Going the Distance with Chain of Custody
Get 100% Visibility of Tissue and Implantable Devices
Originally broadcast on April 26, 2021, 1:00 PM EDT
Chain of custody for tissue and implants is key to averting loss, waste, and costly write-offs. Monitoring their movement from product receipt to use, check-ins and outs from inventory, is critical to maintaining product security and integrity. It sounds easy enough but challenges most. Thankfully, there’s software that moves at the speed of medical implants and RFID technology that tracks, monitors, and protects the integrity of these valuable assets for hospitals. Learn to maximize chain of custody with extended visibility, security, and control. Incorporate the right tools to ensure significant return on investment.
Yeah Thank you for joining us for today's webinar on going the distance with chain of custody and getting 100 visibility of the implant supply chain. Before we begin, I'd like to invite you to submit questions to the presenters at any time during the webinar just type those questions into the chat box at the bottom of your screen and our presenters will address them at the end of the webinar to ensure we get through all of the material with that let's begin our presenters today, our Jason ralph vice president of sales for the eastern region at Mbita. Jason has over 15 years of sales and sales leadership experience where the focus in health care software as a service applications. He has spent the last 10 years providing solutions to address tissue and implant tracking an E H. R. Interoperability keith Hoffman is director of sales for ter So solutions. Over the last 11 years, keith has worked closely with torsos, clients in the healthcare and life science markets to drive business value through torsos. Rain R F I. D. Enabled inventory management solutions. He has led the evolution of loaner kit tracking solutions that torso from field visibility to loaner kit processing operations. Prior to joining torso, he felt various sales and marketing roles at companies including CDW and Schneider National. Now I'll turn it over to Jason ralph to begin our presentation. Jason take it away. Thanks peter. Hello everyone. Thank you for being with us today. I'd like to start today's webinar with a brief overview of NVIDIA and for so to provide a foundation for our discussion and a respective companies expertise and implant tracking, chain of custody automation and compliance. As most of you probably know, India delivers health care technologies to complex medical environments, making processes safer, more compliant, more cost effective. With more than 800 product installations are leading edge software manages the full life cycle of tissue implants, blood and plasma. Our products are used by more than 600 customers across health systems, hospitals, blood banks and blood and plasma centers. Now ask key to provide a little about torso. Thanks Jason So torso solutions provides automated inventory management solutions based on R. F. I. D. To the healthcare life science markets, Torso has more than 3500 installations globally through our partnership within Vida. We're in more than 300 hospitals today, with the combined in Vegas software and R. F. I. D. Hardware solution. These solutions span multiple hospital departments including supply chain O. R. Cath Lab surgery centers, Moon Care Centers, Just to name a few. Turkey is a wholly owned subsidiary of pro mega, and torso has more than 20 years of experience in managing high value inventory across the healthcare and biotech supply chains. So I'm gonna turn it back over to Jason to dive into today's topic. It's keith chain of custody tracking the documentation that records the sequence of custody control, transfer analysis and disposition for tissue and implants is key to ensuring compliance. It also helps to avert lost waste and costly write ups for hospitals and health systems, monitoring product movement from receipt to use, check ins and outs from inventory is critical to documenting the custody trail and maintaining product security and integrity. While this process sounds pretty clear cut, it can be challenging to execute execute properly, particularly when dealing with medical implants and tissue. Today will not only cover these challenges, but we'll discuss software solutions that move at the speed of medical implants and R. F. I. D. Technology that tracks, monitors and protects the integrity of these valuable assets. We'll start by looking at medical implants and the tissue and implant chain of custody process for hospitals and health systems to understand the full scope. It's important to note that the Center for Disease Control and Prevention CDC And Mayo Clinic estimate that Americans receive about 370,000 cardiac pacemakers and about one million total hip and knee replacements a year, Experts also estimate that 7.2 million Americans are living with joint implants. This comes at a hefty price and in the US. spending on implantable devices exceeds $86 billion dollars In 2020 Spending on implants represents up to 30 of the hospitals total supply spend. So while compliance is top of mind and discussions about implants, chain of custody, cost control and reductions are equally important due to the potential risks and expense associated with medical implants. Chain of custody and implant tracking are vital for hospitals. Tracking the medical device provides a means of ensuring documentation through life cycle and if something goes wrong with the implant like a recall or need for replacement, that the issue is resolved promptly. Supply chain information systems where hospitals by and monitor the products that use have for years used a non standard method of identifying unique devices. Without a standardized method of identification. The same identification numbers could equally be shared by multiple devices. Even if the devices were different types, needless to say that this spirit identification methodologies on medical devices has led to confusion and patient care issues. The lack of sterilization presented challenges and supply chain management with inefficiencies created it across the board, product tracking, access to current inventory, locating recall, products and knowledge of devices nearing expiration so they can be used or in some cases returned. Increased waste product costs and patient safety risks have resulted. The FADA FDA is unique device identification or you die system was launched in 2007 to help hospitals and device manufacturers tracks their implants uniformly. It was later mandated by Congress while the intention of the F. D. A. S. U. D. I. System is to simplify the device tracking process and reduce errors caused by manual data entry adoption of the process has been complicated and time consuming. To comply with the FDA rule, medical device manufacturers must assign a U. D. Two most devices so hospitals can track the distribution and use of other devices. The FDA IS UDI system includes two requirements. First, the label and packaging of the device must include the U. D. And second. The key characteristics of the device must be submitted as a record in the F. D. A. S. Global unique device identification database or otherwise known as the Good ID. However, to gain the full benefit of the U. D. I. System, hospitals must track medical devices throughout their entire life cycle from the time it's ordered and received to its use in patient care to long term monitoring for safety and efficacy. Uh huh. This is a critical point of our discussion and one that will speak about in more detail later. But it's important to repeat that. In order to gain the full benefit of the U. D. I. System, hospitals must track devices throughout their life cycle and far beyond the point of initial purchase. So how are hospitals and health systems doing it? The U. D. System has allowed health systems, hospitals, physicians, patients and manufacturers to clearly identify products that have been recalled, received data, better data on implant performance and decrease the cost of procuring products and managing inventory. By sterilizing the way implants are tracked and managed hospitals have been able to create operational and clinical efficiencies that translate directly into additional time for patient care. To ensure sterilization, all device manufacturers are required to include a U. T. I. on their label following an FADA final rule in 2013. When fully implemented, the label of most medical devices will include a U. D. In both human and machine readable formats. Medical device manufacturers were required to comply with the FDA IS implementation timeline for each device class. During the roll out period. For hospitals, there are challenges and compliance from day one. Human error and tracking through legacy based paper process make it difficult for hospital teams to order in stock implants, efficiency, manage them while an inventory and track them through use and potential X plant. There are also complexities in sharing the information efficient efficiently in simultaneously with relevant departments in the hospital or across health system. The most common reason for noncompliance is a breakdown in communication amongst the hospital departments, which can include the loading dock, supply chain, clinical departments, the lab and finance processes that are all made harder with manual implant management and cumbersome workflows manually entering product goes into systems and removing UD stickers from implants that are fixing them to physical files can consume vast amounts of time. So when you consider the tracking of medical devices, manually maintain the paperwork, communicating to all stakeholders, managing the process for reporting through point of use and often to potential recall or X. Plant and repeating all this many times each week. You begin to see the drain on hospital resources and increases to bottom line costs, tissue and implant tracking systems are designed to identify, track, monitor and control the movement of tissue and implants from transport to storage to the operating room and eventually to the patient. These systems help optimize tracking task and effectively reduce the amount of work necessary for staff. Automated systems also help improve patient safety by effectively capturing and verifying most processing tasks, creating labels, recording implanted tissue condition and documenting that chain of custody. To ensure seamless capturing transmission of an implant. You. D. I. Hospitals are finding a need to adopt automated electronic capture capabilities to document ups and prevent errors associated with manual entry. For health systems that have implemented automatic data capture has become increasingly important for affiliate hospitals to up their, update their software to support documentation of the U. D. I. The software needs to be sophisticated enough to distinguish between various types of U. D. Barcodes based on the issuing agencies and accurately analyze the device and production identifiers. Software companies offering a paired solution. Barcode scanning technology integrated with a comprehensive database including the good idea. Device manufacturers and other sources will help to ensure quick and seamless digital you. D. Match over the years. In vita, healthcare technologies has developed a number of software platforms that seamlessly integrate with manufacturer's database as well as E. H. R. And M. I. S. Systems to automate inventory receipt and chain of custody tracking. As we mentioned, the manual entry of beauty I into hospital records frequently results in incomplete data and errors. Automating this process helps to reduce errors, optimize inventory, improve compliance and enhance supply chain performance. You. D. Eye trackers inventory module allows the healthcare organization to fully track and managed tissue and implant items upon receipt at the hospital and while being stored until clinical use information as the product code description, lot number, serial number, expiration date quantity, location R. F. I. D. Tag an inventory type which can be owned consigned or brought in. Are easily access and manage through the system. You just can receive shipment, create inventory items, view current tissue and implant inventory. Reserve inventory items for an upcoming case and manage par and reorder levels within the inventory management. The healthcare organization has the following options. Receive shipment shipments pending available inventory list, reserve inventory, manage par and reorder accounts at items direct to inventory and the tissue supply, our registration documentation. You. D. Eye trackers, movement module fries a platform to document the chain of custody for tissue and implant inventory within the hospital, fulfilling joint commissions, regulatory handling requirements. Hospitals are also able to request items, move items between departments, view issued and return inventory back to the supplier and document all of this activity while you. D. Eye tracker does all of this on its own. A few minute moments, you'll hear how it's integrations with R. F. I. D. Automates the movement of many of these functions. All of the data connects with data flowing to and from the R. F. I. D. Storage devices for part of this discussion will turn to keith keith. Yeah, thank you, Jason. That was great. Um I want to talk a little bit about how our food enhances the U. D. I. Experience. So in venus solutions with our feed storage can enable staff to significantly reduce implant retrieval time from storage to operating room. You can minimize product lost and waste due to expiration and stock outs. You can maintain product security. The R. F. I. D. Technology fully integrates with UD Tracker so that allows it to automatically track inventory movement prior to surgery and at the point of view so you get real time visibility, improved inventory management. Among other benefits of that integration, you get to eliminate inefficient reconciliation processes and you can allow hospital staff to focus more time on patients and less time on data entry. So on the front line of this is really the R. F. I. D. Chip or tag. Generally this is a small read only device that can transmit it stored information without an internal power source. So these are passive R. F. I. D. Tags that can be applied to a product these days can easily be incorporated into your conventional labelling systems. So if you think about something that's bar coded you could have very similar data applied to it. The big key difference though is unlike bar coats, R. F. I. D tags do not require line of sight scanning. The second element here as part of the R. F. I. D. System is the R F I. D. Reader. So this is a transmitter that broadcasts did soon frequency signal. So when there's an R F I. D tag within range, it's activated and turned on by the energy from that R F I. D uh signal. The tag then responds by transmitting its information back to the reader. That information that is gathered by the reader and it can either be logged locally and stored there or it's uploaded to the web or some other network or software system on the back end. Yeah, So a key point here too on the chips is they're they're available in a variety of read formats. So there are chips out there that rely on narrow bandwidths that offer a measure of security against unauthorized access and that can be an important consideration if the tag is carrying sensitive information. However, the trend we're seeing right now with R. F. I. D. Is really based on the global standards such as Rain, U. H. F. Gentoo technology and really that enables various inventory management systems in the items supply chain to log its presence. So you can take that from manufacturing, distributing all the way to the patient if sensitive information needs to be included, you can encrypt that to offer protection against unauthorized access. The tank can also carry I. D. Numbers only and then have any additional information stored in a secure database that's only accessible by authorized users. Be a web interface or or software. Um Arf I. D. Really improves the tracking inventory management and validation of implants and each of these characteristics provides additional benefits that can lead to cost savings and improve connectivity. So inventory management really allows hospital staff to monitor usage patterns throughout the organization. And this is a complex process, but it really gives you the ability to analyze what's in stock, how much is in stock, who has the inventory where the inventory is. And you can even get at reorder levels and automated reorder points Next is really about validation and that ensures that any action that has taken place of that desired item on hand. So like tracking the ability to validate through our feeds, technology can reduce medical errors, increase and improve productivity and helped construct the necessary documentation for administrative and auditing purposes. So validation is really in effect an effective step to ensure that the quality of care in a healthcare setting is up to par. And it allows staff to ensure that the patient being treated is in fact the right patient for that treatment that is about to occur. Yeah. So while we know that the demand for supply chain integrity applies to all aspects of medical technology, right at the top of the list where this technology proves value is really with human tissue and implants. So you think about how that growing network of harvesting, storing and distributing viable cells and organs, it just brings a significant new safety concerns and requirements for hospitals and surgical facilities, defining those processes as far as how those materials are collected, stored, distributed and used in a cooperative and collaborative effort, as many different oversight entities. So among those those folks who are providing that oversight are the Food and Drug Administration Center for Disease Control and Prevention, the Joint Commission for Accreditation of Healthcare Organizations and the American Association of Tissue Banks. On top of that, there's various state and local agencies as well, where the human tissue industry itself also contributes. So there's a lot of different entities that are involved in really setting the standards here. So when you think about that extraordinary degree of scrutiny that's applied to the supply of human tissues, you certainly understand why that's merited. And this network clearly requires high standards of accuracy, accountability and control. And so with that number of agencies involved, it adds a significant measure of complexity to the regulatory environment. So if challenge to develop a system for tracking items from origin use, I don't think you could find a more complex or demanding model than human tissue in health care. So how can R. F. I. D. Help you here? Right. The goal of the FDA and the other groups is to make human tissues safer and to verify that their source of supply and delivery are fully documented and accountable. So this effort aims to protect public health while not imposing unnecessary restrictions on research development or the availability of new, existing, new or existing transplants or grafting products. The level of documentation documentation demands a better standard of precision in tracking and inventory control. So the industry is going through a variety of methods for meeting these standards. And one of these are Fi. D. Offers certain unique benefits and advantages over some of these other methods. This includes ready applique ability, efficiency in achieving the required supply chain precision, minimal associated labour and the reduced likelihood of human error. So the level of documentation really needs a new standard of precision in track and control. What What? So the benefits of this. Although most people understand R. F. I. D. The scope of its application really needs further elaboration. So when integrated with him being a software, every step along the product lifecycle from procurement to usage is monitored and tracked digitally to eliminate manual error and the need for repetitive data entry. So both barcode scanning and R. F. I. D. Capture information that is vital to optimizing the implant, supply chain, workflow, efficiency, compliance and ultimately patient safety. Yeah, so the last piece that of a solution like this is an RPG cabinet. So this is where the individual attacked product or material is stored until it's needed for use. So the cabinet has built in readers that recorded tag as it enters or leaves the cabinet. Uh access to that cabinet can be restricted to authorized personnel only, who must use an RPG passkey or even biometric identification. And so the person asked accessing the cabinet and the event involving the tank are documented automatically every time in the system. And so and then additionally, if you need special storage such as temperature or humidity control, the cabinet can be designed to maintain those conditions as well. So through this continued feedback from sensors, the cabinet monitors the storage environment and provides a documented record of storage conditions. So a web based system that can simplify communication between all these elements of the system and eliminate the need for a special dedicated network. Current security protocols offer more than adequate protection for transmit transmitted data. These systems can also be designed so that hardware, software and services combined as a turnkey solution for things like consignment supply with vendor inventory control or host site internal inventory control of tissue products. So a lot of different applications there. Yeah. So key benefits of including our body enable cabinets as part of the implant supply chain. They can provide absolute accountability by tracking every transaction virtually eliminated, shrinkage, maximizing revenue. And that's especially for consignment based products, It reduces the need for physical inventory counts, which can lower overhead costs, eliminate human error reduces stock outs which ensures you always have product available when you need it and it reduces expired product, ensuring that tissue viability and the prospect of improve patient outcomes. Israel with our fighting. So the ability that better identify full chain of custody for tissue products where something came from, who supplied it, how it was handled, how it was inventoried and where it went. That's vital in this process. Yeah. The other piece here is that people make mistakes. So human error is a real thing and the more steps and processes people are forced to follow, the more likely that errors can occur even when you have very rigorous controls around that. So computers on the other hand, Excel at executing routine repetitive tasks. Um And certainly we're not saying that humans should be removed from the equation. However, the advantages and benefits of our feed should be leveraged to take full advantage of that speed, precision, precision and reliability. This also frees up the medical personnel to focus most of their time and efforts on patient care. Yeah. So documenting every detail in the process is an essential element of G. T. P. S. And virtually all other guidelines set by the oversight agencies that we talked about earlier in general. The record keeping requirements are pretty rigorous. One of the primary assets of an R. F. I. D. Cabinet system is the ability to follow and document these data retention policies and protocols automatically to ensure reliability for data recording and communication. The system is engineered with the highest possible degree of validation performance and redundancy. So again, this capabilities of proven strength of digital technologies. The primary objective is to make sure no data are lost. All transactions are recorded as they occur and that the information is promptly communicated to the data center or the system on the back end. So there's certainly many implementations out there of this kind of technology. So one that will touch on here with the case study, um you can see a lot of benefit of integrating R. F. I. D. Technology with the NVIDIA software to give you that complete automation of chain of custody. So one customer that we mentioned here has realized immense annual savings while getting that strict compliance to regulations and patient outcomes improvement. This customer is writing off up to 200,000 per year and expired or missing tissue grafts. Prior to adopting the Envious Software plus R five D Storage cabinet solution. So that's 200,000 years, significant savings through that solution and central really to the discussion today is the foundation of in Vidas innovations. That's the concept that data should be integrated and move freely. So stakeholders have current information at their fingertips. So in terms of implants, data capture begins with the manufacturer supplier and is carried through in a single paper free environment, through the delivery and receipt, inventory point of use. And even beyond that, automated systems also provide unique visibility across the implant to explain life cycle. With that full view comes an extraordinary amount of knowledge for supply chain managers. In particular knowledge that can drive better purchasing and supplier contract negotiations. That knowledge can also spot previously unseen opportunities for efficiency or cost reductions across the supply chain. It can also drive better patient care So in via and torso have a long standing partnership so our customers can reliably document, monitor product movement from receipt to use check ins and outs from inventory. Having visibility into the entire life cycle is really critical in establishing an implant custody trail that maintains product security integrity and patient safety. So you get the help of cutting edge software solutions and that allows health systems to significantly reduce implant retrieval time, minimize product loss and waste due to expired and stock outs and you maintain that product security. So this level of efficiency not only saves precious time and money, but ensures the right products are being used at the right time with the right patient. Well. Uh huh. Yeah. At this point, we'd like to open up the floor to any questions that you may have. Again, we encourage all of our viewers today to send in your questions if you have them and we'll get to as many of them as we possibly can with the time left in today's program. The first question we receive is directed towards you keith the writer is asking. It does the system tell you who removed the tissue from the cabinet? Yes. The system will tell you who removed. So I mentioned earlier the access pass that's that's required to access the cabinet. So in order to actually open that door, you need to present that passed that's assigned to an individual user that unlocks the door allows you to remove that product out and then you close the door it locks again. So you have a complete record of who access access that cabinet when they opened it and exactly what they took at every given time. Thank you very much. Very complete answer. Thank you. The next question here was written and is actually directed towards you. Jason. Does the implant get charged to the patient bill when it is taken out of the cabinet? Yes. So with our combined solution which we refer to as swipe, grab and go, the charging actually occurs once that's documented in the E. H. R. So the the nurse simply signs in with the key card, grabs the item and goes back into the room that there's just don't have to sign into a kiosk and build the item at that time. That's a key differentiator in our solution. Um It allows for an improved nurse experience and what happened to make any corrections at a later time. Great thank you. And then keith, I think this is kind of a follow on question for you. How do you tag frozen items? Well that's a good one. Always a challenge especially. So there's several different ways that you have to tackle that. So one is if you're dealing with existing inventory that's already in a frozen environment, you have to be very careful when you take that out to make sure you're cleaning it off, getting any moisture off the product and then effectively applying applying a label. Now there's a variety of methods that go along with that, including using freezer safe labels that will be sure to adhere and our specifically developed designed for that environment. But the other part of that is there's over packing or flag tags or different kind of storage pouches and systems that you can use to make sure that that tagging goes smoothly. Um And frankly it's a little bit of a custom process for customer. Right? So not everybody's inventory is the same even in a frozen environment. So each each facility might do that a little different. And that's part of what in Vida uh can help you figure out is how to effectively tag all of those items. Gotcha. Okay. And another viewer wonders do you have storage units? And I think Jason this is directed towards you. Do you have storage units for refrigerated and frozen grass? That's right. We actually have all the temperature ranges for room temperature cabinets all the way through -80 bone freezers. We also have refrigerators and -20 and we also have at least two sizes for each temperature range. So we have multiple options for you. Okay. And and keith, do these devices reports the specific temperature of the products inside. So we're gonna report temperature inside the cavity of a freezer refrigerator cabinet, whatever the devices. So we're continuously monitoring that. So every time you you perform a transaction, that temperature data is automatically updated. We also report that every night in what we call a reconciliation scan. That happens kind of off hours or were again reporting temperatures. So you get a significant amount of temperature data reported to you through the system. Okay. So Okay. I don't whether you've answered this question, but somebody just wrote in what parameters are set in place to ensure that the proper temperature has been maintained. And what happens when the temperature goes beyond the desired temperature range? Yeah, there's a few different points there to to make on that. So because we're monitoring the temperature, we know what that set point should be for each customer. So in the system we can set that and say it should not go out of this particular temp range. Right? So what happens if it does well we have monitoring set up as well. So our support team has dashboards of all these devices in the field. So if a temperature were to go out of range, our support team gets notified of that uh and can actually open a case to follow up with a particular customer the other part of that. Is there some alerting that can be set up through the envied a system? But beyond that, we also recommend just redundancy. So a lot of organizations already have temp monitoring systems at their facilities team might already be using. So we have some extra temperature ports. We can also hook up. So if you think about all of those pieces combined, that's a lot of peace of mind to know we are being redundant. We're tracking this in many different ways. And so if something were to happen, you're gonna know about it, right, It's it's not going to happen and you're not going to be notified. And then we have one last question that's come in and please, if you have questions, folks send them in, um we'll address as many of them as we can, but this is a good one. How does implementation happen? Uh Will hospital staff be trained as these refrigerators are installed on site, etcetera. Jason, would you like to address that? Yeah, sure thing. The implementation is fairly comprehensive. The first step is actually a site qualification where we actually send a technician on site to do a walkthrough, assess the actual stores, locations, pathways to those locations, confirm network drop and empower requirements from there will actually hold a series of calls which will ultimately lead to an on site implementation where we power on the equipment. We we we train your staff on how to bag and tag the R. F. I. D. Tags on the particular to photographs themselves, and then train your staff in a classroom setting on how to how to utilize the application in conjunction with the R F I. D. Storage. It's actually been a very successful model for us over the past 10 plus years. Well, that is all the questions we have at this point, so that brings us to the conclusion of our program. I want to take a moment to thank our presenters today for sharing this information. I'd also like to thank you the viewers for your time and being with us and we encourage you to please reach out if there's anything we can do to help you. We hope you all enjoy the rest of your day, stay happy and stay safe. Have a wonderful afternoon. Mhm.