Validation of a New Procedure for a Pacemaker Component

Abstract

Abstract - Company X manufactures pacemakers in Puerto Rico. Over the past years, Company X has been having a significant amount of complaints due to the septum component contained in its pacemakers. Doctors have claimed that during the surgical process of implanting the pacemaker device in the patient, the septum component detaches itself from the device, rendering the device unusable. This validation project presents both the Product Performance Qualification (PPQ) and Installation Operational Qualification (IOQ) of the new septum that will replace the current one that is presenting complaints and its corresponding Controlled Environmental Humidity Chamber. Key Terms - Pacemaker, Septum, Controlled Enviromental Humidity Chamber and Medical Adhesive (Med A).