Saturday, February 06, 2016

The Measure Of A Company



The measure of a man cannot be whether he ever makes mistakes, because he will make mistakes. It's what he does in response to his mistakes. The same is true of companies. We have to apologize, we have to fix the problem, and we have to learn from our mistakes.

Wil Shipley

Software, being written by humans (until Watson gets the hang of it, I suppose) is going to contain errors. When the program has something to do with the medical field, those glitches could cause devastating effects.

Now being human as well, and having made my share of mistakes in interpreting images over the years, I'm not really trying to throw stones at the software folks. But when a glitch is found, there are ways to deal with it, and ways NOT to deal with it.

The latter is easy to recognize. Say one has a shiny new PACS system that skips CT slices intermittently. Telling the customer that it's an issue with the code, and the next fix will come roughly a year after the software went online is probably NOT the best approach. Having a PACS that sometimes doesn't inform the user that there are prior issues, and spending lots and lots of time backpedalling and outlining how the issue was bounced back and forth and back again within the corporate structure is definitely NOT how I want things handled.

So how should our friends in the medical software market do their mea culpa's? An excellent question. Here is how Merge Healthcare did it with two recent letters to their customers.

These two notices arrived January 27, 2016:

URGENT: MEDICAL DEVICE RECALL
Recall #2016-012
January 27, 2016
Dear Radiology Manager or PACS Administrator,
This is to inform you of a product recall involving:
Product:
Merge PACS™ V6.0.2.0 MR2 and earlier. We shipped these products May 2006 through June 2010, or earlier from Amicas. 
Issue:
This recall has been initiated due to an issue in which the patient name in the Halo title bar may not update to match the name on displayed images due to the JAVA running out of memory.
Potential Harm:
Use of this product may result in a mismatch of the displayed patient name on the Halo title bar and the displayed images. 
Product Containment:
A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. The use of Merge PACS does not need to be discontinued.
Instructions:
An upgrade for Merge PACS is available for this issue. Call Merge Customer Service at (REDACTED) to schedule the upgrade. 
If you decide to decline this maintenance release, please complete (REDACTED)
  
Please ensure that all users of the product are provided with this notification. Your assistance is appreciated and necessary to prevent patient harm.
If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide. If you have any additional questions, call Merge Customer Service (REDACTED)
This recall is being made with knowledge of the Food and Drug Administration.

And...

URGENT: MEDICAL DEVICE RECALL
Recall #2016-012
January 27, 2016
Dear Radiology Manager or PACS Administrator,
This is to inform you of a product recall involving:
Product:
Merge PACS™ V6.0.2.0 MR2 and earlier. We shipped these products May 2006 through June 2010, or earlier from Amicas. 
Issue:
This recall has been initiated due to an issue in which the patient name in the Halo title bar may not update to match the name on displayed images due to the JAVA running out of memory.
Potential Harm:
Use of this product may result in a mismatch of the displayed patient name on the Halo title bar and the displayed images. 
Product Containment:
A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. The use of Merge PACS does not need to be discontinued.
Instructions:
An upgrade for Merge PACS is available for this issue. Call Merge Customer Service at (REDACTED) to schedule the upgrade. Reference this recall #2016-012.
If you decide to decline this maintenance release, please (REDACTED)
  
Please ensure that all users of the product are provided with this notification. Your assistance is appreciated and necessary to prevent patient harm.
If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide. If you have any additional questions, call Merge Customer Service at (REDACTED)
This recall is being made with knowledge of the Food and Drug Administration.

You get my drift. Face up to the glitches, let the customers who haven't yet found them know they exist, and FIX them. Sounds like a plan. A plan other vendors need to follow a bit more religiously.


1 comment :

Phil said...

Point taken
but
these errors are between 6 and 10 years old. Did they not know about this until recently. We would hope that this sort of error would be corrected within a few months of release.