What pacemaker is this? The value of unique device identification

Recent high-profile cases where implantable cardioverter-defibrillator leads and metal-on-metal hip implants failed have drawn attention to the need for use of unique device identification or UDI. Natalia Wilson, co-director of the Health Sector Supply Chain Research Consortium says in a recent report that the first step to a more effective system of monitoring device performance and protecting patient safety is to implement a UDI system integrated with electronic health records.

It’s a quintessential scene in crime TV: the coroner finds that Jane Doe has an implanted medical device. He removes the device and finds the serial number, which he gives to the detectives, who type it into a database to find the name of the Jane Doe. Mystery solved!

Unfortunately, that’s not that way it works in real life. In reality, medical devices are not consistently labeled or marked with standard unique identifiers, and there is no master database that can tie a unique identifier to a patient record. In fact, in health care, rather than using the device to identify the patient, clinicians and others may want to determine what device a patient already has in their body, or whether a specific recalled device is in the hospital.

“For medical devices, there has not been a standard format used across health care for marking the part or the device label, nor a standard place that the information is stored digitally,” explains physician and public health expert Natalia Wilson, co-director of the Health Sector Supply Chain Research Consortium at the W. P. Carey School of Business. Recent high-profile cases where implantable cardioverter-defibrillator leads and metal-on-metal hip implants failed have drawn attention to the need for use of unique device identification or UDI.

Wilson hopes to influence use of UDI in health care. In a recent article for The Journal of the American Medical Association, she writes “these examples illustrate the need for a more effective system of monitoring device performance and protecting patient safety.” The first step is to implement a UDI system integrated with electronic health records (EHR).

Unique Device Identification: Better device packaging, and tracking

UDI provides a standard format for device identification. Manufacturers will be required to label their marketed devices with UDI, a unique number designating manufacturer, make, model, and generally lot/serial number and expiration date. “Attention is increasingly being focused on integration into health information technology (HIT) systems so the UDI is linked to a patient electronically,” explains Wilson, who is an active leader of UDI research, education, and national-level efforts.

A system like that will be one large step closer after the Food and Drug Administration (FDA) issues its UDI Final Rule, which is expected at the end of this month (June 2013.) From the Proposed Rule: “The unique device identification system for medical devices established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI) … [with limited exceptions] … Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology … The rule would require the submission of information concerning each device to a database that FDA intends to make public…The UDI shall adequately identify the device through its distribution and use.”

So, in addition to mandating UDI labeling by manufacturers, the rule as proposed supports integration of UDI information into HIT systems. In other words, the device must be labeled with a format where data can be captured electronically. Wilson explains, “This will support the ability to hold device and patient information in EHR.”

The benefits: Improving patient safety, increasing efficiency, lowering costs

A significant benefit of UDI is that it would support more robust device “post market surveillance,” an important source of data on device performance that may inform recalls. This supports patient safety by making it easier to identify device failure, and UDI in the EHR would facilitate finding the patients who have the failing device.

Wilson gives an example of a device recall in a world without use of UDI. In 2010, data from international joint replacement registries indicated that two hip replacement devices were not functioning as expected. That finding led to a large recall that has impacted patients significantly and has been costly to the health care system. “If UDI were used in clinical registries, population databases, and post-market studies, we might be able to create larger datasets and identify non-performing devices earlier, recall them earlier and lessen patient impact,” Wilson explains.

With UDI integrated into HIT systems, “if a recall occurs, hospital systems can query the EHR and determine which patients have that device,” explains Wilson. “Additionally, if a revision or emergency surgery is needed, physicians can access the EHR and obtain clear and accurate device information on the device already in a patient.”

Electronic capture of UDI would also support greater efficiency and error reduction by automating and creating a standard for processes that currently are often manual. “By capturing device information via UDI in supply chain IT systems and using UDI in procurement (contracts, purchase orders, invoices), error reduction, improved efficiency and associated cost savings are expected,” explains Wilson.

Beyond procurement, Wilson says, recall management is an important duty of hospital supply chain management: finding recalled devices and removing them from the patient care setting. This is often manual -- a time-consuming and resource-intensive process.

Manual, non-standard processes can cause errors and inefficiencies in the clinical setting as well. “Consider manually writing or typing in device identifying information when the device is used in patient care,” Wilson says. “Juxtapose that to scanning a UDI. The automated process saves time — time that can be devoted to actual patient care — and reduces the errors that are inevitable in manual processes.”

All of those benefits — improving patient safety, reducing error, increasing efficiency — lead to a benefit that is especially important given skyrocketing health care costs: cost savings. Wilson says, “Use of UDI supports health care cost savings when it enables greater efficiency, error reduction and allows health care practitioners to focus on other duties — whether that’s other supply chain tasks or actual patient care.”

Another way that UDI is expected to save money is by enabling quicker recalls. “Large recalls are very costly,” Wilson says. “If use of UDI in post-market surveillance activities allows creation of larger datasets and earlier availability of data on failing devices, enabling a quicker recall decision, fewer patients should be impacted, and associated costs should be lower.” In addition, a more seamless system should optimize clinical documentation and reduce errors in billing, maximizing health insurance reimbursement.

But not everyone is jumping on the UDI bandwagon

For all the expected benefits of unique device identification and integration of UDI into HIT systems, there are obstacles to UDI implementation and adoption in hospital systems. “Lack of current regulation or meaningful incentive to require use of UDI in patient care settings and competing priorities of hospital systems are significant obstacles to implementation and adoption of UDI,” says Wilson. “Lack of understanding of the value of UDI and financial constraints are additional obstacles.” While the FDA rule will mandate that manufacturers label devices with UDI, it is beyond the purview of FDA to mandate use of UDI.

“UDI implementation requires knowledge of UDI value and collaboration between groups in a hospital — supply chain, clinical, IT — that may not typically work together,” Wilson explains. “In some leading hospital systems, supply chain management has taken the lead with this effort. Developing a vision for UDI implementation will require a cultural shift. Fortunately, signs of that shift are already appearing as certain provisions of the Affordable Care Act necessitate breaking down silos to be successful.”

Implementation of UDI also faces obstacles because many benefits are longer term. “The benefits of mandated national drug codes and electronic medication administration records (e-MAR), for example, are very acute,” Wilson explains. “The nurse scans the medication barcode and scans the patient’s wristband barcode to ensure that the correct medication, in the correct dosage and at the correct time is being administered. Very good research has been performed indicating statistically significant reduction of medication error when using barcode e-MAR systems.”

In contrast, the benefits of UDI are often not as immediately apparent. But they are no less impactful on patient safety and patient care. “Part of my current research is conducting objective evaluation of barcode scanning of implantable devices and developing the clinical and business case for implementation and adoption of UDI in hospital systems,” says Wilson.

Just as resistance to electronic health records have been overcome, so can barriers to UDI implementation, she says.

“Regulation, meaningful incentives or link to reimbursement can be policy levers for health care providers to use UDI,” Wilson says. For example, there have been ongoing conversations about UDI in EHR as a Stage 3 meaningful use criteria (providers must implement UDI in order to receive Medicare incentive payments), UDI in claims forms as a reimbursement requirement or UDI use as a requirement for accreditation through the Joint Commission (a private, not for profit organization that evaluates health care organizations that voluntarily seek accreditation).

Wilson is part of a broader group of researchers and health care practitioners working to support the implementation and adoption of UDI. She participates in a workgroup with the Washington D.C.-based Brookings Institution, which has hosted workshops and webinars to help educate stakeholders on UDI and is currently working on an implementation roadmap. In addition, Wilson is actively researching UDI use in orthopedics, looking for measurable outcomes that can be improved by barcode scanning and automated capture in HIT systems.

The UDI Final Rule that the FDA issues later this month will likely be at least somewhat different than the Proposed Rule, and it will certainly not please everyone, but Wilson is optimistic that the ruling -- in combination with the work that she and her colleagues are doing, and conversations they’re having about implementing UDI -- will bring the health care system one step closer to a place where the question “What pacemaker is this?” is easily answered.

Bottom line

• There is no standard format across health care for marking or labeling medical devices, nor a standard place that the information is stored digitally.
• The Food and Drug Administration (FDA) has proposed a rule that would establish a unique device identification (UDI) system for medical devices. The UDI Final Rule is expected to be released at the end of June 2013.
• Expected benefits of UDI include better “post-market surveillance” (and, as a result, better patient safety); a standard for device documentation; improved efficiency and reduced error by automating and introducing a standard (UDI) to processes that are often manual; and cost savings.
• For all the benefits of unique device identification and integration of UDI into HIT systems, there are obstacles to UDI implementation among key health care stakeholders.
• Whereas FDA can mandate manufacturers to label their marketed devices with UDI, mandating use of UDI is beyond the purview of FDA.
• Barriers to UDI implementation can be overcome, perhaps by making UDI a meaningful use criteria (providers must implement UDI in order to receive Medicare incentive payments), a requirement for reimbursement or a requirement for accreditation through the Joint Commission.