2D Custom Barcode Laser Etching

Compliance: The Food and Drug Administration passed a law in 2007 that requires a Unique Device Identification (UDI) to be implemented on medical devices and packaging with a specifically formatted machine-readable code.

Directly applied UDI marks should meet many criteria:

  • Not affect the surface finish of the device negatively
  • Must not corrode or fade
  • Ensure counterfeit protection
  • Marked in high contrast
  • Legible and readable
  • Remain stable through multiple high alkaline sterilization and cleaning procedures

FDA Approved

Tracking individual surgical instruments that meets the above criteria can be achieved by applying a 2D or 3D laser mark for easy identification and using various scanners to identify the item for proper placement within a surgical set. Laser marking does not use glues, adhesives or chemicals.

Once the surgical instrument is marked properly, it is very important to enter each data point into the respective tracking system, naming the instrument with consistent and accurate nomenclature.

 

Custom Laser 2D Barcode Etching and Data Entry Services include:

UDI Application

  • New instruments will be marked, scanned, and then entered into the tracking system.

Precision Laser Marking

Data Entry and Editing of Surgical Instruments

Data Entry/Editing

  • Existing instruments already marked will be reviewed for accurate description and unnecessary duplicates will be eliminated. Any marks not being picked up by the scanner will be removed and reapplied.

Count sheet revisions

  • as directed necessary count sheet changes will be made.

Count sheet revisions

Identify all missing instruments

Identify all missing instruments

  • needed to make the set complete, finding replacements, then scanning them and entering them into the system.

Quality Assurance

  • A number of surgical trays will be inspected per visit to verify cleanliness using a specialized lumen technology.

Quality Assurance

Process Improvemt

Process Improvement

  • An unbiased and daily report will be provided to the including pictures, findings, and recommendations for improvement as needed.

Weekend Service

  • will be provided at no extra charge and will be easier to target surgical specialties.

Weekend Medical & Surgical Instrument Repair Services

Training

Process Improvement

  • Anthem Surgical will train and create a job description for an in-house super user. (QCC)