A unique device identification system, which starts to go into effect later this year, requires manufacturers to mark both the device and the packaging with a unique identifier that will include the product lot number, expiration date and manufacturing date to make them more easily identifiable in the case of a recall or safety event. The phased rollout begins this year with the packaging of high-risk implantable devices.
The ONC's recommendation last week applies to EHR vendors that voluntarily go through a third-party certification process and would go into effect in 2015. The voluntary certification system is expected to give EHR vendors more notice about what requirements will be part of future federal rules.
However, many of the proposals that are included in the proposed rulemaking are likely to end up in HHS' Stage 3 meaningful-use criteria in 2017. The UDI proposal applies only to unique identifiers for implantable devices and not other lower-risk products.
The ONC suggests that EHR vendors “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.”
Required information to capture would include the device brand name, version or model, single-use indicator and MRI safety status.
During a session Tuesday at HIMSS, Steven Posnack, ONC's director of federal policy, described the UDI proposal as “relatively basic.”
Some patient groups applauded the ONC, with Dr. Josh Rising, director of the medical device initiative for Pew Charitable Trusts, calling the proposal a great first step toward improving patient safety.
But the proposed rule has raised concerns with EHR vendors. The Electronic Health Record Association said the proposal is burdensome and costly. “It's much heavier than we expected,” said Dr. Mark Segal, chairman of the association's public policy workgroup and vice president of government and industry affairs for GE Healthcare's IT division.
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