How to Conduct an FMEA for a Disposable Medical Device

FMEA medical device (Failure Modes & Effects Analysis)

An important quality assurance function is assessing risk for the critical characteristics of a disposable medical device, throughout its lifecycle. This is true for any disposable medical device product where compliance is required with either the US FDA, the EU (requiring CE mark), ISO-14791 quality standard, or even to demonstrate cGMP compliance.

In order to establish a process for conducting and documenting risk analysis, all manufacturing risks associated with production processes must be documented, detailed and when possible solved proactively. This is the purpose of Failure Modes & Effects Analysis (FMEA medical device), a method that helps medical device manufacturers identify, break down, control and review the risks associated with product development and manufacturing.

Preparing for FMEA

As in every analysis process, it is critical to have good quality inputs in an FMEA, in order to expect actionable results that will actually help safeguard the disposable medical device. That is why an important first step to conducting an effective FMEA is gathering the correct information that will go into the FMEA process. 

Firstly a timeline with all the exact phases of new product development must be established. Secondly every phase should have its own tasks, with responsibilities assigned for every task involved. Finally for every task or process function there need to be an analysis of the risks regarding failure modes and effects, as well as causes and corrective or preventive actions that need to be taken, in order to minimize risk.

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Conducting FMEA for Medical Device

Any FMEA process begins with a risk assessment of the general medical device manufacturing process. Although every medical device developer has their own exact way of documenting and conducting FMEA, following are the most critical steps and information that every FMEA for medical device should include.

1. Know Your Process

To initiate the FMEA requires a detailed description of the process. The items mentioned below need to be documented for every process step, providing a basis for the whole FMEA.

  • Process Function: A detailed description of every operation in a concise way that clearly indicates the purpose of this process step. 
  • Potential Failure Mode: A description of how a specific operation can potentially fail to meet requirements or design intent, assuming the incoming materials or parts were received according to specifications.
  • Potential Effects of Failure: The effects a failure can have on the subsequent operations of the process, including the next or subsequent operations, all the way to the impact it may have to the final customer.
  • Potential Causes of Failure: A description assigned to show how each failure mode could occur. Since the goal is to identify, correct, and control the cause of failure, it is important to avoid ambiguous phrasing and be specific in describing the potential causes of failure.

2. Prioritize Risk

  • Risk Severity: Indicates the seriousness a failure mode effect can have to the subsequent operation.
  • Probability of Occurrence: Indicates the estimated frequency (or the likelihood) in which a specific failure can occur. Historical or other empirical data can be taken into account to assess probability of occurrence, when available. 
  • Probability of Detection: Indicates how probable it is for a failure mode to be identified or detected in case it occurs. When estimating probability of detection, factors such as quality checks frequency and sampling size need to be taken into consideration.
  • Risk Priority Number: In terms of FMEA for medical device, estimating the risk means calculating the risk priority number. This is done by taking into account the risk severity, probability of occurrence, and probability of detection of every failure mode. Once the risk priority number has been calculated for every step, the failure modes are ranked in order of criticality. This way it is evident where effort should be given first to take corrective or preventive actions and reduce risk.

3. Take Action

Current Process Controls

In every process step mentioned above, the process controls currently in place need to be clearly stated since it is those that serve to detect, prevent, and ultimately limit or even eliminate the effects of a failure mode. These include both IPCs (in process controls) during an activity, as well as post process controls such as batch release scheme sampling controls.

The recommended actions can be defined according to each failure mode’s risk priority number and process controls. These can be both preventive or corrective actions, with the goal to reduce the overall risk of each failure mode, which ultimately means one or more of either: decrease risk severity; decrease the probability of occurrence, and lastly increase the probability of detection.

The Disposable Medical Device Specialists

Quasar has over 30 years experience in the development and mass production of disposable and reusable medical devices. Working with us grants you access to an established Quality Assurance system that is tied in with our world class medical device development infrastructure and mass production facilities.

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