CENTRAL STERILE SUPPLY DEPARTMENT OPTIMIZATION Business Intelligence and Clinical Excellence BY BILL DENTON AND DEREK MUDD Can your facility trace a flexible endoscope through the entire re-processing cycle from last patient to next patient? With recent implementation of requirements from Centers for Medicare and Medicaid Services (CMS), the answer is “yes”. However, can your facility say the same for a specific hemostatic clamp which was sent through the steam sterilization process? In most cases and in compliance with current requirements, a hemostat can be proven as sterile due to it being “associated” to a set that can be traced through the sterilization cycle. This “association” has been considered appropriate for proving sterilization in the past for many reasons. One of which is the daunting task of identifying one component out of, in some cases, hundreds of identical items in an inventory has not been possible. However, that “association” may become insufficient with new mandates and proposals that will change how traceability of handheld surgical devices is defined. Positioning your CSSD operations for future Unique Device Identification recommendations Past and Present Toll Free: 866-747-4200 Office: 858-486-6030 www.noviastrategies.com Nancy Lakier [email protected] Bill Denton [email protected] To see other articles in this series, visit www.noviastrategies.com What used to consist of surgical marking tape or engraving to identify instruments as set components has given way to the ability to individually mark reusable surgical instruments permanently with information specific to each of those instruments. As technology has advanced within the surgical instrumentation arena so has marking technology. The use of permanent linear, two dimensional bar coding, and Radio Frequency ID allows manufacturers as well as hospitals to safely and cost effectively identify individual surgical supplies and instruments. In 2007, Congress passed legislation mandating the FDA to establish the Unique Device Identification (UDI) System which is intended to assign a unique identifier to all medical devices within the United States. When implemented, the new system will require: w The label of a device to bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or an exception is made for a particular device or group of devices w The unique identifier to be able to identify the device through distribution and use w The unique identifier to include the lot or serial number if specified by FDA The UDI is expected to improve patient safety, in part by helping to identify counterfeit products and by improving the ability of staff to distinguish between devices that are similar in appearance but serve different functions. In addition, the UDI will facilitate and improve the recall process, while also creating efficiencies within the medical system. (Crowley, 2013) benefITs of workIng Towards ComplIanCe now Whether the new UDI mandates evolve into regulations of tracking individual instruments to the patient, moving down that road now will reap many benefits beyond compliance to possible future regulations. Using UDI in combination with an ITS will allow for improved productivity tracking, asset management, complete and accurate instrumentation inventory, budgetary planning, as well as compliance with original manufacturer’s recommendations for reprocessing and sterilization. If you do have a tracking system in place: There are several questions to be asked to confirm that the department is indeed properly positioned to comply with the new mandates. w Does the system recognize one of the technologies to assign UDI to individual instruments? w Does the system interface, bi-directionally, with the facilities current EMR and/or the Supply Chain replenishment systems? w Is the system currently or capable of tracking at the instrument level. If the answers to all of these are yes, the department is positioned well for the coming UDI mandates. If the answer to any of these is no, your ITS vendor should be contacted to begin planning for them. If you don’T have a tracking system in place: Although an ITS may not be currently utilized within your facility, there are steps that can be taken now to prepare for the eventuality of implementing a system. w Begin communicating the upcoming rulings and the impacts outlined above to decision makers w Begin exploring options for marking your existing inventory, either with your current instrument repair vendor or with a company specializing in instrument marking w Talk to your instrument vendors and ask about their plans for complying with the mandates and leverage them to assist in becoming compliant with the upcoming changes w Begin verifying set components against count sheets. Are the descriptions and quantities accurate? This work will serve the department well when the time comes to implement an ITS. Classification Item Types Class I Low risk Items: • Hand held surgical instruments • Ultrasonic cleaner Class II Pose Possible Risks: • Sterilizer equipment • Biological and chemical indicators Stringently Regulated Devices: • Heart valves • Implantables • Pace makers • Life saving devices • Life sustaining devices Upon a final ruling released in 2014, a timeline based on item criticality, will dictate when the mandates will go into effect for each class with the lowest risk items mandated to include UDI within seven years of the final ruling. (Crowley, 2013) The proposed effective dates for UDI requirements are outlined at http://www. fda.gov/medicaldevices/ deviceregulationandguidance/uniquedeviceidentification/default.htm (Kux, 2012). However, at a glance, the time line shows compliance with labeling requirements mandated over a seven year time frame, with Class III required within 3 years, Class II within 5 years, and Class I with 7 years of a final ruling. Class III What this means to my operations? Instrumentation manufacturers have begun addressing these new mandates by including UDI barcoding on new instruments. Unfortunately, unless a facility is new and all the sets were recently purchased, many will be faced with the possibility of adding UDI to its entire existing instrumentation inventory by 2020. With this new ability to trace individual surgical instruments, as well as the increased focus on sterilization and reprocessing of those instruments, the possibility of tracking every instrument to the patient it was used on is very real in the future. In recent years more and more facilities, both large and small have begun to see the value which an Instrument Tracking System (ITS) brings to a Central Sterile Supply Department (CSSD) for a variety of reasons. Whether it is to better report the productivity of a department or employee, or proactively manage accountabilities of employees, or count sheet maintenance the value of what was once considered a luxury may now be required in order to comply with these new mandates going forward. The bottom line… Whether an ITS is being utilized within your facility or not, these new mandates will give all facilities the opportunity to improve patient care as well as improving efficiencies. As with any change or new technology there will be growing pains. However with the proper preparation and planning, positioning your CSSD department now will pay off in the long run. Novia can help… With Novia’s broad experience across a diverse range of facilities and knowledge of many ITS systems, we can provide assistance with your journey towards the future. Working with your CSSD leaders, we can assist with identifying feature functionalities crucial for your specific facility, assist with the ROI process, perform and verify inventories, assess incumbent systems and current level of implementation, vendor negotiations, implementation planning and assistance. All of which allows your leaders to focus on the work of the department rather than the daunting task of implementing a new ITS or improving a current system. w Crowley, J. (2013, March 23). US Food and Drug Administration. Retrieved April 12, 2013, from Medical Devices: http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm Kux, L. (2012, July 2). Regulations.gov. Retrieved April 28th, 2013, from Proposed Rule Document: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0090-0001
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