Guidant to create new patient safety officer post, put product performance reports online

By Lisa Kerner

Erie, Pa., March 21 - Guidant Corp. said it has started to implement recommendations from an independent panel's report - including establishing a new post to monitor patient safety and posting product performance reports online.

The move followed a recall of some pacemakers marketed by the company and related actions taken by Guidant's Cardiac Rhythm Management (CRM) business in mid 2005.

The products of the CRM independent business unit, pacemakers, implantable defibrillators and their related lead systems, are used for symptom-control in high-risk patients.

According to the panel's report, a death in March 2005 related to a low-frequency potential defect in an implantable defibrillator product was the cause of friction between physicians involved in the patient's care and CRM representatives.

The defect was originally mitigated by manufacturing revisions in April and November of 2002. However, about 4,000 unmitigated devices remained in inventory (by CRM, its field sales force and hospitals) and continued to be implanted.

CRM's failure to attempt to retrieve the unmitigated devices, and the fact that physicians were not alerted to the defect and manufacturing changes, led to Guidant's formation of the independent panel in August 2005.

Among the panel's recommendations were the establishment of an external advisory committee, the hiring of a physician responsible for patient safety, strengthening management links between the corporation and its CRM business unit, and integrating patient-safety concerns into analysis of product performance.

"Guidant has already begun to implement changes that will address some of these recommendations, including taking steps to provide enhanced information through the expanded product performance report we now make available to physicians and patients on our web site," Guidant Corp. chairman and chief executive officer James M. Cornelius said in the release.

"This Guidant initiative will be supplemented by additional communication recommendations made by the panel. And, as an immediate response to one of the panel's major recommendations, the company is actively recruiting for the newly created position of chief medical and patient safety officer at CRM, a physician who will be responsible for overseeing all issues relating to patient safety."

Based in Indianapolis, Guidant develops, manufactures and markets products and services that enable less-invasive care for medical conditions.

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