BEST of Rowan, LLC - Comment

Document ID: FDA-2011-N-0053-0003
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 23 2011, at 12:00 AM Eastern Standard Time
Date Posted: September 7 2012, at 12:00 AM Eastern Standard Time
Comment Start Date: February 4 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: 
Tracking Number: 80bf6b27
View Document:  View as format xml

View Comment

I have been servicing medical equipment for 29 years. I am a CBET and in 1990 became the 105th CRES. Retired from Fed. Gov. 27 years, 21 of which were servicing radiation machines and components. I am self-employed at this time. You need to be aware of a radiation safety issue which affects the general population. It is a matter of certain CR digital imagers replacing film processors in the U.S. General practitioners are not aware of a loss in resolution and an increase in radiation dose to patients after replacing the film processor with a CR digital imager. In 1995, MQSA regulations caused me to destroy two (2) of my customers mammography machines due to focal spot size of .6mm. This Standard was chosen by knowledgeable professionals who determined that a .6 focal spot was not small enough for the resolution needed for breast imaging. Now, 15 years later, we all know that ionizing radiation causes cancer and does not discriminate between breast or lung tissue. Some CR imagers have poorer image resolution than the film processor it replaced and require more radiation dose for the same image. There should be a Standard resolution phantom image for general radiology just like mammography. This Standard must apply to both film screen radiography and CR digital imaging alike. Maximum radiation dose and minimum image resolution quality is determined with a phantom image. Systems which can not meet this Standard must be replaced or not allowed. Just like in 1995, time is now. Mitigate the damages now.

Attachments:

BEST of Rowan, LLC - Comment

Title:
BEST of Rowan, LLC - Comment

View Attachment: View as format msw12

Related Comments

   
Total: 1
BEST of Rowan, LLC - Comment
Public Submission    Posted: 09/07/2012     ID: FDA-2011-N-0053-0003