Sunnyvale, CA — (ReleaseWire) — 12/19/2018 –Author: Danny Rader
“Implant Files” have released details on their global investigation, reporting on the potential harm to patients caused by medical devices. The International Consortium of Investigative Journalists (ICIJ), is a collaborative, investigative project spanning 36 countries that reportedly identified ramifications of poor product traceability standards. The report, published on November 26, 2018, lays out the case for a more communicative and streamlined recall process in which patients are kept updated on the status of their medical implants.
In their investigative report, Implant Files examines the cases of people such as Bonnie Magar who unknowingly lived with a defective medical device for years which threatened her health and compromised her well-being. According to Woodman, “Magar was one of over 250,000 implant recipients in the U.S. alone to receive a pain pump implant before global reports of overdose and withdrawal symptoms motivated the U.S. authorities to ask for a halt in production”. Multiple disclaimers, voluntary recall processes, and unclear communication via recall notices have complicated a process which directly affects patients’ lives. Magar’s story is a clear example of the pitfalls in current recall regulatory practice.
With hundreds of thousands of medical device reports on suspected device-associated deaths, serious injuries and malfunctions being reported to the FDA each year, it is necessary now more than ever to lean on available technology to expedite the recall process. The need to incorporate efficient recall processes of medical devices used in a patient needs to become a fundamental requirement for implantation of medical devices. Congress acknowledged this need and kicked off a global movement after passing legislation in 2013 that requires every medical device be identified through its lifecycle via a unique device identifier (UDI) that contains detailed medical device information and is registered with the FDA’s Global Unique Device Identification Database (GUDID). UDI information is associated with a patient at the point-of-care, and captured and recorded in the provider’s electronic health record (EHR), creating ample opportunity for tracking down and communicating recall alerts to patients with potentially hazardous medical devices.
The enactment of UDI created a standard for device traceability, but existing UDI documentation methods at the point-of-care are subject to human errors or the inability to capture the device identifier (UDI-DI) and production identifier (UDI-PI) data electronically. This results in a break of traceability for the medical device. To assist providers and manufacturers with the legislation introduced by the FDA, Matrix IT’s patented TRACTUS Scanning System scans micronized data matrix codes on different medical device substrates and geometries. The micronized data matrix code can be as small as 0.3mm. TRACTUS matches the scanned medical devices UDI-DI with the FDA’s GUDID database. Before the medical device is used or implanted into a patient, both sterile packaged and hospital sterilized devices are traced with TRACTUS in the operating room to check for product issues such as recalls and expiration dates, offering a point-of-care solution that keeps surgery staff informed about medical devices before use in a procedure. This technology keeps patients safe and offers a reliable and efficient alternative to the disadvantages of manual entry and cross-reference sheets provided by manufacturers to nurses in the operating room.
TRACTUS offers solutions outside of the operating room as well. The technology is built to integrate seamlessly with participating hospitals’ EHR to provide hospitals and medical device manufacturers with key device reports. This data provides valuable insights on which implants were used and, when combined with other essential patient data, can provide valuable information on device performance and patient outcomes. “There are a number of supply chain and transactional benefits associated with scanning and capturing implant and medical device data at the point of use,” says Mike Schiller. “Healthcare providers can confidently and accurately generate purchase orders for consignment inventory. Order requisitions can be created based on actual inventory usage moving the healthcare supply chain closer to a true demand planning model compared to the current forecasting model for inventory management. And finally, UDI capture promotes an efficient transaction process from purchase order creation, to receipt, and payment.”
The medical device industry manufactures devices intended to save lives or improve a patient’s quality of life, but patients need to know that a device is safe before it is used or implanted into them. TRACTUS accurately and quickly documents where a device is used or implanted; it also provides regulatory bodies and other healthcare stakeholders with access to data previously unimagined to determine safety of new devices or danger of devices already on the market. The aggregate data provided by this technology can be used by regulators, hospitals, and manufacturers to recognize dangerous trends that previously took years to identify. Matrix IT is proud to offer technology that tackles processes that were thought to be challenges; the TRACTUS solution confronts the pitfalls head-on by tracking the life cycle of each medical device and implant before, during, and beyond use in the operating room.
For more information, visit https://www.matrixthis.com/