Jeremy Elias, Founder & CEO, TrackMy Solutions , TrackMy Solutions
In an age defined by remarkable advances in medical technologies, implantable medical devices have expanded in type and sophistication, providing improved quality of life for millions of people. However, on the flip side of the flourishing medical implants market is a grim tale. Over 600 million medical devices were recalled between 2018 and 2019. Most hospitals, surgery centers, and device manufacturers continue to be plagued with inefficient recall strategies. Nearly six billion dollars are spent annually on recalls, warning letters, and settlements due to medical device issues. However, the most unfortunate aspect is the patient fatalities and adverse health outcomes related to defective implantable devices that are occurring at alarming rates. There have been approximately 80,000 plus patient fatalities in the last ten years tied to device quality issues. Against this challenging backdrop, the Kansas City - based TrackMy Solutions is dedicated to patient safety pertaining to implantable devices through their TrackMy Implants software product. “Our resolute focus is on preventing the entry of defective implants into patients by sealing gaps in medical device management throughout the point-of-care cycle, along with allowing a provider and patient to track the device for recalls and adverse events after the implant procedure,” says Jeremy Elias, CEO of TrackMy Solutions.
The genesis of TrackMy traces back to an unfortunate incident when Elias’s best friend’s grandfather passed away due to a defective and recalled pacemaker. That incident proved to be a catalyst for bringing to market a solution designed to significantly improve patient awareness, education, and informed decision-making regarding their implants. “Our solution is entirely focused on increasing patient safety, improving health outcomes, and ultimately saving lives,” says Elias. With over 13 years of experience in healthcare IT, Elias is a visionary keen on bringing people together to solve complex problems.
Recently, TrackMy has teamed up with Xcelrate UDI, a similarly focused healthcare technology company, who’s barcode scanning technology enables hospitals to identify and prevent the use of recalled and expired medical implants at the point of care. The joint partnership of Xcelrate UDI’s point of care healthcare solution and TrackMy’s post-care patient support solution offers the industry’s first and only Closed-Loop Automated Solution (CLAS) to bridge the communication gaps in the healthcare industry that ultimately put implant patients at significant risk every day
The CLAS Advantage
At the point of care, CLAS provides a real-time solution for healthcare providers. Barcode scanning eliminates the risk of implanting faulty, recalled, or expired implants before surgery, and workflow automation updates the electronic health record with medical device data in seconds instead of minutes. CLAS reads all medical device and biologic labels, works with all EHRs, and works in real-time to improve clinical decisions regarding medical device and tissue use.
After surgery, CLAS provides lifetime support to implant patients via an electronic implant ID card. This allows patients to easily share their medical device data with healthcare providers, view real-time updates and alerts regarding their implants, and can make timely decisions regarding self-care should a quality event require attention.
Our solution is entirely focused on increasing patient safety, improving outcomes, and ultimately saving lives
Without CLAS, healthcare facilities rely on antiquated processes that increase patient risk. Manual processes make supply management difficult and time consuming. Reactive recall management is dependent on USPS paper notices that delay the ability to identify and remove impacted items from their inventory. Health records and billing systems rely on manual documentation that include errors and omissions.
For patients, there is little to no education about how quality issues (including recalls) are handled, device makers rely on paper mail to communicate quality issues, and delays in communicating critical updates can be life threatening.
“Ultimately, our complete solution leads to increased revenue through proper and efficient clinical documentation and follow-up care, ease of operations leading to decreased cost, improved overall perception, patient retention and patient satisfaction for hospitals; and peace of mind for patients with implants knowing they will be notified immediately should their implants require attention. We are focused on delivering on the quadruple aim for our clients through optimal performance by reducing cost and improving clinician and patient experience, all leading to better outcomes,” says Elias.
What makes CLAS a cut above the rest is its fully integrated complete service offering. It is a turnkey solution with no costly integrations, no required inventory build and automation focused on accuracy to eliminate expensive data omissions, inaccuracies, and compliance risks. The implementation of the whole system is done in less than five weeks, compared to six to 12 months required by other vendors. CLAS eliminates documenting in multiple systems, works to keep staff within their normal workflows, and provides the industry’s only prevention effectiveness reporting. With its dedicated group for patient advocacy and engagement, TrackMy Solutions offers free concierge services to patients, helping them find information about their device.
Emphasis on Safety
CLAS is a gamechanger for the healthcare industry and a lifesaver for implant patients. Meléndez recalls a customer success story in 2019 where Ethicon, a subsidiary of Johnson & Johnson, issued a Class I recall (the most severe and potentially life threatening) for one of their staplers. The recall included over 600 separate lot numbers, making it tedious to trace and remove the impacted staplers manually. With CLAS implemented, several of these recalled staplers were unknowingly pulled for surgery (7AM start) but prevented from use once the nurse scanned them.
Conversely, there are thousands of patients today who have no idea that their implants have been either recalled or have some other known quality issue that should be addressed. “To date, we have notified 14 individual patients of device recalls,” states Elias.
TrackMy Solutions and Xcelrate UDI have recently released a novel solution named UDI Clearinghouse+ for medical device manufacturers to digitally track and deliver recall notices to health providers and patients.
Patient safety is the focus and through this partnership, it is clear that TrackMy Solutions and Xcelrate UDI are committed to closing the loop with medical device management and providing solutions that reduce the risk for implant patients. “In our ongoing partnership with Xcelrate UDI, our goal is to provide CLAS to 30 percent of the U.S. market within the next five years and reduce the implantation of unsafe devices at the point-of-care by at least 80 percent within our client network,” concludes Elias.