Radiofrequency identification

Radiofrequency identification (RFID) systems are used in healthcare establishments to trace and track equipment. The system consists of two parts, a tag (which may be active or passive) and a detector (‘reader’). The tags are small memory chips that store information (e.g. a serial number, date of next service) and are attached to the equipment. The readers can be hand-held or fixed at a particular location. Such a system can also be used to track the whereabouts of patients.

Concerns have been raised with the MHRA about the possibility of RFID systems interfering with electronic medical devices. Working out the risks of interference 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 – eg store room = low/no risk; 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 interference. 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.

We have studied a number of published papers and articles as part of our regular review of the risks of interference from mobile communications. The latest research from The Netherlands 1 indicated adverse interference at separations of less than one metre, which is similar to mobile phones.

At this stage it is reasonable to say that RFID readers should be treated like mobile phones and should be kept out of areas with sensitive electronic medical equipment, such as intensive care and specialist baby units. It may also be appropriate to avoid using the readers in operating theatres and critical care areas until further evidence is available.

The risk of interference will also depend on the type of reader and how it is used. If mobile readers are used in storerooms and non-clinical areas the chances of causing adverse incidents are remote. With portal readers, risks exist if they are used in close proximity to patients connected to critical care devices or who have an implanted active device.

Some systems appear to use wide area networks, to allow devices to be located anywhere within a hospital. These often require active RFIDs, but overall signal levels from the tag appear to be low.

The USA’s Food and Drug Administration (FDA) has also been undertaking a review of RFIDs in healthcare facilities and, like the MHRA, has not received any incident reports of electronic medical devices reacting to RFID tags or the readers.

At present we don't know enough about the extent and mode of use of RFIDs in UK healthcare establishments to fully assess the risks. However, like mobile phones, it is important not to lose sight of the benefits while warning of the hazards. The MHRA will continue to monitor the situation and we will provide updated information on RFIDs in healthcare as it becomes available.

Ref 1 Van der Togt, R, van Lieshout, EJ, Hensbroek, R, et al (2008) Electromagnetic interference from radio frequency identification inducing potentially hazardous incidents in critical care medical equipment, Journal of American Medical Association, 299 (24) pp. 2884-2890.

FDA page on Radiofrequency identification (RFIDs) (external link)

For further information contact:
Mel King
020 7084 3286
mel.king@mhra.gsi.gov.uk

Catriona Blake
020 7084 3219
catriona.blake@mhra.gsi.gov.uk