Thursday, November 20, 2008

Product Safety Notification

I posted about the FDA's letter of warning about Centricity on August 20, 2008. Three months later, on November 14, 2008, GE sent a letter to our site notifying us of the problems and promising repairs.

It seems that Centricity RA1000 workstation software versions 2.1.x and 3.0.x have a few problems.

Issue 1: Patient Jacket

There is a patient safety issue involving patient jacket content intermittently becoming unintentionally out of synchronization with the image(s) being displayed. This results in a mis-match between the information listed in the patient jacket and the image(s) being displayed. The Centricity PACS RA1000 provides the user with a message in the patient jacket header indicating that the patient jacket does not match the current displayed image(s).

This issue has been reported as occurring in the following workflow: While viewing images on a Centricity PACS RA1000 workstaton, the user immediately clicks on the "Show Patient Jacket Palette" button on the image titlebar or the "Show Palette" button on the taskbar. Intermittently, the patient information that gets loaded in the patient jacket, does not match the patient whose images are currently displayed. Instead, the patient jacket loads patient information for a patient whose images were previously displayed. In this condition, the user can continue to view the mismatched images in that patient jacket.

The expected operation is that when the "Show Patient Jacket Palette" button or "Show Palettes" button is clicked, the patient jacket should load the patient whose image(s) are currently displayed.

NOTE: It is still possible for the user to intentionally select an exam in the worklist that is different from currently displayed images. In such a case, the patient jacket will sync with the exam information selected in the worklist, and the PACS system will provide the user with a message in the patient jacket header that the patient jacket does not match the current exam. This specific workflow is normal behavior and is not identified as a potential patient safety concern.

SAFETY INSTRUCTIONS: The patient name/ID of the Patient Jacket content should be carefully checked, after immediately displaying an exam, to ensure it is consistent with the information for the displayed image(s).

If the patient jacket goes out of synchronization with the displayed image(s), it should be re-synchronized by re-opening the patient jacket palette (by selecting the "Show Patient Jacket" button on the image title bar). If that action does not result in appropriate re-synchronization, then the workstation application should be restarted.

Issue 2: Default Display Protocol

There is a patient safety issue involving Default Display Protocols (DDPs). DDP's are hanging protocols used to lay out images when displaying a study.

If the user/site DDP was configured to place the current and historical studies in different regions than the system default DDP, the user may believe that the old study is the new one and vice versa. If the user does not check the Study Date and Time of the exam on the image title bar, then they may interpret the current exam as a historical and vice versa.

SAFETY INSTRUCTION: When displaying images, the user should check the following to determine if there are historical comparison exams, and in which image regions they are loaded:

1. The study date/time as displayed in the image title bars of every image region.

2. The italicized folt of the label in the image title bar. The current study will be displayed in an italicized font, whereas historical studies will display in a non-italicized font.

3. The Patient Jacket and the Comparisons Hotzone on every image title bar, which will show whether there are historical comparison exams and, if so, how many.

The user could also check the name of the applied DDP, as it appears on the Display Functions combo button, to see if the applied DDP is a user/site DDP or a system default DDP. This is helpful if a known convention is followed when naming user/site DDPs for easy recognition.

The gist of all of this engineer-speak is simply that you should confirm what you are looking at is what you think you are looking at. Probably good advice in all settings, not just those prompted by FDA warnings.

For what it's worth, this is not the first such notification for Centricity RA2000. This link takes us to a letter that went out just under a year ago, covering a glitch in the exam notes window which likes to ignore special characters such as "greater than" or "less than" (which I think will confuse as well.) Makes it hard to post lab values and such. And here's another one:
A potential patient safety issue involving incorrect study date and time information being displayed in the report screen and title has been identified. Incorrect study date and time displays may lead to a potential patient misdiagnosis. These date and time display inaccuracies may vary from minutes to years depending on certain circumstances and workflows.

I guess it's really hard to test out every permutation of problems that might arise with such a complex piece of software. Personally, I can't wait for the Dynamic Imaging revisions....

1 comment :

Anonymous said...

"I guess it's really hard to test out every permutation of problems that might arise with such a complex piece of software."

It's impossible.