An independent enquiry commissioned by heart device maker Guidant has concluded that the firm’s strategy for reporting problems with its products has consistently failed to take patient safety into account.
The panel of experts – consisting of cardiologists, ethicists and statisticians – were asked by the firm to analyse its policies and actions regarding post-market surveillance of its devices, and how well safety information was communicated to physicians and patients.
“We found overall device reliability to be well within acceptable performance expected of devices of that type, but internal and external communications methods burdened the company’s ability to manage and communicate low frequency malfunctions,” commented panel chair Dr Robert Myerburg, Professor of Medicine and Physiology at the University of Miami.
Consequently, it has been recommended that Guidant, which is in the process of being taken over by rival device maker Boston Scientific, give its safety reporting procedure a major facelift, so that even just a single faulty device can be identified and acted upon if there is a risk of patient death or serious injury.
In addition, the panel advised that the firm should set up an external board of experts to monitor its devices, evaluate any health risks and determine how to best to deal with any problems should they occur.
James Cornelius, Chairman and Chief Executive Officer of the firm, remarked: “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 website…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.”
The company is facing numerous lawsuits and government investigations, having recalled or issued safety bulletins for around 88,000 of its defibrillators and for over 200,000 of its pacemakers since the summer of last year. This has caused many industry observers to question the firm’s $27 billion price tag, which Boston Scientific will pay if the merger goes ahead as planned.
