A modern hospital uses more than 5000 types of medical devices, ranging from asimple tongue depressor to a complex pacemaker. The criticality of their reliabilitymay vary from device to device. The failure of medical devices in the past due tohardware and other reasons has been very costly in terms of fatalities, injuries, dollars and cents, etc.
Furthermore, some of today’s medical devices have becomevery complex and are expected to operate under a stringent environment, thus puttingmore pressure on their reliability assurance during the design phase. Other instrumentalfactors requiring better reliability of medical devices include:? Liability suits? Public pressure? Government regulations: one typical example of such regulations is theMedical Device Amendments to the Federal Food, Drug and CosmeticAct in 1976, thus empowering the Food and Drug Administration (FDA)to regulate medical devices during their design and development phases.
Since 1976, the FDA demands that all medical devices be safe and effectivefor their intended purpose and in fact in the mid 1980s, the FDAadded the term reliability to its original demand. Subjecting a medicaldevice to a reliability program provides a systematic approach to theproduct development process and assures that the regulatory requirementsare adequately satisfied. It also gives confidence to a certain degree thatinspection by regulatory bodies will not lead to major discrepancies. Allin all, improved reliability medical devices will be safe, cost-effective,and easy to maintain.
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