3/10/10

A Check on Accu-Chek - Fun and Games with FDA Filings

Every month the FDA releases a list of medical devices they have cleared through the Premarket Notification process. This is also known as PMN and 510(k) but what’s in a name anyway?

This often seems little more than a paper game of claiming a device is substantially equivalent to some other device so it should be allowed to be marketed. Looking over these I get the feeling sometimes the documentation may as well read, “Hey we are no worse than that thing!”  That basically is the standard folks, I aint saying it any better but ita aint no worse.

OK maybe I exaggerate. Or maybe not. You be the judge. Here are some humorous diabetes related 510(k) filings recently released:

The OK Meter:

No pretentions of greatness at all. It is just OK. But wait while merely aspiring to be OK they do manage to hose the user with dual strips. 

I can just see the sales material. Our meter is ordinary, just… well… OK. But that not all with TWO strips you are twice as ordinary!
DEVICE: OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090609.pdf


As long as you can see - listen to this, “This meter has some speaking functions but is not intended for use by the visually impaired.”
DEVICE: MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093635.pdf
Not to be confused with ezManager Max, there is the EasyMax meter.
DEVICE: EASYMAX V  SELF MONITORING BLOOD GLUCOSE SYSTEM
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092894.pdf

Want to test you blood and you blood pressure with the same device. We got it baby. (Does the BP meter squeezing the arm make it easier or harder to get blood out of your finger?)
DEVICE: ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093592.pdf

I have saved the best for last – from the Home Head Office Bureau of Backup Redundancy Department, located on Street Road, this is my favorite bit of dual double speak.

They named their product to sound like someone else, claim substantial equivalence to that other product based on the “same working principle” and then point out the test principal is a difference. 

http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082965.pdf
They say:
A claim of substantial equivalence is made to ACCU-CHIEK Aviva System
(k043474). Both of them have the same working principle and technologies.


Followed by: 



That all seems like silly fun and games but what if some kindly but some what befuddled by alliteration type comes along and confuses their A-Check for an Accu-Chek and puts the wrong strips in their meter?

Not so much fun. Come to think of it I would be pissed if I were easily confused. Oh wait I am.

3/8/10

Love Ya / Mean It Sarah



LY/MI Sarah.

Sarah is one of my good friends over at CWD. Our daughters are the same age and as a result we tend to hang out at Friends for Life. Sarah wrote on D kids eating like they would if they didn’t have type 1 and ‘just’ cover it with insulin.

Sarah took this to a different level and I am so very impressed by how well she expresses a long term holistic approach that is so very hard to see in day to day variations. No where in this does Sarah suggests it is easy. It isn’t.

She wrote:
I think that the truth about food and D is far more nuanced than most of us really like to admit.

I'm a very big advocate of letting D kids be kids first and people with a chronic metabolic disease second. I have always allowed Maddie to have regular kid food. I want her to have a healthy attitude about food. I want her to able to enjoy social and communal eating. I want her to enjoy preparing good food and trying new things.
I hope that through being a broad omnivore she will come to have the sort of relationship with food that should she decide as a teen or an adult to follow a less carby, less refined diet than the average person, she will be doing so from a place of knowledge rather than with a sense of deprivation.


What I'm getting at, is that I believe that it would be easier to maintain minimal glycemic variability in an adult through eating a lower carb, high veg. high fiber, lean protein diet. But I believe that the path to this diet is through exposure to lots of foods and developing a smart palate, not through limiting a kid's food choices now.
Wow!

That certainly isn’t ‘just’ giving insulin. I find there is vast complexity to balance. Balance is beyond science. It is an art form. An art that families living with type 1 can appreciate but few others even know exists.

In fact the better families are at this odd art the more invisible it becomes to others. Here Sarah eloquently points out that the art of balance goes well beyond carbs, fat, activity and insulin. She brings into focus a longer term idea of balance. Even when we get all the day to day stuff right, there are developmental, emotional and maturity complexities to consider that are difficult enough without a chronic condition. Sarah - "nuanced" is an understatement.

Type 1 care is a daily juggling act with implications that touches far more than any one blood test. I salute all of you who practice the art. Its beauty is seen in the joyous lives people living with diabetes and little external sign of the effort their normal takes.

Love Ya / Mean It Sarah. You're and artist.

3/4/10

Declaration of Preauthorized Independence

Inspired by K2's tweet:

When in the Course of human events it becomes necessary for one people to dissolve the preauthorization form which have connected them with another and to assume among the powers of the earth, the separate and equal station to which the Laws of Nature and of Nature's God entitle them, a decent respect to the opinions of mankind requires that they should declare the causes which impel them to the separation.

We hold these truths to be self-evident, that all people are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. — That to secure these rights, Health Care Systems and Insurance are instituted among us, deriving their just powers from the consent of the insured, — That whenever any Dysfunctional System of Health Care becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Insurance, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness. Prudence, indeed, will dictate that Insurances long established should not be changed for light and transient causes; and accordingly all experience hath shewn that mankind are more disposed to suffer, while evils are sufferable than to right themselves by abolishing the forms to which they are accustomed. But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Insurance, and to provide new Guards for their future security. — Such has been the patient sufferance of these Colonies; and such is now the necessity which constrains them to alter their former Systems of Insurance. The history of the present Insurance System is a history of repeated injuries and usurpations, all having in direct object the establishment of an absolute Tyranny over these People. To prove this, let Facts be submitted to a candid world.
  • It has refused to Assent to Laws, the most wholesome and necessary for the public good.
  • It has forbidden It Governors to pass Laws of immediate and pressing importance, unless suspended in their operation till its Assent should be obtained; and when so suspended, It has utterly neglected to attend to them.
  • It has refused to pass other Laws for the accommodation of large districts of people, unless those people would relinquish the right of Representation in the Legislature, a right inestimable to them and formidable to tyrants only.
    It has called together lobbyist to legislative bodies at places unusual, uncomfortable, and distant from the depository of their Public Records, for the sole purpose of fatiguing them into compliance with its measures.
  • It has erected a multitude of New Offices, and sent hither swarms of Officers to harass our people and eat out their substance.
  • It has kept among us, in times of peace, Standing Armies of Cliams Adjusters without the Consent of our legislatures.
  • It has combined with others to subject us to a jurisdiction foreign to our constitution, and unacknowledged by our laws; giving its Assent to their Acts of pretended Legislation
  • For quartering large bodies of paper pusher among us:
  • For protecting them, by a mock Trial from punishment for any Murders which they should commit on the Inhabitants of these States:
  • For cutting off our Trade with all parts of the world:
  • For imposing Co-pay on us without our Consent:
  • For depriving us in many cases, of the benefit of Treatment prescribe by out Doctor:
  • For abolishing the free System of Simple English rules, establishing an Arbitrary government, and enlarging its Boundaries so as to render it at once an example and fit instrument for introducing the same absolute rule into these Colonies
  • For taking away our Charters, abolishing our most valuable Laws and altering fundamentally the Forms of our Governments:
  • For suspending our own Legislatures, and declaring themselves invested with power to legislate for us in all cases whatsoever.
  • It has abdicated Government here, by declaring us out of its Protection and waging War against us.
  • It has plundered our seas, ravaged our coasts, burnt our towns, and destroyed the lives of our people.
  • It is at this time transporting large Armies of form Mercenaries to compleat the works of death, desolation, and tyranny, already begun with circumstances of Cruelty & Perfidy scarcely paralleled in the most barbarous ages, and totally unworthy the Head of a civilized nation.
  • It has excited domestic insurrections amongst us, and has endeavoured to bring on the inhabitants of our frontiers, the merciless Pre-Existing Conditions whose known rule of warfare, is an undistinguished destruction of all ages, sexes and pre-existing conditions.
In every stage of these Oppressions We have Petitioned for Redress in the most humble terms: Our repeated Petitions have been answered only by repeated injury. A Prince, whose character is thus marked by every act which may define a Tyrant, is unfit to be the insurer of a free people. Nor have We been wanting in attentions to our Insurance brethren.

We have warned them from time to time of attempts by their legislature to extend an unwarrantable jurisdiction over us. We have reminded them of the circumstances of our emigration and settlement here. We have appealed to their native justice and magnanimity, and we have conjured them by the ties of our common kindred to disavow these usurpations, which would inevitably interrupt our connections and correspondence. They too have been deaf to the voice of justice and of consanguinity. We must, therefore, acquiesce in the necessity, which denounces our Separation, and hold them, as we hold the rest of mankind, Enemies in War, in Peace Friends.

We, therefore, the Representatives of the People With Diabetes, in General Congress, Assembled, appealing to the Supreme Judge of the world for the rectitude of our intentions, do, in the Name, and by Authority of the good People of these Colonies, solemnly publish and declare, That these united Colonies are, and of Right ought to be Free and Independent States, that they are Absolved from all Allegiance to the Insurance Crown, and that all for  connection between them and the State of Industry Double Talk, is and ought to be totally dissolved; and that as Free and Independent States, they have full Power to levy War, conclude Peace, contract Alliances, establish Commerce, and to do all other Acts and Things which Independent States may of right do. — And for the support of this Declaration, with a firm reliance on the protection of Divine Providence, we mutually pledge to each other our Lives, our Fortunes, and our sacred Honor.

3/3/10

Sixteen Spice Salute

I came home to a box from the spice store. Mixing is the beginning of many things good. I think it is safe to say Bobby Flay's 16 spice is the cornerstone of my cooking.




Great on pork. Brilliant on chicken that gets poached in orange juice. I had run out and life was getting dull. Much happieness.

Mixing it up makes the house smell great.

Thanks Bobby!

2/21/10

Axle. We don't need no stinking axle.

We had a little issue driving to church today. Apparently this is meant to be one piece not two.

Missed chruch.



- Posted using BlogPress from my iPhone

2/17/10

K & K2 LYMI

I think in some cases I need to be sure no good deed good unpunished. In one of my more Zen posts I wrote:
I am happy to point out two lovely ladies who helped me get the honoring bit there straight. I trust this is not trite praise.
I have learned that looking at somebody who is struggling and honoring their suffering without giving them some trite formula is often little more than the courage to share my own experience without any expectation of return. I love the people who have showing me how to do that. To a woman and man none claims to be a perfect diabetic or parent. They simply shared their daily triumphs and challenges. They honor each other’s struggles and in doing so are simply human to one another.


Kerri is the Diabetes Online Community’s Queen of sharing the daily joy s of life. She has enriched us all in the process. Be afraid Kerri I have plans. But until I manage to get my maniacal plot hatched I encourage y’all to join her for a webinar on February 24, at 8pm as a way of saying thanks and probably laughing and learning too. The particulars are HERE.

K2 aka Kelly Kunik hit the big 5-0 - Fifty thousand visit to Diabetesaliciousness! She is rightfully proud. While she doesn’t want to sound like a schmuck about it, nobody has ever accused me of dignity. I am happy to shill the living daylights out of her accomplishment. Go to her blog and pass on some congratulation and thanks. She has the grace to honor struggle without trite formulas.

K & K2 Love Ya / Mean It

Backward Ho!

When I was a wee lad, way back when dinosaurs roamed the earth, I traveled across the country in a motor home. Yes it was so long ago they weren’t even called recreational vehicles yet. We were in a group with a few other families. My Uncle Jack aka “the Moose” aka “Uncle Moose” was our fearless leader. He may have been one of the aforementioned dinosaurs. (I mean that in a loving old school rocks kinda way.)

We hit all your name brand National Parks and some lesser scenic venues. When it was time to go The Moose would holler, “Backwarrrrrrrd HoooooOoooooo!” Kids would come running and scrabble into their respective vehicles and the caravan pulled out to new adventures. The call was a satire of the old pioneer wagon train movies’ ‘Forward Ho.’ It was always funny because Uncle Jack sold it and the scramble was a spectacle we reveled in producing with him.

The Moose has been leading motor home caravans to your name brand National Parks and lesser scenic venues of the Great Beyond for decades. Yet his call of Backward Ho seems to have taken hold with the purveyors of connected and mobile medical devices.

Sadly they haven’t figured out Uncle Jack was all about the next adventure and was kidding with the backwards bit.

My feed reader tries to keep track of what is news in the medical mobile wireless connectivity world. I want it to find the Holy Grail of diabetes data management - software that is worth using. It would get all the various diabetes toys to play nice at the scenic overlook and come scrambling sharing information at the first call. Here is the kicker the toys should just do it so we don’t have to. Then make some kind of useful suggestions. No Holler needed.

My feeder gives me tons of articles to read. Blood glucose get mentioned a lot of these articles so does the Continua Health Alliance. Alert YDMV readers may notice I have written about Continua before. This week the news is all about how GSMA (a cell phone innards association) is partnering with Continua.

Sounds like progress right? So what does it have to do with The Moose?

Simple, we are going backwards. You know that Health 2.0 bit where health care consumers have a voice? Amy has written aboutHealth 2.0 saying:


“I’ve spoken and written a lot on Health 2.0 myself, and when people ask me what the term means, I usually give them this simple two-part explanation:

1) Health 2.0 is where new, interactive web technology meets a new, more patient-centered approach to healthcare. It’s giving people access to tools and information they never had before, to empower them.

2) It’s about changing the engagement model with healthcare providers, so that “the medical establishment” treats patients more like partners in their own care.

Sadly this not what my reader is telling me. Patients as partners is not part of the mobile e-patient plan. Backward 1.0!

Development is very much a function of trade associations of Big Honking Companies. I once asked Continua, 'Where do patients fit in?'

They said, in essence, the Big Honking Companies employ a lot of people. They want to take care of those people and that is how consumers get represented. Oh and they want to keep their health cost in check so electronic records are awesome. I may be over simplifying a tad but not much.

To all you Big Honking Companies out there, the Holy Grail is about collecting our data and providing us with actionable information to help self manage. Our use of the stuff you see as brands, franchises and annuity streams from consumables is a function of you partnering with us as we self manage.

Forward 2.0