Medical Equipment Design Blog

Medical Equipment Design

The Medical Equipment Design Blog is the place for conversation and discussion about medical grade materials and products, electrical and electronic equipment, computers, imaging & software, and home healthcare & diagnostics as used in the medical industry. Here, you'll find everything from application ideas, to news and industry trends, to hot topics and cutting edge innovations.

Previous in Blog: Form Follows Function Follows Safety   Next in Blog: Rescued by the Phone
Close
Close
Close
6 comments

A Call to Discard the Device Approval Process

Posted August 10, 2011 1:08 PM

In response to an apparent increase in medical device recalls due to failures and patient injuries, the Institute of Medicine recently released its long-awaited review of the 510(k) process. The report finds the device clearance process flawed and urges the agency to create a new integrated premarket and postmarket regulatory framework that is risk-based, grounded in sound science, and ensures safety throughout the device life cycle. Pushback from manufacturers has already been voiced. What's your reaction?

The preceding article is a "sneak peek" from Medical Equipment Design, a newsletter from GlobalSpec. To stay up-to-date and informed on industry trends, products, and technologies, subscribe to Medical Equipment Design today.

Reply

Interested in this topic? By joining CR4 you can "subscribe" to
this discussion and receive notification when new comments are added.
Guru
Popular Science - Weaponology - New Member United Kingdom - Member - New Member

Join Date: May 2007
Location: Harlow England
Posts: 16498
Good Answers: 661
#1

Re: A Call to Discard the Device Approval Process

08/11/2011 2:59 AM

The process certainly needs revising.
With any type of aproval you end up with over zealous types nit picking over trivia.
E.G.
On one pice of medical equipmant I once had a guy trying to reject it because an illuminated mains on/off switch with the O of the | symbol for on and off on it had the O symbol too oval.
The fact that the switch illuminated green when on was sufficient indication.
I told him that if he could tell it was supposed to be a O then it was obviously ok and wasn't too oval. Conversely if he couldn't tell that it was a O then it was obviously just a 'decorative feature' and thus not a failure as the illumiation was the thing providing indication.
You can immagine how many hours and phone calls the exchange took.
Del

__________________
health warning: These posts may contain traces of nut.
Reply
Guru
Technical Fields - Technical Writing - New Member Engineering Fields - Piping Design Engineering - New Member

Join Date: May 2009
Location: Richland, WA, USA
Posts: 20945
Good Answers: 779
#2
In reply to #1

Re: A Call to Discard the Device Approval Process

08/11/2011 4:33 AM

Just out of idle curiosity, what was the aspect ratio of the offending oval?

(If large enough to make it look like another I, that might be a problem.)

__________________
In vino veritas; in cervisia carmen; in aqua E. coli.
Reply
Guru
Popular Science - Weaponology - New Member United Kingdom - Member - New Member

Join Date: May 2007
Location: Harlow England
Posts: 16498
Good Answers: 661
#3
In reply to #2

Re: A Call to Discard the Device Approval Process

08/11/2011 5:08 AM

You are just teasing me now.
The bright green light was a good clue of when it was on.
It was a like a 0 not a O.
The only way it could possibly be a problem is if the symbols were raised and it was intended for use by someone blind, however the symbols were not raised and I expect there are special symbols for the blind.
Del

__________________
health warning: These posts may contain traces of nut.
Reply Off Topic (Score 5)
Guru
Hobbies - CNC - New Member Popular Science - Biology - New Member Hobbies - Musician - New Member

Join Date: Dec 2008
Location: Canada
Posts: 3498
Good Answers: 144
#4

Re: A Call to Discard the Device Approval Process

08/11/2011 4:37 PM

The trouble with the 510(k) process is that devices are approved on the basis of "substantial equivalency" to previously approved devices, without being tested.

It's not hard to see why this would lead to problems. Some other device was tested and the 'substantially equivalent' one approved afterwards does not have the same specs. Failures for medical devices can have injurious consequences, so by all means, testing should be rigorous.

In some cases, "substantially equivalent" products were approved on the basis of prior approved products which had not been tested in the first place! Yummy.

Obviously Del's example of the switch is the opposite of this! This is someone wanting a 'cosmetically' identical product in a way that has nothing to do with safety or effectiveness. Now, if the cosmetic nitpickers could be transferred to the 510(k) department where they belong, and put the happy rubber-stampers in charge of 'how oval can the O be' we'd all be better off...

__________________
incus opella
Reply
Guru
Popular Science - Biology - New Member Hobbies - Musician - New Member APIX Pilot Plant Design Project - Member - New Member Hobbies - CNC - New Member Fans of Old Computers - ZX-81 - New Member

Join Date: Jan 2007
Location: Centurion, South Africa
Posts: 3921
Good Answers: 97
#5

Re: A Call to Discard the Device Approval Process

08/12/2011 10:44 AM

Maybe artsmith or someone can help me out here

Some time I went in for a TURP, they used a GYRUS 744200.

At first " thought it was great , I was out of hospital on the third day , with no pain or discomfort.

But the improvement was not that spectacular.

I did a search and found

The Total Product Life Cycle 2007 - 2011 obtained from the MAUDE adverse effect reports to the FDA show 1 Death , 26 injuries , 232 malfunctions & 23 other. 2011 only show 2 incidents.

Some batches were withdrawn.

My questions are :

Did it improve over time or did they stop using it?

Are the failure rate low, high or medium?

Is the MAUDE reporting system trustworthy?

__________________
Never do today what you can put of until tomorrow - Student motto
Reply
Guru
Hobbies - CNC - New Member Popular Science - Biology - New Member Hobbies - Musician - New Member

Join Date: Dec 2008
Location: Canada
Posts: 3498
Good Answers: 144
#6
In reply to #5

Re: A Call to Discard the Device Approval Process

08/12/2011 12:59 PM

Is the MAUDE system trustworthy?

From the FDA page:

"MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices."

No trustworthiness claims are made for the MAUDE system, on the contrary.....

There are only four results to a search for clinical studies on TURP GYRUS outcomes listed in PubMed to date. They indicate that GYRUS results are similar or better to monopolar, but that more studies may be called for. The simple search for TURP GYRUS returns 26 articles; 'TURP GYRUS device failure' and 'TURP GYRUS adverse events' returned no results, so there's nothing to indicate serious concerns about the device in medical practice. The MAUDE data may be the only available record of failures or malfunctions, at this point in time, except insofar as they may be reported in the individual studies under the search.

If some batches were withdrawn, it seems likely that a defect was identified and corrected. I would expect that the 2010 record would be your best gauge of the current state of affairs, since 2011 is only half through and it probably takes time for such reports to be made.

__________________
incus opella
Reply
Reply to Blog Entry 6 comments
Interested in this topic? By joining CR4 you can "subscribe" to
this discussion and receive notification when new comments are added.
Copy to Clipboard

Users who posted comments:

artsmith (2); Del the cat (2); Hendrik (1); Tornado (1)

Previous in Blog: Form Follows Function Follows Safety   Next in Blog: Rescued by the Phone

Advertisement