Practice Management

Hello,
We will be deploying remote reading work stations to some of our radiologists and the topic was raised if these stations need to be FDA approved.
Can anyone weigh in if all components of the remote reading work station need to be FDA approved? 

Thanks,
Kerri

------------------------------
Kerri Spadaccia
Radiology Practice Manager
Progressive Physician Associates
Bethlehem PA
610-868-1100
------------------------------

Original Message------

Hello,
We will be deploying remote reading work stations to some of our radiologists and the topic was raised if these stations need to be FDA approved.
Can anyone weigh in if all components of the remote reading work station need to be FDA approved? 

Thanks,
Kerri

------------------------------
Kerri Spadaccia
Radiology Practice Manager
Progressive Physician Associates
Bethlehem PA
610-868-1100
------------------------------

Original Message------

Yes – If you are providing final reads you will need to use FDFA approved workstations and monitors.

 

Keith E. Chew, MHA, CMPE, FRBMA
Senior Vice President

INTEGRATED MEDICAL PARTNERS
EMPOWERMENT. INNOVATION. RESULTS

Keith.Chew@integratedmp.com
D|414-359-5520   C | 217-971-5293  

18 Hawks Nest | Chatham, Illinois     62629
www.integratedmp.com

 

Original Message------

This brings up a question:

What are the FDA requirements for non Mammography workstations?

And are there any requirements other then for the diagnostic monitors?  I would think we simply have to meet the specifications provided by the PACS vendor in respect to CPU, Memory etc.

I know in NY we have other requirements from the DOH in regards to Monitor QA and documentation. 

But I cannot find a federal Radiologist requirement to use a FDA approved monitors for non Mammo cases.

I found this:
https://www.federalregister.gov/documents/2017/10/02/2017-21078/display-devices-for-diagnostic-radiology-guidance-for-industry-and-food-and-drug-administration

But that is geared towards the monitor industry, not radiologists.

Thank you,

 Brice DeWire

Director of Operations
Radiology Associates of New Hartford
185 Genesee St, Suite 600
Utica, NY 13501
315-793-8806 ext 258 

Virus-free. www.avg.com

​There are MQSA requirements for mammography monitors and reading stations, but to my knowledge, there are not FDA, or other regulatory, requirements for diagnostic radiology workstations.

------------------------------
[James] [King,] [MD]
[President]
[Phydata, LLC]
[Nashville] [TN]
[615-986-6400]
Jim
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Original Message:
Sent: 04-02-2018 10:31
From: Kerri Spadaccia
Subject: FDA Equipment for remote reading stations

Hello,
We will be deploying remote reading work stations to some of our radiologists and the topic was raised if these stations need to be FDA approved.
Can anyone weigh in if all components of the remote reading work station need to be FDA approved?

Thanks,
Kerri

------------------------------
Kerri Spadaccia
Radiology Practice Manager
Progressive Physician Associates
Bethlehem PA
610-868-1100
------------------------------

As far as I know, there are no FDA requirements on a diagnostic workstation other than on the viewing software itself. If the viewing software is mainly a "viewer" then it falls outside of the scope of a FDA 501(k) application for medical devices. If there is more complex functionality involved (I.e. measurements, 3D reconstructions, etc.) then FDA applications are required. I believe that a PACS is considered a FDA Class 2 device.
I will assume that you are using  an "established" PACS vendor's software, so the FDA applications have more than likely been filed and granted.

------------------------------
Ian Soutar
Chief of Operations and Technology
Cape Radiology Group, Inc.
Cape Girardeau MO
(573) 334-1072
------------------------------

Original Message:
Sent: 04-02-2018 10:31
From: Kerri Spadaccia
Subject: FDA Equipment for remote reading stations

Hello,
We will be deploying remote reading work stations to some of our radiologists and the topic was raised if these stations need to be FDA approved.
Can anyone weigh in if all components of the remote reading work station need to be FDA approved?

Thanks,
Kerri

------------------------------
Kerri Spadaccia
Radiology Practice Manager
Progressive Physician Associates
Bethlehem PA
610-868-1100
------------------------------