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The Internet of Things (IoT) has been described as the interconnection via the Internet of computing devices embedded in everyday objects, enabling them to send and receive data. This article takes IoT one step further and explores this connected world as the Identification of Things. The progression from two-dimensional (2D) UPC codes to a radio-frequency identification (RFID) EPC code is equivalent to putting barcodes on steroids. PaladinID calls these RFID EPC codes smart codes, and here’s why. RFID technology is now beginning to advance the efficacy of medical devices as never before.

According to barcode standards association GS1, “When unique EPCs are encoded onto individual RFID tags, radio waves can be used to capture the unique identifiers at extremely high rates and at distances well in excess of 10 m, without line-of-sight contact. These characteristics of RFID can be leveraged to boost supply chain visibility and increase inventory accuracy.”

Barcodes have historically been used for device identification, and RFID adds another dimension by enabling authentication and verification, as well as substantially increasing efficiency and accuracy in managing and tracking medical devices throughout the course of the supply chain. From the manufacturer to the medical facility, RFID can reduce errors and redundancies while keeping devices functioning at optimal performance.

Why RFID?

Why is RFID a good solution for medical devices? Consider the FDA requirements that mandate unique device identification (UDI) for medical devices. With a UDI system already in place, barcodes can become smart codes by having RFID sensors embedded in the barcode labels. RFID sensors can be engineered to withstand the high temperatures of sterilization, and by using thermal data logging technologies, hospitals can track assets through use, sterilization, and reuse.

Achieving these benefits ultimately requires connecting with a global RFID network, and as the medical device industry explores IoT opportunities for medical devices and other healthcare assets, it can rely upon the Internet to support a single network for access to websites around the world. As for the required RFID network that will provide businesses with full visibility and track and trace capabilities from the point of manufacture through to delivery to the hospital, clinic, or medical office, there are some considerations to keep in mind. To achieve a systemic RFID network, manufacturers, hospitals, and healthcare facilities need to implement a single technology operating under a uniform global standard.

To date, there has been an adoption delay in the standards required to achieve this vision. As enterprises begin implementing RFID to meet mandates and regulatory requirements as well as to realize the associated business advantages, they are faced with standardizing on either one of the two available frequencies — UHF (ultrahigh frequency) Generation 2 or HF (high frequency), or both. Today, UHF is the de facto choice for case and pallet tracking applications, and it is well proven and deployed worldwide and across industries.

Until now, conventional wisdom has asserted that HF is the proven and better technology for item level (or near-field) applications. While it is true that HF is a proven mature technology, it is now becoming clear that UHF is equally as reliable and ensures stronger performance than HF at the device level. Although HF is limited to operation in the near-field, UHF offers enterprises a single protocol and infrastructure for all applications — from item-level applications on the conveyor belt in the manufacturing plant to the shipping and pallet applications in the storage areas to secure surgical suites in hospitals and clinics. The UHF-RFID protocol offers a global platform that can enable the worldwide and end-to-end supply chain visibility required to streamline operations and reduce costs.

Shifting from 2D barcodes to RFID-embedded labels enables them to be an integral part of activities such as inventory management, asset tracking, replenishment, and more.

The Benefits of RFID

In May 2017, one of the Northwell Health hospitals, a 245-bed acute care facility, deployed a passive UHF RFID-based solution to identify where its assets are located within zones, thereby improving efficiency and patient satisfaction. This RFID system allows the hospital to locate equipment and other assets such as wheelchairs, IV stands, and rolling monitors within a particular zone or room in real time. Having immediate visibility and understanding whether equipment is in use or ready for use makes the hospital more efficient without adding personnel. The system also enables hospital operations to observe use trends and optimize maintenance and sterilization processes.

This is the beginning of a groundswell shift from 2D barcodes to RFID-embedded labels (see Figure 1). Incorporating RFID into the supply chain improves medical device performance, distribution, and delivery in many areas, including:

  • Inventory management — inventory is only valuable when it is available and ready for use.
  • Patient tracking — tracking streamlines the care experience and reduces human error.
  • Asset tracking — lost or misplaced inventory can cause delay in patient care; ready access to assets improves the overall patient experience.
  • Life cycle management — management of assets is critical for those that have a shelf life or require calibration.
  • Billing — integrating the data collected with RFID sensors can assist in streamlining billing processes.
  • Replenishment — assets that are used can be tracked for replenishment, ensuring available inventory.
  • Sterilization tracking and equipment maintenance — alerts can be programmed so that the manufacturer’s maintenance requirements can trigger notifications.

“By embedding RFID and its sister technology NFC [near-field communication] in medical devices, we are able to use low-cost technology to enable all these systems to work together. We’re making nonintelligent devices intelligent,” says Tim Daly, industry expert and co-founder of one of the world’s first RFID/NFC-networked platforms.

Here are additional examples of how RFID technologies are being incorporated into hospitals and the medical device supply chain:

Workflow for tracking medical devices using RFID in healthcare facilities. RFID readers are installed at entrances and exits to each zone.

Operating room management — enabling secure surgical suites and reducing overage and waste in surgical devices and instruments.

Streamlining the assignment of UDIs — unique device identification to medical devices (FDA requirement).

Enhancing UDI performance — enabling validation and authentication throughout the entire device life cycle.

The pharmaceutical industry uses RFID to reduce counterfeit or expired drugs. “RFID has already been embraced by pharmaceutical companies as an effective measure to combat the growing counterfeit problem. Implementing RFID technology makes operations accurate and efficient, and it reduces the need to manually scan and track devices,” says Neil Mitchell, senior director of Alien Technology (San Jose, CA).

Making the Shift to RFID

RFID technology is expanding into medical equipment and devices. The following discussion presents an overview of how an RFID network can be incorporated into medical devices, and how both hardware and software are integrated within a healthcare facility ecosystem.

RFID systems can be designed to manage temperature sensitivity and withstand sterilization and on-metal conditions where RFID sensors must be encased so that the RF works. Working with providers that can identify the appropriate scanning equipment (readers) and required sensor features is an important first step. Identify a turnkey RFID solutions provider that will support you in connecting existing UDI (FDA required unique device identification) with manufacturing, operations, sterilization, compliance, and maintenance systems. While a thorough approach to connecting these elements is encouraged at the onset, keep in mind that additional links to service, standards, and compliance can be added at any point. Components required for systemwide integration include both software (ID management platform) and hardware: tags, labels, readers, antennas, cables, and multiplexers.

Barcode labels embedded with RFID sensors (smart codes) are either printed and encoded on premise using a simple thermal transfer printer, or they can be provided by an outside vendor. Currently, 30 percent of smart codes in the biotech industry are encoded on-site, and 70 percent are preprogrammed. The smart code labels are associated to the device UDI, effectively connecting a unique device, asset, or surgical tool to the healthcare facility’s database (EAS, Oracle, etc.). Device manufacturers are able to install the smart codes during the manufacturing process, and using writeable sensors, the UDI can be associated upon being received by the healthcare facility. Once the smart codes are placed, no line of sight is required to identify, locate, authenticate, and track the device.

Physical conditions and device casing material dictate the specifications for RFID smart code labels. Facility locations are identified as zones (surgical suites, staging areas, post-op and pre-op, etc.), and RFID readers are installed at the entry/exit portals of these zones (see Figure 2). As the tagged devices move from one zone to another, the RFID reader antenna sends out RF energy, and the smart code data is read by the antenna. As devices and assets move throughout the facility, this activity is recorded in the ID management platform connected to the facility’s database.

The data from the ID management platform is associated to the healthcare facility’s database to be used for business analytics, visibility, decision tools, etc. For example, a case full of knee replacement parts that each have unique IDs may travel through various portals from a surgical supplier to hospital storage to surgical suite. Once the correct size knee replacement part is used in surgery, the balance of the knee replacement parts can be sent to sterilization (another portal) and returned to hospital storage for reuse. Using RFID to track this entire process produces a chain of custody that not only complies with FDA requirements, but captures vital data for asset management as well as patient care and billing.

Conclusion

RFID has been part of pharmaceutical and retail supply chain for decades, and the medical device supply chain is the next frontier. Device manufacturers, distributors, and hospitals and clinics are gearing up for serialization and allocating funds for the equipment required to implement RFID at all points in the supply chain. The cost of RFID readers is being incorporated into operating budgets as the ROI is established for reducing human error and improving operational efficiency.

This article was written by Dana Ritchie, CEO of PaladinID (Laconia, NH). Contact him at 888-972-5234. For more information, Click Here.