Constructing a Database That Can Input Record of Use and Product-specific Information

• Published in: Japanese Journal of Radiological Technology Vol. 68; no. 7; pp. 857 - 864
• Main Authors: Kawai, Satoru, Satoh, Kenichi, Yamamoto, Hideo
• Format: Journal Article
• Language: Japanese
• Published: Japan Japanese Society of Radiological Technology 2012
• Subjects: Adverse Drug Reaction Reporting Systems; Angiography; Data Collection - methods; Data Collection - trends; Database Management Systems - trends; Databases, Pharmaceutical; Electronic Data Processing - methods; Electronic Data Processing - trends; Equipment and Supplies - adverse effects; GS1-128; Humans; Japan; medical accident; Medical Errors - prevention & control; Medical Information System Development Center (MEDIS-DC); Pharmaceuticals and Medical Devices Agency (PMDA); Radiology Information Systems; the side effect of pharmaceutical products
• ISSN: 0369-4305; 1881-4883
• DOI: 10.6009/jjrt.2012_JSRT_68.7.857

In Japan, patients were infected by viral hepatitis C generally by administering a specific fibrinogen injection. However, it has been difficult to identify patients who were infected as result of the injections due to the lack of medical records. It is still not a common practice by a number of medical facilities to maintain detailed information because manual record keeping is extremely time consuming and subject to human error. Due to these reasons, the regulator required Medical device manufacturers and pharmaceutical companies to attach a bar code called "GS1-128" effective March 28, 2008. Based on this new process, we have come up with the idea of constructing a new database whose records can be entered by bar code scanning to ensure data integrity. Upon examining the efficacy of this new data collection process from the perspective of time efficiency and of course data accuracy, "GS1-128" proved that it significantly reduces time and record keeping mistakes. Patients not only became easily identifiable by a lot number and a serial number when immediate care was required, but "GS1-128" enhanced the ability to pinpoint manufacturing errors in the event any trouble or side effects are reported. This data can be shared with and utilized by the entire medical industry and will help perfect the products and enhance record keeping. I believe this new process is extremely important.