Packaging Provides Initial Dataset Necessary for Patient Confidentiality

Wed, 08/28/2013 - 3:49pm
Tom Egan, Vice President, Industry Services, PMMI

Making sure patient information is secure begins with coding on the package. No matter to whom the medical device is targeted—for a specific patient, hospital, or doctor—the coding placed on the package is the first part of the data set used to track the device. As such, device manufacturers want to ensure the accuracy of the data collected on the packaging line, and then upload the information to their internal secure databases.

Coding and tracking systems used by medical device manufacturers in their packaging operations provide the initial production data that becomes part of the patient confidentiality record. The packaging operations serve this role by:

  • Providing the means to accurately code data onto the package, such as a serial number, lot code, date of manufacture, or contents
  • Verifying with an inspection system that the code and package are accurate and complete
  • Ensuring that complete package information is transmitted to the secure database of the manufacturer

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