Replying to Amin’s post on the intended use of Medical devices. I believe the company developing the device should do their due diligence in determining potential adverse effects of how their device is interpreted and used. A company should be responsible for the “assumed” use in this case if a majority of patients have been found to misuse their device and cause harm in an accidental manner. Where the patient is genuinely trying to operate the medical device in a manner in which he/she believes it is intended to be used. If this does ultimately pose harm to a large patient population, that indicates a major systemic gap in their design itself, potentially the user interface, or overall instructions for use. There are ways to avoid issues like this.This can be done through a variety of methods such as tamper proofing the device or something like a one time use syringe that can be inoperable after one use. The instructions should specifically detail how the device should be used and leaves less for the end user to interpret and formulate their own method of use. Labeling and instructions for use and the less ambiguity you provide for the end user the better for a medical device.