GS1 Ireland led an international coalition which successfully employed a sterile field scanner during surgery. The “TRACTUS” scanner by Matrix IT Medical Tracking Systems effectively collected detailed medical device information from extremely small codes known as data matrix codes on hospital-sterilized implants at Wheeling Hospital in West Virginia, USA. For the first time, full medical device traceability was proven on these implants, allowing for future device analytics.

(Photo: https://mma.prnewswire.com/media/782488/GS1_Ireland.jpg )

(Photo: https://mma.prnewswire.com/media/782486/GS1_Ireland.jpg )

(Photo: https://mma.prnewswire.com/media/782487/GS1_Ireland.jpg )

(Photo: https://mma.prnewswire.com/media/782489/GS1_Ireland.jpg )

Patient injury and death motivated governments worldwide to pass laws requiring medical devices be traced through their life cycles. Known as Unique Device Identification (UDI), a substantial barrier to compliance is the inability to fully identify hospital-sterilized devices.

“Many implants and surgical instruments are removed from their packaging, placed into trays and sterilized in the hospital,” said Alan Gormley, Industry Engagement and Solutions Manager at GS1 Ireland. “The surgeon typically uses only what is needed, and the rest are returned to be re-sterilized for another surgery. Once placed into trays all detailed information from the package label can be permanently lost,” he said.

TRACEABILITY IS A MUST

Mike Schiller, Senior Director of Supply Chain for the Association for Healthcare Resource & Materials Management-a professional membership group of the American Hospital Association-has been working to solve challenges associated with UDI documentation.  Schiller said, “for these devices, fast, accurate and complete traceability is a must, but has been a significant challenge for hospitals.”

Further complications include the inability to identify how many times these devices were used on patients and/or re-sterilized so that they may be safety checked. Many of these devices may have been sterilized or used hundreds of times.

BEST PRACTICE GUIDELINES

The aim of the coalition of top worldwide healthcare stakeholders known as ‘Blueberry Castle’ (BBC), is to analyze the speed and accuracy of numerous documentation methods for surgical implants.  From this data, a “best practices” guide for manufacturers and hospitals is being created.

AHRMM participates in the Blueberry Castle project and hosts and convenes several Learning UDI Community workgroups designed to solve challenges in UDI adoption. Schiller said, “AHRMM is excited to be a part of this project and looks forward to seeing continued success in this arena.” He said, “UDI adoption has the potential to reduce healthcare costs while improving patient outcomes in the long term.”  Schiller stated, “hospital sterilized medical device documentation has been a challenge, but one we are solving.”

PRIOR PILOTS

Prior simulated surgery pilot results at Wickenburg Community Hospital in Wickenburg Arizona concluded that only two methods could collect all medical device information, including lot numbers, expiration dates and serial numbers. Richard Wedig, Chief of Clinic and Surgical Services Officer at Wickenburg Hospital said, “other documentation methods were shown to be error prone, could slow down surgery and could not document detailed implant information.” Wedig said “We found there are only two methods to collect the UDI during surgery; packaging scanning and sterile-field scanning.”

Scanning UDI placed onto packaging requires two staff members. One is usually the circulating nurse, who is responsible for patient safety during surgery. The circulator is diverted from his or her primary patient safety task each time he or she must search for the exact package from a large cart of implants, verify the package integrity, scan the label, open the package, drop the implant onto a sterile table.  Once the device is placed onto the sterile table, the surgical scrub technician retrieves it, loads the device onto a tool and hands it off to the surgeon.  “While this is occurring, the surgeon is waiting,” said Mitch Wagner, MD., orthopaedic surgeon at Wickenburg Community Hospital.

ADVOCATING FOR PATIENT SAFETY

The Association of periOperative Registered Nurses (AORN) is the leader in advocating for patient safety and excellence in perioperative practice and healthcare.  As a coalition participant, AORN noted that challenges were identified with manufacturer sterilized packaging and has advocated for full UDI documentation prior to implantation.  Those challenges require large amounts of storage space, have potential sterile packaging failures, and increased surgical times while the patient is under anesthesia.

The second option is for manufacturers to laser mark the UDI directly onto each implant via very small data matrix codes. Each device is placed into trays that are sterilized before surgery and positioned into the operating room sterile field.  The scrub technician removes the correct device from the tray, and scans the laser marked data matrix code via sterile field scanner before handing it off to the surgeon.  Staff noted that it’s the first time they have been able to fully document hospital sterilized implants before being handed off to the surgeon and requires no extra staff.

A FIRST IN THE U.S.

Wheeling Hospital in West Virginia has become the first U.S. hospital to use the sterile field scanner for UDI documentation during surgery.

David B. Cohen, M.D., the neurosurgeon who carried out the first surgery employing the scanner, reported his satisfaction with the new medical device documentation system, saying, “Scanning the UDI was easy and efficient as it did not delay the surgical process.”

David Rapp, Chief Information Officer at Wheeling Hospital, stated, “Wheeling Hospital is a technologically advanced hospital.  As Chief Information Officer (CIO), I wanted Wheeling to be first to utilize this new technology. My hope was that it would integrate seamlessly in the operating theater.  Change can be difficult and it’s important that a new technology doesn’t interfere with surgery. I’m delighted to say that in our first clinical use, the feedback I’ve had from the clinical staff was overwhelmingly positive.”

HOW STERILE FIELD SCANNING WORKS

During surgery, sterile draped wireless scanners paired with intelligent software are employed to maximize the efficiency and accuracy of clinical care documentation at the point of care. The system captures, and documents hospital sterilized medical device information, while a handheld scanner is used to scan sterile packaged devices.

Until now methods to document medical devices used in the operating theater have been subject to human error and lacking in adequate traceability of devices in the event of a recall.

With a scan just before implantation TRACTUS collects all implant and surgical supply data. This information is transmitted to the software interface where each device is matched with the patient’s surgical site and recorded in the patient’s health record where they will have immediate access to their medical device information.  TRACTUS cross checks government databases to ensure that recalled devices are identified before surgery.  This is the last chance to verify that no active recall exists on a device before it’s implanted.

“Results from the study demonstrate that laser-marked GS1 DataMatrix codes, using GS1 globally unique identifers allow the capture of the full UDI and has been observed to be the fastest and most accurate,” said Alan Gormley.

This information may be used by medical device manufacturers to manage their inventory and know where all affected devices are located, in the event of a recall. The healthcare industry will be able to use the data to help combat counterfeits and analyze performance trends of devices and surgical procedures, ensuring the appropriate implant for each patient is selected. By tracking every medical device manufacturers, hospitals and payers will save significant healthcare dollars while improving patient safety and providing better care.

FDA REQUIREMENTS

Blueberry Castle participant Jay Crowley is the Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences.  He was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. Crowley developed the framework and authored key requirements for FDA’s Unique Device Identification system.  Crowley said, “We (the FDA) envisioned the application and scanning of laser marked data matrix codes on medical devices before the technology was available.  I am pleased to see such promising results stemming from our efforts at the FDA.”

Netflix recently released a highly critical documentary titled “The Bleeding Edge,” which reported on challenges facing the FDA and the medical device industry over how to determine which devices are safe for market release and which devices should be recalled from the market.  Because of the efforts of Crowley and others at the FDA, the immediate access to key data will soon be available to aide industry and regulatory agencies throughout the world to further measure the effectiveness and safety of medical devices.

The FDA is building the National Evaluation System for health Technology (NEST) to more efficiently generate better evidence for medical device evaluation and regulatory decision-making. NEST will generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.

The European Union MDR is slated to take effect soon and will set the framework for similar activities within the EU. Today, that feedback could take years to collect – if ever.  “By employing UDI, regulatory agencies and industry will have access to far more data far more quickly than ever before,” said Crowley.

IMPROVING PATIENT OUTCOMES

Kyle Hansen MD, Medical Director at Matrix IT, has a deep understanding of the advantages of UDI device capture and documentation in healthcare. He said, “UDI is expected to reduce healthcare costs by as much as $100 Billion.”

“Technology has advanced to the point where we are leveraging what is technologically feasible to improve patient care by documenting medical devices. No longer do we have to rely on the manual entry by OR staff to make sure that the information regarding medical devices is accurate,”

Dr. Hansen said. “We now have technology that can read the scannable codes on medical implants and automatically capture that data in real time, with complete accuracy to make sure that moving forward we can track patient outcomes and ensure product safety and ultimately, improved patient outcomes.”

Irish Hospitals are slated to be next in the study.

GS1 Ireland is a not for profit organisation dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally. The GS1 system of standards is the most widely used supply chain standards system in the world.

GS1 numbers and barcodes enable organisations of any size to order, track, trace, deliver and pay for goods across the supply chain, anywhere in the world. GS1 is recognised by the International Standards Organisation (ISO), the European Standardisation Committee (CEN) and the American National Standards Institute. Today, over two million-member companies in 145 countries use GS1 standards as part of their daily business communications, representing some five billion scanning transactions a day.www.GS1ie.org

Matrix IT, Medical Tracking Systems Inc. is the developer of the world’s only universal operating room UDI collection platform capable of data capture of all surgical device information, regardless of how it is presented. The Tractus sterile field scanner captures UDI information from medical devices marked with data matrix codes containing the full UDI.www.MatrixThis.com

Wheeling Hospital has served the Northern Panhandle of West Virginia, Eastern Ohio and parts of Pennsylvania longer than any other hospital in West Virginia. It was founded in 1850 by Bishop Richard V. Whelan and Dr. Simon Hullihen and is owned by the Diocese of Wheeling–Charleston.  The hospital has 247 beds, and the medical staff totals 275 primary care and specialty physicians. www.wheelinghospital.org

For more information or interview requests, contact:
Alan Gormley, GS1 Ireland
Alan.Gormley@GS1IE.org

Beyond IoT 2019 promises to be bigger and better with world-renowned technology gurus from Silicon Valley and beyond coming to Páirc Uí Chaoimh in Cork, Ireland on January 21st.

Tickets are on sale now: Website – http://beyond-iot2.com

The healthcare industry is evolving. The manner in which caregivers perform their duties is changing to improve efficiency, minimize patient risk and save valuable healthcare dollars. A major component of these objectives is traceability. While companies like Stryker were able to efficiently handle a recall of thousands of devices, other companies, such as Poly Implant Prosthesis, have faced bankruptcy due to poor traceability. Lackluster or nonexistent traceability is hazardous, financially debilitating and presents real consequences to healthcare providers’ ability to effectively carry out their duties.

In 2010, French company Poly Implant Prostheses (PIP) used banned, non-medical grade silicone for breast implants that were vulnerable to leakage and posed a significant risk to patients (Jones, 2012). Due to the lack of sufficient device traceability systems, most of the patients were unable to be tracked down. According to Michelle Roberts of BBC News Online, “It’s estimated about 47,000 women had PIP implants fitted, and most are still living with them”. As a result of the implants being banned, PIP went bankrupt in 2010 (Roberts, 2018). This is a dangerous scenario that could have been averted, but it was this scandal that brought to light the need for tighter regulation to improve patient safety.

Implementation of strong traceability standards helps deliver an effective carrying out of the recall chain of command. In stark contrast to the PIP scandal, medical device maker Stryker Corporation’s voluntarily recalled almost 17,000 orthopedic implant devices after discovering a packaging problem that potentially damaged product during the shipping process and compromised recipients’ safety (VickiY, 2015). Unlike PIP, Stryker kept extensive records of their patient data and notified their customers directly by email and an urgent acknowledgement response form. Jeanine Guilfoyle, Stryker’s senior public relations manager, confirmed that Stryker also contacted all affected medical facilities that used the faulty product to further ensure notification of the product recall was received by recipients. Recalls are a costly but vital necessity of a functional healthcare system; having efficient traceability systems in place helps ease the recall process and avoid unnecessary suffering and legal costs.

In addition to the problems brought to light by the PIP scandal, inefficient use of available technologies has led to the following product traceability issues within the healthcare industry:

Manual registration of device information

Manual registration of device information was thought to be the ideal solution to preventing a recurrence of the PIP scandal. It was widely believed that many hospitals were unable to present the patient data of thousands of women who had breast implant surgery due to poor record-keeping. However, manual registration comes with its own challenges—nurses were spending a large portion of their time on data entry. This significantly reduced the amount of time they could spend with their patients by more than half (56%) (Telegraph, 2010).

High costs incurred by loss or expired medical devices

When medical devices are not properly identified and recorded, it becomes extremely difficult to trace lost and expired devices. As a result, cost of care increases and patient outcomes cannot be monitored.

These issues affect the caregiver’s ability to provide quality care to their patient. In an effort to advance healthcare practices regarding tracking medical devices, Congress passed legislation in 2013 that requires every medical device and surgical implant to have a permanent unique device identifier (UDI) or direct part mark, with all information concerning the device submitted to the FDA’s Global Unique Device Identification Database (GUDID). This legislation introduced a standardized industry-wide method of collecting data on medical devices that, when paired with available technology, can revolutionize device traceability before, during, and after use in the operating room (OR).

The FDA’s legislative mandate has since gained global recognition. As a member of the International Medical Device Regulators Forum (IMDRF), an organization founded under the initiative of harmonization of legislations on medical devices across the world, the European Union approved a new regulation on medical devices (MDR) similar to the mandate issued by the FDA. This new legislation goes into full effect on May 2020. The EU’s recognition and implementation of strong traceability standards will promote the regulatory framework improving health care delivery.

Full implementation of UDI can be challenging for the medical industry from a technology standpoint. A potential solution to this is the integration of medical technology like Matrix IT’s patented TRACTUS software and Sterile Field Scanner, the first and only kind of its technology in the world. This technology provides simple data capture that shifts the registration workload from caregiver to machine while allowing medical personnel to allocate more time and resources to the needs of their patients. As the only universal UDI collection system, TRACTUS captures inventory utilization from direct part mark (sterile field), reference sheets, packaging, and manual entry. The software saves nurses and caregivers time that would otherwise be used recording device information. 

Benefits of Using Technology to Reinforce Strong Traceability Standards

TRACTUS medical technology ensures patient care by helping prevent the use of recalled product and counterfeit items at the point of care and enhancing the ability to track implant outcomes. In addition, the integration of TRACTUS offers better inventory management, e-commerce opportunity, and UDI compliance.

How does TRACTUS do this?

TRACTUS employs the best in the cloud and machine learning space with the aid of Google’s software and services. The TRACTUS sterile field scanning technology automatically identifies all implants and utilized medical devices associated through its integration with the GUDID and FDA recall databases before wirelessly documenting the data into the Electronic Health Resource (EHR). Unlike manual registration which is susceptible to human error, this technology quickly reads essential data, employs machine learning to decide what to do with that data, and eliminates potential for human error as a result of tedious manual registration. When medical equipment and patient data are properly managed, it leads to a more efficient logistics—reduction of lead time, ordering, and receipt of orders. With the regulatory and compliance changes that the UDI Final Rule has brought, TRACTUS brings health organizations the performance that their medical facility needs to succeed with proper and accurate documentation.

In recent times, traceability has become increasingly important in the healthcare sector due to legal requirements and product quality demands. With TRACTUS, healthcare providers can quickly and easily create comprehensive and detailed reports using the power of machine learning. The proper traceability technology allows the storage parameters possibility of tracing, product history and the location of medical products. In conclusion, the Matrix team—the team behind the TRACTUS technology—is solving the traceability challenges by interacting with existing inventory management systems and directly interfacing with the hospitals EHR. It is technology like TRACTUS which enables healthcare institutions to implement and maintain strong traceability standards.

More

Named “Blueberry Castle,” the study will assess the current manual methods of operating room implant documentation versus documenting via scanning technologies. As hospitals continue to digitize Medical Health Records, it is as important to convert manual recording methods to automated barcode scanning methods thus minimizing the chances for human error.

Much like scanning in the grocery store checkout, Wickenburg Community Hospital is the first hospital in the world to use Matrix IT’s Tractus Platform to document medical implants, instruments and supplies used during surgery in the operating room. “We are pleased to be involved with this important study,” said Richard Wedig, Chief Officer of Surgical Services. “Sterile field scanning will allow us to document medical implants with improved accuracy. The accurate data will lead to improved patient care and safety. In addition, the data collected will allow us to analyze implant performance globally which will lead to better implant/patient outcomes,” he said.

“Given the clinical and financial importance of Unique Device Identification (UDI), a coalition was formed to observe and report on the results of using GS1 standards-based barcode scanning to help ensure regulatory compliance and increase patient safety,” said Alan Gormley, Head of Industry Engagement and Solutions for GS1 Ireland. “The coalition includes some of the world’s top UDI stakeholders,” said Gormley, “such as GS1 Ireland, American Hospital Association’s AHRMM, Association of Peri-operative Registered Nurses (AORN), U.S. and European government agencies and others who have demonstrated a commitment to ensure the success of a global UDI rollout.”

The study will help realize international medical device data collection objectives, such as the U.S. FDA’s National Evaluation System for Health Technology (NEST) and the European Union’s Medical Device Regulation (MDR) programs. These initiatives are designed to use the data collected to identify opportunities to reduce healthcare costs while identifying methods to improve patient outcomes.

Wickenburg Community Hospital CEO, Jim Tavary said, “We are thrilled to be a part of this innovative international consortium that is blazing a virtual path to improved patient safety. This study is a wonderful example of harnessing information technology to trace medical devices from the point of implantation in the surgical suite through their journey with each patient in the healing process,” he said.

CTO Brandon Donnelly was quoted as saying:

“Our association with the Irish Medtech Association is a continued commitment for SteriTrack to bring an unmatched degree of service, innovation, and confidence in our UDI platform for the EU market.”

SteriTrack is excited to engage with industry in a collaborative method that furthers the discussion of implant and instrument tracking through the means of automation.  This compliments well with the upcoming speaking engagement schedule at the Google Java Center on “Game Changer in Healthcare | Direct-Part Marked Hospital-Sterilized Medical Implants with Tractus”.

“Our goal is to provide services and collaboration with the NHS, trusts, and hospitals in a manner of open communication, partnership, and a real goal to solve the local market needs.  In order to provide this level of service and support, we recognized the need to get setup in the country.”

This comes at a time where the Medical Device Regulations posted in the April 2017 release have increased the requirements for the capture of information.  SteriTrack Limited, a Matrix IT Medical Tracking Systems Inc. company, currently holds the only complete and comprehensive scanning and software platform for the operative theatre.  With the ability to capture direct part mark implants and instruments in the sterile field, the disruptive technology is slated to provide clinicians with a critical tool for both ease of documentation and compliance with the regulations.

The event was located in Cork, Ireland with the skilled members of NIMBUS from the Cork Institute of Technology taking the charge on planning and promoting the event.  New startups were greeted by the Cork Chamber of Commerce, IDA Ireland, and Enterprise Ireland, among many other notable agencies that were giving free advice and guidance on how to fund and setup a successful startup.  As part of the notoriety of the event, Engineers Ireland officially recognized the daylong event as a learning opportunity with contact hours for engineers.

Prominent themes of company structuring, the importance of data, machine learning, and cloud computing, providing a peek into the future of the exciting technological advancements on the horizon.  The attendee engagement and numbers were so high that SteriTrack has decided to run several more events in Ireland throughout the year that will focus on similar topics.  As quoted, CTO Brandon Donnelly said:

“This was the best way that we could think of to help the community and young entrepreneurs while providing an educational experience on the foundations and future of technology.”

The move comes at a time where there are more companies than ever before trying to stand out and be unique.  SteriTrack being a new and disruptive technology in the healthcare sector, capturing unparalleled health data was in a unique position to discuss how to capture a market by storm.  To learn more about the event, check out https://www.beyond-iot.com/ .

This exciting event offers a unique opportunity for multi-nationals, SME’s, start-ups, entrepreneurs and academics to hear what international, battle-tested entrepreneurs, technologists, investors and dedicated researchers expect from the next wave of technology innovation and investment and to learn how their organisations can drive profit from it.

Headlining the event, direct from Silicon Valley, is Vitaly Golomb, world renowned venture capitalist, serial entrepreneur, best-selling author, and one of the gurus behind HP Tech Ventures, the corporate venture arm of Silicon Valley’s original start-up that focuses on global, early-stage investments in frontier technology.

Vitaly will bring his deep knowledge and experience to young entrepreneurs and corporate leaders alike to unleash their innovation and set them on the path to winning the future. “We are in the midst of the next industrial revolution where entire industries will be transformed in the next decade. At Beyond the Internet of Things, I will provide an in-depth view of next-wave technologies that Silicon Valley VCs are investing money in and how you should be investing your time.” 

Among the array of international speakers, Internet of Things TED talk master, Professor John Barrett, will open the event with his insightful views on how the Internet of Things and beyond can shape our future. Early-stage advisor, UK technology market expert and Founder of ConCap Ltd, Stuart Hillston, will also be on hand to advise tech companies on how to develop and articulate a commercial strategy that appeals to investors and to outline the stepping stones essential for businesses to reach international markets.

Free entrepreneurial, investment and funding clinics featuring one-to-one sessions between attendees and the people behind some of the world’s most influential companies will be held throughout the day. These sessions will provide invaluable advice and guidance on how attendees can facilitate investment, innovation, collaboration, and foster new commercial relationships.

Particular attention will be paid to matching attendees needs to the most appropriate funding mechanisms for their enterprises and providing updates on the latest funding calls, supports and investment opportunities available from Enterprise Ireland, H2020 and Science Foundation Ireland, as well as routes to access innovation and research resources from across Ireland and beyond.

The latest Gartner industry report indicates that 8.4 billion connected things are currently in use worldwide (up 31% from 2016) and expected to reach 20.4 billion by 2020. With total spending on endpoints and services expected to reach almost $2 trillion in 2017, this is an essential event for all who want to understand where this new wave of technology and investment is heading and how it can be best embraced and exploited.

Standard tickets are priced at €120. In order to promote and support Ireland’s vibrant start-up industry, there are limited FREE TICKETS FOR START-UPS! You must register for start-up tickets, entry will not be permitted to those without a ticket. Tickets are available here.

This is your chance to be inspired by the tech world’s most successful innovators! Spaces for entrepreneur clinics are limited and are on a first come first served basis. To book your clinic contact Brian Cahill 087 7824314 / brian.cahill@cit.ie.

Discounted Clayton Hotel weekend accommodation packages are available for event attendees. Contact Brian Cahill 087 7824314 / brian.cahill@cit.ie.