Abstract

The medical device industry strives to improve the delivery of key device information

through the package to patients, doctors and end users. To achieve this goal Indications For Use (IFU) and user manuals have been major tools and are necessary components required in Medical Device Package according to Food and Drug Administration (FDA) standards.

Historically there have been challenges caused by packaging information materials aspects

such as manufacturing, transportation and translation. The need for extensive packaging and labelling has ultimately contributed to increased cost of manufacturing for devices. It is also important to know what information a customer needs and recognize that the safety of the consumer is of the utmost importance. The development and implementation of new

technologies and procedures in a medical device industry may be complicated and slow but it is a necessity to improve safety and provide maximum comfort to the end user. Barcodes and Two Dimensional code have been used in the medical device industry for tracking purposes; however, the focus of this thesis was using QR codes (two-Dimensional barcode) in medical device package without IFU, user guides and manuals to enhance patient safety, reduce cost and enhance the breadth of information available to the ultimate users. Access to the information was achieved by just taking a picture or scanning the QR code which was printed on a medical device package. This thesis also assesses the feasibility of implementing the QR code technology on medical device package and a case study is conducted that elaborates on the cost analysis.

Library of Congress Subject Headings

Medical instruments and apparatus--Packaging; QR codes

Publication Date

2009

Document Type

Thesis

Student Type

Graduate

Degree Name

Packaging Science(MS)

Department, Program, or Center

Packaging Science (CAST)

Advisor

Changfeng Ge

Advisor/Committee Member

Raymond Lareau

Advisor/Committee Member

Daniel Goodwin

Comments

Physical copy available from RIT's Wallace Library at R857.P33 N34 2009

Campus

RIT – Main Campus

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