Thursday, February 14, 2008

Letters Of Warning

The fellow that wants to sell us a Hawkeye so bad he can taste it sent out a press release the other day to just about everyone in my state that has anything to do with Nuclear Medicine. Except for me, of course. I've since seen the same release at a dozen other sites, including AuntMinnie, and it's probably common knowledge by now. No doubt its viral spread has been assisted just a little bit, so I'm not reporting anything new here. Within the press release is a link to the FDA that shows a copy of a letter to Siemens noting a software problem with PET/CT's installed prior to July, 2006. I won't quote the whole thing, but in essence there have been 4 complaints about the computer pulling the wrong PET to go with the wrong CT. Siemens fixed the problem, but didn't do proper risk analysis and according to the letter didn't actually issue a software patch. The letter goes on to say that Siemens has significant problems with their complaint process, and so on. The letter used the term "adulterated" which means that Siemens isn't completely conforming with with the "Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820)." That means that they haven't addressed completely the concerns in the remainder of the letter.

Now, I won't tell you that this isn't serious, but we do have a Siemens PET/CT that was installed January, 2005, and we have not had the problem described. Frankly, it would be very obvious if the wrong PET image was trying to mate with the CT (get your minds out of the gutter!) as the activity in the various hypermetabolic organs would not match. We just haven't had this happen. (I found a reference to a SPECT/CT with a similar problem.)

The press release noted a second letter to Siemens within the past month (actually it was more accurately the prior two months) concerning their use of some marketing hype about the vascular software on some of the Siemens/Accuson ultrasound scanners, the Arterial Health Package, or AHP. It sees that Siemens didn't bother to obtrain marketing approval or clearance for the AHP, just the scanners themselves. So, selling the scanner with the AHP is illegal, and the scanners are "misbranded" and "adulterated".

And Siemens is working on fixing these problems ASAP. According to AuntMinnie:

A Siemens spokesperson said the company is working to comply with the requests in the letter.

"Siemens formally responded to the FDA to inform them of corrective actions to address the issues," said Tom Schaffner, Siemens Medical Solutions manager of media relations, in an e-mail to "Most of these actions have already occurred, and some necessary software updates are currently being tested that will be applied as soon as possible. With its warning letter, the FDA is now requesting detailed documentation of these corrective actions."

It is said that those who live in glass houses shouldn't throw stones, and that maxim is true here as well. It seems that my favorite larGE company has had some wrist-slaps as well. And in fact, they too received two letters, although these were just under nine months apart, much less embarassing than receiving them six weeks apart. I wonder why our caring salesperson has never sent us press releases about these particular letters of warning.

The letter from November 16, 2007, concerned a malfunction with an R&F room. Specifically, "(d)uring testing in both rooms on September 27, 2007, x-ray production was possible when the primary protective barrier was not in position to intercept the x-ray beam as required by 21 CFR 1020.32(a)." I could find no response as yet. At least the machine wasn't adulterated. The second letter of warning is from February 22, 2007, and had to do with a problem with MRI coils and breast biopsy plates. It seems that some of these were indeed "adulterated" in that they did not conform to the Current Good Manufacturing Practice, etc., etc. The biopsy plate sterilization process wasn't validated, although there was an adequate response to the FDA on this. There were coils shipped without verification and validation. There was identification of "soldering problems" as part of manufacturing errors, but inadequate documentation of how this was to be corrected. There was also an inadequate complaint mechanism.

No doubt these problems are fixed or being fixed as well.

Personally, I'm going to monitor the FDA website more closely. Press releases and word of mouth from the sales staff might not be adequate to inform us of the foibles of our vendors. But I'm sure glad that some are ready willing and able to keep us informed. . . about their competition, anyway.

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