Medical Device Daily Washington Editor

GAITHERSBURG, Maryland – Within the last year, we have seen automatic external defibrillators (AEDs) go from available by prescription only to approval for over-the-counter (OTC) sale.

Could pulse oximeters be next? Maybe so, but probably only if adhering to an FDA panel’s quite common mantra of: “more data needed.”

The Anesthesiology and Respiratory Therapy Devices panel of the FDA’s Center for Devices and Radiological Health met last Friday to discuss general issues raised by OTC sales of pulse oximeters and make recommendations about possible marketing for their use without a prescription.

Overall, panel members seemed in favor of such an approval. And there were the usual differences of opinion regarding whether there is enough data available, at present, to make a more solid recommendation for or against.

For a company to obtain approval for OTC marketing, it would have to submit a premarket approval application to the FDA, thus going beyond 510(k) requirements.

At present, there are a small number of consumer products available that function as pulse oximeters.

Nonin Medical (Plymouth, Minnesota), for example, manufactures devices for sports enthusiasts. The company’s FlightStat product is a finger-mounted monitor for pilots to check for in-flight hypoxia. And Nonin’s SportStat is marketed to mountain climbers, hikers, skiers and other athletes interested in measuring their blood oxygen saturation and pulse rate.

Both are available without a prescription. The difference, according to the FDA representatives at the panel meeting, is that no medical claims are made for these consumer products and that athletes would use these devices in much the same as they would a treadmill or other exercise equipment.

At the same time, however, the devices the company manufactures for medical use are “mostly identical” to those marketing for consumer use, Phil Isaacson, founder and managing director of Nonin, told the panel.

For most panel members, the main issue is not the traditional endpoints of efficacy or safety, since the devices pose little safety risk to those using them. The issue for them appeared to be how potential OTC users would interpret the data that these devices provide.

“I think we need to see a trial population to see how these people use the data,” said panel member David Birnbach, MD, professor of anesthesiology, obstetrics and gynecology at the University of Miami School of Medicine (Miami). “Do these devices raise a red flag when they shouldn’t? Or do they lead patients to a false sense of security? Clearly more data is needed, but I think it should move forward. I see more positives than negatives.”

Birnbach also suggested that if people are able to use an AED available over the counter, a pulse oximeter would be a “natural combination” with that device.

Jacqueline Leung, MD, professor of anesthesiology at the University of California, San Francisco, agreed that more studies are needed, but she said that pulse oximeters – if accuracy data were provided – could provide a helpful diagnostic tool to patients who need it, much like a digital thermometer or a blood pressure monitor.

“On the other hand, if someone is sick enough to need a PO [pulse oximeter] at home, it should be made under the direction of a physician,” argued Charles Cote, MD, vice chairman and professor of research in the department of pediatric anesthesiology at Children’s Memorial Hospital (Chicago).

The panel recommended that before OTC status could be granted to any pulse oximeter product, some sort of study needs to be conducted to identify what patients need and how they use the product before it is made widely available.

More accuracy data also would be needed, the panel advised. More precise labeling and instructions obviously would be required as well, the panel said.

OTC availability of the devices “just feels like the right thing to do, but I am reluctant without further studies,” said Alan Lisbon, MD, panel chairman and vice chair for critical care at Beth Israel Deaconess Medical Center (Boston).

On average, the FDA reports reviewing more than 20 510(k) submissions annually for pulse oximeters. The two leaders in the sector are Nellcor (Pleasanton, California) and Masimo (Irvine, California).