The kinder, gentler FDA

Things I learned the other day:

Some cosmetic companies promote their products with claims such as "CRUELTY-FREE" or "NOT TESTED ON ANIMALS" in their labeling or advertising. The unrestricted use of these phrases by cosmetic companies is possible because there are no legal definitions for these terms.

There are no Federal standards or definitions that govern the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA.

Cosmetics is a whole different world, I think I'll open up a shampoo company.

Disgruntled former employees

This rant against a testing lab came up in one of my news feeds. I won't discuss the complaint specifics, but I will say that in my experience the testing lab in question has done an acceptable job for us in the past, although we never audited them. This is a touchy subject, but I will plow ahead and hope no one takes what I say the wrong way. Pretty much every time someone quits a regulated company there is a chance of the former employee calling the regulators. Generally it turns out that the employee does not know as much as they think they do or that the regulators don't listen.

It would be much more beneficial for everyone involved if the employee tried to work it out within the company, even if they fill out 17 corrective actions on the last day, I would be cool with that- the company would rather know what needs to be fixed (or is perceived to not be working) than not know (plus I'm not the one following up corrective actions). The vast majority of companies are very concerned about patient safety and go above and beyond requirements.

If you are a disgruntled employee, I suggest you evaluate the problem again and make sure you're correct, talk to the person responsible, then management, then start a corrective action (you can switch those two up depending). I assume that most companies are set up where anyone can start a corrective action, although this might just be a small company thing. Once you get to that point, you're pretty much powerless to do more within the company besides complain, but the corrective action forces the issue and someone is required to document how it is being handled. If none of this works and you are certain that regulations are being violated and patient safety is in danger, then be the whistleblower.

If you are a disgruntled employee and don't know what a corrective action is and everyone is ignoring you, what you want to do is run it by two quality people at the same time, then get a copy of the quality manual, which you were probably trained on your first day, and read up.

Document Control Roundtable 6/25/08

I will be staying up late for this Document Control and Records Management in Regulated Environments meeting on Wednesday night. If you want to say hi I'm the geeky looking unshaven guy with the totally hot wife. Yes my wife is going and is in the medical device quality field- the fun discussions we have!

58 is too young to die

Unless you've been living under a rock the last week, you now know that Tim Russert has unexpectedly died at age 58 of a heart attack.

WebMD describes the condition:

That's when the bottom chamber [of the heart] beats at 400-600 times per minute, has no effective blood flow to the brain, you black out, and then, unless it's reversed, you die in three to five or seven minutes or so. This is the rhythm that's treated with an external defibrillator, and had one been available and used, it's certainly possible that he could have been resuscitated.

While Health Blog goes into some more details:

None of that prevented a cholesterol-laden plaque from rupturing while he was doing voiceovers Friday morning for this Sunday’s edition of Meet the Press. The resulting clot, an autopsy indicated, apparently caused his heart to go into ventricular fibrillation which led to cardiac arrest. The autopsy also showed he had an enlarged heart–a manifestation of coronary disease.

This report from the New York Times indicates efforts to revive him through CPR were almost immediate, followed by unsuccessful attempts at defibrillation when an ambulance arrived.

It sounds like he received about the best treatment that can be reasonably expected (CPR then the defibrillation when the ambulance showed up) and presumably had good care leading up to this (some thoughts by others at Kevin, M.D. blog). Although defibrillators are more common than ever, I think the odds of someone recognizing that one is needed within 5 to 7 minutes is pretty low. If some good comes of this, I imagine it will be more defibrillators, more people who at least can potentially recognize when one is required and the limitation of stress tests. Although now every negative stress test might lead to patients demanding cardiac catheterizations and that is not necessarily a good thing.

Photo from Wikimedia Commons.

New medical device discussion board links

I've added The Cove, ASQ Discussion Boards, and CR4 Forum: BioMech & BioMed to the links. I think reading them even counts as work!

UPDATE: I've also reorganized the links on the right side to incorporate some of Blogger's new features.

Materials handling- contaminated product & paper based document system

The ISO 13485 auditor picked on us for not having a procedure for dealing with returned product that was contaminated. Fortunately, MD&DI was on top of this issue in a John Lincoln article in 1999.

Also there is a request to reorganize the design history file (DHF), device master record (DMR) and the "technical file". Is it too late to get a summer intern?

We're also trying to switch from a paper based documentation system to an electronic one. This seems to be fairly popular in the quality department, but it is actually more work for them. They still have to file away the master copies with the signatures and now they have to make sure the electronic versions get put in the right place. I'm all for it, but I'm confused by their uncharacteristic willingness to do more work. The main debate is do we do it going forward as we need documents or is someone going to scan them all in. I think its a little ridiculous to not just scan them all in now and be done with it, it will save time in the long run, but I think I'm going to lose that argument. Thats fine, it better be worded very carefully or I'll bide my time until I can write up a corrective action when I can't find an electronic document I need.