Originally Published MPMN April 2007

EDITOR'S PAGE

Unique Identifiers Are Needed, But Not for All Devices

Last September, we wrote about FDA’s request for comments on the use of unique identifiers for medical devices. Since then, FDA received almost 90 comments, many of them from industry. A lot of them echoed the same thought.

Those respondents believed that some sort of unique identifiers were needed, but only for certain classes of products. For example, implantable devices, or those used in surgical procedures, should be able to be tracked.

We agree with this. It doesn’t seem necessary for manufacturers to go to the expense and possible additional regulatory hurdles for things like hospital beds or tongue depressors. Those items are not likely to harm patients.

Instead, unique identifiers should only be required for those products that have a direct impact on the lives of patients.

One such device in the pipeline is a radio-frequency identification (RFID) tag for artificial body parts. A recent patent application by Eastman Kodak (Rochester, NY; www.kodak.com) describes the tag as being designed “to break down under mechanical stresses rather than by chemical reaction. Such a tag may be affixed to an artificial heart or natural body part. It is then implanted and can be remotely queried. When wear on the body part, for example, an artificial hip, has proceeded to a predetermined level, the tag is rendered useless, thus alerting the remote query that the body part has achieved an unsatisfactory level of wear.”

Even some devices that would appear to cause no harm to patients should be identified. Surgical sponges are one of the leading safety concerns in operating rooms across the country.

According to a study in the New England Journal of Medicine, patient retained surgical sponges occur at an estimated rate of 1 of every 1000–1500 intraabdominal operations. This can result in serious complications for the patient, including infection, the need for another operation to remove the object, and even death.

RF Detect, made by RF Surgical (Bellevue, WA; www.rfsurg.com), is a surgical disposable detection system for surgical gauze, towels, and sponges. A sterile radio-frequency chip is embedded in the products. When a wand is waved over the patient, it alerts the users when an RF-tagged device remains in the patient before closing the surgical procedure.

Previously, operating room nurses would have to conduct several counts of all supplies to make sure nothing is left behind. But such a method can be flawed.

“Using the (RF Detect) system is easy and will help ensure that when the counts are recorded as correct, they truly are correct,” says Alecia Cooper, RN. “Sadly, we know studies show that in 80% of retained object cases, the counts were recorded as correct.”

Medgadet.com reports that Siemens and other companies are starting to embed RFID chips in surgical sponges as well.

These examples show how identifiers are needed and helpful for patient safety. Manufacturers should be thinking about incorporating such devices into their
products—regardless of FDA’s decision.

Susan Shepard, Managing Editor

Copyright ©2007 Medical Product Manufacturing News