title: FDA adverse Event Problem Codes: standardizing the classification of device and patient problems associated with medical device use.
abstract: The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community.
  
  
  METHODS
  In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed.
  
  
  CONCLUSIONS
  Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.
authors: FDA's Center for Devices and Radiological Health, Office of Surveillance and Biometrics, USA. terrie.reed@fda.hhs.gov
authors: Terrie L
authors: TL
authors: Reed
authors: Diana
authors: D
authors: Kaufman-Rivi
mesh_terms: D003625:Data Collection / Q000379:methods / Q000592:standards*; D003628:Database Management Systems / Q000592:standards*; D004282:Documentation / Q000379:methods / Q000592:standards*; D004869:Equipment Safety / Q000379:methods* / Q000592:standards; D005568:Forms and Records Control / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration