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?


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.

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