Research Report. Radio Frequency Identification Devices (RFIDs) Effect of RFIDs on lifesaving equipment

Transcription

1 Research Report Radio Frequency Identification Devices (RFIDs) Effect of RFIDs on lifesaving equipment Background It has been suggested in the Journal of the Medical Association that lifesaving equipment may be switched off by RFIDs (radio-frequency identification devices) which are used to track people and machines. Research Question: Research Report Apart from that published in the Journal of the Medical Association, is there any further published evidence that suggests that RFIDs may interfere with lifesaving equipment? Summary RFID is a general term that is used to describe a system which transmits the identity (in the form of a unique serial number) of an object wirelessly, using radio waves; this is sometimes referred to as contact-less technology. A typical RFID system is made up of three components: tags, readers and the host computer system. In the original research, medical equipment situated within metres of an RFID reader broadcasting a signal to nearby RFID tag was tested to see if any Electro-Magnetic (EMI) was detected. Tests carried out in a non-clinical environment showed that caused by RFIDs induced potentially hazardous incidents in medical devices. However, the scenarios in which the tests were conducted can be described as scenarios in which the devices were used at their highest output and in close proximity to medical devices. A preliminary literature review was carried out to ascertain if any further evidence could be found which corroborates or negates the original research. To date, no other literature has been published which corroborates or negates the work. Conclusions and recommendations for the use of RFIDs in healthcare environments are put forward. Version 1 Page 1 of 12

2 Abstract RFID is a general term that is used to describe a system that transmits the identity (in the form of a unique serial number) of an object wirelessly, using radio waves; this is sometimes referred to as contact-less technology. A typical RFID system is made up of three components: tags, readers and the host computer system In the original research article, medical equipment situated within metres of an RFID reader broadcasting a signal to nearby RFID tag was tested to see if any Electro- Magnetic (EMI) was detected. Tests carried out by van der Togt, van Lieshout et al, in a controlled non-clinical testing environment at the Academic Medical Centre, University of Amsterdam, showed that caused by RFIDs induced potentially hazardous incidents in medical devices. The scenarios in which the tests were conducted, can be described as worse case scenarios in which the devices were used at their highest output in close proximity to medical devices. A preliminary literature review was carried out to ascertain if any further evidence could be found which corroborates or negates the work carried out by van der Togt, van Lieshout et al. To date, no other literature has been published which corroborates or negates the work carried out by the University of Amsterdam Research Group. Method Literature review, and discussion with Medicines and Healthcare Product Regulatory Agency (MHRA). Findings from original research The University of Amsterdam researchers tested 41 pieces of medical equipment 3 times; each test was conducted within metres of an RFID reader broadcasting a signal to nearby RFID tag. Tests carried out showed that the equipment malfunctioned 34 times (28%). Malfunctions were deemed hazardous, significant or light, 22 of the malfunctions reported were noted as being hazardous, 2 were reported to be significant, and 10 were reported as being light. (Van der Togt et al., 2008) The 3 scales used in the study to describe the effect the EMI had on the critical care equipment are adapted from the critical care adverse event scale, the effects associated with each point on the scale are described in Table 1. In the Dutch study, types of hazardous malfunction reported included ventilators switching off or changing rates, syringe pumps stopping and external pacemakers malfunctioning. (Appendix 1 identifies the devices examined and details the malfunctions reported. Version 1 Page 2 of 12

3 Scale/Rating Light Significant Effect denoted Influence on monitoring without a significant level of attention needed, for example a disturbed display. Influence on monitoring with a significant level of attention needed, causing substantial distraction from patient care, for example an incorrect alarm or inaccurate monitoring of blood pressure. Direct physical influence on the patient by an Hazardous unintended change in equipment function, for example total stopping of ventilator or syringe pump. Table 1: Effects indicated by the critical care adverse effect scale Implications In areas containing sensitive medical devices, the potential risk suggested by the Dutch research team depends on the distance between the reader and any medical device. It should be noted that adverse occurred at separations of less than 1 metre, which is similar to that caused by mobile phones. However, the initial impression given by the research results was that the risk associated with RFID would be greater due to the fact that the median distance for all incidents established in the paper was 30cm and therefore more critical when compared with the median range of 3cm established with modern mobile phones. As mentioned previously, due to the fact that devices were tested in close proximity to critical care equipment at high power outputs, the scenarios described in the Dutch research paper are somewhat different to those commonly found within Healthcare Environments. To date no further evidence has been published which corroborates or negates the work carried out by van der Togt, van Lieshout et al. Therefore with the current level of information available it is difficult to ascertain what the likelihood of malfunction actually is. It should be noted that many pieces of communication technology, for example mobile phones, can interfere with medical equipment and therefore must be managed appropriately. Tags The Dutch study indicated that the main risk of does not come from tags, which are very low power devices. The low power associated with their use means that although RFID tags will be directly attached to medical devices, they are unlikely to interfere with their operation. Version 1 Page 3 of 12

4 Readers Readers tend to have higher powers, up to several watts. The Dutch research work has indicated that the main risk of EMI comes from readers; the risk of EMI is dependant on where the readers are used. The risk of is higher if the RFID is used close to medical devices which are being used for intensive care and therefore, may well be a problem. Consequently, it is not advisable to use readers in this situation, as is the case with mobile phones. In contrast there are many situations where tag readers could be used in complete safety. Risk Assessment Electro magnetic has only been detected at relatively close ranges, therefore those using RFIDs should assess the likelihood of RFID chips being placed within such a short range of hospital equipment. Until more information is gained about the use of RFIDs working out the risks of is not straightforward as there are many factors involved. These include: type/power rating of reader; type/power rating of tag; distance between reader and medical device; location of use: o store room = low/no risk; o operating theatre = higher risk. Although the tags are directly attached to medical devices, they are very low power devices and so are unlikely to cause. The main risk comes from the RFID readers that tend to be higher powered, up to several watts, putting them in the same risk bracket as mobile phones Reports of To date the MHRA (Medicines and Healthcare products Regulatory Agency) has not received any incident reports regarding RFID ; they are however proactive in monitoring the situation. The Federal Drugs Agency (FDA) has not received any incident reports of active implantable medical devices reacting to RFID tags or the readers. They too are monitoring the situation. Version 1 Page 4 of 12

5 Conclusions and recommendations Conclusion 1 Many pieces of communication technology can interfere with medical equipment and therefore must be managed appropriately and in some instances guidelines for their use within the healthcare environment are already established (e.g. Mobile phones). As readers have the similar power output and the distance at which is noted is similar to that of mobile phones, it can be said the risk associated with their use is likely to be in the same bracket as that of mobile phones. It may be surmised that the risk posed by and the way that the risk is managed should be similar to that of mobile phones. Therefore, the level of risk will depend on where they are used, for example; if RFIDs are used in storerooms and non-clinical areas the chances of causing adverse incidents are remote; whilst if they are used in operating theatres and intensive care wards the possibility of exists; with portal-type readers potential risks will depend on whether patients connected to critical care devices have to pass through them. Recommendation 1 As has only been detected at relatively close ranges, those using RFIDs should assess the likelihood of RFID chips being placed within such a short range of hospital equipment. Additionally it may be prudent to screen for potential mishaps at wider ranges. Conclusion 2 The study's authors did not recommend removing or banning the RFID technology from hospitals, noting that it does have a strong potential to help healthcare providers. They stated medical equipment makers should now develop ways to protect their medical devices from radio frequency. Recommendation 2 Those purchasing devices should require that manufacturers should re-engineer devices to withstand radio waves. Additional testing and efforts to create standards for how these devices should be used, may take years to establish. Conclusion 3 t enough is known about extent and mode of use of RFIDs within the UK. Version 1 Page 5 of 12

6 Recommendation 3 Due to the fact that at present not enough is known about the extent and mode of use of RFIDs in UK healthcare it is difficult to fully assess the potential risks caused by such devices. Until such information is known it is reasonable to state that RFID devices should be treated like mobile phones and not used in close proximity to operating electronic medical devices. Furthermore, use of readers in operating theatres and critical care areas should be avoided until further evidence is available. Future Work MHRA has published General Safety Information and Advice for use of RFIDs within the healthcare environment. Details can be found at the following web address: icalinformation/radiofrequencyidentification/index.htm further work is to be carried out by Health Facilities Scotland at this time. A periodic searching of the literature will continue and future findings or changes to guidance will be reported back to the service. Version 1 Page 6 of 12

7 Appendix 1 An overview of devices examined and findings. From Electronic Supplementary Material to the article: Effects of Electromagnetic from Radio Frequency Identification on Critical Care Equipments Classification: H = hazardous, S = significant, L = light Type Of Device (Distance In Cm) Signal (Type) Infusion/Syringe Pumps Classification Graseby MHz H Alaris IVAC MHz H B.Braun Compact (S) B.Braun Infusomat (P) B.Braun Infusomat (P) MHz L MHz L 5 125kHz H Alaris IVAC MHz H B.Braun perfusor ft B.Braun perfusor fm B.Braun Infusomat Space MHz H 0,1 868MHz L no Details Stops working, error messages, resetting not possible. Stops working, error messages, after reset pump works normally again. Beep heard from loudspeaker. Rattling noise heard from loudspeaker. Stops operating, error message. Stops operating, error messages. Stops operating, acoustic alarm. Lamp 'battery' switches off. Version 1 Page 7 of 12

8 Type Of Device Medtronic 5348 Single chamber Medtronic 5348 Single chamber Biotronik EDP20/A Medtronic 5388 Dual chamber Medtronic 5388 Dual chamber (Distance In Cm) Signal (Type) External Pacemakers Classification MHz H kHz H MHz H MHz H 5 125kHz H Mechanical Ventilators Hamilton Galileo MHz H Hamilton Galileo kHz S Drager Evita MHz H Hamilton Raphael color and Siemens Servo 300A and screen 390 Details On demand: pace pulses are given erroneously. On demand: pace pulses are given erroneously. Pace pulses are given erroneously. On demand: pace pulses are given erroneously in both atrium and ventricle. On demand: pace pulses are given erroneously in both atrium and ventricle. Ventilation triggers erroneously, higher ventilation frequency at flow curve at display. Stops operating, loss of settings, automatic restart. Version 1 Page 8 of 12

9 Type Of Device Gambro AK200 ULTRA S B.Braun Diapact CRRT Guidant Zoom Latitude programming system 3120 Guidant Zoom Latitude programming system 3120 Medtronic 2090 The Programmer Medtronic 2090 The Programmer Datascope System 97 (Distance In Cm) Signal (Type) Hemofiltration/Dialysis Devices Classification MHz H MHz H Pacemaker Programmers MHz S kHz H MHz H kHz H Intra-Aortic Balloon Pumps MHz H Details Stops operating (recoverable from operation panel), acoustic alarm. Can be continued. At 0 cm: stops working, sometimes treatment stops, reset Stops operating (recoverable from operation panel), acoustic alarm. in atrial and ventricular electrocardiogra m (EGM) Active tag, solely: in atrial and ventricular electrocardiogra m (EGM) Communication with ICD disturbed, LEDbar on programming head disrupted. Communication with ICD disturbed, LEDbar on programming head disrupted. Stops operating, settings lost. Version 1 Page 9 of 12

10 Type Of Device Arrow Acat 1 plus & Arrow AutoCat2Wave. Surgical company Fluido (Distance In Cm) Signal (Type) Fluid Warmer Classification MHz H Cardiopulmonary Bypass Device Sarns MHz H Haemonetics HaemoLite2Plus Agilent/HP CM- S Monitor with ECG module M1001A/B Agilent/HP CM- S Monitor with ECG module M1001A/B GE S/5 Avance, GE Aestiva/5, Philips Airway Gases M1026B Philips Heartstart Medtronic lifepak 20 Medtronic lifepak 12 Autologous blood recovery device 5 868MHz H Anaesthesia Devices MHz L kHz L Defibrillators MHz L 5 868MHz L Details Resets automatically and resumes operating normally when signal is removed. cardioplegy pump into band skid mode, no change in rotational speed. Change in rotational speed in ECG. in ECG. noise from loudspeaker. noise from loudspeaker. Version 1 Page 10 of 12

11 Type Of Device Marquette MAC leads ECG Marquette MAC leads ECG Philips Intellivue MP30 with module M3001A PhilipsIntellivue MP50 & Philips Intellivue MP90 Hill-Rom Avant Guard & Hill- Rom Total Care Maquet Alphamaquet Sarns/Terumo TCM II Laerdal LSU (Distance In Cm) Signal (Type) 12 leads electrocardiogram device Classification MHz L kHz L Monitors MHz L IC Bed Operating Table Hyper/Hypothermia Device Vacuum Pump Details in ECG. in ECG. ise from loudspeaker. References: Van der Togt R, van Lieshout EJ, Hensbroek R, et al. (2008) Electromagnetic from Radio Frequency Identification Inducing Potentially Hazardous Incidents in Critical Care Medical Equipment. Journal of the American Medical Association. Vol pp Electronic Supplementary Material to the article: Effects Of Electromagnetic from Radio Frequency Identification on Critical Care Equipment. Accessed 23/04/09. MHRA Radiofrequency Identification Version 1 Page 11 of 12

12 icalinformation/radiofrequencyidentification/index.htm Accessed 26/05/09 Version 1 Page 12 of 12