WASHINGTON, D.C. – Today, Senators Jim Banks (R-Ind.) and John Hickenlooper (D-Col.) introduced the Medical Device Electronic Labeling Act. This bill would let patients access their medical device labels and instructions online, while preserving the option to request paper versions free of charge for those who still want paper.
Senator Jim Banks (R-Ind.) added, “Patients should be able to access their medical device instructions online, while still having the option to get free paper copies if they want. This bipartisan bill just makes sense.”
Senator John Hickenlooper (D-Col.) said, “Americans deserve quick and easy access to information about their medical devices on their phones and computers, not just on paper they have to sift through. Our bill puts it at their fingertips.”
Scott Whitaker, AdvaMed President and CEO, added, “Doctors and patients increasingly turn to online resources for information about how to use medtech. Electronic instructions are easy for consumers to access and for manufacturers to update quickly, without the delay caused by issuing paper manuals. This efficiency would help doctors and patients use the medtech as effectively as possible, achieving the full intended benefits of each innovation. We thank Senators Banks and Hickenlooper for working to modernize this critical aspect of health care. With this, we now have bipartisan e-labeling bills in both houses of Congress, so there’s no reason we can’t get them passed and signed into law this year.”
See the full bill text here.
Key Provisions of the Medical Device Electronic Labeling Act:
- Allow medical device manufacturers to provide labelling information to patients electronically, subject to safety requirements, in the same manner as they already provide it to health care professionals.
- Give patients the option to request paper versions, at no additional cost.
- Maintain the same content requirements for digital and paper labelling information.
- Grant the Secretary of Health and Human Services flexibility to add to or change the content of labelling information, subject to public notice and comment.
Background:
Existing law sets safety and instructional labeling requirements for medical devices and allows this information to be provided digitally, only when the medical device is used in a health care facility or by a health care professional. Health care professionals can opt in to receiving the medical device labeling information on paper, at no additional cost. Many prefer digital information because it is more convenient, easier to read, and reduces excessive paper waste.
Most Americans prefer to access health, product, and safety information digitally, but existing law does not allow them to do so for medical devices. All medical device instructions and labels are still provided to patients on paper, often amounting to dozens of pages.
