Integrity Matters
May 3, 2006
Quality medicine tied to integrity
Question: (E-237)
Dear Jim:
You have discussed in your column faulty medical devices
and your concerns about the health risks created for
patients, more than once. Next week I am having a second
Guidant defibrillator surgically removed and a third
one implanted. Is this an engineering problem or an integrity
issue?
Response:
Perfection is an elusive goal. However, health providers
are held to a higher standard, or at least they should
be. Whether it is the ambulance team, emergency room
professionals, staff at a physician's office, surgeons,
hospital employees or the makers of equipment that assists
with diagnosis and treatment - 100 percent quality is
required.
Your situation is disturbing. You have a heart problem
and your medical team has advised your working with
the same equipment provider, now for a third time.
If this is the only reputable manufacturer of the device
that you need, your dilemma is obvious. You are caught
in the frustrating situation of not knowing how many
times you can go through the "drill" - which is likely becoming
increasingly stressful without increasing harm to your own health. Anxiety must
be hounding you and your loved ones.
Obviously, you have sought medical counsel. What about
second opinions, third opinions? Perhaps someone other
than the surgeon directing you to this process should
assess your readiness - physically and emotionally
- to go through this invasive surgical procedure again.
Only you can make the decision for what you are willing
to endure.
If you were purchasing an automobile, how many "lemons" would tolerate
from the same dealer or manufacturer? Perhaps you are simply a statistical anomaly
and will be "good to go" with the third installation of the important
heart device. Certainly, your report is about quality in manufacturing. It may
be about integrity, but, rest assured, there will be those eager to help you
file a lawsuit - possibly for a variety of reasons.
My research on this topic would indicate that an overwhelming
number of these defibrillators are surgically implanted
and work effectively. Your situation is different.
The procedure for this replacement is described as
minor surgery. My father said, "Minor surgery happens to other people. All my surgery is
major because it is on me."
Advice - if possible and not risking your health:
- Consult with other medical professionals, soon.
- Get help in finding an alternative product.
- Insist on additional performance testing on the device,
should your advisers and you conclude to proceed with
the same manufacturer.
- Review the results and, when confident, proceed.
Technology, quality, medicine and integrity are tied together
and your life depends upon that integrated connection being
solid and predictable.
