Devices

Where does the time go? I was looking at my calendar yesterday a few weeks back and I had so many plans for January. Now I have to shift all those plans to February. Or the rest of the basement and the dining room will never get painted.

The biggest plans for this week are for devices:

First I am getting a CPAP machine today. I am not looking forward to it. I have no idea if I will be able to sleep with something on my face. But if it makes me sleep better I am happy. Sleeping better can help you lose weight and feel rested. I would be happy with either result. I get the machine today and have to pay a total of about $200 over the next 9 months to pay for it which isn't bad. But if it doesn't work out for me I can return it.

The other device is a mini TENS machine for pain relief. Yesterday, I was a sucker and fell for a sales pitch at a Home Show for a Magic Massage Ultra from Enovative Technologies.

Its tiny. It comes with little pads that I can put on my body anywhere it hurts. It seems to have helped a bit already. I got a deal but I do feel like a sucker for falling for a sales pitch. But if it can help me reduce pain in areas, I'm willing to try it.

It even came with 'slippers' that I can use on my feet (but you can't walk in them). Otherwise its about the size of an old iPod Nano so I can stick it in my pocket and walk around the house with it on. Right now its on my shoulder which is a bit sore today.

So I am taking advantage of technology to help me be healthier. I am already living better through chemistry due to the amount of pills I take. So this is just the next step.

Crowdfunding

So crowdfunding is a great concept. It helped get a friend's son injured in Thailand home in a first class seat when he was too injured to sit in a regular seat. It helped numerous independent movies get started. It can raise funds to help a family displaced by fire or other disaster.

But what about crowdfunding medical device design and start up? I would never have thought of that. I prefer my crowd funding to go to individuals and not to companies, especially overseas companies which makes me feel there is little or no recourse to get my money back or new product.

What I find a tad scary is companies are using crowd funding to fund the design and meet FDA approval requirements. So even if you think the concept is awesome, why are you prepaying for something that may never happen - and may end up with the 'As Seen on TV' label.

But now it seems companies are crowdfunding their new medical devices. Maybe it may make them get to market sooner but it doesn't speak to the company's financial stability. If you give them money to get off the ground, how are they going to continue to be solvent as the product develops? And what if they need to make multiple modifications to get approval? Will they continue to crowdfund? Go back and ask everyone for more money?

I kind of get the heebeejeebees on this one.

I'm not that standardized

Here's a new proposal. Give surgeon's a black box to help prevent medical errors, like they have in air planes.

The proposal:

"Inside the operating room, video cameras track every movement. Outside, a small computer-like device analyzes the recordings, identifying when mistakes are made and providing instant feedback to surgeons as they operate.

This is the dream of the surgical "black box." Operations could become flawless. Post-operative complications could be significantly reduced. Surgeons could review the footage to improve their technique and prep for the next big case."

The goal is so a surgeon learns of a mistake when it can be corrected and not after the fact. They get a computer assist. And more significantly they could be adopted in the US without FDA approval as they are not a device or anything.

I'm not saying that I am against improving medical errors or anything. I have myself dealt with a few mishaps in the OR but I do not think the human body is standard enough for this. Each human is unique. That's it. We are all one of a kind.

If someone wants to operate on me, I have many issues - from lack of thyroid, previous surgeries which have left scars, and more. I know they can be programmed into a computer before hand but still.  An individual human being is needed who can interpret the information and unique qualities of the body they have opened up in front of them.

I think of it this way. You are going to a strange place and you program the address into your GPS and start on your merry way. But then the GPS sends you to a road which has a detour and it recalculates around it, so you keep going. It even tells you when you are speeding to give you additional information and recalculates your arrival time. Then it forgets to tell you that the off ramp is on the left and not the right. And then there is an accident ahead so you try to get off the highway and make another detour. And then your GPS sends you down a one way street in the wrong direction.

You needed a human there to guide you to read the signs and notice the detour ahead. Or to tell you about a new problem the patient is having.

A friend had a bad colonscopy and had to have a colectomy. The surgery took much longer than expected because the doctor who removed the polyp at the colonscopy did not note correctly where it was that it happened so the surgeon had to spend quite a bit of time looking for the exact spot. What would that little black box do then? React like the robot in "Lost in Space"? 'Danger, Will Robinson, danger!' That wouldn't exactly prevent much of anything.

There is research going on with these currently in Canada with plans to test them in Canada, Denmark and South America.

But I am really not ready for them to be used on me anytime soon. I would rather have a better trained surgeon than a computer assisted surgeon operating on me.

When medicine goes wrong

How do you undo a surgery? Well you can't restore all the little nerves, blood vessels, tendons and muscles to their pristine  untouched state - that just doesn't work. But you can have implanted thingies removed and replaced with a newer model. But this means the whole mental, financial, physical stress of the original surgery all over again and more. I mean we hear about the cases of the doctors took out the wrong part, or someone received the wrong medication or wrong dose, or got an infection in the hospital. But what happens when its a much bigger mistake affecting thousands?

One example from this morning's news is that a child who received a transplanted blood vessel and two others who received kidneys now all have hepatitis C. These were all traced back to a single donor and a testing error at a tissue bank and some delayed communication. These three people now face lives full of illness. How do you undo that one? You can't. Ever.

But here is a much larger example of medicine gone bad. There was a French company which used non medical grade silicon in its breast implants - silicon meant to be used for mattresses (ick!). The company was stopped in 2010 but there are 30,000 French women with their implants, 1000 of whom have had them rupture so far. The French government is recommending that all 30,000 women have these removed. There have also been 8 cases of cancer possibly linked to the implants and one death.. A rupture is very painful and requires additional surgeries. So the French government has banned them. But the company had made 300,000 implants over the 12 years in operation - some went to the UK and many went to South America and other parts of the world.

The British government is downplaying the cancer risks from these implants and claim they don't have a cancer link. But they didn't mention the risks of them rupturing, recommend consulting with the implanting surgeon if there are concerns and are not recommending removal of this brand of implants.

But BACK UP A MINUTE, a company used inferior quality materials to make medical implants and where are the fines, penalties, lawsuits? I am not a fan of stupid lawsuits but in this case where 30,000 women are going to have to have a second surgery. Even if France's national health care pays for it, that is still a lost cost. What about the emotional and physical strain?

Yoo hoo, the 'morons' (and I use that term loosely, feel free to substitute a stronger word if you want) who made the decision to use the inferior silicon and the other 'morons' who approve them should be held accountable in some way - financially, civilly, and criminally. Some where a long the manufacturing pipeline there was some deception which will cost millions of dollars/pounds/Euros to the general public as well as physical pain and suffering and emotional distress when faced with more surgery.

This is a situation which is relatively scary. I mean it was caught here but what about other cases of this we do not know about elsewhere in the world? Medicine when done wrong is really hard to undo and should be avoided at all costs.

More on medical devices

I've written about this before. If you get a medical device implanted in you and it doesn't work, how do you give it back and get a new one? Hmmm... That's right up there with trying to uncook overcooked food.

Some geniuses (and I use the term loosely) commissioned a report to review the process by which medical devices are approved and regulated. They are now amazed to find out the process needs complete review because it does not look at safety and effectiveness of the devices.

How can a process approve and regulate something if they don't look at safety and effectiveness? And if they are so smart in the first place, why did they have to review the process in the first place? Let me guess, they thought they were perfect and couldn't be wrong and requested the review to prove they were right.

I think my point (and I always need a point) is that if the system is flawed and approving items which are not safe and/or effective, perhaps they should reconsider how they are doing it? If I have a medical device in me, I want to be very sure it is safe and effective. Perhaps the industry should not be about money but about the patients.

Look out - change ahead!

First - mental note to self - it may look like water on the road but it could be ice, which is slippery and will cause you to fall on your butt and cause bruises later on.

We have change ahead and of course there are protests - even though the changes should prove good in the long term. The FDA wants to change the way medical devices are approved. The current system was started in 1976. Times have changed since then. Any system based on information that is 35 years old probably does need a tune/upgrade/replacement. Think of it this way, if your kitchen was 35 years old with no upgrades in the meantime, you might need some new appliances and a coat of paint to say.

But of course the big drug companies are protesting the change. Their lobbying group said: 'they would make device reviews longer and more expensive, hurting innovation and endangering jobs. The group represents most of the largest device firms, including Medtronic Inc., Stryker Corp. and Johnson & Johnson.'

Of course they say that because they have to change and spend money to adapt their business policies. But one of the bigger problems with the 1976 system is there is a loophole that allows the approval of some items that slip through the process.


'The so-called 510(k) system for devices was created in 1976 to grant speedy approval to devices that are similar to products already on the market. It is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing. Hip replacements and drug pumps are among the devices cleared under the system.'

So if a new device is slipped through because it is similar to products already on the market, but if device A went through the approval process and 25 years later and 25 new models later, how similar is the 25th generation product to the original device A? Your IBM selectric typewriter was approved in 1976 and now you are typing on your iPhone. What's the difference?

I see nothing wrong with change. Change is inevitable. We cannot stay the same and expect the word to stay the same. Technology has changed everything as well.