topic Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct? in Ask A Question for DSD

Two similar Values for Clinical Storage Handling Type Code - which one is correct?

c2b30 — Wed, 15 Jan 2025 15:00:29 GMT

SHC47 - Electrostatic sensitive device
SHC33 - Electrostatic sensitive devices

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

Theo — Wed, 15 Jan 2025 16:56:57 GMT

Hello @c2b30 ,thank you for utilizing our customer community.

I reviewed your request, and both fields refer to the same attribute shown in Item Management, as demonstrated in the screenshot below:

The reason you see two separate fields for this attribute is due to updates regarding the options available in the dropdown list.

How to Use the IM Participant Dictionary

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

c2b30 — Wed, 15 Jan 2025 17:03:20 GMT

It's not the attribute in question it's the valid values. One valid value has "device" plural, and the other value has "devices" with an "s"... How can you have the same valid value listed for the same attribute. Seems very confusing. Which one should be used?

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

DanV — Wed, 15 Jan 2025 18:04:04 GMT

Thank you for reaching out to our customer community. Welcome.

We will review the similar valid values with our standards SME and will reach back out once we have clarification.

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

DanV — Wed, 15 Jan 2025 18:35:49 GMT

Hello @c2b30

Our standards SME provided the following GDSN definitions:

The code for Electrostatic sensitive devices is SHC33

The code for Electrostatic sensitive device is SHC47

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

c2b30 — Thu, 16 Jan 2025 13:54:39 GMT

Okay they are valid values for GDSN but only SHC33 is valid for EUDAMED per this document. UDI Devices - enumerations.pdf

SHC47 is not listed as a valid value for EUDAMED.

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

Scott_Brown — Thu, 16 Jan 2025 14:36:25 GMT

Morning,

Understand that EUDAMED only accepts SHC33. However, this attribute is not restricted to used for only EUDAMED. It can be used for other retailers and other products where SHC47 is applicable for use.

The code names are set by regulatory bodies not by GDSN or 1WorldSync. We agree that the code names are very similar and would hope that the regulatory bodies would consider altering to reduce the similarity.

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

c2b30 — Thu, 16 Jan 2025 15:09:38 GMT

Completely understand, but do you happen to know which regulatory body is requiring this so the discussion can be started.

Re: Two similar Values for Clinical Storage Handling Type Code - which one is correct?

Scott_Brown — Thu, 16 Jan 2025 15:18:18 GMT

It is a mix of organizations. Some of the values appear from the EU and other countries. I also see some coming from UNECE.