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 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.
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
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