McCoy to manufacturers: Wake up!

Tuesday, September 30, 2008

Bob McCoy is one of the HME industry’s staunchest proponents of testing respiratory equipment independently to determine its real-world effectiveness. The managing director of Valley Inspired Products, his research company, has produced two editions of “A Guide to Understanding Oxygen Conserving Devices” based on his independent studies. He’s now opening his own sleep lab-for research only-so he can further test respiratory equipment on sleeping patients. HME News recently talked to McCoy, the current homecare section chair for the American Association for Respiratory Care (AARC), about this new development.

HME News: So, why add a sleep lab to your research efforts?

Bob McCoy: We don’t know much about oxygen and sleeping patients. Most patients on regular oxygen equipment haven’t had a sleep study. So we don’t know if the prescription is correct. We had one (oxygen conserver) study where I had data on 10 patients using wrist oximeters, but it didn’t tell me anything about the patient’s sleeping situation. The critique was, How do you know that patient was sleeping? You don’t.

hme: How did you conduct that study?

McCoy: I hooked them up on a wrist ox, came back the next day and downloaded the explanation. If the oximeter said no desaturation, that would be a positive; if all you were looking at was numbers, which is what a lot of researchers do, the oximeter says, “Hey, you had a great night.” And they are going, “I didn’t sleep a wink. That thing was clicking all night and kept me awake.” If you look at just the numbers, the device works. If you look at the patient, it didn’t work at all because they didn’t sleep.

hme: A sleep lab will provide a more definitive result?

McCoy: I’m using a full polysomnograph, and this will be scored by a registered polysomnograph technician and interpreted by a board certified sleep doctor. That adds credibility because I’m just a respiratory therapist.

hme: Since manufacturers pay you to test their products, what happens if they don’t agree with the results?

McCoy: If we don’t get the same results, we’ll look at methods. Did we set it up the same? That is usually where the problem is. Once we set them up the same way and we buy into the set up, we should get the same results.

hme: Since you’re certified by an investigative review board (IRB), a positive test should be a product’s seal of approval.

McCoy: Yes. If a manufacturer is paying for this and they get a negative result, they say, “We are going to fix this.” They won’t publish negative results. The thing I do is if we do a study and things don’t look good, we say here is what went wrong. The manufacturer can go back and fix it and we’ll test it again, and if the results turn out good, we’ll publish them.

hme: I suspect not all manufacturers want to subject their products to independent testing.

McCoy: Manufacturers should be doing that more. I’ve seen some setups that were biased to make their product look better, and I didn’t buy that setup. When we do the comparison testing with products on the market and the results don’t look good, it is because the manufacturer presented the product based on economics and marketing potential and not on clinical potential. It’s a sad situation.