The FDA has the "CHECKLIST OF COMPLIANCE WITH ESSENTIAL REQUIREMENTS OF MEDICAL DEVICES DIRECTIVE, #2.  Essential Requirements".  Isn't the Doctor is also required to follow the procedures for use of the device (including using the blades ONLY once and cannulas) to also eliminate and reduce risks as far as possible?  These risks include permanent patient injury (which happened to me and at least one other patient of The Doctors).  Note particularly item 4 below where it indicates that the device MUST NOT be adversely affected that it jeopardizes patient safety "when the device is subjected to the stresses which can occur during normal conditions of use."