Implementing QR Code Technology in Medical Device Pacakage

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