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TGA Issues Guidance on Patient Implant Cards, Information Leaflets

Posted 07 August 2019 | By Ana Mulero 

TGA Issues Guidance on Patient Implant Cards, Information Leaflets

Australia’s Therapeutic Goods Administration (TGA) issued guidance Wednesday to aid industry in following best practices for patient implant cards and patient information leaflets.
Medical device manufacturers with a presence in the Australia market have been required to provide the patient information materials since 2017. But “there are other features of leaflet and card design that can be very helpful for patients,” TGA says. The agency’s guidance outlines information to “further improve the way this information is provided” to recipients of devices.
The guidance outlines general design principles. These encourage applying layman terms to ensure the patient information materials are easily understood and user-friendly designs by considering the intended device recipient and the recipient’s needs in developing the materials.
TGA also explains how to appropriately use images in the leaflet and color contrast. “Some people are color-blind and colors can look different in different lighting conditions,” the agency notes. “It may be difficult or confusing to identify the required information and we may consider this to be unacceptable” if an implant card only uses a color element to distinguish information.
The agency also posted on Wednesday updates to its October 2018 guidance on patient information leaflets and implant cards, including corrections to industry’s compliance dates.
As part of the medical device safety action plan TGA released in April, the agency said that it will encourage health care facilities to ensure patients’ awareness of the information materials.
Best practice for Patient Information Leaflets and Patient Implant Cards

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