Implantable device list

Implantable Device List Implementation Cases – Meaningful Use Stage 3

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Implantable Device List

In this post we will explain the implementation cases of MU3 criteria – Implantable Device List. Detail cases are as follows

Assumption = We will enter the UDI (Universal Device Identifier) information against some specific visit for the patient.

1)      System will allow the user to Add, Update, Delete and Search functionality on the UDI list of specific patient.

2)      Add Scenario

a)      User will input UDI in the text field on the UDI entry screen.
b)      System will parse the input UDI in the following fields.
·         Device Identifier
·         Batch/Lot Number
·         Expiration Date
·         Production Date
·         Serial Number
·         Retrieved Information from Global Unique Device Identification Database.
·         Status [Active/In Active]
 
c)       User will Click save button to persist the input values in the database.
d)      System will redirect the user back to the UDI list screen.

 

3)      Update Scenario

        a)       User will search and select the UDI from the patient’s associated UDI list.
b)      System will display the following information to the user on the screen in the edit mode.
·   Device Identifier
·   Batch/Lot Number
·   Expiration Date
·   Production Date
·   Serial Number
·   Retrieved Information from Global Unique Device Identification Database.
·   Status [Active/In Active]
 
c)       User will make the changes in the above data fields as per need and then Click update button to persist the new input                 values in the database.
d)      System will redirect the user back to the UDI list screen.
 

4)      Delete Scenario

a)       User will search and select the UDI from the patient’s associated UDI list.
b)      System will display the following information to the user on the screen in the read only mode.
·   Device Identifier
·   Batch/Lot Number
·   Expiration Date
·   Production Date
·   Serial Number
·   Retrieved Information from Global Unique Device Identification Database.
·   Status [Active/In Active]
 
c)       User will Click delete button 
d)      System will display the message to the user “Are you sure you want to delete the associated UDI from the selected                Patient [Y/N]”
e)      If user select “YES” then
f)       System will delete the associated UDI from the patient records and will redirect the user back to the UDI list                        screen.
g)       If user select “NO” then
h)      System will simply redirect the user back to the UDI list screen.
 

5)      Search Scenario

a)       User will be able to search on the following data fields on the UDI list page.
·   Device Identifier
·   Batch/Lot Number
·   Expiration Date
·   Production Date
·   Serial Number
·   Retrieved Information from Global Unique Device Identification Database.
·   Status [Active/In Active]
 
b)      User can search on the basis of single data field or the combination of data fields mentioned above.
c)       System will display the records in the UDI list.
 

6) Get Attribute from Global unique Device Identification Database      

System will allow the user to Retrieve the “Device Description” attribute associated with a Unique Device Identifier in the Global Unique Device Identification Database via “Get Device Attributes”button on the UDI entry screen mentioned in Step 2 (a) above.
7)      User will click “Get Device Attributes” button.
8)      System will make a call to some web interface or web services or downloadable module to retrieve the following information.
          Web Interface Access would be available after signup on the following URL.
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416117.htm
a)       Description of the implantable device referenced by at least one of the following:
§  “GMDN PT Name” attribute associated with the Device Identifier in the Global Unique Device Identification Database
OR
§  “SNOMED CT® Description” (mapped to the “GMDN PT Name” attribute)
b.      The following Global Unique Device Identification Database entries:
§ Brand Name
§ Version or Model
§ Company Name
§ What MRI safety information does the labelling contain; and
§ Device required to be labelled as containing natural rubber latex and dry natural rubber (21 CFR 801.437)
 
9)      System will allow the user to enter UDI against the specific patient.
 
10)   User can associate 1 or many UDI with the specific patient.
11) All the Implantable Device List data is mandatory for CCDA document.
We tried to cover all cases basic scenario for the implementation of 170.315(a)(14): Implantable Device List MU3 measure. In future posts we will try to cover other MU criteria as well. For details about meaningful use certification check our website.
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