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STANDARD PRACTICES The human side of UDI by Karen Conway, Executive Director, Industry Relations, GHX


s the Food and Drug Administration (FDA) rolls out its Unique Device Identification rule that requires manufacturers to assign and label their prod- ucts with unique device identifi ers (UDIs), the complexities of the regulatory landscape and the variation in processes across the healthcare delivery system continue to be illuminated. Take human cells, tissues and cellular


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and tissue-based products, better known as HCT/P, as an example. These include a wide range of tissue and cellular products including arteries and veins, bone grafts, heart valves, cornea, skin and tendons. The production and distribution of these prod- ucts are regulated by the FDA Center for Biologics Evaluation and Research (CBER), one of six main centers within the FDA, but separate from the Center for Devices and Radiological Health (CDRH), which is responsible for the UDI rule. However, a few HCT/P, such as tendons with sutures attached, demineralized bone products combined with certain handling agents and femoral veins intended as A/V shunts, are considered medical devices and therefore covered by the UDI rule. The use of these products falls under the jurisdiction of The Joint Commission, which requires health- care organizations to create standardized processes around the acquisition, receipt, storage and issuance of these products. The Joint Commission also requires that systems document the use of HCT/P in a recipient’s medical record; if the HCT/P is considered a medical device, that documentation must use the UDI. Also, while individual health- care delivery organizations might have standardized processes, there is signifi cant variation among facilities, even within the same parent system. The 2015 Edition Health Information Technology Certifi cation Criterial Final rule also requires that the UDIs for implantable devices — including those for implanted HCT/P that are considered medical devices — be represented with a UDI in a patient’s electronic health record (EHR), and the UDI must be able to be parsed into the device identifi er (DI) and the production identi- fi er (PI). For most medical devices, the PI includes the lot, batch or serial number


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and the expiration date — whatever the manufacturer uses to control production of the product. For HCT/P, the production identifi er must also include a distinct iden- tifi cation code (DIC) that can be traced back to the donor. ICCBBA, one of UDI issuing agencies authorized by the FDA and special- izing in HCT/P, has a dedicated production identifi er for the DIC, known as the Donor Identifi cation Number, which is embedded in the ISBT 128 (ICCBBA’s UDI compliant code). A single Donor Identifi cation Num- ber can be used to identify all of the tissue products prepared from a particular donor by a specifi ed tissue processor. The only time there is a different PI for tissue from the same donor is when that tissue is processed by a different tissue bank. Despite safety precautions, tissues have


been implanted into recipients, only later to have it discovered that the donor had an infection that can be transmitted through transplantation. The ISBT 128 is designed to rapidly identify affected HCT/P by minimiz- ing the numbers associated with tissue from the same donor. In the event of a recall, a single Donor Identifi cation Number can be used to fi nd all of the impacted tissue from that donor that was processed by a specifi c tissue bank. Without the Donor Identifi ca- tion Number, every piece of tissue has a different lot and/or serial number, even if it came from the same donor, greatly increas- ing the complexity of recall management. In 2011, when it was discovered that tissue donated by a man infected with hepatitis C virus (HCV), it took a month for the tissue processor to notify all of the surgeons who had implanted some of the infected donor’s tissues into their patients. Because data on the surgeons was not uniformly available, tissue from the infected donor continued to be used after the infection was first discovered. This is another consequence of lack of standardization: When different facilities or individual clinicians manage HCT/P differently, it becomes more dif-


56 July 2016 • HEALTHCARE PURCHASING NEWS • hpnonline.com


fi cult to take effective action quickly. And when tissue products are handled manu- ally, it is very diffi cult to distinguish the DIC. Electronic systems, on the other hand, can be programmed to recognize the Donor Identifi cation Number in the ISBT 128 code. Further complicating things are the multiple regulatory agencies and evolving requirements, e.g., UDI, and variation as to which departments or functions within healthcare delivery organizations have re- sponsibility for HCT/P. Sometimes it is the blood bank, other times the OR or materials management. Hospitals and other healthcare providers are facing increasing regulatory requirements, from multiple agencies. Once again, I believe the UDI rule, while


aimed at manufacturers, creates an oppor- tunity to break down some of the silos that exist in the provider environment. Who has responsibility for HCT/P in your hospital? Who will be responsible for ensuring UDIs are captured in EHRs for implantable de- vices? Have you begun considering how you will use UDIs to better manage supply chain and revenue cycle processes? Are your IT systems capable of handling UDIs or are you still managing implantable devices and HCT/P manually? Are you collaborating with different departments and clinicians to solve for new regulatory, technology and process challenges, or are you problem solv- ing in silos? Please share your challenges and solutions, even if they are works in progress. We are all in this together and can learn from one another. HPN


As the Executive Director, Industry Relations at GHX, Karen Conway works with industry associations, standards bodies, government agen- cies, analyst fi rms, academic institutions and the media to identify opportunities for hospitals and suppliers to optimize supply chain operations and improve business and clinical performance. Conway is chair-elect of the board of directors of AHRMM, the supply chain organization for the American Hospital Association. Conway is cur- rently writing a book on the Accountable Health- care Leader, drawing upon the concepts developed in her 2013 global leadership book, Leading from the Edge, which she co-authored with the former chief talent offi cer of Cisco. Conway serves on the editorial board of Healthcare Purchasing News.


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