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Compliance In Focus
Posted by John Lehmann on Tue, Jan 8, 2013

Does a Lack of Device Labeling Standard put Patients at Risk?

Device Labeling StandardRecently an announcement of a Public Workshop was posted on Federal Register (FR). This workshop, “Accessible Medical Device Labeling in a Standard Content and Format,” is to investigate the growing need for medical devices to be labeled in a clear and concise manner. Currently, there is a lack of direct regulation that defines a standard for medical device labeling. FDA hopes this workshop will begin the process of establishing a standard.

As stated from the FR posting, “FDA is holding this public workshop to address these growing concerns and to solicit responses from the medical devices industry, healthcare practitioners, caregivers, and patients regarding a standard content and format of medical device labeling and methods to make medical device labeling accessible and searchable while keeping patient safety a priority.”

The scheduled workshop will engage shareholders in discussions regarding:

  • Summary of FDA Work on Labeling
  • Standard Content and Format of Device Labeling
  • Repository of Medical Device Labeling for Home Use Devices

The looming question- Could patients be at an increased risk, or negatively impacted, by the absence of a standard? Taking into account:

  • More medical devices are being used in patient homes which means the safety and use resides with the patient/caregiver
  • Without a standard content format there could be increase of device error, especially when operating or troubleshooting a device
  • Lack of a repository or database which would allow access to a catalog of labels

FDA has conducted research studies and surveys concerning this issue. However, FDA is still encouraging public comments regarding the standard. The workshop will also be streaming live via webcast. The public workshop will be held on April 29, 2013.

Will you be participating in some way? We are curious to hear your thoughts on these points and the overall effort to standardize the labeling of medical devices. Feel free to leave your comments below.

Photo Credit: clarkworth

Monitoring as a Mindset

Topics: Patients, Federal Register, Device Labeling, FDA


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