Reporting In

A few weeks ago, I received this message from one of the top Merge execs (emphasis mine):

Notification of Enhanced FDA Reporting Methodology

Dear Valued Customer,

As part of our commitment to ensure compliance and driven by our objective to deliver high-quality medical devices, we want to inform you of a change in our quality management processes to provide greater transparency to our customers and raise the bar on delivering quality in the medical device industry. I also want to take this opportunity to reiterate Merge Healthcare's commitment to implementing corrective actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and all regulatory requirements. Merge's executive management team takes the FDA’s observations seriously, and we have been fully cooperating with the FDA to resolve any questions or concerns expressed by the FDA.

Merge Healthcare has enhanced its FDA reporting methodology to report to the FDA product corrections and removals including those that may be classified by the FDA as Class III recalls. For clarity, Class III recalls signify the lowest potential risk situations, representing minimal impact to patient care. In this context 'recall' can be a form of communication and should not be interpreted as always requiring an update to a product. This change in policy will also increase transparency and notification to the FDA of Corrections and Removals associated with our medical devices. As a result, it is very possible that you will see an increased number of reported events on the FDA website. You will also see an increased number of messages from us, explaining the details around the event and any required action that may need to be taken.

So what does this mean to you? It means that we will continue to provide timely and comprehensive communication and information about the use of our products and overall product quality. It also means we will continue to deliver solutions you can trust and that help you provide the best patient care possible. And lastly, it means we will continue to provide world class support of those solutions and provide the opportunity for you to take advantage of our latest product advancements.

Merge Healthcare intends to advance the delivery of quality, patient-centric solutions in healthcare. We thank you for your continued partnership with Merge Healthcare and look forward to continuing to serve you for your current and future needs.

If you have any questions or would like to discuss this matter further, please feel free to reach out to me at your convenience.

I am gratified to read this; it is an upstanding and even courageous stance.

Software, being written by human beings, always contains some mistake or glitch or something. The PACS created by Merge, and its predecessor AMICAS, are no exceptions. THIS LINK takes you to the 11 complaints I could find about Merge PACS. THIS LINK shows a few more, older complaints when AMICAS ran things.

By the way, MAUDE in the list of problems stands for: "Manufacturer and User Facility Device Experience". I guess that could be positive or negative.

Having a problem? Your government is here to help you. Search for it at:

http://www.fda.gov/default.htm