Scenario
Apply HACCP process to assuring product quality, reliability, and safety of a medical device.
A pacemaker (or artificial pacemaker) is a medical device which uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart rate, either because the heart’s native pacemaker is not fast enough, or there is a block in the heart’s electrical conduction system.
Modern pacemakers are externally programmable and allow the cardiologist to select the optimum pacing modes for individual patients. Some combine a pacemaker and defibrillator in a single implantable device. Others have multiple electrodes stimulating differing positions within the heart to improve synchronisation of the lower chambers of the heart.
Pacemakers usually have multiple functions. The most basic form monitors the heart’s native electrical rhythm. When the pacemaker fails to sense a heartbeat within a normal beat-to-beat time period, it will stimulate the ventricle of the heart with a short low voltage pulse. This sensing and stimulating activity continues on a beat by beat basis.
For this exercise take the following approach in sequence:
• HACCP Preliminary Tasks – Prepare flowchart of process
• HACCP Principle 1 – Conduct a hazard analysis
• HACCP Principle 2 – Identify the CCPs (critical control points) in the process
• HACCP Principle 3 – Establish critical limits for preventive measures associated with each identified CCP
• HACCP Principle 4 – Establish CCP monitoring requirements
• HACCP Principle 5 – Establish corrective action to be taken when monitoring indicates that there is a deviation from an established critical limit
And finally, for this exercise there is no requirement to address the remaining HACCP principles:
• HACCP Principle 6 – Establish effective recordkeeping procedures that document the HACCP system.
• HACCP Principle 7 – Establish procedures for verification that the HACCP system is working correctly.