How safe is the IOPI?

The IOPI poses no significant risk to either patient or clinician. The patient does not need to be electrically grounded, and the instrument is powered by a 9 volt battery. There is no conductive pathway from the patient to the instrument. Therefore, electrical hazards from the IOPI are very very small.

What is the risk of disease transfer from the tongue bulbs?

Tongue bulbs supplied by IOPI Northwest are clean but not sterile. After careful washing and air drying, they are individually packaged in envelopes suitable for sterilization. Cold ethylene oxide (EO) may be used as the preferred method of sterilization if they must be sterilized. This method has been used for many years with IOPI tongue bulbs without ever changing their physical properties.

Is the IOPI approved by the FDA?

The IOPI is registered with the FDA, but it is not "approved" because the FDA does not approve medical devices. When the IOPI was initially introduced to the market it was scrutinized by the FDA. Eventually it was decided that the IOPI is comparable to other registered devices like hand dynomometers.

Are there published "normal values" for tongue and hand strength and fatigability?

The IOPI User Manual includes the results of a statistical model showing the 95th percent range of measurements made upon a wide age range of male and female normal subjects. These data were collected by Dr. Donald A. Robin and his colleagues at the University of Iowa. Since that time, a number of published research reports have provided additional data on normal subjects and some patient groups. See Normal Values for graphs depicting the results of this study.

How do I buy an IOPI, and how much does it cost?

Blaise Medical, Inc. sells the IOPI. Their website, www.Blaisemedical.com, provides sales information, including the price.