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Health Hazard Analysis TipsHealth hazard analyses (HHAs) are a necessary part of the medical device manufacturing process since the FDA revised Medical Device Good Manufacturing Practices Regulation, 21 CFR Section 820 in 1996. They were replaced with the Quality System regulations and included the use of design controls in the development of new medical devices. The FDA recommends and expects the use of risk analyses tools as a way to better identify, analyze, control and monitor risk of medical device use.

To avoid costly device recalls, lawsuits, and other potentially damaging actions as the result of a poorly designed and/or manufactured device, it’s important for medical device manufacturers to develop a concise, comprehensive, and standardized risk assessment methodology to ensure that potential issues are caught early in the design process to minimize costly delays and patient risk.

If a problem with a medical device occurs fairly frequently or appears to be serious, the manufacturer must decide whether to issue a recall. Before that happens, the manufacturer must implement an HHA to determine the need for a recall using a standardized evaluation form to aid information-gathering and analysis. Equally important is the comprehensiveness of the analysis to better examine the broadest safety issues without regard for financial implications.

A proper HHA should answer questions such as:

  • Has disease or injury occurred as a result of the device’s use?
  • Could existing conditions contribute to a clinical situation resulting in the exposure of humans or animals to a health hazard?
  • How likely is it that the hazard will occur?
  • What are the short- and long-term consequences of the hazard if it does occur?
  • Is a recall necessary?
  • What impact will the hazard have on various population segments such as infants or the elderly?

If a medical device manufacturer does not have effective health hazard risk analysis and assessment procedures in place, it runs the risk of triggering an FDA health hazard evaluation and a possible forced product recall. To ensure that the company is positioned to effectively manage risk, it should:

  • Develop a comprehensive risk and hazard analysis document
  • Identify and engage risk analysis stakeholders and participants
  • Learn to conduct a hazard analysis meeting
  • Establish meeting ground rules
  • Develop methods to identify potential hazards
  • Adopt risk rating methods
  • Develop risk mitigation strategies
  • Fully understand risk assessment and residual risk

If you’re a medical device manufacturer and need to better understand health risk analysis and develop the right strategies and procedures to effectively handle it, consider hiring an experienced health risk analysis consultant with FDA quality system regulations and risk management experience. To learn more, visit https://www.medicept.com/, call us at 508-231-8842, or email us.