MEDICAL DEVICES

To advocate that the Food and Drug Administration (FDA) and manufacturers of drug preparation, drug distribution, and drug administration devices and associated new technologies ensure transparency, clarity, and evidence be provided on the intended use of devices and technologies in all phases of the medication-use process; further,

To advocate that the FDA and device manufacturers ensure compatibility between the intended use of any device and the drugs to be used with that device.

Rationale

The lines between devices, drugs, and technology are blurring as new and innovative technologies combine drugs and devices. Because drugs and medical devices undergo different approval processes, it is important that compatibility between the intended use of any device and the drugs to be used with that device be ensured during the approval process so that unintended and possibly detrimental consequences do not occur. In addition, clinicians require information about the intended use of devices in all phases of the medication-use process in order to make the best-informed decisions about patient care.