Thursday, October 2, 2008

NIOX MINO for asthma monitoring part 2

I had the opportunity to meet with the regional representative from Aerocrine, the manufacturer of one of two recently F.D.A.-approved machines that can measure exhaled nitric oxide in the breath. I have written earlier about the NIOX MINO machine here and given an update about coding here. Here's what my test drive was like.

For comparison, fortunately I have been able to work with the research version of the NIOX MINO for the past 2 years. They are not quite to same, because the commercially marketed version is smaller, about the size of a small shoe box. I was intrigued to see it, partially because I have waited for months. Reportedly, no one else has one in S.C. Onwards, operating the NIOX MINO is fairly simple because there are only a few buttons. The machine is turned on, and then when ready, the patient first inhales through the device. The air passes through a filter that measures the ambient room's nitric oxide concentration. Then the patient exhales slowly at a medium rate for 10 seconds. If the rate is too low or too high, the machine makes a whistling sound, indicating the rate is too high or fine or too low. There is a screen on the back of the machine. During the test, a cloud floats above the upper line, or between two lines, or below the lower line. These correlate with the flow rates. Patients are positioned in front of a mirror so they can see the screen. If 10 seconds of exhaling have been completed acceptably, then the machine now begins to test the sample's nitric oxide concentration. Note that unacceptable attempts do not use up the machine's chemicals. After 1 minute and 25 seconds, a number is displayed on the screen. This is the net difference between the exhaled and inhaled nitric oxide levels. This number can be transferred by wire or infrared beam to a computer and then saved or printed out. A docking station with a printer is also available. The cartridges for the filter and the disposable mouth pieces after the original purchase are an extra cost. They are sold in lots of 100 or 300. After 3,000 uses, the machine will need to be completely replaced because the chemicals inside are all used up. It automatically makes a sound to remind the user that the machine needs to be calibrated about every 45 measurements. This takes 10-15 minutes. The NIOX MINO appears to be solidly built, but we couldn't do the ultimate test. Drop me and watch me work JUST fine. This has happened numerous times with our spirometer and the sensors do NOT like being dropped. So in this area, durability, the jury is still out.

As I outlined earlier, there are some hurdles against the rapid introduction of this device in normal, daily medical practice. First, literature is mixed as to its clinical usefulness. Sorry, in fact, in the September issue of the Annals of Allergy, two separate articles stated that strong evidence is lacking to support this device. I acknowledge with time, that this may change, but that's where we're at. Second, the device retails for about $3,000 plus the cost of mouth pieces and scrubbers. New technology has always been a little bit pricey in medicine. Worst to me is having to re-purchase a new machine after 3,000 measurements. The salesman offered a purchase plan to be paid monthly, for the length of the contract, which in essence reduced the price of the machine, had some reduced prices on the mouth pieces, and the kicker includes a free, new machine when the first machine is not functioning. Third, reimbursement from insurance companies is just beginning. I can't state the amount, because of secrecy agreements. You'll have to do your own footwork here. This could be the deciding factor. With insurance reimbursements plummeting, ask yourself would the machine be cost effective in your practice? Fourth, who could perform the test maneuver and would you use it if they could? For us, the gold standard will continue to be pulmonary spirometry.

That's it in a nutshell. The salesman was polite, patient throughout my interrogation, and knowledgeable, kudos to him, so if you have questions, do not hesitate to contact him and ask me.

1 comment:

Marcus said...

I came across a medical Journal which states that FENO was measured according to current guidelines using a NIOX MINO electrochemical analyzer or a NIOX chemiluminescence analyzer (both Aerocrine, Solna, Sweden). The latter was available at the Research Unit, 5km. from the Health Centre, but was used only when there was technical failure of the NIOX MINO.

Is it true? Any information about it?

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