search.noResults

search.searching

note.createNoteMessage

search.noResults

search.searching

orderForm.title

orderForm.productCode
orderForm.description
orderForm.quantity
orderForm.itemPrice
orderForm.price
orderForm.totalPrice
orderForm.deliveryDetails.billingAddress
orderForm.deliveryDetails.deliveryAddress
orderForm.noItems
STANDARD PRACTICES


Driving UDI adoption: Notes from the 2016 UDI Conference


by Karen Conway, Executive Director, Industry Relations, GHX T


oday, there are approximately 550,000 unique device identifier (UDI) re- cords in the Food and Drug Admin- istration’s (FDA) Global UDI Database (GUDID). In a little over three months, that number will have soared past 3 million, as manufacturers meet the third deadline for submission, for all Class II devices. Class II devices represent the largest regulated class of medical-surgical products sold in the United States, about 43 percent of products. Combine that with products already in the database, including the highest risk group (Class III) and all implantables regardless of class, and the majority of products will be assigned a UDI and listed in the GUDID by September 24, 2016. This represents an important shift in the UDI regulation, from something that manufacturers must do to keep selling their products in the U.S. to a tool that the healthcare system can start putting to good use. Recognition of this shift was apparent by the near standing room only crowd at the “Realizing the Value of UDI” track on the second day of the UDI Conference held in Baltimore in April. Presented by the Association for Healthcare Resource and Materials Management (AHRMM), the track featured presentations by providers, suppliers and technology companies work- ing together to achieve value and improve healthcare effi ciency from more accurate and unambiguous identifi cation of medical devices. Representatives from the FDA and the National Library of Medicine also pro- vided an update on AccessGUDID, the on- line portal that allows the public to search and download data from the GUDID. One of the most tangible arguments for the value of UDI came on the fi rst day when


# of Medical Procedures in 2010 (US)*


1,000,000 Cardiac Catheterizations 719,000 Total Knee Arthroplasties 332,000 Total Hip Replacements


*Source: CDC/NCHS National Hospital Discharge Survey, 2010 **Source: WardsAuto – 2010 New Vehicle Sales


66 June 2016 • HEALTHCARE PURCHASING NEWS • hpnonline.com


SUBMIT YOUR QUESTIONS email: editor@hpnonline.com phone: (941) 927-9345 ext. 202


the FDA’s Senior Advisor for UDI Adop- tion, Terrie Reed, compared how recalls are handled for automobiles and medical devices, respectively. As the chart depicts, the numbers of certain makes and models of new cars sold in 2010 were similar in magnitude to specifi c types of procedures involving implantable devices performed that same year. But there is considerable difference in how the data linking people and products is captured and how that impacts the recall process. For example, many of us have likely received notices from automobile manufacturers about re- calls or repairs that need to be completed on our cars. Those recall notices fi nd us, even if we have moved out of state. That’s because the automobile industry works in concert with state and local governments to match specifi c cars by Vehicle Identifi cation Numbers (VINs) with the individuals who own them via automobile registration data. Now compare that to medical devices. In a world without UDI, a patient undergoing a procedure in which a device is implanted would typically receive a paper implant card containing the manufacturer’s pro- prietary code and the serial number for the device. The patient would then need to store that card in a safe place and would likely not have it with them in the case of a medical emergency. Now, with the avail- ability of UDIs for all implantable devices, we have the opportunity to capture the UDI (including lot and serial number) for


# of New Cars Sold in 2010 (US)**


1,230,500 Hondas 908,600 Nissans


358,500 Volkswagens


that device in a patient’s electronic medical record. Barring the interoperability issues we still face with electronic health records, healthcare providers would know, even if the patient did not or was not able to tell them, that he or she has a specifi c medical device implanted. There still remains the challenge of an easy and swift way to iden- tify which patients have which devices and where those patients are in the event of a recall, but capturing the data electronically in a patient’s record is a foundational step in the process. Now consider one other critical differ-


ence. When was the last time you saw someone in the automobile industry try to capture the VIN manually? Barcode scanners are routinely used to capture VINs, but in healthcare we still capture product data manually, especially in the OR and other procedural suites where the patient-product connection is most critical. Perhaps this is one use case where a shorter proprietary product code is easier, but it is certainly not safer, given that the same product code could stand for very different products sold by different manufacturers. Yes, the UDI is longer, but we have tech- nology (barcode scanners, RFID readers) that can overcome that challenge. If other industries can do it, so can healthcare. UDI takes us one step closer. 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 currently writing a book on the Accountable Healthcare 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. Con- way serves on the editorial board of Healthcare Purchasing News.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72