FDA reminds facilities to maintain PACS or face penalties, risk image loss
The FDA has posted an advisory to its website, reminding facilities that if a PACS fails and images are lost for reasons that should have been preventable, action can be taken against the facility for improper compliance.
“Lately, when it comes to record retention, we have seen facilities laboring under some false assumptions: My facility's Picture Archiving and Communication System (PACS) will last forever; its hard drives will never fail; my PACS doesn't need to be backed-up and doesn’t need regular maintenance, refreshing, or upgrading,” the statement read. “Although none of these statements is true, several recent MQSA compliance cases have shown us that some facilities evidently believe these myths.”
The advisory also said this is more than just a legal technicality for providers to keep in mind; it’s also a matter of patient health.
“We all realize how important prior mammograms can be when screening for or diagnosing breast cancer,” the statement read.
The FDA added that attempting to restore a lost image can cost up to thousands of dollars, and it isn’t even always successful.
This advisory comes after the FDA has witnessed multiple facilities lose a high volume of images. In two particular recent cases cited, one facility lost 20 percent of its mammograms, while another lost more than 6,000.
To avoid such loss, as well as any potential actions taken by the FDA, the statement lists four suggestions for maintaining PACS:
- Invest in server-based or cloud-based backup storage
- Train all staff members on storage backup procedures
- Immediately apply all PACS manufacturer software updates
- Follow manufacturer recommendations in regards to hardware, especially hard drives
The statement concludes with a simple summary: “Investing in your PACS isn't simply investing in technology; it's investing in the health and well-being of the patients who come to you for their mammograms and who depend on you to provide them with the best mammography services possible, and it keeps your facility in compliance with the MQSA regulations.”
Full text of the advisory is available on the FDA’s website.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.