8 min reading time

And 200,000 is the low estimate.

Medical errors will take 200,000+ lives in the U.S. this year.
It’s 3 million lives worldwide.

I attended the World Patient Safety Forum this weekend and learned:
– Medical errors are the third leading cause of death.
– $1.3 trillion = yearly spend on healthcare that harms patients.

President Bill Clinton spoke. See video at http://medgroup.biz/clinton-kiani

There were very few device manufacturers present.

I asked Jim Bialick, president of the Patient Safety Movement Foundation (PSMF), “We’re talking almost exclusively about mistakes that medical personnel make. How are device players part of the solution?”

“There’s a very clear way,” he said.

“Particularly for those that produce products that create patient data. If information can’t flow together, smart tools that… aid in clinical decision making… aren’t as powerful as they can be.”

Masimo CEO and PSMF founder Joe Kiani added, “If you’re making devices that deliver information, make a pledge to share your data with whomever can use it to aggregate the data to improve patient safety.”

You can do that at http://medgroup.biz/safety-pledge. Zoll CEO Rick Packer (also present) was among the first to make that pledge.

I continued the conversation with Joe.

Hage: For device manufacturers, is this all about data?

Kiani: There are other ways: The way they develop their products, thinking about safety, redundancy, human factors; about the hospital so patients are given the right care at the right time.

Hage: Is there an arm to your movement that deals with human factors, instructions for use, easier training, better precautions…?

Kiani: Not yet! That’s a good idea! Come to our June 10th symposium in Virginia, let us know your thoughts, we’ll try to incorporate them.

So if you have an idea regarding patient safety, start with the discussion below and ask me for June 10 details.

You can see the full Clinton keynote and short Bialick and Kiani interviews at http://medgroup.biz/clinton-kiani

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For today’s discussion, is patient safety even on your company’s radar? Do you see it as an opportunity, an expense, or both?

And if you’re presently doing something about patient safety, please share it here. You deserve recognition!

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EVERYTHING IN MODERATION
As leader of the community, I made a difficult but necessary decision to keep our group running smoothly in light of recent changes to LinkedIn’s group platform.

All discussions and comments throughout all Medical Devices Group properties are moderated. While your comments will show up only after I approve them, at least we’ll keep the group spam-free.

Details at http://medgroup.biz/moderation

Note: I check the 300,000+ member group daily, subgroups less frequently. If you need immediate attention regarding your discussion or comment, please email me at JHage@MedicalDevicesGroup.net.

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PANTHERS OR BRONCOS?
Guess the right score for free 10x admission (and boasting rights): http://medgroup.biz/superbowl

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Free webinar today for those selling into EU, Asia/Pacific, and North America: http://medgroup.biz/EPR-compliance-fees

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Jorge Garcia
Principal Science and Engineering Adviser – Medical Devices Branch – Therapeutic Goods Administration
If a manufacturer of a medical device hears of a single mistake that has led or could have led to injury, then that can be filed under user error for future reference. If the manufacturer hears of the same mistake over and over again by a few users in a few facilities, then the error is foreseeable and should be made impossible or at least much harder to make THROUGH A CHANGE IN DESIGN, because it is clear that the existing risk abatement measures (instructions, warnings, etc.) are ineffective. Unfortunately I’ve had to make this argument far too often.

Svetlana Mitrovski
Teaching Associate Professor at University of Illinois at Urbana-Champaign
You know, my two cents on this: I teach chemistry at the college level and many of my students are pre-med students. I have to admit that we are educating these students in ways that do not allow them to be able evaluate results from instruments nor are we educating them to understand the quantitative aspects of the results they are analyzing. It is common knowledge at our school that those who can’t do math, go into pre-med (this is, of course, not a rule that applies for everyone, but it is a very common pattern I see).

Javier Miguel Cabrera Contreras
It is possible to prevent osteoarthritis in large joints. Just like dentists do with, caries avoiding tooth destruction
It could be very interesting to know how many lives are lost due to failures in joint prosthesis implants , and health complications from this type of a very old method. See: www.biototalhip.com visit : Google “Do we need to expend $83 billion dollars in joint prosthesis?

Pien Kranenburg
Online Marketing Casa Blanca bij Vakantiewoning nabij valencia
Post transfusion sepsis has a very high mortality rate worldwide, while the scientific reports about this subject is under-reported. We know, because of our own pilos in the Netherlands, Spain and India, that the safe temperature range is often exceeded in the transfusion chain. It is common knowledge that this results in unwanted bacterial growth an injury. We have developed a system that monitors the entire life cycle of blood components. With the bedside check we make sure that blood that has become too warm, not is tranfused into the pateint. Beside that, we do an extra blood type check, the wrong one would be deadly. Left over blood after surgery could be safely reused if kept cool. After our medical certification, starting soon, our system is market ready. I also write a blog about this subject: https://kwicdoteu.wordpress.com/

Larry Brewton
AXON-II HELPS DOCTORS SOLVE CHRONIC PAIN PROBLEMS
It looks like we all are concerned abut avoidable patient death. What is important is that many of the devices we market have an impact on this grim statistic.

Mohammed Fasiuddin
Technical Sales at IFFCO Group
Blindly believe 100% Assurance on medical Devices.

Nanda Ramamirtham
Studio owner at iLoveKickBoxing.com at iLoveKickboxing.com
At RTI.com we are working with GE Healthcare http://finance.yahoo.com/news/rti-presents-inside-story-ge-165939511.html, mdnpnp.org as well as others on the issue of medical device interoperability with a goal to move death by medical errors from #4 on the list of of avoidable deaths to #10.

Feng-Chi Ho
Global members
Medical error who to have bad policy of modern medicine where to see one tree
and not to lookina at the whole forest to
result in? Doctor who lacking good skills
and full experiences in clinical medicine

Antonin Cuc
Head of Dept. Health and Safety at work at Ministry for Labour and Social Affairs
Dear friends! There are 200, 000 dead as a lowest expertise point estimate of dead – but more probable yearly average needless dead patient is about 380 thousands of Patients in USA, but there are probable about next 400, 000 needless heavy injured Patients! Since ten years I am imputing all pariticpants such sorrowful discussion the main aspect: You said as sumary causes MEDICAL MISTAKES, but you have no courage to detect “How indentified medical mistakes there are to detect exactly!” You have no courage to ask the perfect built the Qustion: “How percent of yearly dead patients are needless dying with reasons of casual illegal technician usage of Medical Devices contrary Technician requirements Law!” I dont allow no Doctor of Medicine to derive a sample with about 1200 dead patient in duration year 2014 to detect results of criminal analyse!

Meg B.
Know – how, innovation & focus. Med tech business acumen.
( CRT =Controlled Randomised Trials)

CRTs of endovascular procedures demonstrate that high fidelity simulation indicate there is improved performance and accelerate skill adoption in clinical operators. Are we doing all we can to be the best at what we do prior to operating on patients?

Mark Swanson
Principal Quality and Regulatory Consultant
Has anyone had a touch with the MDIC and the ongoing efforts on Case for Quality (originally an FDA program)?

Del Ames
Sr. Global Lean Manager- at Vishay/Dale Electronic
I would have to say training the trainer is a huge opportunity. To many times we have a tendency to have anyone train them. Most often there in lies the problem. Not everyone can train. Having a wife who’s works in and heads up surgery I hear about these issue way too many times. Even though devices have to properly communicate the right data there is no solid plan put in place to align/integrate all these devices nor the proper IT systems to handle them. To many areas are piece mealed instead have a detail plan/vision put in place to support and enforce the implementation in its’ entirely. Medical boards and Administrator cannot vision how everything would be integrated therefore not truly committed to the cause.

Mike Chappell
Sales Manager at Currently looking for a new position
vital. . insurance, quality control and training.. not in that order.

David Ziv
Business development and innovation consultant at Freelancer
It seems there is always tension between technology and discipline when talking about patient safety. I think the idea is to find the golden path between the two. I also found out that in many case convenience = compliance. In that respect I believe there are also opportunities out there. If you take a look at the ICU bed, it is a messy environment, so there are a lot of opportunities to organize it and improve the workflow around the bed and the patient.

Margie Abernethy
Blogger at Happy, Healthy over 50 at Self-Employed
It’s a much bigger problem than just devices, Dr. Richard M. Satavava and Joe Hage. Many of the errors include problems in the OR specifically or medication administration errors.

Willi Glettig
Owner of LCC Engineering & Trading GmbH and co-owner of Koldsteril
Dear Stephane,
Of course I am frustrated because we have done everything possible. As pragmatic entrepreneur you don’t start such a project if you are not confident that you will everything right and succeed. I have built a number of successful new technology companies in various countries and have turned around mismanaged companies. I am independent science-to-market entrepreneur since 1980. For the first 25 years I was fortunate to meet lots of doers. During the past 10 years it was mainly talkers.
In our project we produced two PhDs, worked together with many hospitals and microbiological labs. Have conducted thousands of tests. Since we created a new technology we also had to develop new analytical and micro biological assays. We worked together with leading hygiene specialist in various countries. We had in-vitro and in-vivo test with Pasteur Inst and amazed the scientist how quickly and effectively we destroyed prions in endoscopes at room temperature. We build a number of prototypes for laboratory and industrial environments.
We were scrutinized by the Swiss Government through “CTI Start-up” and certified with the CTI label. We presented our company to VCs in London, Turin, Munich, Dusseldorf and Zurich Stock exchange and got lots of praise for the quality of our business plans and technology. We won a number of business plan competitions. A few very large Pharma, Biotech and Medtech companies promised to procure our equipment as soon as we have FDA registration. We worked together with leading dental tool and implant manufacturers to discover that we deal with frustrated managers that thought we handover our technology free of charge.
With new disruptive technologies it is very easy to attract a huge amount of people with consulting interest, future visions, success recipes but no money. To commercialize our technology we require approx. $ 3 Mio to get FDA registration and for product launch.
There is also some hope. I have three clients from my other company – they are doers and successful entrepreneurs. They told me if I can find another three investors they would participate with $500K equity investment each.
Regards Willi

Brian Newman
Consultant General and Vascular Surgeon
frightening!

Silvia Barra
Technical and scientific translator and writer | EN, FR>IT | Chemist and chemistry specialist
A very interesting issue. I translate user manuals and softwares of medical devices and I can add that bad translations/misunderstandings can create great damage to patients (other than to medical devices producers)

Stephane Morvan
▶ Marketing Great Medtech Innovations
@Willi (others, sorry for being OT): I read your post with interest. I sense a bit of frustration on the business development side of what seems to be a great product. My guess is that you probably need more market traction before you can get proper funding, but getting this additional bit of market traction (whose by product would be undisputed clinical data) may require funding to begin with… Would you mind sharing in a separate post your ideas and the hurdles you have faced..?