SurgiCount Medical: Clinical Studies: RF & RFID

An RFID or scanning device must be reliable enough to either replace or enhance the current process. The failure rate of these RFID devices is currently not known.

Verna C. Gibbs, Preventable Errors in the Operating Room:
Retained Foreign Bodies after Surgery—Part I, Current Problems in Surgery Volume 44, Issue 5, Pages 281-337 (May 2007)

In a controlled nonclinical setting, RFID induced potentially hazardous incidents in medical devices.

Electromagnetic Interference From Radio Frequency
Identification Inducing Potentially Hazardous Incidents in
Critical Care Medical Equipment. van der Togt et al., JAMA,
Vol. 299 No. 24, June 25, 2008

SurgiCount is unable to offer links to clinical studies of either the RFDetectT or SmartSpongeT systems as neither products' vendors publish clinical studies performed on either their products or on the underlying technology behind their products.

Other studies do exist however.

JAMA Interference Study
The study, available here, was published in the June 25th, 2008 issue of the Journal of the American Medical Association (JAMA), is the work of co-author Dr Erik Jan van Lieshout of the Academic Medical Centre of the University of Amsterdam and colleagues.

The researchers used two types of RFID equipment, active and passive. Active RFID tags transmit information whereas the passive type of RFID has to be read by a special receiver. Incidents of interference were classed into three types: hazardous, significant, or light The results showed that in 123 tests (3 per medical device), RFID induced 34 incidents. Of these, 22 were classified as hazardous, 2 as significant, and 10 as light. The passive (868-MHz) RFID signal induced more incidents (26 incidents in 41 tests; 63 per cent) compared with the active (125-kHz) RFID signal (8 incidents in 41 tests; 20 per cent). The passive (868-MHz) RFID signal induced more incidents (26 incidents in 41 tests; 63 per cent) compared with the active (125-kHz) RFID signal (8 incidents in 41 tests; 20 per cent). The passive RFID signal interfered with 26 medical devices, including 8 that were also affected by the active RFID signal. Conclusions: In a controlled nonclinical setting, RFID induced potentially hazardous incidents in medical devices.

FDA & CDRH Study
The FDA’s Center for Devices and Radiological Health (CDRH) has a static white paper, available here, reviewing and discussing RFID in health care applications. Excerpt:
“In 2006, FDA, in collaboration with the AAMI Cardiac Rhythm Management Devices EMC Task Group, conducted laboratory tests of pacemaker and ICD reactions to RFID. Five medical device manufacturers and five RFID companies provided equipment for this study. The devices were exposed to emissions from RFID readers operating at three different frequencies and at various distances from the devices. Preliminary findings showed inappropriate reactions in some of the devices. Reactions included inhibited pacing and inappropriate delivery of ICD therapy. FDA continues to study RFID and its potential effects on medical devices. As it becomes available, FDA will communicate new information to the public through its website, the news media and other channels.”

University of NEBRASKA RFID Research Evaluation
Published in May 2007 on the online Surgical Endoscopy website, this white paper, available here, also reviews the concept of RFID embedded sponges. Its limited results were equally disappointing.
“The initial experiment indicated that water would prove to be the primary obstacle to overcome for project success. While the porcine test resulted in positive read rates when the sponge was placed inside the body cavity and removed, full submersion or the sponge into water caused much more disruption in reads.”
As institutions are looking for technology designed to be more accurate than hand counting’s 99.9996%, SurgiCount Medical does not feel comfortable providing hospitals with solutions based on these technologies.

Macario/Clearcount Clinical Evaluation
In the summer of 2006, Macario et al. published an 8 patient, 28 sponge, non-real clinical evaluation of a prototype RFID wand product in the Archives of Surgery available here
This was not a valid clinical study of a product, but instead solely a conceptual evaluation of RFID embedded gauze. After the 8 procedures were finished but just before closure, RFID-embedded sponges were placed in the incision point. While all 28 sponges were detected, the authors of the study concluded: “Despite this engineering success, the possibility of human error and retained sponges remains because handheld scanning can be performed incorrectly.” Since the evaluation was published, ClearCount has seemingly opted to go in a different direction with an emphasis now on a counting machine and not a detection machine. Hospitals should not confuse the prototype's 2006 clinical evaluation as a clinical evaluation, let alone a valid clinical study, of the current product ClearCount has on the market today. They are different products with different technologies, just with the same brand.

SurgiCount is committed to working within the AORN, Joint Commission, and FDA guidelines and in not providing a method to circumvent practices designed for safety and accuracy.

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