Guidant (Indianapolis) and its Cardiac Rhythm Management (CRM) business do not have “a process for comprehensive internal or external medical review of the clinical impact of product malfunction.“
That statement may be the most direct and, to the company, the most injurious conclusion of a report released yesterday by an independent panel convened in the wake of Guidant's widely reported recall of thousands of implantable cardioverter defibrillators. The panel's goal: review of the company's policies for identifying malfunctions of its implantable devices and its follow-on methods for disseminating such information to physicians and the public.
As corollaries to the above conclusion, the report says that:
- “Information that has the potential for serious consequences may be delayed in reaching CRM [cardiac rhythm management] business or Guidant corporate leadership levels because of inadequate internal reporting requirements.“
- Following emergence of problems concerning its implantable devices, beginning in May 2005, “there was lack of uniformity ad internal strife concerning methods and content of public disclosures.“ Such problems “impacted the timing and uniformity of public statements . . .“
- Guidant “has internal communication and decision-making policies that appear effective as written, but are not adhered to uniformly or efficiently.“
These conclusions are the result of a study by the panel's investigation that was described by its chair, Robert Myerburg, MD – in a statement accompanying release of the report – as “neither a whitewash nor a witch hunt, but rather a search for, and honest appraisal, of the facts.“
Besides issuing its appraisal, the panel provided eight recommendations aimed at correcting Guidant's lack of effective controls and providing a “transparent“ method of reporting the malfunctions and potential risks inherent to its device technologies. (See sidebar for complete list of recommendations.)
Discussion of these risks is not skimmed over by the panel report, but, at the same time, the report takes pains to note that such risks are inherent in medical devices, drugs and any medical therapies, and to point out that such risks are shared by all manufacturers.
In the panel's press statement, David Feigal, former head of the FDA's Center for Devices and Radiological Health and now a research professor at the Arizona Biodesign Center of Arizona State University (Tempe), notes the high reliability and benefits of the devices in question. But he said: “low-frequency failures need to be communicated so that doctors and patients can make informed decision about care. The challenges posed by such circumstances are not unique to Guidant; every manufacturer faces the same kind of problems.“
Perhaps the most relevant criticism of Guidant's failures of internal controls appears in a section discussing the role of the company's product performance engineers and the lack of involvement by “individuals with medical training“ in the evaluation of device risks.
The product performance engineers, the report says, have a large role in the gathering of information, determination of risks and the monitoring of device problems but the demands on them may be excessive “in terms of workload and expertise,“ and these positions are “chronically understaffed, under-appreciated and inadequately compensated for the level of responsibilities that they are assigned and assume.“
As to the role of medical advice, the report says that “medical personnel with clinical training and experience with implantable cardiac devices are not involved in obtaining relevant clinical information related to reported events.“ And that the product performance engineers “are not required to have, and document, formal discussions with medical personnel.“
Other criticisms among the report's “observations“ are a lack of a particular metric “that permits a comparison for a single specific life-threatening trend over time“; “insufficient attention paid to uncertainties“ in estimating failure rates; no way of determining the difference between events that are “random“ or “systematic“; a lack of surveillance of device sold outside the U.S.; and a “previous“ failure to report changes in product manufacturing, components or product testing, except as a product advisory.
Responding to the report, James Cornelius, Guidant CEO and chairman, expressed appreciation for the panel's work and its “incisive and thorough recommendations,“ calling them “a blueprint for improvement and enhancement of our postmarket evaluation of product reliability and communications procedures regarding the performance and safety of our devices.“
He promised implementation of the recommendations and said that the company is already working with Boston Scientific (Natick, Massachusetts) “to ensure a smooth transition of these recommendations following the completion of the pending merger“ of Guidant into Boston Sci, anticipated by the end of this month or early next.
For his part as chairman of the panel, Myerburg praised the company's cooperation in providing “unencumbered access“ to information to develop the report.
“We found overall device reliability to be well within acceptable performance expected of devices of that type,“ he said, “but internal and external communications methods burdened the company's ability to manage and communicate low frequency malfunctions. As a result, we are gratified that the panel's work has been able to lead to a series of recommendations that we believe will improve the company's ability to manage warning signals regarding potential malfunctions – a fact-of-life for any manufactured product – and improve transparency and the communication process between Guidant, physicians and patients.“
Yet to come are the recommendations concerning product reporting, to be issued by a 14-member task force named by the Heart Rhythm Society (Washington) (MDD, Oct. 14, 2005), largely using input from a meeting held by the society last September (MDD, Sept. 20, 2005).