By Danny Rader

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.