Radio-frequency identification (RFID) is a technology that uses radio waves to transfer data from an electronic tag to a reader for the purpose of identifying and tracking the object. Some RFID tags can be read from hundreds of feet away and beyond the line of sight of the reader.  RFID is used extensively in industries such as supply chain or healthcare.

Ted Osinski, Director of RFID Programs, MET Labs

Hospitals have embraced RFID to help them reduce inventory levels, locate and track medical devices, and reduce theft. Since RFID installations do not require installing wires, this technology can be installed in operating rooms and other hospital facilities at a relatively low cost. Depending on the application, hospitals can implement different radio frequencies to suit their needs. Thus a hospital (or any healthcare facility) may use RFID systems with different frequencies. For example, the UHF (Ultra High Frequency) works best when a tag (attached to a device) is within 30 feet of a reader. A hospital typically would install many readers that would report all tags that come into their read range, including tags that may be in adjacent rooms. This gives an unparalleled level of information on the location and movement of medical devices, and their utilizations.

However, can RFID cause a malfunction of an EKG monitor at the hospital bed? This question has been with us from the very beginning. It has turned into countless pro and against arguments pitched by technologists and safety advocacy groups. The public and patients were both guaranteed safety by some, and warned that RFID can kill by others. Studies and countless articles were published to prove each side of the argument. Many of them had hidden agendas, inadequate research and findings were quoted out of context, thus fueling the fire rather than providing answers.

As RFID became more pervasive and widely deployed, the issue of their safety did not go away. What would happen if an accident occurred? This scenario would be a nightmare for RFID vendors, medical device manufacturers, hospitals and others. It would be a bonanza for lawyers. The government might also step in with unnecessary regulations.

Fortunately, the industry is taking steps to make sure such a scenario can be avoided. It is apparent that RFID vendors, medical device manufacturers and laboratories should work together to define testing that is appropriate, thorough and defined in a verifiable, repeatable manner. Recognizing this need, AIM Global’s RFID Experts Group (REG) established a Healthcare Initiative work group. Members of the Global Healthcare Initiative (HCI) include many RFID vendors, the FDA, an independent test lab (MET Labs) and several universities.

Unlike previous tests of selected RF emitters in healthcare settings, the AIM Global Healthcare Initiative will provide a standardized, repeatable test methodology by which manufacturers of medical devices can assess potential RF interference and mitigate it. All major RFID frequency bands in the healthcare setting will be covered.

An additional goal is to establish baseline requirements or guidelines for the proper operation of RF in terms of real-world applications. This will help RFID implementers.

These goals are not far away from being achieved. MET Labs together with the FDA have conducted extensive research and have come up with possible answers. RFID parameters that might cause interference were identified for most implemented RFID frequency bands in the market. You may think of the combination of these parameters as the worst case scenario from the physics perspective. Test methods have been developed to test these parameters. In addition, other variables have been included such as the distance of RFID equipment to a medical device (from close proximity to longer distances).

The next and most important step is to prove that these test methods work in practice. To do so, MET Labs is seeking vendors of medical devices as covered by the IEC 60601 family of standards to submit their products for testing. This will help validate test methods and will also determine whether devices are susceptible or not. As part of the testing, MET will provide free consultation on how to mitigate or eliminate the interference. The identity of participants and device test results are completely confidential and will not be released by MET Labs to anyone.

Upon completion and acceptance by AIM, Inc., the final test protocol will be submitted to recognized national and international standards organizations so that it may be publically available.

The end result of this study will benefit all: patients, hospitals, medical device manufacturers and RFID vendors. It will prove that RFID and medical devices can coexist.

Author: Ted Osinski is MET Labs’ Director of RFID Programs. MET Laboratories is a leading independent test lab for product safety, electromagnetic compatibility and environmental simulation. MET has long maintained specialties in electro-medical device and RFID testing.  Ted can be reached at tosinski@metlabs.com. www.metlabs.com.

Sources:

JAMA RFID study

IEEE Spectrum; Article on Univ. of Amsterdam study

JAMA – The Journal of American Medical Association

HSE – Health and Safety Executive (UK)

RFIDNews: NIST testing