Siemens Requires DMLA Before Providing AIAT Information

I was working on a Siemens Ecam system where the gantry locked up and wouldn’t move. I manually reconfigured the gantry and then I had to enter the new “Reconfiguration Mask and Angle” into the system database to get it to recognise the correct gantry position. I could not perform this task as the level of service key I had was a level 4 and I needed a level 7 key to enter this data.

I called Siemens service and asked for a higher level service key, they told me (as did the area service manager) that I needed to fill out a DMLA (Diagnostic Maintenance Licensee Agreement) license agreement to get this key. I explained to them that the machine I was working on was “Not meeting manufacturers specifications” and all I wanted was to get the correct Assembly and Test Instructions per CFR Title 21 to allow me to get the system back into manufacturers specifications. They refused until I filled out a DMLA.

I do not ever remember reading anywhere in the CFR Title 21 regarding xray equipment that states I have to fill out a DMLA before a manufacturer will allow me access to AIT. What recourse do I have when a manufacturer refuses to comply with CFR? Is this what a FDA 3500 form is for?

Any help is appreciated.

Stephen Longchamps

ImageTalk supported by MedicalParts.com 8-30-2012

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1 Comment

Filed under Information, Service Dirt

One response to “Siemens Requires DMLA Before Providing AIAT Information

  1. Trish Payne (Quality Assurance Manager, Block Imaging Parts & Service) wrote:

    “This is a mistake that most everyone makes at least once when trying to understand AIAT. I made it once myself years ago. AIAT provisions do not cover nuclear cameras or gamma cameras. The guidance for AIAT realtes to Diagnostic X-ray Systems. So quoting 21 CFR for these units will not help. An OEM regulaory friend told me that; nukes do not produce or control X-ray, but rather image radioactive nuclei that have been injected into the patient. Hope this helps you understand why using 21 CFR may not have helped.”

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