The Office of the National Coordinator (ONC), a US health technology implementation advocate, has announced a new proposed rule that would advocate for the integration of the US Food and Drug Administration's (FDA) recent Unique Device Identification (UDI) rule with electronic health records (EHRs).
A UDI is, as its name implies, a system of identifying each medical device using a specific system.
The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
At its core, the rule calls for devices to be marked with a UDI system composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.
In September 2013, FDA released its long-anticipated final UDI rule along with a risk-based implementation timeline. For high-risk Class III medical devices, the UDI system's marking requirements will begin to be implemented in September 2014, while Class II devices will have until 2018 and Class I devices-the lowest risk classification-will have until September 2020 to comply.
What's the UDI - EHR Connection?
Since the UDI rule was first planned, FDA has been hoping that health systems will implement device data into EHRs.
"Right now, patients and clinicians often don't know which devices are implanted in them over the long term-Which hip implant do I have? Has it been recalled?-and UDI can help these patients to remain informed," Jay Crowley, a former FDA official who spearheaded the creation of the UDI system, told Focus in May 2013. "Let's say you have a concern about a device. UDI can incorporate itself into the whole EHR space, opening up new ways to communicate information about a device from the manufacturer, to the clinician, to the patient."
Crowley also touted FDA's Global UDI Database (GUDID) system's capabilities, saying that its integrated web service capabilities can allow a healthcare provider to scan a device being used on a patient, allowing the provider to populate EHR fields with accurate data automatically.
Voluntary Standards Put Forth
In its new proposed rule, ONC appears to agree with FDA's vision of a future in which UDI data is integrated seamlessly with EHRs.
"We believe that EHR technology will play a key role in the widespread adoption and utilization of UDIs and that its use of UDIs can help reduce device-related medical errors and provide other significant patient safety, health care quality, and public health benefits," ONC wrote in the rule. "Specifically, EHR technology could be leveraged in conjunction with automated identification and data capture (AIDC) technology or other technologies to streamline the capture and exchange of UDIs and associated device data in clinical and administrative workflows."
ONC also noted the appeal of using UDI-enabled EHRs to better report adverse events, allowing facilities to "facilitate better and more accurate reporting," including to non-governmental sources of information such as device registries.
Which isn't to say that integration will be easy. ONC admits in the rule that "additional standards and technical specifications will be required to support the full range of capabilities contemplated" in the proposed rule.
"Nevertheless, we believe that it is both feasible and important for EHR technology developers to begin implementing at least the baseline functionality necessary to capture, store, and retrieve UDIs and other contextually relevant information associated with a patient's medical devices, specifically implantable devices."
The regulator goes on to propose that it will move toward UDI integration in EHRs in 2015 through its "2015 Edition certification criterion." The data would be contained in the "Product Instance" data element, it said, and the proposed rule calls for new modifications to define "implantable device," "device identifier," "product identifier" and "unique device identifier."
ONC is accepting comments on the proposed rule-which we should note is voluntary-for 60 days.
Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements