Hugo and his Defribillator

I first met Hugo Campos last year and I soon learned his story, but honestly? I thought maybe he was a bit on the fringe. I was wrong. This year we worked together to introduce patient voices into two conferences: Health 2.0 and Medicine 2.0. I came to know the tall, handsome man -- who appears quite healthy -- and he's remarkable. When the FDA held public hearings last month about medical devices, Hugo managed to be added to the agenda.

Thank goodness! With his permission, his testimony appears below. I believe it speaks for itself (emphasis and hyperlinks mine).

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Good morning. Thank you for the opportunity to be here.
 

My name is Hugo Campos and I am a heart patient
living with an implantable cardiac defibrillator.

implantable coronary defibrillator (ICD)

Each year, hundreds of thousands of Americans
are implanted with pacemakers, loop recorders and cardiac
defibrillators like mine.

However, not a single one of these patients has access to the wealth of personalized data that is continuously collected by their implantable devices.

It is time for us to change this.

Pacemakers and ICDs are small, battery-powered,
electrical impulse generators that are implanted in
patients with slow heart beats or who are at risk of
sudden cardiac arrest.
 

In addition to providing life-saving therapy, these medical
devices collect and store advanced diagnostic information
pertaining to their normal function and a patient’s clinical
status. This information is transmitted to a secure and
private network owned by the manufacturer of the device.
 

Some of the data collected is made available to clinicians
through a secure Web site, enabling them the convenience
of monitoring patients without the need for in-office visits.
However, this data is not made available to the patient
who originates it.
 

Studies have shown that remotely monitored patients
experience a significant reduction in time from
clinical event to clinical decision and also benefit from
shorter hospital stays and reduced costs per
hospitalization.
 

This clearly makes the point that access to information
saves lives and money.

Yet, even in light of such evidence, patients continue to be
denied the right to access such useful and incredibly rich
data about their bodies.

The main obstacle, in my view, has been the Cardiac
Rhythm Management industry itself, which claims that a
pacemaker or defibrillator is put into a patient’s body for
the therapy it delivers, not for the information it gathers,
and that making this data available to patients does not fit
their business model.
 

The types of information collected by a modern ICD, for
example, vary from trivial to potentially critical. Among
other things, the device monitors its own battery voltage,
the amount of time it takes to deliver a life-saving shock,
collects and stores intracardiac electrograms, and monitors
a patient’s heart rhythm, daily activity, arrhythmia
episodes, and even the build-up of fluid in the lungs —
which is critical to patients dealing with congestive heart
failure.
 

 

In addition, patients who are at risk for atrial fibrillation and atrial flutter have a higher propensity for stroke and heart failure. Atrial arrhythmias can also cause the ICD to deliver inappropriate shocks. So, rapid patient awareness of atrial fibrillation is crucial for those at risk.

Access to our data can do more than just help patients take
control of our disease. It may also help with timely
identification of device-related malfunctions, and
ultimately, contribute to better patient engagement and
improved health outcomes.
 

Knowledge is power. And a patient privy to his data is an
empowered partner in his own health and healthcare.
Access to my device’s data can help me track, understand
and manage my condition better, become more active in my care, and work more effectively with my providers.
 

I rely on the FDA to protect me. And I need the FDA to
stand with me in this quest for openness, access and
transparency.
 

In the spirit of the new rules proposed last week by Health
and Human Services Secretary, Kathleen Sebelius, that
strengthen patients’ rights to access their own laboratory
test results directly from labs, I would like to ask the FDA
to follow suit and publicly declare that patients also have
the right to the raw data collected and stored by the
manufacturers of their implantable devices.
 

I have the right and the responsibility to care for myself,
but cannot do so without information. It is time to fix this
and put patients and our families at the center of our own
care. And I call on the FDA to help us get there.
 

Thank you.