Risk Analysis for the Medical Device Industry

Being in the medical device industry means understanding and properly applying the risk analysis principles. We all know examples of sad stories of patients who were overdosed on radiotherapy devices, injured by electric shocks, over-infused on the infusion pump, and so many other tragic cases of death and patient injuries. While we cannot change the fact that every device from simple to the most complex has inherent risks, we must identify such risks, study and mitigate them wherever possible, and then weigh them in against the device benefits. It is this risk/benefit ratio that medical device manufacturers need to work with by keeping the associated device risks as low as possible.

An effective way to manage this process is to employ a risk analysis using such tools as Failure Mode Effects Analysis (FMEA) or Fault Tree Analysis (FTA). Failure mode effects analysis is used during the design phase of the device life cycle. FMEA is a bottom-up method intended to evaluate the effects of defects at the component level and determine appropriate design changes. The main purpose of FMEA is to identify potential design problems early on in the process so that they can be eliminated or reduced before they can negatively affect the safety or effectiveness of the final device. Failure mode effects analysis follows this general steps sequence:

• Define the function of the device being analyzed.
• Identify all potential failures.
• Determine the causes of each failure types.
• Determine the effects of potential failures.
• Assign a risk index to each of the failure types.
• Determine the most appropriate corrective/preventive actions.
• Monitor the implementation of the corrective/preventive to ensure that it is having the desired effect.

In the Fault Tree Analysis (FTA), a top-down approach is used to identify a possible safety hazard and then lists all the means/conditions/failures that may create this hazard. A general sequence of conducting the FTA is as follows:

• List possible hazards, e.g. electrical shock, fire, misdiagnosis, injury, etc.
• What failures, or combination of failures, will lead to the named hazards?
• Diagram the fault tree.
• Use the tool to intercept or design out unacceptable consequences.

Today, risk analysis is required for medical devices by most of the world regulatory authorities. The application of risk analysis spans the entire life cycle of the device, starting from the design and development phase to post-marketing design changes. Risk analysis is also being increasingly called out by the regulators for integration into the entire quality system. Examples of this include applying risk analysis during complaint investigations and Corrective and Preventive Action (CAPA) implementations.

mdi Consultants has assisted hundreds of companies with devices ranging from orthopedic applications to infusion pumps to software controlled imaging diagnostics with all subject matters related to risk analysis. We offer companies competency training for their personnel in the risk analysis methodology based on the standard ANSI/AAMI/ISO 14971 Medical devices—Application of risk management to medical devices. We also assist with all phases of performance and review of risk analysis to ensure it is scientifically sound and regulatory compliant. Not only such exercise in risk analysis helps our client companies address the necessary pre-requisite requirement for FDA, EU and Health Canada marketing license applications, it also adds significant practical advantages. First and foremost, the companies with properly completed and executed risk analysis are able to prevent or reasonably reduce the harm to patients receiving treatment by their medical devices. Additionally, the companies benefit from eliminating the costs related to product recall as well as product liability lawsuits. In other words, risk analysis is an indispensable tool that every medical device establishment must be thoroughly familiar with and comfortable using.