Electronic components in medical devices, like those in aerospace and military applications, are highly sensitive to electrostatic discharge (ESD) during manufacturing. Boston Scientific’s Cardiac Rhythm Management (CRM) Group protects its cardiac devices from electrostatic energy through an ESD quality program that relies on benchmarking.
Boston Scientific Corporation, one of the largest medical technology companies in the world, develops and manufactures medical devices used in a broad range of specialties from cardiology and neurology to urology and gynecology. In 2006 the company expanded its presence in cardiac devices with the acquisition of Guidant, a company best known for the manufacture of defibrillators and pacemakers. The CRM Group has designed engineering and manufacturing sites at Arden Hills, Minn.; Redmond, Wash.; Clonmel, Ireland; and Dorado, Puerto Rico. The largest is the Minnesota campus with 3,000 employees in nine buildings on 100 acres.
Static control has been an important issue in the manufacture of cardiac devices for the past three or four decades. At least as far back as the 1980s, manufacturing personnel wore wrist straps connected to ground to safely dissipate static energy on their bodies.
As the technology changed and the sensitivity of components grew, static control became increasingly important. In the mid-1990s, as the business expanded, static-protective flooring was installed in new spaces and personnel in those areas wore special ESD footwear. In addition, continuous monitors were installed at workstations to ensure wrist straps were always connected to equipment ground.