Medical Labeling Problems

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Section 201 (m) defines 'labeling' as: 'all labels and other written, printed, or graphic matter. (1) upon any article or any of its containers or wrappers, or. (2) accompanying such article' at ...

One-Third of Medical Errors Caused by Poor Labeling - Class Action

https://www.classaction.com/news/poor-labeling-causes-medical-errors/

In fact, an Institute of Medicine study found that labeling and packaging issues (particularly confusing instructions) were the leading …

Labeling Requirements - Misbranding | FDA

https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding

Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s …

Specimen mislabeling: A significant and costly cause of …

https://acutecaretesting.org/en/articles/specimen-mislabeling-a-significant-and-costly-cause-of-potentially-serious-medical-errors

Standards & Practices in Medical Device Labeling - RBC …

https://rbccorp.com/medical-device-labeling-standards/

Medical device labeling symbols, warnings, information displayed on a user interface (UI), and documentation are all considered “labeling” by ISO 13485. ... This prevents unforeseen problems like …

FDA Guidance on Development of Medical Device Labeling

https://www.regdesk.co/fda-guidance-on-development-of-medical-device-labeling/

Reducing Labeling Problems The Agency further describes the approach to be applied by medical device manufacturers in order to mitigate the risks associated with potential misinterpretation of labeling …

Medical Device Labeling Changes and Challenges – EU …

https://www.celegence.com/medical-device-labeling-changes-challenges-under-eu-mdr/

Labeling receives prominent attention in the new EU MDR/IVDR regulation that has been released to ensure high standards of quality and safety for medical devices being produced or supplied. Therefore, it is of …

Labeling Mistakes and How to Avoid Them

https://www.mddionline.com/packaging/labeling-mistakes-and-how-avoid-them

Labeling, (i.e., instructions for use, user guides, etc.) used to be an afterthought—the final step before submitting a medical device or combination product …

ISMP Warns that Medical Marijuana Product Labeling …

https://www.ismp.org/news/ismp-warns-medical-marijuana-product-labeling-problems-have-led-errors

Efforts are currently underway to examine medical marijuana labeling issues and provide recommendations for improvement. ISMP is a member of an expert group convened by …

Pre-analytical pitfalls: Missing and mislabeled specimens

https://psnet.ahrq.gov/web-mm/pre-analytical-pitfalls-missing-and-mislabeled-specimens

Common events included improper specimen labeling, collection/preservation, and transport. Of these 684 events, 8% resulted in either the need for additional treatment, or …