Once the product is out in the market, and the company has done everything possible it is up to the user to use the product as indicated. The company should have written clear labels and directions as to how to use the medication, when not to take it or ask a doctor. It has happened to me that on some occasions I was prescribed some strong painkillers and when I went to pick it up at the pharmacy I was told to wait to speak to the Pharmacist. She explained to me how to take the medication, and when to stop. I thought this was another good example of risk management that companies can take. It can help ensure healthcare providers that patients are aware of the medication they’re about to ingest. But as many of you have said, ultimately it is up to the user to use the product with diligence. As to what Dr. Simon said, I would think that during surgery, doctors, nurses, and techs are aware of how to use the medical devices, and if it’s not the case, they could rely on common practices that will not need the device.