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CHAPTER 8 SLOWING THE PACE: THE INDUSTRY’S TIME OF TROUBLES Ever since the early 1970s, physicians and manufacturers in the field of heart-rhythm management have had to operate in a highly unsettled political environment in the United States. The second decade of implanted cardiac pacemakers proved a watershed because the federal government shifted course to try to ensure the safety and effectiveness of medical devices that would be implanted within the body. The Medical Device Amendments of 1976 required, for the first time, that device manufacturers carry out extensive laboratory and clinical tests of new life-sustaining devices and secure the approval of the Food and Drug Administration (FDA) before they would be allowed to introduce these products to the market. A consumer protection law above all, the Device Amendments embodied a rising public anxiety about the potential dangers of medical technology. Device manufacturers and many physicians feared that the new legislation would slow the pace of innovation in the industry, but these concerns turned out to be exaggerated. The 1970s also brought other changes to pacemaker manufacturers and doctors. Product recalls at Medtronic and Cordis enabled new firms such as Intermedics to gain sizable market shares. As competition intensified, manufacturers raced to introduce new components and features that would burnish their reputations and steal a march on rivals. New circuitry and other improvements enabled the manufacturers to introduce smaller, more reliable pacemakers—but these new devices were also more complex and spelled new challenges for doctors. Despite the improvements in pacing’s capacity to treat heart-rhythm problems, the general public was given a picture of a field that was troubled and possibly corrupt. Charges that physicians were implanting ‘‘too many pacemakers’’ made national headlines in the early 1980s and portended a slowing in the growth rate of cardiac pacing. PACEMAKER RECALLS DISRUPT THE INDUSTRY Since the inception of implantable pacing, every manufacturer had produced units that subsequently malfunctioned. In a few cases, especially in SLOWING THE PACE 187 the early 1960s, these failures had led to patient deaths. The early failures can generally be ascribed to the firms’ inexperience at designing and manufacturing implantable devices and doctors’ inexperience at managing them. By the 1970s, the basics of pacemaker manufacture and treatment were well enough understood that new companies such as CPI or Intermedics could quickly enter the industry and introduce competitive products. But partly because pacing had gained acceptance as a ‘‘normal’’ procedure and the basic engineering knowledge was widely shared, product failures received a much higher level of unsympathetic public attention than had been true a decade earlier. A series of product failures during the 1970s contributed to the disruption of the pacemaker industry: they hastened General Electric’s withdrawal from the business entirely, set Cordis on a downhill slide from which it never recovered, altered physicians’ perceptions of Medtronic, and gave aggressive new companies an opportunity to capture significant slices of the market. These widely publicized problems quickened the companies’ acceptance of the lithium battery, which permitted hermetic sealing of the entire pulse generator and not the circuitry alone. Several deaths were attributed to pacemaker failures, and though some of these could not be confirmed, the recalls raised doubts in the public mind about implantable pacemakers, leaving the industry in a particularly weak position during the shaping of the legislation that empowered the FDA to regulate medical devices. The first major recall of a sizeable number of pacemakers occurred in January 1972, when General Electric notified physicians that 125 of its model A2073 implantable ‘‘standby’’ pacemakers had experienced a circuitry malfunction that caused the device to drive the heart at abnormally rapid rates. GE advised doctors to replace the units on an accelerated schedule even if they appeared to be functioning normally. As more reports came in, GE issued a second letter covering all its implantable standby pacers manufactured in the summer of 1971, a total of 574 units. Early reports suggested that these defective pacemakers had caused seven deaths and two injuries, but a later review of the data blamed only four of the deaths on device failures. A third GE advisory covered 257 more of the same model. Finally, at the request of the FDA, GE on February 1, 1975, extended its advisory to all units of model A2073 still in use, a total of 1,241 pacers. One or two more deaths, beyond the original four, were later ascribed to failures of this model.1 Pacemaker manufacturers...

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