mdi ConsultantsUnique Device Identification – Request for Use Cases
FDA recently had questions concerning how the UDI will affect the device industry. UDI has been put in place in the pharmaceutical industry because of a major problem with drug counterfeiting. The UDI allows for the tracking of a drug batch from the place of manufacture through the shipping – distributor and right to the store. Is UDI necessary for the device industry? There have been some cases of device counterfeiting but this counterfeiting does not represent a similar problem as it does with drugs. Why? Because the drug counterfeiting is usually with a drug that has no active ingredient and the patient’s safety could be in jeopardy. With devices, though this could be the case in just a few medical devices. The chance of a counterfeit going undetected is highly unlikely. So, is UDI for devices really required? That is what the FDA is trying to determine and so they have made a request for Use Cases. Here is what the FDA has posted on their website looking for information.
The UDI Team is collecting stories addressing common concern/questions with UDI implementation. Please use the template below to send us the Use Cases that are the most important to you to the e-mail address: [email protected].
FDA suggests the following format for each use case:
• Use Case Name
• Description of Use Case: Provide a brief story that thoroughly describes a situation involving potential positive or negative affects on data quality, timeliness of data entry/access, adverse event reporting, recalls or any other area of concern that FDA should consider during UDI implementation.
• Reason for Providing this Use Case: State the reason you think that this use case is important for us to consider
• Specific UDI Issues: Provide a bulleted list with brief descriptions of the specific issues that are addressed in this use case. Examples include: allocation rules, system requirements, use of data standards.
• Specific Business Rules to address (optional): List any business or validation rules that may be applicable to this story.
• Other Considerations: Identify any considerations for the use case that may need to be addressed during design or implementation.
IIf you would like to discuss the UDI issues that you may have, contact mdi at [email protected].