Case Study

An illustrated example used to work though particular scenarios and assist the reporter in understanding and achieving specific determinations. Certain device malfunction situations may be difficult to describe. We have tried to provide some cases to illustrate how one would determine the appropriate device code in a given situation.

Component Code

Component codes indicate what specific component or assembly of the device was associated with the event. This code is optional and should only be used to further describe a particular Device Problem Code. For example, select wheel + crack to describe a crack in a wheel of a device.

Note: Device Component Codes are a subset of the Device Problem Codes. They have been created as part of the CDRH Event Problem Code improvements. Do not submit a Component Code without an associated Device Problem Code.

Device Problem Code

Device problem codes describe device failures or issues related to the device that are encountered during the event. Each report should include at least one Device Problem Code, but there is no maximum limit to the number of Device Problem Codes that can be reported.

Event Problem Code

Refers to any of the three types of codes (Component, Device Problem, or Patient Problem) that are used to describe a reported event.

FDA Code

Refers to the 4-digit code number assigned by FDA for each Component, Device Problem and Patient Problem Code for data entry purposes. Format: ####. FDA codes are distinguished on our educational references in the following format: FDA ####. Under electronic reporting, the concept code will eventually replace the current FDA-assigned code and assist in the event codes being adopted as device problem terminology by a variety of organizations. Until further notice, both FDA and C-codes will be accepted as valid codes.

Hierarchy

A diagram or flowchart that shows how various terms are related, The Device Problem Code Hierarchy is characterized by a downward direction arranged according to device specificity – from to device-general to device-specific. The Device Problem Code Hierarchy is organized into parent/child relationships which provides for an intuitive way to understand the enhanced codes.

Inactive

This is a code that will be available for conducting searches on historical data but will no longer be available for assignment as a new problem code. During the analysis of the original codes, there were several criteria used for inactivating a code:

• not used more than five times in the past 3 years
• ambiguous and not able to be clarified
• not considered a device, patient, or component code
• similar/duplicative meaning to a preferred term
• combination of a problem term and a component or device name

An example of an inactive and, therefore, merged term due to duplicate meaning:

• The terms ‘blockage’ and ‘occlusion’ both existed in the original coding system and both have similar conceptual meaning. There were far more reports that were coded with ‘occlusion’ than with ‘blockage.’ Therefore, the Device Problem Code, ‘occlusion’ was selected as the preferred term for this concept. ‘Blockage’ will no longer be accepted as a valid term.

An example of a merged term due to it being a combination of a Device Problem and a Component:

• ’Balloon burst’. This code consists of a component (balloon) and the problem identified with the component (burst). FDA CDRH recommends reporting this as two codes in order to fully clarify the component and problem. Therefore, the codes ‘balloon’ AND ’burst’ should be used to describe the event. ‘Balloon burst’ will no longer be accepted as a valid code.

Merged

See Inactive - above

NCI Concept Code (C Code)

An alphanumeric with the format C##### that uniquely identifies each term in the NCI Thesaurus. Each Patient, Device, and Component term is also assigned an NCI concept code. Under electronic reporting, the concept code will eventually replace the current FDA-assigned code and assist in the event codes being adopted as device problem terminology by a variety of organizations. Until further notice, both FDA and C-codes will be accepted as valid codes

NCI Metathesaurus

The secondary source for the Patient, Device, and Component Codes – see http://ncimeta.nci.nih.gov/ . A comprehensive biomedical terminology database that contains 1,200,000 concepts mapped to 2,900,000 terms with 5,000,000 relationships. NCI Metathesaurus currently contains most public domain vocabularies from the National Library of Medicine's UMLS Metathesaurus , as well as a growing number of other cancer-related vocabularies.

NCI Thesaurus

The Patient, Device, and Component Codes can be found in the NCI Thesaurus - see http://nciterms.nci.nih.gov/NCIBrowser/Dictionary.do

It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities. The NCI Thesaurus provides definitions, synonyms, and other information on nearly 10,000 cancers and related diseases, 8,000 single agents and combination therapies, and a wide range of other topics related to cancer and biomedical research. It is maintained by a multidisciplinary team of editors, who add about 900 new entries each month. Note: the NCI Thesaurus will lag the FDA resource files for the most up-to-date version of the codes by at least one month after CDRH Event Problem Code enhancements or changes are introduced.

Parent/child

The type of hierarchical structure that was utilized for revamping the device problem terms. The hierarchical tree structure is determined by the parent/child relationship that exists among all device problem terms. A child can have only a single parent, but a parent may have many children. The Patient and Component Codes have only one or two levels of parent/child relationships. The Device Problem Code Hierarchy has 4 parent, or top-level headings, with many children, or lower-level headings stemming from these top levels. The hierarchy extends 5 levels below the top levels, totaling 6 levels in all.

Patient Problem Code

Patient problem codes indicate the effects that an event may have had on the patient, including signs, symptoms, syndromes, or diagnosis. Each report should include at least one Patient Problem Code, but there is no maximum limit to the number of Patient Problem Codes that can be reported.

Patient problem codes have some level of hierarchy, but overall they remain in a list format that has been integrated into the extensive NCI hierarchy in the NCI Thesaurus (see http://www.nci.nih.gov/cancerinfo/terminologyresources). Inclusion in the NCI Thesaurus and NCI Metathesaurus enables users to map to recognized patient controlled vocabularies (e.g. SNOMED CT (Systematized Nomenclature of Medicine--Clinical Terms) a comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and MedDRA, Medical Dictionary for Regulatory Activities a clinically validated international medical terminology )

Preferred term

CDRH considers the preferred term (PT) to be the item that most represents the concept describing a particular device problem, component, or patient problem. During the review of all existing codes, those that were not preferred fell into two major categories: synonym and inactive.

Synonym

An original problem code where the term description was modified to create a more clear preferred term description. The code number for the preferred term and the synonym will always be the same. See our Coding Tools / Resource Files page.