This page contains a Flash digital edition of a book.
STANDARD PRACTICES


UDI in the OR: Simulating for success


by Karen Conway, Executive Director, Industry Relations, GHX and Dennis Orthman, Sr. Director, Strategic Marketplace Initiative


ast month’s column focused on how compliance with the Food and Drug Administration’s (FDA’s) Unique Device Identifier (UDI) rule is shedding light on the high degree of variation in the orthopedic device supply chain. A UDI system is intended to adequately identify a medical device through distribution and use and provide better visibility to real world performance of products used in patient care. Current operational practices related to the management of implantable devices in the surgical setting pose some unique challenges for accurately captur- ing the UDI at the point of care. Earlier this year, the FDA called upon Strategic Marketplace Initiative (SMI), a collaborative of healthcare providers, sup- pliers and associated technology and busi- ness partners, to help study the processes around the clinical supply documentation of non-sterile implants. These products are often owned and consigned by the manu- facturer and not purchased until use. They are housed at the provider location or hand delivered by the manufacturer’s representa- tive shortly before the case. The implantable products that could be used in the case and their associated instrumentation are placed in procedural trays (often in a specific confi guration to support the surgeon) and sterilized prior to the procedure. After the case, the trays are replenished “in the fi eld,” usually by the manufacturer, but sometimes by the provider or central sterile processing. As a result, these products are no longer physically associated with their UDI compli- ant labelling, making it hard to capture the UDIs at the point of care. SMI formed an initiative team comprised of several of its provider, supplier and technology members, as well as the Association of PeriOperative Registered Nurses (AORN) and the Inter- national Association of Healthcare Central Service Materiel Management (IAHCSMM). In June, SMI, in conjunction with a major academic medical center, conducted simula- tions of two surgeries – an ankle trauma case and a spine surgery – to observe the process by which the UDIs for the implantable products used in the cases were documented during the procedure. The simulated surger- ies incorporated three of the fi ve approaches


L


SUBMIT YOUR QUESTIONS email: editor@hpnonline.com phone: (941) 927-9345 ext.202 Mail: HPN Standard Practices 2477 Stickney Point Road, Suite 315B Sarasota, FL 34231


recommended by the Orthopedic Working Group of the Advanced Medical Technology Association (Advamed): 1. Implants placed in procedural trays with corresponding inventory sheets that in- clude the vendor catalog number matched to a UDI barcode.


2. Implants in procedural trays with the UDI direct marked on the product itself


3. Implants delivered in sterile packaging (as opposed to being sterilized in the pro- cedural trays)


The objective of the simulation was to un- derstand the impact of these labeling strate- gies on the surgical process and to determine if they enable and support the effective cap- ture of UDI product data. SMI has published a summary report of its observations, which is available at no charge on the SMI website (see below). The key observations revealed the following: 1. To effectively capture UDI data at the point of care, the UDIs for the products prepared for a case need to be integrated into the provider information systems, including enterprise resource planning (ERP) and materials management information sys- tems, electronic health records (EHRs), and surgical information systems.


2. The primary impact is on the circulator, a nurse who is responsible for clinical supply documentation in addition to patient care responsibilities. In one case, the circulator chose to delay scanning the UDI until after the procedure in order to maintain the surgeon’s pace. This interfered with the circulator’s patient care duties.


3. It can be hard to locate and scan the correct UDI, whether it is on packaging or inven- tory sheets. In one case, the device identi- fi er and the production identifi er (the part of the UDI that contains data such as lot and serial numbers and expiration dates) were positioned too close to effectively scan the barcode.


62 October 2015 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com


4. Scanning in the sterile fi eld is currently not a generally accepted practice because of patient safety concerns.


5. UDI information from direct marks on products can be captured manually or with a scanner if the mark contains a barcode and scanning technology can be used. In the simulations, the information was read aloud to the circulator and at times verifi ed by the manufacturer rep- resentative in the room.


6. Any labelling strategy that lengthens the total surgical time or interrupts a sur- geon’s tempo is not acceptable as it can impact patient care (and costs).


7. Adding UDI barcodes to current inven- tory sheets with manufacturer part num- bers, in one case, expanded the one page inventory sheet to 55 pages.


8. Partial UDI data (the device identifi er only) can be obtained by cross-referencing to manufacturer product number but production data is not obtainable in this manner.


9. Using more sterile packaging is a concern for several reasons: • Extra effort must be made to ensure the right instrumentation is available (with non-sterile implants, the matching instruments are usually placed in the procedural trays with the products)


• Sterile packaging takes up considerably more space


• Unwrapping and removing sterile products from packaging can add time to a case.


10. The variations in processes across provider and supplier organizations — driven by surgical technique, OR design, staffi ng, time of day, technology, and fi eld replenishment — make the develop- ment of a standardized approach to UDI capture diffi cult.


While the SMI summary complements the continuing work being conducted by Ad- vaMed, the report recommends expanded analysis and user input from other surgical sites across the country, as well as a much deeper look at the impact of UDI capture on the surgical team’s circulating nurse. Much work remains to be done. You can down- load a copy of the SMI summary report for free at www.smisupplychain.com. HPN


STANDARD PRACTICES


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