CDRH Event Problem Codes |
|
| Type of Code | Definition | FDA Form 3500A location reference | eMDR Concept Code / Preferred Term |
|---|---|---|---|
| Patient | 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. *see Appendix 1 - Guidelines for selecting Patient Problem Codes. |
Block F10 | C54450/Patient_Problem Note: These refer to the Subset Code and Subset Name which has no FDA equivalent. |
| Device | 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. | Block F10 | C54451/Medical_Device_ Note: These refer to the Subset Code and Subset Name which has no FDA equivalent. |
| Component | 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. A Component Code cannot be submitted without a Device Problem Code. |
Block F10 | C54577/Medical_Device_Component Note: These refer to the Subset Code and Subset Name which has no FDA equivalent. |
The updated problem code system is based upon the CDRH Event Problem Codes that have been used to report adverse events to FDA for more than 10 years. FDA systematically reviewed and analyzed the existing codes and grouped them into meaningful categories. This analysis reduced the number of codes by eliminating ambiguous or duplicative terms.
The resulting coding system includes:
In this document, you will find three Appendices to assist you in the selection of the most appropriate Patient, Device and Component Codes for the reported event.
Appendix 1: Guidelines for Selecting Patient Problem Codes
Appendix 2: Checklist for selecting Patient, Device and Component Codes
Appendix 3: Coding Concepts Table
Note: Also available online at the CDRH Event Problem Codes website.
A set of Resource Files can be found at the CDRH Event Problem Code website at http://www.fda.gov/cdrh/problemcode.
These files will assist in downloading, viewing, selecting the appropriate CDRH Event Problem Codes:
The FDA resource files listed above will always contain the most up-to-date version of the CDRH Event Problem Codes. The following links to NCI vocabulary are provided for those who wish to explore more detailed information about the terms – e.g. synonyms, NCI code information, etc.
Note: While in the transition period between existing and improved coding systems, please expect significant differences between codes stored in the NCI databases and those referenced in FDA CDRH files.
See Appendix 3: Coding Concepts Table
2.1.1. Patient Problem Code
2.1.2. Device Problem Code
2.1.3. Component Code (Optional)
2.2.1. Patient Problem Code
2.2.2. Device Problem Code
2.2.3. Component Code (Optional)
2.3.1. Patient Problem Code
2.3.2. Device Problem Code
2.3.3. Component Code (Optional)
The instructions for entering each of the three CDRH Event Problem Codes are as follows:
1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describes what happened to the patient as a result of the event. The topmost level of the hierarchy will not be accepted as a valid code. See Patient Problem Code resource files to aid in patient problem code selection:
2. Enter the 4-digit FDA Code number in section F10 in the box labeled “Patient”. Select as many Patient Problem Codes as appropriate. The 3500A form allows entry of 3 codes in Section F10. Feel free to record additional codes on a separate sheet, mark it "F10", and provide the report number and page number, or by inserting additional codes in the H10. Block on the 3500A form.
1. Select the lowest-level (i.e. most detailed) code(s) from the Device Problem Code Hierarchy that most accurately describes the device failures or problems encountered during the event. Codes at the topmost level of the hierarchy will not be accepted. See Device Problem Code resource files to aid in device problem code selection:
2. Codes are not shown for higher level terms because FDA does not encourage reporting at the highest level of the hierarchy. Device Problem Codes must be selected from Level 2, Level 3, Level 4, Level 5 or Level 6 of the Device Problem Code Hierarchy. Codes from Level 1 of the Device Problem Code Hierarchy are not allowable codes for entry into the FDA 3500A form. These higher-level codes are provided to aid in understanding the context for coding the Device Event, but are too general to be useful for coding an adverse event.
3. Enter the 4-digit FDA Code number in section F10 in the box labeled “Device”. Select as many Device Problem and Component Codes as appropriate. The 3500A form allows entry of 3 codes in Section F10. Feel free to record additional codes on a separate sheet, mark it "F10", and provide the report number and page number. There are no requirements for indicating or tracking the level of the Hierarchy selected.
4. If a particular component can be associated with the Device Problem, enter the 3 or 4 digit FDA Component Code in the box labeled ‘device’. See section 2.1.3 below.
1. Select the lowest-level (i.e. most detailed) code(s) from the Component list that most accurately describes the component associated with the Device Problems encountered during the event. See Component Code resource files:
2. Component Codes are not required, but can be used to further describe a Device Problem selected in the Device Problem Code. NOTE: Do not submit a component Code without a Device Problem Code.
3. Enter the 3 or 4-digit FDA Code number in section F10 in the box labeled “Device”. Enter up to 3 codes from the Device Problem and Component Code Hierarchy. Select as many Device Problem and Component Codes as appropriate. The 3500A form allows entry of 3 codes in Section F10. Feel free to record additional codes on a separate sheet, mark it "F10", and provide the report number and page number.
When the codes are live (July 1, 2009) please use the following instructions for entering Submitting CDRH Component Codes is not offered at this time. Stay tuned for announcement in coming months.
The instructions for entering each of the three CDRH Event Problem Codes using the HL7 ICSR messaging format are as follows:
1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describe what happened to the patient as a result of the event. See Patient Problem Code resource files to view or download the Patient Problem Codes, Problem Code definitions, and files showing a mapping between current and enhanced codes.
2. Do not use the FDA codes for submitting the Problem Code electronically. Instead, use the associated 6-character alphanumeric C##### NCI Code.
3. Use HL7 ICSR messaging format to transmit the selected codes. Below is the original HL7 ICSR coding to represent selection of Patient Problem Code FDA 2132; C50802 – ventricular tachycardia:
- <subjectOf>
- <observation moodCode="EVN">
- <!-- Event Problem Codes\Patient Problem Codes, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- Value is populated with valid MAUDE Patient Problem Code such as Aneurysm -->
- <!-- use FDA OID for codeSystem in value -->
<observation>
<code code="C53983" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Patient_Problem_Code" />
<value xsi:type="CE" code="2132" codeSystem="2.16.840.1.113883.3.24" />
</observation>
</subjectOf>
The following shows the changes required to represent selection in the enhanced coding system. Specifically, the 4-digit FDA code 2132 for ventricular tachycardia will be replaced with the associated NCI code – C50802 and the codesystem name will change from FDA (2.16.840.1.113883.3.24) to NCI (2.16.840.1.113883.3.26.1.1)
- <subjectOf>
- <observation moodCode="EVN">
- <!-- Event Problem Codes\Patient Problem Codes, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- Value is populated with valid MAUDE Patient Problem Code such as Aneurysm -->
- <!-- use NCI OID for codeSystem in value -->
<observation>
<code code="C53983" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Patient_Problem_Code" />
<value xsi:type="CE" code=" C50802" codeSystem=" 2.16.840.1.113883.3.26.1.1 " />
</observation>
- </subjectOf>
4. Repeat the above segment of code for all selected codes. There is no upper limit to the number of CDRH Event Problem Codes that can be assigned.
1. Select the lowest-level (i.e. most detailed) code(s) from the Device Problem Code Hierarchy that most accurately describes the device failures or problems encountered during the event. See Problem Code resource files to view or download the Device Problem Code Hierarchy, Problem Code definitions, and files showing a mapping between current and enhanced codes.
2. Device Problem Codes must be selected from Level 2, Level 3, Level 4, Level 5 or Level 6 of the Device Problem Code Hierarchy. Do not use the FDA codes for submitting the Problem Code electronically. Instead, use the associated 6-character alphanumeric C##### NCI Code. Note: Problem Codes from Level 1 of the Device Problem Code Hierarchy are not allowed values. These higher-level codes are provided to aid in understanding the context for coding the Device Problem, but are too general to be used to code an adverse event. There are no requirements for indicating or tracking the level of the Hierarchy selected.
3. Use HL7 ICSR messaging format to transmit the selected codes. Below is the original HL7 ICSR coding to represent selection of Device Problem Codes FDA 1449; C63083 – Parameter calculation error due to software problem and FDA 1457; C62876 – paravalvular leak(s):
<subjectOf>
- <!-- Event Problem Codes\Device Code, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- use FDA OID for codeSystem in value -->
- <!-- Value populated with valid MAUDE Device Problem Code such as 1449 parameter calculation error due to software problem and 1457 paravalvular leak -->
<deviceObservation>
<code code="C53982" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Device_Problem_Code" />
<value xsi:type="CE" code="1457" codeSystem="2.16.840.1.113883.3.24" />
</deviceObservation>
</subjectOf>
The following shows the changes required to represent selection in the enhanced coding system. Specifically, the 4-digit FDA code 1457 for paravalvular leak will be replaced with the associated NCI code - C62876 - code and the codesystem name will change from FDA (2.16.840.1.113883.3.24) to NCI (2.16.840.1.113883.3.26.1.1)
<subjectOf>
- <!-- Event Problem Codes\Device Code, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- use NCI OID for codeSystem in value -->
- <!-- Value populated with the enhanced NCI Device Problem Code, C62876 -->
<deviceObservation>
<code code="C53982" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Device_Problem_Code" />
<value xsi:type="CE" code=" C62876" codeSystem=" 2.16.840.1.113883.3.26.1.1 " />
</deviceObservation>
</subjectOf>
4. Repeat the above segment of code for all selected codes. There is no upper limit to the number of CDRH Event Problem Codes that can be assigned.
5. If a particular component can be associated with the Device Problem, the reporter should assign the Device Problem to C54451 in the first segment, then assign the Component Code to C54577 in the second segment in order to associate the component with the preceding device. If more than one problem exists with a component, enter all Device Problems, then end with the component.
2. Component Codes are not required, but can be used to further describe a Device Problem. A Component Code cannot be submitted without a Device Problem Code. To see an example, please refer to CDRH Event Problem Code Case Studies in this document and online at the CDRH Event Problem Codes website.
Use the same XML HL7 ICSR segment as used for the Device Problem Code. Future releases of the HL7 ICSR will have a separate tag for component, but this is not currently available. See example for coding Electrical Lead – FDA 452; C50027.
<subjectOf>
<deviceObservation>
<code code="C53982" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Device_Problem_Code" />
<value xsi:type="CE" code="C50027" codeSystem="2.16.840.1.113883.3.26.1.1" />
</deviceObservation>
</subjectOf>
For Further details about the HL7 ICSR and for submitting all vocabulary items using HL7 ICSR, please refer to the CDRH Electronic Reporting website at http://www.fda.gov/cdrh/emdr.
When the codes are live (July 1, 2009) please use the following instructions for entering each of the three CDRH Event Problem Codes Submitting CDRH Component Codes is not offered at this time. Stay tuned for announcement in coming months.
The instructions for entering each of the three CDRH Event Problem Codes using ceSubmitter application: the HL7 ICSR messaging format are as follows:
Note: These instructions may change as additional details become available.
1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describes what happened to the patient as a result of the event. On the Patient Problem Code Filter Dialog screen, enter a term into the search field to pull all relevant codes. The system should return possible patient codes for selection. Select the most appropriate code. (Note: If you need further assistance in selecting a code, see Problem Code resource files to view or download the Patient Problem Codes, Problem Code definitions, and files showing a mapping between current and enhanced codes.)
If you are still unable to assign a Patient Problem Code, select code ‘No code available’ and enter a description of the problem in the associated text field.
2. If you wish to add more Patient Problem Codes, repeat step 1.
3. The system will store your code selection(s) and your information will be transmitted electronically via an HL7 ICSR message.
1. Select the lowest-level (i.e. most detailed) code(s) from the Device Problem Code Hierarchy that most accurately describes the device failures or problems encountered during the event.
2. On the Device Problem Code Filter Dialog screen, use the search or browse function to select the appropriate code. Enter a term into the search field to pull up all relevant codes,
3. Select ‘details’ for a desired code. The Details screen will list the parent and children of the selected code as well as definitions and synonyms. Use this information to determine code selection. If you are still unable to assign a Device Problem Code, select See Problem Code resource files to view or download the Device Problem Code Hierarchy, Problem Code definitions, and files showing a mapping between current and enhanced codes.
If you are still unable to assign a Device Problem Code, select code ‘No code available’ then enter a description of the problem in the associated text field.
4. Device Problem Codes must be selected from Level 2, Level 3, Level 4, Level 5 or Level 6 of the Device Problem Code Hierarchy. The ceSub application will not allow you to select Device Problem Codes from Level 1 of the Device Problem Code Hierarchy. These higher-level codes are provided to aid in understanding the context for coding the Device Problem, but are too general to be used to code an adverse event.
5. If you wish to add more Device Problem Codes, select ‘Add another code’ and repeat steps 1-4.
6. The system will store your code selection(s).
7. If a particular component can be associated with the Device Problem, see the Component coding instructions below.
Component Codes are not required, but can be used to further describe a Device Problem selected in the Device Problem Code. A Component Code cannot be submitted without a Device Problem Code.
1. Select the lowest-level (i.e. most detailed) code(s) from the Component list that most accurately describes the component associated with the Device Problems encountered during the event. On the Component screen, use the search or browse function to select the appropriate code. Enter a term into the search field, to pull up relevant codes. The system will return possible codes for selection. Select the most appropriate code. (Note: If you need further assistance in selecting a code, see Problem Code resource files to view or download the component codes, Problem Code definitions, and files showing a mapping between current and enhanced codes.)
2. If you wish to add more Component Codes, select ‘Add another code’ and repeat steps 1. There is no limit to the number of Component Codes that can be selected.
3. The system will store your code selection(s) and your information will be transmitted electronically via an HL7 ICSR message.
For Further details about the ceSubmitter application and for submitting adverse event reports using that electronic option, please refer to the CDRH Electronic Reporting website at http://www.fda.gov/cdrh/cesub/eMDR.html.
FDA CDRH strongly encourages the selection of an available code from the Patient and Device Problem Code sets. However, we are aware that there are unusual circumstances when a code cannot be selected. These codes are categorized under the parent, “Missing Value Reason” meaning there is no meaningful code that best captures the event. Please see below table for instructions:
| Code Description | NCI C–code Number | FDA Code Number | Use When… |
|---|---|---|---|
| Missing Value Reason | cannot code at this level | cannot code at this level | Do not use. Missing Value Reason is a parent term for all null flavor codes. |
| Not Applicable | C48660 | 3189 |
A code is not applicable for this field. There may not be an appropriate code to capture the adverse event. CDRH recommends completing a Code Request Form and submitting to CDRH to ensure that an appropriate code is available. For more details about a coding request, see Requesting a New Code. |
| No Information | C53269 | 3190 |
No information is available for this field. There is not enough information about the adverse event to assign a Patient and/or Device Problem. An example would be if no information was given about the patient outcome or there was no patient involved. |
| No Code Available | C64343 | 3191 |
Information is available to code the component, Device Problem, or Patient Problem, but an appropriate code does not exist. CDRH recommends completing a Code Request Form and submitting to CDRH to ensure that an appropriate code is available. For more details about a coding request, see Requesting a New Code. |
| No Known Device Problem | C76126 | Used when coding for Device Problems only: FDA 2993 | A device issue may be associated with the adverse event outcome; this association is not known at time of report submission. |
| No Known Impact or Consequence to Patient | C76143 | Used when coding for Patient Problems only: FDA 2692 | Patient impact or consequence in a reported event is not known at time of report submission, or there is no patient involvement in association with reported event. |
A Case Study is 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. Included below are some case examples to illustrate how one would determine the appropriate CDRH Event Problem Code in a given situation.
Coding Scenario
|
FDA Code Historically used |
Suggested FDA Code and NCI C-code |
Reason for Change |
|---|---|---|---|
Unable to find a code or codes that describe an adverse event. |
2203 - Other (for use when an appropriate device code cannot be identified) |
FDA 3191; C64343- No Code Available |
Other was overused and contributed to a lot of ‘noise’ in the adverse event reports. If ‘no code available’ is used, the expectation is that the reporter will fill out a change request to recommend a new problem code. |
Difficult to select a code and be confident that it had the appropriate meaning. Selected term that made sense to reporter based upon own interpretation of what code meant because the term was too general. |
1047 - Back-up, failure to |
FDA 1047; C63195 – Failure to back-up (Parent: Data Back-up problem) OR |
The term failure to back-up was not previously defined and was not grouped with other terms in a way that would assist the reporter in understanding the meaning of the term. Reporters used the term to describe failing to back-up software as well as failing to back-up a wheelchair. The new hierarchy provides parent terms (more general terms), child terms (more specific terms) and definitions to assist in code selection. |
Difficult to locate a unique device problem not associated with a component or difficult to find a combination of a device problem and component that describes the adverse event. |
1049 - Balloon Rupture Component Code: N/A |
FDA 1546; C62965 - Material Rupture And Component Code: FDA 419; C49837 - Balloon |
All combinations of Device/Component Codes were inactivated. Component Codes previously included in a Device Problem Code were separated from Device Problem Codes to allow a reporter to identify a device issue with a particular problematic device component, or accessory. For example, if you wish to report that a balloon ruptured, select the Device Problem Code Material Rupture FDA 1546; C62965 and the Component Code, Balloon FDA 419; C49837 to distinguish between the device component and reported issue. |
Use of the same word to describe a patient problem and a device problem. |
1212 - Entrapment (Device Problem) versus 2327 – Entrapment |
FDA 1212; C63210 - Entrapment of Device or Device Component versus FDA 2327; C50548 - Physical Entrapment |
There is often confusion about what is a patient problem and what is a device problem. In this case, entrapment of device as a Device Problem Code indicates that a device and/or device accessory is caught in a patient. Physical Entrapment as a Patient Problem Code indicates that a patient is entrapped by a device, i.e. bed rail. Definitions have been added to clarify such confusing terms. |
There is a mixing of device problem codes with evaluation codes. |
1530 - Replace |
Term Inactivated |
This term was inactivated because it fails to demonstrate the device issue which occurred. The term Replace indicates an Evaluation Result. The Evaluation Codes are being evaluated to include such codes. Note that there are still some evaluation conclusion codes that remain in the device problem codes. These have been retained to allow User Facilities to report evaluation results to FDA because there is no other code where this can be reported. Evaluation codes from manufacturers are still considered to be the final evaluation of a device issue. |
Codes with similar descriptions may now be under different parts of the hierarchy. Be sure to look throughout the hierarchy to pick the appropriate code. |
1668 - Unwrap, difficult to versus 1669 - Unwrap, failure to |
1668 was inactivated Preferred Term: FDA 2940; C63154 - Failure to Unwrap (Parent - Difficult to Open or Remove Packaging Material) FDA 1669; C62949 - Failure to Unfold or Unwrap (Parent – Material deformation) |
Again, the hierarchy provides context for which term to select. These two similar codes are displayed in hierarchy under two different parent terms in order to capture whether the event was a packaging issue (FDA 2940; C63154) OR a device property issue inherent to the device (FDA 1669; C62949) versus. Failure to unwrap as a packaging issue would be an issue with the packaging/shipping process. Whereas if a device is supposed to unfold or unwrap after it is applied and it fails to do so, that would be considered material deformation. |
The process to request a new code follows:
Step 1: Contact the Change Control Board (CCB) to obtain a code request form:
Phone: 240-276-3464.
Fax: 240-276-3454
Email: cdrh.eventcode@fda.hhs.gov
Step 2: The CDRH Event Problem Code CCB will review new requests and establish priorities based on documented rationale for the new code. Routine requests will be reviewed, on average, once a month.
Step 3: The CDRH Event Problem Code CCB will provide documentation and justification when a proposed code is authorized or vetoed. CCB will notify the requestor whether a proposed code is authorized or vetoed or if there are any questions about the request. Therefore, it is very important to include contact information in your request.
Step 4: If authorized, the new code will be added to both the NCI Thesaurus and to the appropriate code hierarchy in MAUDE
Step 5: All stakeholders will be alerted to the existence of new codes via a subscription to the FDA CDRH Event Problem Code website.
For more detailed information about the initiative and the CDRH Event Problem Codes, see ‘Guidance for Industry: Addendum to the Instruction Manual for completing the 3500A Form: Event Problem Code Changes’
The purpose of coding patient problems for Medical Device Reporting (MDR) is to facilitate the surveillance of medical device safety data by consistent and accurate coding. Assigning a code number to event problem code terms provides a short hand description of the patient event that is used for data analysis. In order to enhance coding consistency and accuracy device user facilities and manufacturers are encouraged to maintain internal documentation of code selection procedures and inclusion criteria for each code selected.
At least one patient problem code should be selected for every adverse event reported.
If an exact code can not be matched to the adverse event, select the best code possible. However, if an appropriate code can not be found in the existing coding manual, submit a New Code Request Form.
indicate the effects that an event may have had on the patient, including signs, symptoms, syndromes, or diagnosis. For example, a patient developed “erythema and breathing difficulties“ after a catheter was inserted.
- If “possible anaphylactic or anaphylactoid reaction” is also reported, it is sufficient to select only the code “# FDA1703; C50460 – Shock, anaphylaxis”.
- If “anaphylaxis reaction” is not reported, it is appropriate to select the codes “# FDA1840; C26901 – Erythema” and “# FDA1816; C2998 – Dyspnea”.
Event Outcome and Treatment Modality
All codes associated with additional procedures and surgeries have been inactivated because they are not directly associated with the device in use. In addition, we encourage reporters to specify patient outcomes in Section B2 of the 3500A form. Do NOT select the following Event Outcome and Treatment Modality as Patient Problem Codes, UNLESS it is the ONLY information reported.
Patient Problem Code
|
FDA and C-Code # |
Reason not to be selected for F10 |
Example |
Where the data should be captured |
|---|---|---|---|---|
Death |
FDA 1802 C28554 |
“Death” is less descriptive. Select the code only when no other information is available. |
If “death due to a ruptured aneurysm” is reported, select the codes “Aneurysm” and “Rupture”, instead of “Death”. |
“Death” can be captured in Sections B2 (Event Outcomes) and/or H1 (Type of Reportable Event) of the MedWatch report. |
| Disability | FDA 2371
C21007 |
“Disability” is less descriptive. Select the code only when no other information is available. | If “disability due to an amputation 2ndary to occlusion of prosthetic vascular graft” is reported, “Occlusion” and “Amputation” should be selected. | “Disability” can be captured in Sections B2 (Event Outcomes) of the MedWatch report. |
Pre-existing Medical Conditions/History
Do NOT select pre-existing medical conditions/history as Patient Problem Codes, UNLESS the pre-existing condition is worse during/after the use of the device.
For example, a patient has a history of vein thrombosis in legs. A vena cava filter was implanted for preventing the thrombus migrated to pulmonary artery. Do NOT select “thrombosis” as Patient Problem Codes, UNLESS the symptom of thrombosis in legs is worsening, or the thrombus has migrated to the pulmonary artery after the device (filter) is implanted.
Use checklist as a tool to assist you through Event Problem Code selection.
[ ] Determine method for Medical Device Report Submission
Paper Version of 3500A
Electronic Submission using HL7 ICSR
ceSubmitter
In addition to Device Problems encountered during the reportable event, are there:
[ ] Adverse patient outcomes?
[ ] Device components affected by the device issue?
[ ] See Coding Tools/Resource files for selecting applicable Patient, Device and Component Codes.
[ ] Did you find appropriate code(s) for each identified:
[ ] Patient Problem?
[ ] Device Problem?
[ ] Did you find appropriate code(s) for each identified device component(s)?
[ ] Did you select all codes necessary to describe all:
[ ] Patient Problems
[ ] Device Problems
that occurred during the event?
[ ] Did you select all device components affected by the device issue?
[ ] Did you submit the adverse event report with F10 fields complete?
Note: CDRH would like to limit the use of "No Information" codes. If you do not think there is an appropriate Patient, Device or Component Code, please request a New Code Request form at the CDRH Event Problem Codes website.
The table below defines commonly used concepts
Concept |
Definition
|
|---|---|
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. Component Codes should always be associated with a Device Problem Code. 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: ####. 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 |
An original code that will no longer be available for coding adverse events because it:
An example of an inactive and, therefore, merged term due to duplicate meaning:
An example of a merged term due to it being a combination of a Device Problem and a Component:
|
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 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, patient problem, or affected component. 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 the Device and Patient Problem Code Disposition Documents located on the CDRH Event Problem Codes website. |
Updated April 2, 2009
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