Radio Frequency Identification (RFID) and Real Time Locating Systems (RTLS): MedSun Small Sample Survey Summary
MedSun: Newsletter #66, November 2011

Survey Topic: Radio Frequency Identification (RFID) and Real Time Locating Systems (RTLS) - Summary of Responses
Years Conducted: 2010 - 2011



Background
Hospitals, like their retail commercial and industrial counterparts, are deploying systems which employ RFID (Radio Frequency Identification) and RTLS (Real Time Locating Systems) technology for a wide variety of applications. Applications may be as diverse as access control, inventory control, theft management, real time tracking of the location of specific devices and even interrogation of RFID-based devices embedded in patients' implanted medical devices.

The FDA is studying the nature of RFID and RTLS systems and working with manufacturers to learn how these systems co-exist in the hospital environment with a variety of medical devices and systems. This survey effort was to learn how hospitals plan for and deploy these systems, where they are located, how they are used, and if there are any concerns or experiences with interaction between these systems and nearby medical devices.

The survey was conducted with nine healthcare professionals from nine MedSun facilities. Survey respondents work in various hospital departments such as Clinical Technology Services, Environmental Safety, Cardiac Services (for the cardiac catheterization and electrophysiology labs), Compliance, and IT Services and Information Systems. The information that follows is a summary of responses.


Summary
Eight of nine respondents currently have RFID or RTLS systems in their facility. One facility does not currently have a system but previously piloted a product that is no longer available. The respondents with RFID systems use several manufacturers and most have the RFID technology throughout the entire facility. Those that do not have it house-wide, have RFID systems in areas such as the Cardiac Catheterization and Electrophysiology labs, the Operating Room, Obstetrics, and Interventional Radiology.

In response to where RFID readers are installed, some have fixed RFID readers in their facilities while others do not. Those who have fixed readers have them installed on door frames, in hallways, patient rooms, and inside cabinets. Non-fixed readers are part of a wand system, are located in consoles, or are readers that plug into outlets. None of the respondents report having any signage that identifies where the readers are located.

Most report having RFID systems that are active-tag systems with some operating on the hospital’s 802.11 wireless system. However, other systems operate frequencies in the 433 MHz or 900 MHz frequency range. Also, the times for transmitting information from the readers range from every millisecond to once every 10 minutes.

Respondents are currently tracking multiple and varied devices in their facilities. They report utilizing RFID for portable assets and other expensive equipment that frequently moves around the facility. Infusion pumps, portable monitors, wheelchairs, beds, and ventilators are among those devices that are tracked the most. Telemetry boxes (Wireless Medical Telemetry System), pacemakers, bladder scanners, defibrillators, custom ultrasound, vital sign monitors, balloon pumps, CVVH machines, pulse oximeters, surgical sponges and towels, coronary stents, and electrophysiology catheter devices are mentioned as being tracked using RFID technology.

Prior to implementation, several respondents report working with vendors to monitor RFID interaction with other medical devices. During implementation, almost all respondents describe in detail the consideration given to where the RFID hardware is placed and its proximity to potentially sensitive medical devices and systems. Before installation, several hospitals tested for interference by taking RFID tags into certain areas. One respondent notes that an RFID tag was causing delays with ventilator alarms so in that particular facility tags are not placed on life support systems. Another respondent reports interference to an RFID sponge tracking system from devices such as an anesthesia machine, EKG monitor cables, surgeons’ headlamps, electrosurgical units, and video towers. Also at the room level, sensors in some equipment interfere with RFID tags resulting in interference with alarms. The remaining respondents, however, report no problems with medical devices in the vicinity of RFID readers.

Currently, most respondents are piloting or planning to deploy other RFID-based inventory control systems including those that scan supplies, for example, in supply closets on nursing units, or systems that track emergency department patient records. Several are also looking into refrigerator temperature trackers for alerts when a temperature falls out of a threshold.

The majority of respondents do not use RFID devices to track medications or other pharmacy products. However, one respondent’s hospital is currently looking into a program that tracks expiration dates of medications. Another hospital uses a bar coding program for medication administration.

When asked about the use of access control or “people finder” systems, several are currently looking into them to track both patients and employees. Some reasons include tracking patients who may be confused or have a brain injury and also for tracking patients in the Emergency Department to avoid delays with x-rays and lab testing. Two facilities are using RFID/RTLS technology to protect infants from abduction with a system that alarms when infants are taken outside of certain locations. In contrast, some respondents know that management and employee unions have concerns with implementing these types of systems. Additional comments relate to hospital cultures that are not ready to implement “tagging patients” at this time.

Almost all respondents report collaboration with multiple hospital departments during the decision-making process to purchase, implement and support RFID/RTLS equipment. These departments include information technology, biomedical engineering, nursing, purchasing, materials management, and finance. Information Technology usually takes the lead and is responsible for supporting RFID/RTLS equipment. A “lesson learned” from a respondent is to obtain more input from clinical staff before implementation. Another respondent, whose facility piloted an RFID system, plans to choose a larger manufacturer next time since their manufacturer stopped marketing RFID products.

Overall, responses indicate many advantages to RFID or RTLS systems in hospitals such as improved inventory control, which may decrease the time staff need to look for equipment, improved cost containment and cost savings, and some report improved patient care. Additionally, it is important to test RFID or RTLS systems for electromagnetic interference with devices in the individual hospital environment prior to purchase and implementation.


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Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff is made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.


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