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Medica Devices - FDA Recalled Davol Company Hernia Patches - Many Patients Were Not Notified

Posted Nov 13 2009 10:01pm

Here’s a prime example of a story to where the hospital admitted they did not notify the patient, so again take a look at this link below and perhaps image it may find some value.  One person died with the implanted devices according to this article.   We now have a class action suit with 100,000 patients over this device.   The price of tagging for free is beginning to sound very affordable. In this case the doctors and hospitals were left on their own to find out.  Ok so in this case and on the video, FDA says it is the responsibility of the manufacturer to notify the doctors and the hospitals with the hope they will notify patients and they say they will follow up, with what?   The FDA says they don’t have the patient names, so duh?  What if your doctor passes away and what if your hospital closes, maybe some folks at the FDA have not read enough current events lately.  

What system do they have in place?  All the news stories of late say they have none!  It looks like we are down to passing the buck and perhaps afraid to look at some new and free technology that would help get the job done.  If I were Davol I might look at this free solution to put the tag on the packaging of the device and again have a “tag” online where patients can use their phone or even read a section about the recalls. 

We just had a recall announced today with spinal devices that have been recalled. 

Tracking Medical Device Recalls – Sounds Like A Good Place for a Microsoft Tag Data Base at the FDA

Actually I sent this off to the FDA to use Windows Tags to scan medical devices before they are used in surgery.   This is done with any smartphone, BlackBerry, IPhone, etc.  The software is free and consumers could use it too and it would give the FDA a data base to easily research for recall notices.  So far I have not heard anything, but maybe in light if this recall, perhaps Synthes might take a look as it would certainly give an instant avenue of information on a recalled device.  All a manufacturer has to do is put the 2D tag on their packaging.  You can read more at the link above.  The tag looks like the image below, which by the way works.  Try it with your phone. 

In this case since the device is already been implanted, for goodness sakes put a searchable data base with tags on the internet and the FDA can maintain their copy and monitor when changes are made. 

One other item I might add too is that the tags could be stored in a personal health record too, so the patient can aim and shoot at the tag for the updated information, gee how hard is this?  

RazCode/Windows Tags – Bar Coding to Add Information to PHRs, EHRs, and More…

If you are going to have to have surgery, you are going to have to dig up all your past medical history, allergies, etc. so while you are at it gathering all the information together, why not start a PHR at the same time?   Makes sense to me since you are having to look up and bring all this information forward before surgery anyway?  This looks like a time for collaboration here and getting the patient involved at the same time with a little empowerment too, you think? 

Medical Device Manufacturer + Patients +Technology + Hospitals + Doctors = Success!   BD 

PROVIDENCE, R.I. (WPRI) - Thousands of patients are affected by a hernia patch recall, but some of those patients say they were never told about the potential danger.

Diane Conetta of Cranston is one of those patients.  In Conetta's case, Rhode Island Hospital admits it neglected to inform Conetta's surgeon of the recall.

"What frustrates me the most is that I wasn't even told. Nobody notified me," Conetta said.

Conetta had a hernia patch implanted during surgery in 2005.

According to the FDA recall notice, "This can lead to bowel perforations" and other serious injuries.

The Target 12 Investigators learned that Davol started recalling larger versions of this patch as early as 2005. Target 12 also uncovered a letter sent by Davol to chiefs of surgery dated March 2006.

Migliori said Davol notified its customers about the recall, but its customers only include the hospitals and doctors the products were sold to, not patients.

"And they left the doctors and hospitals on their own to find out who had these patches and go through the process, but many doctors weren't aware of the process, many didn't actually know the recall had occurred," Migliori said.

Patients Not Told of Medical Device Hernia Patch Recall | Target 12 | WPRI.com

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