RFID technology may mess up medical equipment
Considered optimal transportation and identification tools, they have become a symbol for modern hospitals: RFID tags. But according to a new study radio frequency identification devices (RFID) may disrupt medical devices. Moreover, the FDA is concerned that the increase in digital technology might be dangerous for patients.
RFID systems can cause “potentially hazardous incidents in medical devices” the Journal of the American Medical Association (JAMA) summarizes a study which will alarm many hospital directors. Over the past few years RFID technology was the shooting star, the magic tool that supposedly makes life much easier as it tracks and traces people and products, e.g. as anti-theft devices in shops, on ID cards or as the little transponder on the car windshield that pays the toll automatically.
In hospitals RFID is supposed to improve both patient safety and cost management. A simple band around the wrist controls the transportation of the patient to the operating theatre, tracks blood samples and medical supplies. Now, Eric Jan van Lieshout and Remko van der Togt from the Academic Medical Centre of the University of Amsterdam had a closer look at the technology that increasingly conquers hospitals and their research indicates that RFID could cause critical devices such as pacemakers or ventilators to fail.
“We wanted to investigate the safety of RFID in healthcare because it hasn’t been tested”, van Lieshout told Reuters. His team examined whether the presence of RFID transponders and readers interfere with the operation of 41 different electronic medical devices. They checked both a constantly active RFID system powered by batteries and a passive one which is only activated when the tags enter the transmitter’s electronic field. The results are cause for concern: In 123 tests the researchers found 34 incidences of interference causing 22 problems that could endanger patients – from switching off ventilators to completely stopping syringe pumps, van Lieshout said.
The passive systems, the research indicated, cause even more severe troubles. The tags have a higher energy transmission and operate at a frequency of 868 megahertz. They produce three times more disruptions than the active system which operate at 125 kilohertz. The interferences occurred mainly at very short distance of approx. 30 centimetres but also at six meters.
At the same time the market for RFID tags and systems in healthcare is predicted to skyrocket from $120.9 million in 2008 to $2.03 billion in 2018, according to IDTechEX, a market research firm focusing on RFID technology. Particularly important will be item level tagging of drugs and so-called real-time locating systems (RTLS) for staff, patients and assets to improve efficiency, safety and availability and to reduce incidents such as surgical sponges being “forgotten” inside the patient, or to protect babies from kidnapping.
Donald Berwick, president of the Institute of Healthcare Improvement in Cambridge concludes in accompanying editorial in JAMA that “health care is full of tightly coupled, hard-to-see systems, and the naïve introduction of a change as apparently isolated RFID tags … might cause remote and dire consequences far away in space and time.”
FDA concerned about computer code mistakes
Meanwhile also the American Food & Drug Administration (FDA) is concerned that microprocessors, which run everything from patient monitors to artificial pancreases, may have potential endangering software flaws.
The Baltimore Sun reports that a federal team of software experts discovered a flaw in a computer code that caused a drug pump to administer heavy overdoses, which led to a recall, warnings and rewriting of the equipment's software. Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software, according to The Baltimore Sun.
A product that malfunctioned because the computer code running it includes a mistake can be increasingly serious, reported The Sun. But to date the medical device industry have been slow to follow the FDA in adopting new forensic technology because it is costly and still evolving. Brian Fitzgerald, who heads the FDA's software specialists, told The Sun that clues are scarce and answers far from immediate. The team must pore over the entire code, looking for tiny flaws in the logic that, on the rare occasions it is summoned into action, could have “disastrous consequences.”
Photos: Fraunhofer Institut für Produktionstechnologie, Asklepios Kliniken
09.07.2008
