[527479]
I use a cpap - constant positive air pressure- device every night for sleep apnea and hypopnea. Late last year i switched masks to a cannula manufactured by innomed. The cannula consists of two plastic tubes connected to a cannula device that fits in the nostrils. The tubes are translucent, white and very flexible at the start. About four months of use later, the tubes have hardenend into an unbendable configuration and have darkened. I am familiar with plasticizers used in plastic devices. The hardening and color change indicate that whatever plasticizer was used has bled away during use of the cpap, and of course the only place it can go is in my lungs. An internet reference indicates that bio-2-ethylhexyl- phthatate -dehp- is commonly used in medical devices, including "air tubes. " the reference goes on to say that the americal academy of pediactrics has advocated not to use meidcal devices that can leach dehp into patients. It goes on to say that"... While dehp has a low lethal toxicity, it affects certain organs at low concentration , specifically... The lungs... " my question is: has the innomed cannula device ever been tested for long-term exposure to the lung and does it have fda approval for that use? I frankly suspect that the tubes are "food grade" plastic not designed for use in a medical device.
Patient Sequence No: 1, Text Type: D, B5