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U.S. Department of Health and Human Services

Medical Devices

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Implementation Specifications

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DATES TO NOTE

  • FDA has begun accepting the new codes, but will continue to accept the inactivated codes available in the current Code listing. Note: there are 25 component codes that have updated code numbers. See Table 2 for the changes.
  • April 2, 2010 - Target date to reject all inactivated and retired codes specified in this update. At this time, no old codes or code numbers will be accepted.

Table Of Contents

Overview

Summary of Enhanced System

Selecting a CDRH Event Problem Code: Resource Files for Coding Reports

Resource Files
Definition of Concepts

How to Select and Submit a Device Event Code

Paper Version of 3500A Form
Electronic submission using HL7 ICSR
eSubmitter
When a Code Cannot Be Selected

Case Studies

Change Control Process

Appendices

Appendix 1. Guidelines for Selecting Patient Problem Codes
Appendix 2. Checklist for selecting Patient, Device and Component Codes
Appendix 3. Coding Concepts Table

 Overview

The Food and Drug Administration Center for Devices and Radiological Health (FDA CDRH), in cooperation with the National Cancer Institute Enterprise Vocabulary Service (NCI-EVS) completed an adverse event vocabulary effort that updated CDRH Event Problem Codes (Device and Patient Problems , reference Block F10 of FDA Form 3500A). FDA CDRH in collaboration with the NCI-EVS reviewed each of the types of event codes, modified their use and organized the codes in a structured fashion. Three different types of codes, Patient Problem Codes, Device Problem Codes and Component Codes were affected. The following table (Table 1) summarizes the three types of CDRH Event Problem Codes, definitions and reporting references:

Table 1: Summary of the three types of CDRH Event Problem Codes, definitions, and reporting references.

Type of Code   Definition FDA Form 3500A location referenceeMDR 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
_Codes_FDA_CDRH

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_
Problem_Codes_FDA_CDRH

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
_Or_Accessory_Terminology_CDRH

Note: These refer to the Subset Code and Subset Name which has no FDA equivalent.

 Summary of Enhanced System

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:

  • Parent-Child relationships to establish coding context
  • Definitions based upon accepted industry standards and accepted public health usage
  • Mapping to other terminologies
  • A Change Control Process for adding new or modifying existing codes

Appendices

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.

 1. Selecting a CDRH Event Problem Code: Resource Files for Coding Reports

 1.1 Resource Files

A set of Resource Files can be found at the CDRH Event Problem Code website.

These files will assist in downloading, viewing, selecting the appropriate CDRH Event Problem Codes:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Code Hierarchy Viewing files
  • Patient Problem Code Disposition File – An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term". The file also indicates which terms were inactivated or newly created as part of this project.
  • Device Problem Code Disposition File – An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

Supplemental Sources

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.

  • FDA Data Council – Shows all FDA Data Standards Resources including FDA Terminology hosted by NCI Enterprise Vocabulary Services. This includes the CDRH Event Problem Codes.
     
  • NCI Thesaurus - Scroll down the webpage and click on CONNECT button to enter the thesaurus. Enter 'FDA Center for Devices and Radiological Health Terminology' in the initial search box to see all CDRH Event Problem Codes. You may also enter an individual code.
     
  • NCI Metathesaurus – To see all CDRH Event Problem Codes, enter ‘FDA Center for Devices and Radiological Health Terminology’ in the initial Search box to see all CDRH codes. You may also enter a known code description. The Metathesaurus is similar to the NCI Thesaurus except it also shows a mapping of the particular term to other terminologies including MedDRA, ICD-9 etc. Mappings to other terminologies are located in the ‘Sources section’ that appears as part of the coding entry. Also included on the page are: Synonyms, Definitions, Concepts more general, Concepts more specific and Concepts related to the selected term. Note that the Metathesaurus contains many terminologies so it may be more difficult to use than the NCI Thesaurus.

 1.2 Definition of Concepts

See Appendix 3: Coding Concepts Table

 2. How to Select and Submit a Device Event Code

 

2.1 Paper Version of 3500A Form

2.1.1. Patient Problem Code
2.1.2. Device Problem Code
2.1.3. Component Code (Optional)

2.2 Electronic submission using HL7 ICSR

2.2.1. Patient Problem Code
2.2.2. Device Problem Code
2.2.3. Component Code (Optional)

2.3 ESubmitter

2.3.1. Patient Problem Code
2.3.2. Device Problem Code
2.3.3. Component Code (Optional)

2.4 When a Code Cannot Be Selected

 

  2.1. Paper version of 3500A Form

 

The instructions for entering each of the three CDRH Event Problem Codes are as follows:

Note: Only use FDA codes for paper submissions

2.1.1. Patient Problem Code

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:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Patient Problem Code Disposition File – An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term". The file also indicates which terms were inactivated or newly created as part of this project.
  • Patient Problem Code Hierarchy – organizes the patient problem codes as a hierarchical listing

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.

2.1.2. Device Problem Code

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:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Device Problem Code Disposition File – An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Device Problem Code Hierarchy – organizes the device problem codes as a hierarchical listing

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.

In order for Field F10 to be complete, you must select at least one patient problem code and one device problem code.

For malfunction reports only:
Use FDA code 2199: no consequences or impact to patient to describe reportable malfunctions involving a patient who sustained no adverse outcomes.
Use FDA code 2645: no patient involvement to describe reportable malfunctions not involving a patient.

2.1.3. Component Code (Optional)

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:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Component Code Hierarchy – organizes the component codes as a hierarchical listing
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

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.

Please note: there are 25 component codes that have updated code numbers. See below (Table 2) for the new FDA Code assigned to these 25 component code terms.

Table 2: Summary of the 25 Component Codes with NEW FDA Code assignments.

 Component Term  C-code  Old FDA Code NEW
FDA CODE
KNIFEC540211029 3156
PusherC540231031 3157
SWITCH, PUSH BUTTONC540131024 3154
ThermometerC500591001 3158
ThermostatC502211002 3159
ThyristorC502221003 3135
TimerC502231004 3136
TrackballC502241005 3137
TransceiverC502251006 3138
TranslatorC502291007 3139
Transmission lineC502301008 3140
TransmitterC502311009 3141
TransponderC502321010 3142
TransportC502331011 3143
TRIACC502341012 3144
TrimmerC502351013 3145
TunerC502401014 3146
VALVE CAMC540161025 3155
VaristorC502631015 3147
VibratorC502651016 3148
ViewerC502661017 3149
WasherC502671019 3150
WaveguideC499761020 3151
WindowC502681021 3152
YokeC502731022 3153

  2.2 Electronic submission using HL7 ICSR

When the codes are live please use the following instructions for entering each of the three CDRH Event Problem Codes using the HL7 ICSR messaging format:

2.2.1. Patient Problem Code

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.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Patient Problem Code Disposition File – An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term". The file also indicates which terms were inactivated or newly created as part of this project.
  • Patient Problem Code Hierarchy – organizes the patient problem codes as a hierarchical listing

2. Until further notice, electronic submitters may choose to submit Event Problem Codes using either the FDA or C-codes. Eventually the C-codes will replace the current FDA-assigned code to facilitate Event Problem Code adoption as device problem terminology by a variety of organizations.

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.

2.2.2. Device Problem Code

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.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Device Problem Code Disposition File – An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Device Problem Code Hierarchy – organizes the device problem codes as a hierarchical listing

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. Until further notice, electronic submitters may choose to submit Event Problem Codes using either the FDA or C-codes. Eventually the C-codes will replace the current FDA-assigned code to facilitate Event Problem Code adoption as device problem terminology by a variety of organizations. 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.

In order for Field F10 to be complete, you must select at least one patient problem code and one device problem code.

For malfunction reports only:
Use C-Code C50675; FDA code 2199: no consequences or impact to patient to describe reportable malfunctions involving a patient who sustained no adverse outcomes.
Use C-Code C50912; FDA code 2645: no patient involvement to describe reportable malfunctions not involving a patient.

2.2.3. Component Code (Optional)

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 Problem encountered during the event. See Problem Code resource files to view or download the Component list.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications..
  • Component Code Hierarchy – organizes the component codes as a hierarchical listing
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

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.

  2.3. ESubmitter

When the codes are live please use the following instructions for entering each of the three CDRH Event Problem Codes using eSubmitter application:
Note: These instructions may change as additional details become available.

2.3.1. Patient Problem Code

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.)

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Patient Problem Code Disposition File – An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term". The file also indicates which terms were inactivated or newly created as part of this project.
  • Patient Problem Code Hierarchy – organizes the patient problem codes as a hierarchical listing

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.

2.3.2. Device Problem Code

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.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Device Problem Code Disposition File – An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Device Problem Code Hierarchy – organizes the device problem codes as a hierarchical listing

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 eSubmitter 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.

In order for Field F10 to be complete, you must select at least one patient problem code and one device problem code.

For malfunction reports only:
Use C-Code C50675; FDA code 2199: no consequences or impact to patient to describe reportable malfunctions involving a patient who sustained no adverse outcomes.
Use C-Code C50912; FDA code 2645: no patient involvement to describe reportable malfunctions not involving a patient.

2.3.3. Component Code (Optional)

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.)

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Component Code Hierarchy – organizes the component codes as a hierarchical listing
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated 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 eSubmitter application and for submitting adverse event reports using that electronic option, please refer to the CDRH Electronic Reporting website.

  2.4. When a Code cannot be selected

FDA CDRH strongly encourages the selection of an available code from the Patient Problem, Device Problem, and Component Code sets. However, some codes found in the CDRH term sets are considered too high a level to be used to describe events. More descriptive codes within those high levels are available and should be used instead. Those high level codes that cannot be used to describe an event and are listed below.

Table 3: Summary of Non-Selectable Codes

Code DescriptionNCI C–code NumberFDA Code NumberCode Type
Missing Value ReasonC486553192Patient and Device Problem Code
Patient Problem/Medical ProblemC540272688Patient Problem Code
Device operational issueC629542914Device Problem Code
Physical property issueC629373008Device Problem Code
Facilities issueC628082935Device Problem Code
Human factors issueC631182948Device Problem Code
Device Component or AccessoryC497553049Component Code

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 (Table 4) for instructions.

Table 4: Summary of 'Null Flavor' Codes

Code Description NCI C–code Number FDA Code Number Use When…
Missing Value Reasoncannot code at this levelcannot code at this levelDo not use. Missing Value Reason is a parent term for all null flavor codes.
Not Applicable C486603189A 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 C532693190No 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 AvailableC643433191Information 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 ProblemC76126Used when coding for Device Problems only: FDA 2993A 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 PatientC76143Used when coding for Patient Problems only: FDA 2692Patient 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.

 3. Case Studies

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.

Table 5: Summary of common coding scenarios

Coding Scenario

 

FDA Code Historically usedSuggested FDA Code and NCI C-codeReason 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 AvailableOther 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 toFDA 1047; C63195 – Failure to back-up (Parent: Data Back-up problem) OR
FDA 2983; C63039 – Mechanical Jam (Parent: Mechanical Issue)
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
(Patient Problem)

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 - ReplaceTerm InactivatedThis 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.

  4. Change Control Process

The process to request a new code follows:

Step 1: Contact the Change Control Board (CCB) to obtain a code request form:

Phone: 301-796-6670
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’

  Appendix 1. Guidelines for Selecting Patient Problem Codes

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.

General Principles

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.

Specific Principles

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 F10ExampleWhere 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.

 Appendix 2. Checklist for selecting Patient, Device and Component Codes

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
[ ] eSubmitter

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.

 Appendix 3. Coding Concepts Table

The table below defines commonly used concepts

Concept

Definition

 

Case StudyAn 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. There are 25 component codes that have updated code numbers. See Table 2 above.

Device Problem CodeDevice 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 CodeRefers to any of the three types of codes (Component, Device Problem, or Patient Problem) that are used to describe a reported event.
FDA CodeRefers 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.
HierarchyA 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:

  • Has not been used by reporters more than 5 times in the past 3 years
  • Is an ambiguous term and is not able to be clarified
  • Is not considered a device, patient or Component Code based upon the definition of these codes.
  • Has similar/duplicative meaning to a preferred term
  • Is a combination of a problem 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.
MergedSee 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 MetathesaurusThe 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://ncit.nci.nih.gov/ncitbrowser

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/childThe 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 termCDRH 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.
SynonymAn 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.