Thursday, March 08, 2012

On Medtronic's Most Recent Medical Device "Correction"

Yesterday, Medtronic, Inc, the world's largest medical device manufacturer, notified me in clinic about another problem with one of their lines of defibrillators via a Dear Doctor letter (1 Mbyte) headed by the line "URGENT: MEDICAL DEVICE CORRECTION."

It seems this term is now commonly seen on other Medtronic device advisories as well.

I wondered how the marketing and legal folks at Medtronic could use that term on the top of such a letter.  After all, there is no "correction" that I can see in their "Dear Doctor" letter given to me.

By way of background, the letter explained there is a problem with a very small subset of Medtronic's Entrust (US market) and Escudo (overseas market) line of defibrillators which began to be used in 2005.  After 30 months of implant, a drop from 3.0V to 2.61V (ERI) can occur in 1 week to six months in rare cases. It is estimated that there are approximately 39,000 patients with these devices still implanted worldwide with 21,600 of the remaining devices in U.S. patients.  The root cause of the defect described in the letter is thought to be a battery short that develops as the battery in consumed.   Consequently, the battery may not last the expected three months after the device reaches its initial elective replacement indicator and doctors are advised to replace the generator immediately once the device reaches this indicator.  Importantly, no deaths have occurred as a result of this defect but there is a theoretic potential that a device might not reach an effective discharge voltage after the battery depletion occurs.  For doctors and patients, this alert ranks pretty low on the concern scale, provided patients are monitored closely and have their battery-reaching-ERI alerts programmed "ON." (Please see the above linked letter for full details)

This issue of what to call these device alerts is not a small issue. In early 2005 when a rash of serious ICD problems began to surface, they were uniformly called "device recalls." But the Heart Rhythm Society recognized the problems with this nomenclature:

Terminology should be commensurate with risk. HRS has previously recommended that the term “recall” not be used in reference to devices that do not require removal or explant, as it may foster miscommunication and lead to unnecessary and potentially harmful interventions.  Research supports the concept that the specific wording chosen to warn patients has critical implications and that some words (urgent, danger, FDA) and some phrases (FDA Public Safety Warning, Product Danger Alert, Public Safety Warning) are perceived as being just as important as phrases that include the word “recall.” The term “recall” has regulatory and legal implications that extend beyond cardiac rhythm management devices and substantial hurdles must be overcome to change the terminology. Nevertheless, the FDA is encouraged to explore the legal and regulatory alternatives to facilitate the establishment of a simple and intuitive nomenclature to publicly communicate important information out implanted medical device performance.

As a result, the terms "advisory alert" or "safety alert" were proposed to describe less serious communications with doctors and patients regarding important device communications.

So why now "important device corrections?" In cases like this, I feel it would be best that device manufacturers stick with terms that industry and physician groups have agreed so that the appropriate level of concern is conveyed to doctors and patients alike without sugar-coating the defects. That way when these letters are issued, we're all on the same page.


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