This report was from an independent panel commissioned by Guidant corporation after Guidant received significant press for failure to take timely corrective action, including lack of clinician notification, of low probably known defects that could and did lead to deaths. This was focused in cardiac rhythm management products such as implantable pacemakers and defibrillators.
The report has some interesting insights in regard to:
– some of the pitfalls in use of probability in risk management.
– the importance in distinguishing acceptable risk criteria from the need to disclose/notify regarding known product defects – even if the probability is remote – active versus passive transparency in disclosure of issues.
It mentions software as a component of medical devices on Page 4, discusses a software memory loop problem on page 34 that led to both a Class I and a Class II recall, (details of these recalls are on page 100), and on Page 101 a programmer software change for a magnetic switch related defect is discussed that was related to a voluntary physician notification.
The full report is at the link provided: Guidant Panel Report 0306