Pacemaker reliability: design to explant

Pacemaker reliability can be thought of as a measure of the change in quality during lifetime or mean time to replace (MTTR). Quality has been defined as the totality of all the features designed and built into a pacemaker, or any product. If these features are to function as intended for the designed MTTR, a formal quality system which covers design, qualification manufacturing, distribution and market monitoring must be in place. Some important elements of the quality system are shown. Managerial discipline is one of the most critical features of the quality system. No system will be effective if it is compromised or abandoned in a crisis. These different elements can be thought of as tools which are used by management, engineers, scientists and mathematicians. When used in accordance with procedures these tools shape the product into usable form which will meet customer expectations.