When a patient needs an implanted device replaced, how do clinicians identify which particular implant the person has? The answer is that they often change hats from surgeons to detectives to try to piece together that information. The initial team may have typed the information into the EHR somewhere.
One recent study based on surveys of surgical societies projected significant time invested, and sometimes the inability to identify failed implants. That is because there is no standardized way to document information about implanted devices in the current generation of EHRs. But that is about to change. The capture of unique device identifiers (UDIs) in health records will be required for ONC certification under the recently released 2015 certification rule, and UDI data will have to be transmittable as part of the Common Clinical Data Set in order to meet meaningful use Stage 3 requirements.
The certification rule provides the capability for hospitals and providers to document which devices are implanted in a patient, link with an external database to input human-readable information directly into the EHR, and exchange UDIs among providers through the Common Clinical Data Set.
I recently had the chance to speak with Ben Moscovitch, officer of medical devices at the nonprofit Pew Charitable Trusts, about the significance of the inclusion of unique device identifiers as a required field in EHRs in the 2015 criteria released Oct. 6.
He stressed that medical devices implanted in patients are important elements of the patient health history, yet today there is no standard way to document which devices are implanted in patients. “Including UDIs in patient EHRs will provide information on which devices are implanted in patients, and have several benefits including to facilitate recall resolution,” he said. Once there is a recall, the hospital, provider or patient can know if the patient has been impacted. It also can help improve adverse event reports, he noted. Currently adverse events are under-reported and can lack critical information such as accurate information on which device had the problem. “Including the UDI would ensure that more accurate information is included in adverse event reports. It will also enhance clinical decision support, because when patients are seen by multiple clinicians, they know which devices are implanted in the patient and can provide care accordingly.”
Moscovitch said that some health systems use their EHRs to analyze product performance and patient outcomes. Including the UDIs will allow those health systems and other researchers to evaluate device performance and outcomes. For instance, Mercy Health System did a pilot project that incorporated UDI into its cath lab and researchers were able to use that data to compare device performance.
Between the proposed and final certification rules, ONC expanded the number of fields required to allow for more information to be shared, he said. The proposed rule included a device description field that was not standardized across devices. The final rule includes other fields, including whether the device is MRI-compatible. “By including these other fields such as MRI compatibility, the patient and clinician will have more information at their fingertips to inform care decisions without having to go to an external database to type in the UDI and obtain that information,” Moscovitch said.
The final rule from the FDA requires that the UDI be depicted in two ways: human readable, such as a string of numbers, and available for automated capture such as through a bar code. ONC in its regulations strongly urges EHR vendors to develop capabilities to support the automatic capture of UDI, and indicates UDI should rarely if ever be typed in manually, given manual entry is more prone to errors.
In August I wrote about a task force convened by the Food & Drug Administration on medical devices. It recommended that the federal government and other stakeholders support the creation of a comprehensive partnership on medical devices to monitor the products' performance after they become commercially available. The recommendations call for a master network of data in each clinical area where devices are used. The task force noted that information on medical devices exists in registries, electronic health records and claims data, but the disparate locations make it difficult for regulators, doctors and patients to understand and use it efficiently.
I asked Moscovitch if having UDIs documented in EHRs is a first building block in this effort to better monitor the performance of medical devices. “Exactly,” he said. That registry task force, a separate planning board and others have indicated that UDI capture in EHRs is essential to conducting more robust product evaluation throughout the product lifecycle,” he said. “In addition to EHRs, they have expressed support for UDI registries and UDI in claims data, which provides is good longitudinal data on patient outcomes long after surgery.”