by Brad Sokol
Posted on 10-01-2021 08:12 PM
"The Gray Sheet" | Medical Devices, Diagnostics & Instrumentation
Radio Interference? FDA Studies Potential RFID Impact On Implantables
Radiofrequency fields are becoming more prevalent in hospitals and other public spaces as a tracking identification tool, but government scientists worry the energy waves could impact the performance of implantable devices such as pacemakers and defibrillators. Little is know about how radiofrequency identification (RFID) systems may interfere with pacemaker and implantable cardioverter defibrillator (ICD) performance, so FDA researchers, implantable cardiac device makers and RFID system manufacturers have begun to investigate the issue. Engineers at CDRH's electromagnetic and wireless technology lab at the new White Oak facility in Silver Spring, Md., are testing pacemakers and ICDs from five major cardiac implant manufacturers using seven different RFID readers. Seth Seidman, an electrical engineer at the agency's Office of Science and Engineering Laboratories (OSEL) who is leading the project, says FDA receives numerous incident reports related to electromagnetic interference from cell phones, anti-theft systems and metal detectors, but the RFID issue is "pretty new." RFID is also one favored method of tracking individual devices under a unique device identification system that FDA is developing (see chart: "1Will UDI Require RFID?").
RFID Is Not The Only Alternative For Tracking, Brad Sokol of Fast Track Technologies, a research consulting firm specializing in RFID and other emerging technologies, agrees that the issue can be resolved through improved product designs, but also suggests that new, upcoming technologies may better resolve the interference problem.
"It depends on the frequency that you're using. It depends on the strength of the signal you're sending out to interrogate the tag," he explained. "There are ways for pacemakers not to be interrupted. However, companies aren't really looking at this yet." RFID is not the "cure all" for tracking devices in hospitals and patients, Sokol says. Instead, he highlights pipeline products that use MEMS (Micro-Electro-Mechanical Systems), a technology that creates "machines" with dimensions on the micrometer scale.
RFID system makers include Texas Instruments, Philips, Siemens and Germany-based Feig Electronic. A 2005 study forecast that the U.S. market for RFID and related technologies in the hospital and health care sector would grow to $8.8 billion by 2010.
• RadarFind Gives Hospitals New Tools To Contain Infectious Disease
MORRISVILLE, N.C. (January 29, 2008) – The hospital-focused design of the RadarFind Real Time Location System
(RTLS) empowers hospitals to deploy the indoor tracking system as part of their overall infection control efforts.
While other companies offer Real Time Location Systems designed to help hospital staff more quickly locate critical patient care equipment, only RadarFind provides valuable, accurate information about a device’s status and location history, which can assist a hospital’s infection control and surveillance. RadarFind’s unique asset tag provides status information in two ways. First, when a staff member moves a simple slider switch to indicate that a medical device (such as an infusion pump) is available, in-use or needs cleaning, the tag communicates this information to the RadarFind server, which displays that piece of equipment as green (available), yellow (in use with a patient) or red (needs cleaning) on RadarFind’s locator maps and reports. Second, because the tags themselves include a color-coded bar, staff have a visual cue on each tagged device to quickly determine that equipment is disinfected and available for patient use. “The ability of our system to provide real-time status information about medical equipment sets it apart from other systems and allows RadarFind to play an instrumental role in hospital infection control efforts,” said Terry Kane, M.D., chief executive officer for RadarFind. RadarFind was developed after two years of intensive, physician-guided research and development focused specifically on the needs of hospitals. RadarFind offers clear advantages over other systems in the marketplace in terms of superior technology, accuracy, ease of installation and affordability.
Designed to seamlessly integrate with existing hospital infrastructure and operations, the system requires no new wiring and operates independently of a hospital’s critical IT network. RadarFind’s readers (locators) plug into existing hospital-grade electrical outlets, with the outlets still available for other electrical devices. These readers communicate with advanced ID tags affixed to equipment and the intuitive tracking software simply displays information on hospital staff’s screens.
Establishing a Pattern for Infection Prevention
Part of the challenge busy hospitals face is locating and cleaning critical equipment, and documenting that it has been properly disinfected prior to being used by another patient. The RadarFind system quickly conveys equipment location and status via any employee-accessed computer. However, the system can also track and report a particular device’s time-stamped location history and correlate that with specific patients, especially those who have contracted antibiotic-resistant infections. Causal relationships between contaminated medical devices and infected patients can be easily determined and additional preventative measures can be introduced to reduce device contamination.
“Put simply, a real-time location system that fails to alert patient care providers when a piece of equipment needs to be sanitized overlooks a potentially significant culprit in the spread of disease within hospitals,” said Vincent Carrasco, M.D., chief medical officer for RadarFind. At Halifax Regional Medical Center (HRMC), a 206-bed facility located in Northeastern North Carolina, nursing staff look forward to using RadarFind to improve their efforts to protect patients from the spread of infection.
“Just knowing where equipment is and its status will help in so many ways, not the least of which is infection control,” explained Vice President of Nursing Karen Daniels, RN, at HRMC. “By being able to identify equipment we can insure that only clean, processed equipment is ever brought into a patient room. Equipment used in an isolation room also can be clearly identified and properly decontaminated before being moved from isolation.”
Current Events Highlight the Need
Current news stories about the spread of drug-resistant “superbugs” have highlighted the seriousness of controlling the spread of infections that strike patients while in a hospital (referred to by the Centers for Disease Control and Prevention (CDC) as hospital-acquired infections). According to the CDC, there are an estimated 1.7 million hospital-acquired infections each year which result in approximately 90,000 deaths. A recent study in Emerging Infectious Diseases found that hospital-acquired infections are the sixth leading
cause of death nationally, costing the health care industry $6 billion annually. Methicillin-resistant Staphylococcus aureus (MRSA), a widely publicized type of antibiotic-resistant hospital-acquired infection, can cost hospitals roughly $30,000 per case. Brad Sokol, CEO of Fast Track Technologies, a health care consulting firm, has estimated that our nation suffers 13,000 to 26,000 thousand deaths annually from infection caused by contaminated medical devices and instruments.