Guidant Pacemakers Ethical Case Study

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Guidant Corporate overlooked their ethical responsibility when the company manufactured faulty seals for peacemaker and implanted cardiac devices (ICDs). The United States Department of Food and Drug Administration (FDA) issued a class I notification recalling 30,000 defective ICD associated with Guidant Corporate (Meier, 2005). Physician-researchers identified a technical and engineering mishap, which threaten the life of patients using Guidant pacemaker devices. The action forced Guidant to recall all the faulty devices to avert a social-economic crisis. In 2005, the Guidant manufacturer of pacemakers had to recall faulty pacemakers that were classified by the FDA as life hazardous defibrillators. Pressure from the media highlights ethical concern and lay blame on engineering negligence for the loss of life of a 21-year old patient who used one of the faulty sealed pacemakers and died of sudden cardiac arrest while undertaking normal exercise (College of Dental Hygienists of Ontario, 2006). The patient in question was using a Prism 2 DR model 2861 ICD pulse generator that was made in 1991 and approved by the U.S. Food and Drug Administration FDA. My audience is the FDA that has failed to protect the public from hazardous pacemaker and ICDs that cause adverse health care concerns (U.S. Food and Drug Administration, 2005). A broken seal caused a high voltage flow that resulted in a short circuit that developed from a tube and leads component of the defibrillators. Issues associated with malfunctioning because of a faulty seal were conversant to Guidant employees for three years without any ethical concern to rectify the sale of faulty devices. Guidant compromised the lives of people entrusted to the Corporation for the sake of making higher profits. Possible solutions to this problem are for Guidant to compensate patients by paying for new heart devices and make an official apology to all concern parties.

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Guidant was aware that more 1991 device models that behaved in a similar manner causing a life-threatening situation. That explains why in 2002 Guidant changed the engineering concept by manufacturing defibrillators that were housed in a way that prevented short-circuiting tendencies. Even though Guidant changed the 1991 model by adopting the 2002 model, the company failed to inform other patients to change to the new model to avoid facing similar short-circuiting hazards. The company failed to communicate fearing a public outrage and possible future discrimination of its products in the market since the information would affect their market segment. Management equally failed to use ethical standards in selling faulty defibrillators without informing patients about the disadvantages associated with the pacemaker. Although the information was hidden, a group of physicians disclosed the data to the media, which further compromised the public image of the company since a one-sided story was published in the New York Times (Meier, 2005). Proposed solutions to faulty pacemakers rest with technical and technological research to identify problems associated with short-circuiting and the seal on pacemakers. Besides, Guidant Corporation has to compensate patients hurt by faulty heart devices…

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