Medical Device Recalls – Do You See the Pattern…?

~ Let’s stop doing the same thing over and over – expecting different results ~

Whenever I review the latest entries on the FDA Recall List, I’m still surprised when I see the Reason for Recall information. Especially since several device manufacturers appear on the list – repeatedly.

Here are a couple of entries:

“XYZ Medical” is recalling the “ABC” Product due to a manufacturing error that may cause parts of the chamber to split into layers, allowing water to overflow the chamber and to back up into the patient breathing circuit.’ ‘If this occurs, an excessive amount of water could enter the airway or lungs of a ventilated patient and lead to serious adverse health consequences, including injury or death.’”

“123 Corporation” is recalling the “DEF” Ventilators because a software problem may cause the ventilator to shut down unexpectedly without sounding an alarm.’ ‘If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences such as brain damage, or even death.’”

As you can see, these are critical problems which have serious consequences – possibly death.

Near the end of 2017 for one Recall Notice, a heart controller, which circulates blood throughout the body when the heart is too weak to pump blood adequately on its own – created a patient safety issue for patients who couldn’t change their back-up system controller quickly enough, when at home.

The Reason for Recall listed 19 reported injuries and 26 deaths. That’s pretty scary, if you ask me.

Here’s the worst part.

For the majority of these issues, the Reason for Recall is preventable – it just requires thinking out of the box.

Here’s what I mean.

Most of these faults/defects were discovered during unidentified hazards – they were caused by abnormal system behavior or unexpected user-initiated actions.

In other words, standard Hazard Reviews, Risks and Risk Mitigation will not identify needed requirements, therefore Requirements Based IV&V won’t discover these issues.

The FDA Recall List proves this point.

So, what can be done?

I asked a software development process improvement expert about the issues listed above, and this is what he said:

“I believe this should have been identified in the software DFMEA or PFMEA and assigned a design or process mitigation.

Unexpected user-initiated actions are more of a corner case variety.  A main purpose of the Product Risk Assessment is to look at all possible hazards and harms that occur from the top down identifying what can possibly go wrong (hazards), what the possible (harms) are and the severity of the harm.  

These then translate into mitigation requirements (design, manufacturing and as a last resort labeling and training). With no really defined requirements or mitigations greater testing is needed. The Labeling and Training and unknown possible errors are easily and seamlessly addressed using Advantu Recall Prevention.  

The PRA is essentially a Fault Tree Analysis (FTA) top down approach and attempts to identify product “User Errors”. The greater the Human Factors input is into identifying possible risks the more complete identified risk mitigations will be.”

Here’s my common-sense summary:

If you have life threatening issues being reported in multiple FDA Recalls – and the majority of the Reasons for Recall show the issues were discovered due to “unexpected user-initiated actions” – then you need to update/change your product development and manufacturing processes in order to find those hidden (critical) defects…before product release.

Makes sense, right?

Let’s take it a step further; what if there was a collaborative approach bringing together expertise from Marketing, Clinical, Regulatory, Quality, Development and Manufacturing – that would help ensure very few (or none) of those dangerous flaws escape to Design Transfer and finally to On-Market?

Here’s how it works.

Say you have a project where new features are being added to a previously released product – so you’re building the follow-on version.

Gather your entire project team and conduct an interactive “white board session” together – to find hidden defects, caused by unexpected or abnormal behavior.

The FMEA Inductive Logic + Product Risk Assessment Approach:

  1. Display a list of all the planned new features, possible product and design risks and mitigations & functional and mitigation requirements
  2. Map each new requirement to the specific code and corresponding code or hardware specification for that requirement & possible related requirement changes
  3. Identify all the potentially impacted code for existing features – which surrounds the specific code for the new and related requirements
  4. Create ‘what if’ scenarios for all potentially impacted existing features & new requirements
  5. Prioritize all scenarios by Risk Zone utilizing the Impact versus Probability Process 
    High Impact, High Probability High Impact, Low Probability
    Low Impact, High Probability Low Impact, Low Probability
  6. Add all High Impact scenarios directly into R&D and SQE Plans
    • SQE’s will create targeted negative test cases to isolate and expose hidden critical defects lurking in the code (with project team peer reviews for these test cases)
    • The majority of these critical defects are typically caused by unexpected behavior, which are not found during standard IV&V
    • All low impact scenarios can be set aside, and based upon risk zone, safely tested when time permits
  7. Update process documentation for ongoing process improvement training

You’ve identified all the “High Risk” areas in the code, you’ve revealed otherwise unknown critical defects lurking in the code – which typically appear during abnormal system behavior or unexpected user-initiated actions – and you can mitigate all of them, prior to product release.

Plus, you can update your process documentation for your ongoing process improvement training across the company – for the benefit of every project moving forward.

This process is a critical aspect of our recall prevention program.

If you would like to know how to Prevent a Medical Device Recall for your Products, Contact us! (form below)


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