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A Tool to Analyze Medical Device Problems: The Food and Drug Administration Device Problem Codes

McCullough, Charles E. MSEE; Reed, Terrie MSIE; Kaufman-Rivi, Diana MPH

Journal of Clinical Engineering: April/June 2012 - Volume 37 - Issue 2 - p 56–62
doi: 10.1097/JCE.0b013e31824c99f1
FEATURE ARTICLES
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Most, if not all, hospital clinical/biomedical engineering departments currently use Computerized Maintenance Management Software for maintenance of their equipment inventory, scheduling of preventive maintenance, and documentation of corrective and preventive maintenance activities. In addition, this software is often used for maintenance of replacement parts inventories and generation of management reports for budgetary and other purposes. The clinical engineer currently uses the maintenance history stored in the Computerized Maintenance Management Software to identify trends of equipment breakdown patterns and justify replacement of outdated or problematic equipment.

Most, if not all, hospital clinical/biomedical engineering departments currently use Computerized Maintenance Management Software for maintenance of their equipment inventory, scheduling of preventive maintenance, and documentation of corrective and preventive maintenance activities. In addition, this software is often used for maintenance of replacement parts inventories and generation of management reports for budgetary and other purposes. The clinical engineer currently uses the maintenance history stored in the Computerized Maintenance Management Software to identify trends of equipment breakdown patterns and justify replacement of outdated or problematic equipment.

From the Food and Drug Administration, Silver Spring, Maryland.

Corresponding author: Charles E. McCullough, MSEE, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (chuck.mccullough@fda.hhs.gov).

Charles E. McCullough, MSEE, is a biomedical engineer with the Food and Drug Administration (FDA) in Silver Spring, Maryland. The Medical Product Safety Network (MedSun) is an adverse event–reporting program launched in 2002 by the US FDA’s Center for Devices and Radiological Health (CDRH). The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices. For more information, visit www.fda.gov/cdrh/medsun. He can be reached at chuck.mccullough@fda.hhs.gov.

Terrie Reed, MSIE, is associate director, Informatics at the FDA, CDRH, Office of Surveillance and Biometrics (OSB). Ms Reed is the lead CDRH staff member on projects related to the incorporation of data exchange and vocabulary standards into FDA bioinformatics projects and is the business lead for overseeing the internal FDA implementation of the Unique Device Identification. She led the joint project between the National Cancer Institute and FDA CDRH focused on improving and simplifying the device and patient problem codes used to code medical device adverse event reports. In addition, she is the CDRH representative to FDA enterprise-wide initiatives including the FDA Data Standards Council and the FDA Vocabulary Work Group. Prior to working in government, she worked for 13 years at a healthcare facility in Indianapolis in various positions as a process engineer, quality analyst, and medical information specialist. She can be reached at terrie.reed@fda.hhs.gov.

Diana Kaufman-Rivi, MPH, is a public health analyst at the US FDA’s CDRH OSB. As part of the Division of Patient Safety Partnerships in OSB, Diana leads outreach efforts to address reported issues submitted by a select cohort of healthcare providers. Diana was an active member of the Event Problem Code work group and led the educational component of this effort. She can be reached at diana.rivi@fda.hhs.gov.

The authors declare no conflict of interest.

© 2012 Lippincott Williams & Wilkins, Inc.