Medical device reporting is a challenging job, that can be improved with the use of a hazard list. Edwards Lifesciences QA/QC expert shares how this tool changed and FDA auditors attitude.

Thomas B. Morrissey

April 1, 2013

6 Min Read
Edwards Lifesciences Uses a Hazard List to Get FDA Auditors to Listen

Several years ago, an FDA auditor reviewing our complaints files questioned Edwards Lifesciences on some inconsistencies with our MDR (medical device report) practices. He wanted to know why, after years of not filing MDRs for a particular malfunction, we suddenly began filing a year or so before the audit.

hazard.jpgOur explanation impressed him enough to change the dynamics of that particular audit from a process full of tough, probing questions on his part, to one of trust on both sides.

What looked like an anomaly among data points was simply the evolution of a decision-making tool that Edwards Lifesciences had used for reporting product malfunctions: the hazard or malfunctions list.

This list is always a work in progress, and the inconsistencies were the result of revisions made based on a newly documented malfunction-related injury. We were able to utilize our carefully documented discussions to show how our thought process evolved during the document revision process.

Hazard a guess or list the hazards?

Companies have a responsibility to collect, investigate, and report adverse events and certain device malfunctions. Performing these tasks in a consistent manner is paramount to remaining compliant.

Reporting adverse events associated with a medical device is fairly straightforward. If there is an allegation that your product is associated with an injury or death, it needs to be reported. What is a bit more complicated is deciding which malfunctions—officially defined as a failure of the device to meet its performance specifications or otherwise perform as intended—deserves to be filed as an MDR by the light of current regulations.

According to FDA, a malfunction should be considered reportable if any one of the following is true:

  • The chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote.

  • The consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury.

  • It causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences. The essential function of a device refers not only to the device's labeled use, but for any use widely prescribed within the practice of medicine.

  • It involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used.

  • The device is considered life-supporting or life-sustaining, and thus essential to maintaining human life.

  • The manufacturer takes or would be required to take action under section 518 or 519(f) of the FD&C Act as a result of the malfunction of the device or other similar devices.

The first bullet for reporting MDRs presents challenges. How do companies decide if “the chance of death or serious injury occurring as a result of the malfunction is not remote?”

Typically, device companies have complaint handling units staffed by individuals with different backgrounds, and there may or may not be someone with a clinical background providing oversight. It is also common for device manufacturers to produce multiple products and hundreds or thousands of product codes. Multiply this by hundreds of possible device malfunctions and accurately tracking all the possibilities becomes unmanageable.

Can management truly expect such complaint handling units to consistently track real and hypothetical risks on an ad hoc basis and be responsible for the myriad of malfunction possibilities?

Risking Penalties

Many companies are indeed making these malfunction reporting decisions on an ad hoc basis. They rely on “tribal knowledge,” much of which is developed by folks with an incomplete understanding of the regulations and who are thereby putting a company at a very real risk for government penalties, including monetary fines, product approval delays, warning letters, and consent decrees.

Among medical device companies, failure to file timely and accurate MDRs and complaints is still one of the most common deficiencies found by FDA field investigators inspecting a company’s quality systems. It is one of the most frequently cited components of and FDA Form 483, notice of inspectional observations listing quality deficiencies, and worse, an FDA warning letter.

Experienced FDA auditors tend to focus on what complaints companies don’t report as MDRs and won’t hesitate to scrutinize your files accordingly. Having a process that leaves no doubt as to what your company considers as MDR-worthy is important in maintaining compliance.

Resolving the Dilemma

Many companies use a more systematic alternative to tribal knowledge and ad hoc decision making by employing complaint decision trees. Decision trees can be a useful tool but not a complete one.

The hazard list we employ at Edwards helps with this dilemma. The list contains a compilation of product malfunctions or failure modes. Aside from cataloguing malfunctions by different products, it helps us decide when to file an MDR or an MDV (Medical Device Vigilance).

We also use the list as a focal point in our weekly complaint meetings, improving and building its scope over time. We have amended our complaint procedures to require complaint handlers to escalate any complaint-related malfunction for discussion and inclusion on the hazard list if the issue is not already addressed in the document.

Perhaps the most important column in the hazard list (Figure 1) is the clinical rationale, which obviously requires clinical input to evaluate the possible effects on patient that may result from a product failure. At Edwards LifeSciences, we’ve found benefit in having full time clinicians who have used our products in a clinical setting in their previous practice.

The purpose of documenting the failures and the clinical rationale is to maintain consistency among complaint handlers and to guide the team in deciding whether a particular failure mode or hazard has the potential to result in an injury.

Maintaining a hazard list provides complaint handlers with a useful tool to understanding device malfunctions and their potential impact on patients. It also facilitates accurate, consistent reporting of events to regulatory bodies and strengthens the conclusions in your company’s complaint files.





Clinical Rationale








Figure 1.   The Hazard List Template.

Additional benefits of the list include:

  • Providing a rationale for the file for complaint closure, particularly for nonreportable events.

  • Providing a tool for product development teams in FMEAs.

  • Providing a focal point during complaint meeting discussions. The hazard list is a living document that should be updated often.

The initial adoption of this more systematic way of handling complaints is by no means an easy task. It can entail some adjustment pains for team members in complaints handling and a special round of explanation with the government authorities. However, encouraging more medical device companies to get a handle on hazards benefits the entire industry in the long haul.

Thomas B. Morrissey, MD is vice president, quality assurance advance technology and product safety at Edwards Lifesciences LLC

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