manual data entry is one in 300 characters. (In contrast, the lab has found that data matrix barcodes have an error rate of fewer than 1 in 10 million characters scanned.)”
It’s difficult for both the hospitals and the manufactures, said Jay
Crowley, vice president of Unique Device Identification Services and Solutions as USDM Life Sciences.
But hospitals, according to Casady, are often reluctant to address the matter, with many saying they would wait for an EHR system that could accommodate UDI data. And that, he said, is a mistake to assume an EHR system can serve as both a regulatory compliance and medical-device management system.
Rather, it would be wise to incorporate any data from the bar code UDI into an EHR, which could prove useful for patients with implanted medical devices as well as for care teams, Crowley said.
Both Crowley and Casady likened the current practice of manual tracking in hospital to that of a grocery store the labels every item on the shelf – a process that disappeared when software systems came along that could better track inventory, make items easily findable and reducing the likelihood of expired products on the shelf.
“As the device moves around the hospital facility – onto an inventory shelf or directly into the OR – one system might document a catalog number, while another records when it is used in patient care,” the white paper states. “Through the process it’s possible that no one documents the manufacturer’s serial number, which is what the FDA currently uses to identify recalled products.
That, in turn, creates a major headache and “vast expenditure of labor for highly paid, very busy OR and supply chain personnel.”
“It was always a nightmare for us,” said Rose Trojkovich, an OR nurse and surgical services educator at Englewood Hospital in New Jersey, referring to product recalls. “It probably took close to a month or more in order to find the patients effected. Not only is that a problem for patient safety, but also for the labor involved.
“The patient was the last person getting this information, when in fact they should really be the first to get it,” she added.
Recalls of medical devices have been on a sharp rise – in the third quarter of 2013 alone, FDA Enforcement-Reports documented 415 medical device recalls, totaling 29 million units,0ccording to the white paper. The number of class I recall units – including implantable devices – increased by more than 485 percent during the quarter.
The UDI initiative aims to correct that, and it goes beyond just patient safety and hospital bottom lines – the data that can be captured from the device can likely be imported into an EHR and prove useful for patients with implanted medical devices.
“UDI makes it possible to integrate information across disparate IT systems – clinical, operations and financial. It increases visibility into key data on cost and quality drivers,” the report said.
