Reusing single use medical devices

Due to a WSJ article based on a GAO report, reusing single use medical devices, is a somewhat hot topic lately. Key phrase from the article is right here:

AMDR, the reprocessing group, is fighting efforts to require that patients go through formal informed-consent processes. Mr. Vukelich says informed consent is meant for experimental treatments and clinical trials, and not for devices that are legally marketed and approved by the FDA.

The sterilization of reprocessed is probably validated, but it doesn't sound like the performance of reprocessed devices is, I wonder what kind of traceability is required for these devices. I don't see how you can hold the device manufacturer responsible for any problems that come from a reprocessed device since it is basically an off label use. I'm not sure that is a good deal for about 50% off the cost of the devices listed, a saw blade or tourniquet is one thing, but an ultrasound catheter?

It should also be kept in mind that some of the high cost of these devices comes from the regulatory burden placed by the FDA on these products. Some of the cost savings of reprocessing come from letting the reprocesser skip some of these. Why not ease the regulatory burden on the original manufacturer if it is safe to do so? Maybe someone should make a saw blade labeled for zero-use, then reprocess it and see how the costs work out.

Update: A good article on the subject from Halifax Personal Injury Lawyer Blog.

Quality System Auditing

I got tasked with heading up a quality system audit before an ISO audit scheduled to happen later this month. We also have an upcoming State of California visit due to our facility move. This audit we're doing now is actually the first quality audit our company has done not performed by quality personnel- unless you count previous state audits. I think I need to learn how to be grumpier about non-engineering work, my "somewhere in the world there is a medical device company where engineers are doing product development work and we're competing with them" line isn't working. Anyway, we had a meeting, divvied up the areas for each person to audit and we're reporting back this coming week to write up corrective actions as part of the CAPA portion of the quality system.

As a company we're relatively new at this so I know it is going to get contentious with some blame games being played, but hopefully I can head that off by not putting up with it. We are at point A and need to get point B, we need to move forward, going back doesn't get the problems fixed. If management wants to examine the problems more deeply, that is entirely up to them (and obviously management is part of the audit), but it doesn't gain anything for us to sit there and discuss what happened in the past for each item. The problems all distill down to the same two or three issues (I thought he was doing it, no one told me to do it, etc.) anyway, all of which are fixed by doing the audit and corrective actions.

For now we're just going through each SOP on a line by line basis and making sure we're doing what we're saying. Our quality system is a patchwork of procedures that mostly came from other companies that various quality consultants worked for at one point in time. A few years ago the system was traceable to the QSR, but that hasn't been checked lately and is something someone will have to go through in the future to make sure we didn't miss anything. Every item found that we're not doing generates a corrective action, no excuses are tolerated. The corrective actions are documented and clearly designate someone in charge and a time line. This ensures that problems get taken care of, instead of "Oh we were going to do that, but never got around to it." After that a re-audit is required. The quality system isn't rocket science, but some people seem to have a very hard time with it.

Medical device blog update

I added Navigating through R&D Projects to the links list, hopefully he doesn't mind the attention. I like his groupthink remedies. This brings the number of medical device blogs I know about to six or so.

Update: it is now apparently shut down.

Moved the company

We moved our happy medical device company down the road and I've been spending my time working on projects related to moving. Thrilling stuff, like changing the address on labeling and other documentation, not to mention tracking down various missing items. The cleanroom was moved and the floor done, electricity hooked up, next the whole cleanroom will be scrubbed, the filters turned on and all the furniture will be cleaned and moved in. Then it will be given a few days before its certified and the bioburden checked.

Once that is done we can get started doing installation qualifications (IQ) on the manufacturing equipment. After that we are planning on redoing any validation that involves a manufacturing procedure, but not revalidating things that involve material properties for example. Since the validations require sterile product made at the new facility, away we go. I've written enough validations the past six months I think I could work them up in my sleep. It actually feels like running in place and I think company morale is low due to lack of cash bonuses.

I have a few other projects I work on when I have time, but it is going to take a while to get back to normal after the move. I can only imagine what a nightmare it would be moving a mid-sized or larger company. Although overall it is a good thing as it means the company is doing well enough to expand and grow.

Stop Talking. Start Doing.

Creo Quality has a post titled Stop Talking. Start Doing. That is pretty much how I feel 15 minutes into a meeting that lasts two hours and I knew what was going to be said before the meeting. So I just sit there quietly and nod because I've learned that if you just get up and leave when you feel like your time is being wasted or you say as much- people consider you not a "team player". Not that I hate all meetings, I just feel many a morning or afternoon has been wasted because someone doesn't know what they want or just likes to hear themselves talk.

Photo by Stephen Orsillo.

510(k) filed

Our company finally managed to file our 510(k) with the FDA last week and of course I have some random thoughts about the whole thing, I also have planned a big toot my own horn post later. It took approximately two years and $10 million (very approximately on that number) from concept to filing of a disposable and the (non-disposable) electronic controller "me too" device (filed as one 510(k)). There are still some kinks (mostly software) to work out before we are ready for clinicals- but we are pretty close.

In our case, I think it may have been possible to cut costs by 30% or so, but hindsight is 20/20. If we stuck to the long term vision, that could have saved us money. For example, the software guy was rushed to get a working demo up and going early on to show off to an interested third party, then had to go back and reprogram a lot from scratch as the demo didn't have the proper coding structure. Additionally, better management of some consultants could have saved us money and time. I don't think it is insulting to have a consultant doing an hourly or four hourly log sheet and then checking it every now and then against work done, at least for new consultants. Asking them to do mundane things that an assistant should be doing is also not the greatest idea, of course they are eager to do it, they are making $80 an hour + expenses to drive across town and pick up that stuff.

The software turned out to be the hold up and better planning could have saved us a good amount of time. Having an engineer working on just software issues would have helped, having weekly meetings with everyone involved didn't always help because the software guy wasn't able to prioritize correctly. The basic functionality must come first, the screen layouts and some other minor things are just too tempting for some people not to lay off of.

The last device I worked on the disposables packaging was a major problem, and I'm happy to say we managed to avoid most of that this time. The packaging is hard to do (IMO) because you really can't simulate EtO sterilization unless you actually EtO sterilize something and that will cost you probably at least $10,000 and a month and a half. We did the best we could, running the shipping simulation and the sterilization (time, temp, humidity) conditions beforehand, but I still notice some different effects when compared to the actual sterilization.

Getting FDA approval is the next step, but I'm not overly worried about it, the FDA is generally not unreasonable (in my experience) and honestly, the most likely outcome, one set of questions then they require clinical trials before final approval, would benefit the company in a number of ways. I think the hardest part will be after that, selling these things, doctors and nurses are keen on new devices and competition in general, but getting them to actually buy from the new guys is a different story.

Experienced medical device personnel

Can a small company hire experienced device personnel? I've had this discussion with a couple coworkers in the past few weeks regarding our company- keep in mind we're in the bay area with lots of device companies. I think any company with less than 30 to 50 employees is going to have a hard time hiring medical device experienced engineers, quality, and regulatory people. From my experience these guys are in high demand and (in general) a small company has to throw a lot of extra cash at them to get quality candidates to consider working for a small company. Stock options may also work, but the person might still bail if they don't see them being worth anything soon. I say in general because there is some chance something may work out because of location or some other factor.

What is a small company to do? They basically have three options, (1) do without while you grow/train someone up, (2) get a consultant, or (3) throw cash at someone. IMO, doing without even while you train someone is more likely to get you in trouble than a consultant. At least make sure you are training the right person. Hiring consultants is the most popular way things are done, but again, in my experience, ~50% of them are a waste of time and money (part of this might be due to bad management practices). It also looks a little odd if your VP of Engineering or something along those lines is a consultant. Sorry medical device company owners, but my preferred option is throwing cash at someone, I believe it pays off in the long run. Of course, you also need to have an environment they can do well in, if you hire a experienced quality person, then constantly don't listen to him/her, you might as well have picked option 1 and just have your way with someone who doesn't know any better.

That being said, I enjoy working for a small company because you have an impact and feel more people should give it a chance. At one point my boss was designing a bracket as his entire project. At the small company I work for now, a bracket isn't something we'd spend a lot of time on, maybe a day.

The placebo effect.

Manifest Density posts this entertaining thought:

From Derek Lowe's blog:

The actual mechanism of the placebo effect is a field of great interest and potentially great importance.

That's right: someday soon scientists may be working to develop a pill that can mimic the placebo effect.

I wonder if we can get that as an indication for use? That would be very difficult to prove though.