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Is a Non Technical FDA Recall System Like Another BP Oil Spill Waiting to Happen One Day

Posted Jun 11 2010 12:37pm

I don’t mean that the FDA has anything to do with oil, but by comparison if you look at how long, since 2004 since the FDA made the commitment to create a recall program that is easy and accessible for consumers, well we have waited about 6 years.  In that time though we have had some really neat technologies enter the image picture and we are about at the point where we need to start working on this.  Recalls will grow in number simply due to the higher level of intelligence we have today in identifying software issues, malfunctioning devices, side effects and so on.  

When you stop and think about the software end of things with devices (especially those that require software) think about your operating system updates you get with Windows, Apple, Linux and so on.  Even the big guys are constantly updating and improving their software and those are entire operating systems, so this part of the issue with devices is not going to go away any time soon, but we need to learn to live with it and adapt and be able to react quickly with a system that gets to hospitals, consumers, doctors immediately.  

The ECRI institute has a website with Medical device safety reports where you can search and find a multitude of device problems and where you can report them and there’s a lot there. 

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For nearly 30 years, ECRI Institute has gathered and investigated reports of incidents involving medical devices from healthcare providers, patients, and manufacturers from around the world. As a result, thousands of devices have been recalled or modified by their manufacturers. We encourage healthcare providers, patients, and manufacturers to report medical device related incidents and deficiencies to us so we can determine whether a report reflects a random failure or one that is likely to recur and cause harm. Reports can also be submitted to us by letter, telephone, or fax. ECRI Institute acknowledges receipt of the report and informs the reporting party of our finding and opinions in cases for which we can provide guidance; otherwise, we log the report in our system and monitor the situation for developing trends of similar problems. As soon as members of ECRI Institute's staff--clinical engineers and other technical specialists who have expertise in biomedical, electronic, chemical, radiologic, and computer technologies--determine that specific device hazards and problems may exist, ECRI Institute informs the manufacturers and encourages them to respond constructively and correct the problem. The name of the reporting institution and of the person making the report is never revealed without permission.

Recently in the news we have had Johnson and Johnson as being in the public eye with their recalls and today I read where the government says they are not cooperating and they say they are and have submitted documents, so are they 2 speaking the same language?  You know the folks doing the asking may not be able to understand what is being sent and the people sending the information may not be understanding what the Senate wants either, this can go on forever if we ignore it. 

Just like anything else we can’t rely on manual systems to feed a huge crowd so we need to do some serious thinking as when you look now at how drugs and device recalls are handled, you either have to watch the news or read the FDA newsletters, press releases, etc., in other words still a manual process and people miss stuff and so does the FDA for that matter.  Below is a good example of one that was missed but through bloggers and other news outlets people were finally aware, as it was not in the normal web page of the FDA. 

Now what is going to happen when we get hit with several recalls at once, more than a couple companies, and some being consumer products sold over the counter, again this is going to keep coming at us and with each one hopefully the companies get better at correcting, whether it is software, ingredients in drugs, or whatever the case is for the recall.  Safety is going to suffer with this antiquated system we have, like I said the BP oil spill of the FDA could very well be lurking.  Is the process going to resemble something like the BP coffee spill?  This has a bit of demented humor but makes a point with the video below. 

I have made posts about people being implanted with a device that was recalled and for what ever reason, it was not pulled and used in surgery, the device malfunctioned and patients die.  To me this is totally preventable as we have technology to solve this and there are more incidents like this that occur than you think.  This process of using your phone as a scanner is almost easier than using your phone to make a call. 

Do Microsoft Tags Belong in Healthcare? (Microsoft.gov publication of this post)

Do Microsoft Tags Belong in Healthcare

“We are lucky to have Barbara Duck of The Medical Quack write a guest blog post.
Barbara has quite the blog on the medical industry. She was kind to write an amazing post, concerning Tag & Health. Enjoy!
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Do Microsoft Tags Belong in Healthcare?  I Have Some Ideas on This Subject

If you read the Medical Quack you may have seen some of my recent posts on how I think this technology would prove to be an asset to healthcare.  Healthcare, like every other industry today is inundated with information and rapid communication is key.  We have more mobility today with telehealth and other wireless  capabilities emerging into an area that is growing by leaps and bounds, almost faster than we can keep up.  We read about safety notifications and their timeliness and availability all the time, and thus my thoughts grew into the area of another avenue of using cell phones to help keep up.

The opportunity to turn a cell phone into a “scanner” with real time information is huge.  As mentioned above, this can be a daunting task at times and we have people at all different stages with using technology today and in my opinion, using a cell phone makes sense, when all one has to do is open a program on the phone and simply “shoot and aim” and relative information would be available instantly.  Back in October of 2009 I kept reading about all the recalls of devices and created my first opinion/idea post here.  It just made sense to me. 

Some hospitals have used RFID to work with getting recalled devices off of the hospital shelves and this is great, but what about those who have not, clip_image004 and furthermore, what about the consumers and/or patients.  For instance I could be looking for new safety information about an over the counter drug that has been on the news, while someone else who has an implanted heart device may be looking for something else, but one thing in common is that we both need access quickly.

Scan that knee, hip, defibrillator before you use it, takes a few seconds and will help hospital registries function and less mistakes.  Hospitals work hard to do a good job at this, but I continue to read stories to where patients have been implanted with a device that had been recalled and it was missed.  One story in particular involved a man who was implanted with a heart device that had been recalled and he died when it malfunctioned.  To me, this could have been a preventable incident and a life could have been saved if a simple scan would have put up the red flags to not use the device.

Everybody that reads here, knows I am a fan of Tags and I have an entire series of how they can be used in healthcare, they work with RFIDs too.  Watch the video and see how they are used for entertainment.  I guess that must come first, you think?   This is all free too.  Had some great comments on Twitter too.

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This comment talks about how great they work on an IPhone and sees as an enhancement at the hospital.

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This IT person says, yes, combine with RFID at the hospital as they already work with bar coding.

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One other item to note these can be an avenue to get information in to your PHR with your phone with HealthVault too , so that becomes easier if consumers already use the program for other functions, again so darn easy to use, a no brainer.   Something this simple to use will stand to enhance consumers with the use of Health IT too so we get more “participants” all the way around. 

The former chairman of the FDA last week called for increased corporate accountability and with Tags the FDA would also have an easier time themselves monitoring compliance with a synchronized data base. 

We are not that far away from the day to where the current system will be totally unmanageable and not be able to keep up with the demand, times are changing and the FDA needs to change too if we are ever going to see more accountability from companies as they FDA can only be in so many places at one time and the longer the technology is delayed the lower the level of trust from the American public especially when we can begin work on the technology that is available today.

One other little point worth mentioning, have you ever strained to read the very small print on products with safety information?  I’m getting older like the rest of us in the US and by using a cell phone to scan information, guess what, it turns your phone into one big magnifying glass too, I like that a lot.   As well as recall information, safety updates could be included too. 

Right now consumers want information and it is great that we are building data bases to provide community information, but are we being like the oil business and putting all the technology into the building stage and not having any back up/clean up plans?  It certainly seems in methodology that this is going right in the same direction and little or no thoughts are going into preparedness. 

One day we will have recalls coming at us right and left as we will need technology to sort them out and give us instant access.  I just noticed a new FDA announcement this morning with counterfeit products with surgical mesh!  Tags can readily help identify the fakes from the real products too.  BD

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