Health care is full of tightly coupled, hard-to-see systems, and the naive introduction of a change as apparently isolated as RFID tags on endoscope tubes might cause remote and dire consequences far away in space and time.

Donald M. Berwick, MD, MPP, FRCP, Institute for Healthcare Improvement

As you may have seen and heard, a recent study published in JAMA discovered and proved that RFID scanners severely interfere with and shut down critical care operating room machines. The FDA and CDRH have reported tests of their own as interfering with equipment and causing defibrillators to deliver inappropriate shocks.

While marketing departments of some companies may try to spin the facts, the truth is that the FDA itself has not tested (and vouched for) the RF and RFID products on the market for interference with other machines. Nor has the FDA tested to see that either the RF or RFID products are actually accurate to any degree in detecting and/or counting sponges.

Having FDA 510(k) clearance should not be misconstrued as a product having passed through a battery of FDA-supervised tests. Class I clearance only requires a manufacturer to state in its application that its product is the equivalent of another product already on the market and to attest that the product being submitted does not cause interference. The FDA does not test the machines to confirm the manufacturer’s claims. Whether the product “works” or not simply is not part of the Class I 510(k) clearance process.