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:

via Blogger http://ift.tt/1K71Ucn January 25, 2016 at 01:40PM

RAD-AID

If you didn’t know, I’m semi-retired, working only 26 weeks of the year. That would be half of the year for those uncomfortable with mathematics. The ultimate plan is to do this for another 12-18 months (one to one and one half years if you need the conversion factor) and then goodbye to the joys of private practice.

Of course, my ultimate plan lacks some ultimate planning. Being relatively young, and in relatively good health, I’ve got to do something with all that free time beyond writing blog posts few read, and lurking around Facebook and AuntMinnie.com.

A friend knew people who were going to create a flying hospital within an old 747 some airline was going to donate to them. I found this a fascinating concept, and I was forwarding suggestions as to which scanners and PACS and so on might be critical for such a project. Sadly, this has yet to get off the ground, so to speak.

A Merge Healthcare newsletter, however, revealed their partnership with RAD-AID, a world-wide Radiology project that IS active, and in fact has done quite a lot of good already in many far flung places.

Chicago, IL, 10 Sep 2015

Merge Healthcare (NASDAQ: MRGE) today announced a new global collaboration with the nonprofit organization, RAD-AID International, (US Registered 501c3) to bring vital radiology and health information technologies to medically underserved and poor regions of the world. The collaboration—RAD-AID Merge International Imaging Informatics Initiative (RMI4)—leverages Merge’s leadership in radiology information technologies with RAD-AID’s global health outreach network, including 3,500 volunteers, 14 country-outreach programs, 33 university-based chapters and affiliation with the United Nations’ World Health Organization (WHO).

WHO reports that nearly half the world has little or no radiology services. Moreover, most of these low and middle-income countries have no access to health information technologies, such as Picture Archiving and Communication Systems (PACS), Electronic Health Records (EHR), Radiology Information Systems (RIS), Hospital Information Systems and other life-saving health informatics platforms for storing, retrieving and interpreting patient data. In collaboration with Merge’s charitable contributions of software, technical resources and expertise in radiology image-management, RAD-AID will implement these health information technologies at the nonprofit’s partnered international sites along with RAD-AID’s ongoing delivery of clinical education, on-site training and radiology assistance to comprehensively support poor and resource-limited countries.

“This collaboration between RAD-AID and Merge represents a major step forward in bridging charitable outreach and health technologies for the mission of improving global health,” said Dan Mollura, chief executive officer, RAD-AID International.

Serving as an important foundation for this collaboration, RAD-AID has designed and deployed its Radiology-Readiness AssessmentTM tool since 2008, to assess, plan and deliver radiology in poor and medically underserved regions. Over the last seven years, these RAD-AID Radiology-Readiness Assessments confirmed the near-complete absence of health information technology in low- and middle-income countries. To begin addressing this significant health care disparity, RAD-AID and Merge developed RMI4. As a resource for carrying out this initiative, RAD-AID recently enhanced the Radiology-Readiness tool to include PACS-Readiness, a data analytics tool for specifically planning international deployment of PACS in facilities having little or no prior experience with imaging platforms.

“Merge takes corporate social responsibility very seriously and is excited to partner with RAD-AID to bring radiology and health information technologies to medically underserved and resource-limited countries across the globe,” said Justin Dearborn, chief executive officer, Merge Healthcare.

The collaboration envisions the creation of a constructive, educational and supportive roadmap for medical imaging facilities and health institutions in underserved regions of the world to adopt radiology imaging informatics systems.

Now THIS is what I’m talking about. Here’s a chance to deploy the software I appreciate most in areas where it will do a tremendous amount of good. And maybe I could share some of my meager radiology expertise as well. (Ironically, when I first contacted RAD-AID, I was asked if I knew how to implement the dcm4chee open-source system, which I don’t, but perhaps I won’t have to learn it after all…)

RAD-AID itself is an interesting operation.

RAD-AID began in 2008 to answer this need for more radiology and imaging technology in the resource-limited regions and communities of the world. The organization began as a few people at Johns Hopkins, and has grown to include more than 3,500 contributors from 200 countries, 45,000 web visitors per year, 33 chapter organizations, and on-site programs in more than 14 countries.

RAD-AID’s mission is to increase and improve radiology resources in the developing and impoverished countries of the world. Radiology is a part of nearly every segment of health care, including pediatrics, obstetrics, medicine and surgery, making the absence of radiology a critical piece of global health disparity.

The organization sends teams to dozens of countries, and truly has a positive impact upon health care.  I’ve been in touch in particular with the team working in Ghana, and there was even an immediate opportunity to go there which I can’t at the moment.

But the need is great, and we all can help.

Go to RAD-AID.org, and consider volunteering. Even if you can’t volunteer at the moment, please consider a donation, either to the Ghana project HERE, or to RAD-AID in general (popup link on their homepage). 

This is a worthy cause, one which should be close to the hearts of those in the imaging business.

See you in Ghana! (Or maybe Nepal, or maybe…)

via Blogger http://ift.tt/1PO2XNn January 08, 2016 at 11:36AM

The Demonstration

Image courtesy of Dilbert.com

Hi, everyone. I see we have some folks here from Administration, and from IT, and even five or six radiologists. That’s great. I was sent here by your EMR vendor to give you a look at the new RIS add-on, DoctorThingy. It’s a nice piece of software that can be used in either RIS-driven or PACS-driven mode. We could probably run it both ways, but we don’t recommend doing that. Why? Well, you might have some trouble synchronizing worklists, and some exams might just get read twice. We don’t want that to happen, do we? So let’s see how this looks.

Your overhead projector will only work in landscape mode, but we recommend using portrait mode. No, we can’t turn the projector sideways, it’s bolted to the ceiling, isn’t is? Maybe you could all tip your heads to the left? No, no, I’m just kidding. But keep in mind that you would normally see this wonderful informational window stacked on your portrait monitor with another window below it. Of course, you could get one of those nice Barco 12 MegaPixel monitors and have room for lots of windows! Or you might need a fifth or a sixth monitor for our window, and your old PACS text window and your PowerScribe window. Oh, you don’t have that yet? Oops.

Our early implementations of the DoctorThingy were PACS-driven.  That’s probably because no one had invented RIS-driven workflow back then. But now most of our sites go RIS-driven. That means we replace your PACS worklist with our page that includes your worklists. And it will show you how many reports you have to sign, and let you do that without opening another app, and we know you hate opening other apps! When you select a patient, it shows everything you have in the EMR about him. Oh, yes, you can have as many worklists active as you wish. No, that won’t bog down your page. Your PACS can’t handle that? Well, that’s a good reason to go RIS-driven, isn’t it? Ha ha. Anyway, our RIS when teamed with DoctorThingy replaces your worklist completely. You can make any kind of worklist you want, using any criteria you can think of. What’s that? You want just to search for a individual patient? Easy peasy! Here is the search window. You can search by name, date of birth, ID, and AARP number. Really? You want to search by modality? Or you want to go back and review the MRI’s you’ve read in the last week? Hmmmmm. The DoctorThingy search window won’t do that. Never has. But don’t worry. If you minimize DoctorThingy and open CollosusSearch, you can find just about anything…like maybe all the patients with a certain astrological sign who had defagrams in months that contain the letter “R”. Isn’t that worth opening up another app to see? Oh. Forget what I said before about opening another program.

What’s that? You need voice clips on the ER exams? Well, DoctorThingy 1.2.11.3 had voice-clips. You know, saving them as .WAV files and all. But we dropped that. No, we have no plans to put it back. Well, OK, I’ll ask. You have voice-clips in your PACS viewer? That might work. If you can get to your PACS viewer text page. Oh, silly me, it will be hidden by the DoctorThingy window. But if you have a proper portrait monitor, you could still arrange things so you could see it after all. I think.

Oh, you want to know about workflow with your PACS? Oh, yes, we’ve integrated at another site to the same PACS. Yes, ONE other site. You’ll be the second. But we really appreciate your help with beta-testing the system! Yes, the existing installation is in Nome, Alaska. Nome. N-O-M-E. Shall we go for a site visit? You all go on ahead, I’ll meet you there in July. Since I haven’t been there, I really don’t know just exactly how this will work with your PACS. But it’s really really powerful. Great software.

I know you guys want some kind of demo program you can play with. Sorry, but this nice demo you are seeing on the screen is straight from our HQ inside the NORAD mountain. It’s only for the demonstrators like me. No, you can’t have access to it. But your site already has the code. What? It isn’t online yet? Well, once it is, you can probably play with it, if IT can set up a test environment for you. That shouldn’t take too long, right? No more than a month or so. Because I’m told this project won’t go live until April Fools Day, and that’s almost three months from now! That’s certainly enough time for you to iron out any and all difficulties presented by this wonderful software. IT people, do you know how it works? Are you all ready to get it going? Oh, well, you’ll figure it out.

So don’t worry! Just because you are being forced to use this untested integration of new software without adequate prep time which will completely upend the way you do your job shouldn’t bother you! It will all work out. It always does. Just look at how well your PACS runs! On second thought…

If there are no further questions…

via Blogger http://ift.tt/1mFdd1k January 07, 2016 at 10:09AM