What is FMEA in Healthcare?

Written By: Jeff Milkey
  • 10/8/2020
  • Read Time : 1:30 min

We often talk about how Failure Mode and Effects Analysis (FMEA) is key to manufacturing because enterprises and the stakeholders within need a system to identify failures in processes and product equipment early to mitigate overall failure of the product, especially in the field.

But when it comes to healthcare, having a fail-safe method of identifying and addressing errors can literally be a case of life or death with added costly monetary and brand implications.

By measuring quality, however, healthcare enterprises can identify desired patient outcomes for a product, building reliability and risk planning into the product lifecycle. This allows healthcare manufacturing operations to design and develop products that have already rationalized, analyzed and rectified risks before products are put into the field.

FMEA Process in Healthcare

With an array of complex medical devices and processes, it’s inevitable that failures occur in the field. The FMEA process can help analyze and mitigate failures before they happen. For instance, if an MRI machine is being produced, conducting an FMEA to identify and rectify failure points can reduce or totally remove an issue before it’s manufactured and used in the field.

This bottom-up analysis begins in the requirements gathering stage followed by the design stage to help reduce failures in prototype, testing, and manufacturing, but can be conducted in later stages in the field as well.

Generally, conducting an FMEA in the healthcare field requires evaluating:

  • Where the failure is occurring in the process or equipment?
  • What is the frequency of the failure?
  • What is the severity of the failure?
  • What is the likelihood of detection?

By analyzing these questions and quantifying them, a team tasked with the FMEA process can develop a risk priority number (RPN) to help determine predictive and preventative measures. Failures codes can then be developed and applied to anything from a medication process to a blood pressure cuff that will not inflate correctly.

But FMEAs, while effective, are only a small part of the overall close-loop quality that is required to ensure medical devices and healthcare processes are safe. By having a centralized platform to unify engineering, quality, and regulatory teams with shared product information, healthcare manufacturing teams can not only ensure risks are mitigated, but the entire product functions to the highest quality possible.

Windchill provides the leading PLM and closed-loop quality solution for healthcare and life sciences companies. Visit our Quality Management page to see how your peers in the healthcare industry are utilizing PLM to drive quality improvements.

  • PLM
  • Quality
  • Life Sciences

About the Author

Jeff Milkey Jeff started his career at PTC in 2000 as a Windchill Application Engineer and has been focusing on PTC’s medical device solutions for the past 20 years. Jeff was recently promoted to Director heading up the West Central team.