medicaldevicemanufacturers,standardsandthelaw.docVIP

Medical Device Manufacturers, Standards and the Law By Peter A Jordan BA, C.Eng., MBCS Consultant Introduction Any manufacturer faces risk. The most obvious risks arise from strong competition, excessive costs, product failures, or industrial unrest. This paper will address the manufacturer’s safety risk: the risk accepted by the manufacturer that in spite of their best efforts their products will cause harm to a customer or member of the public. It will explore the question that the manufacturer has to answer: “how safe is safe?” from the point of view of different stakeholders. What will emerge is a number of conflicting answers. In choosing a level of safety, the manufacturer is forced to take legal risks, offering products that are not “perfectly” safe and accepting the risk of civil or even criminal liability. The paper will explore how a medical device manufacturer might resolve conflicts between cost and safety in a real, competitive situation. Finally, the paper will suggest ways in which the law and standards could give more help to manufacturers. These considerations are particularly relevant to software. Software provides competitive new features. Time to market and development costs are important, and the desire to minimise these is in direct conflict with the desire to engineer robust (and therefore safe) software. This paper will not address ethics. In my experience, manufacturers are not reckless or cynical about safety. Most safety problems are cock-ups, not conspiracies. We will assume that the manufacturer is well-intentioned, and that failings are due to errors, oversights, ignorance, shortage of time and money or poor judgement. Views of Safety The Patient’s View Patients expect that when they are treated, any device that is used will not make their condition any worse. If they receive treatment that does make their condition worse, their lawyer may advise them to sue the manufacturer. This is especially true in the USA, where lawyers