FDA Transparency at Heart of Device Risk and Recall Discussion

By Maria Fontanazza

The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.

FDA defines Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) as “the processes that FDA follows to determine the risks of certain device problems and the actions firms should take to resolve them”. An HHE provides a guide for classifying a voluntary product recall, while an HRA is a tool used to predict the potential harm caused by a defective device. The definition may sound simple, but the way in which FDA actually conducts HHEs and HRA has been characterized as anything but straightforward by industry.

Transparency has been at the center of the discussion. There needs to be better communication on the part of FDA in how it approaches HHEs and HRAs, and manufacturers are responsible for taking part in understanding the process, ensuring they have the right team involved. “Historically, and today, I think one of the biggest obstacles companies face in terms of transparency is how companies tend to estimate the likelihood that harm may occur upon exposure to a device and how FDA estimates the likelihood of harm occurring,” says Beverly Lorell, M.D., senior medical and policy advisor at King & Spaulding’s FDA & Life Sciences Practice Group (Washington, DC).

In preparation for a conference about HHE, Risk Assessment & Recalls, Lovell sat down with MedTech Intelligence to talk about where companies are experiencing the most difficulty surrounding HHEs and HRAs, and the role that FDA has and will continue to play.

MedTech Intelligence: What are the obstacles a company faces when conducting Health Hazard Evaluations and Health Risk Assessments?

Beverly Lorell: I see three big challenges that companies, both large and small, experience when conducting an HHE.

1.    Ensuring that the right people are at the table and accountable for conducting the HHE and making the final determination of potential risks and their likelihood. I think it’s important that the HHE process include clinical medical expertise that has a deep understanding of the medical condition for which the device is used, the spectrum of patients that may be exposed to the device and its hazard, how the device is used by practitioners in the real world, and the most important, the ability to very objectively and critically identify the most serious health risks that may plausibly occur upon patient exposure to the hazardous or defective device.

2.    Ensuring that all available information is at the table to aid in decision making. This information should include a list of the received complaints related to both actual harms as well near misses, an understanding as to how complaints have developed over time, and assurance that a search beyond the complaint file has been conducted.

3.    Ensuring there is a process for considering worst-case scenarios regarding patient exposure to a defective device. A three-pronged approach should include having a process that avoids the assumption that physicians and nurses create successful workarounds to avoid patient harm from a device hazard; identifying patient subgroups at a higher risk of harm if they are exposed to the device and its hazards; and considering off-label uses that are not addressed in the instructions for use. This will help to address that the HHE process does not blame the healthcare provider or the patient for incorrectly using the device when the core problem may be a design issue or inadequate instruction.

MTI: What issues have manufacturers experienced as it relates to FDA’s transparency, or lack thereof, in conducting HHEs and HRAs?

Lorell: I think FDA’s transparency has steadily improved over past few years. That being said, I think FDA transparency that may affect the industry’s decision-making when it does its own HHE rests on two legs. The first is the public recall database that allows a company to see how FDA classifies recalls for device problems that recur and therefore how the agency assesses health risk and likelihood. The other leg is the HHE process document on FDA’s website, which is far more than a simple form and provides a guide on the agency ‘s thinking.

A way to explain this would be to use the analogy of a football field. There are two ends of the playing field. Some companies estimate likelihood [of harm occurring] using quantitative equations that multiply probability values of separate events and calculate a single numerical probability value. Those processes are problematic because they’re often based on a premise that one could come up with a single definitive numerical probability value based on incorrect assumptions of real-world use of a device.

At the other end of the playing field, FDA’s current process heavily relies on the term reasonable probability. FDA has not been very transparent in how it thinks about the term as it relates to numerical or semi-quantitative terms. It sometimes appears that FDA uses reasonable probability, which goes into a Class I recall classification, to mean reasonable presumption that harm will occur in a few or more patients.  

So if I were to target one area in which there’s a frequent disconnect and where there would be an opportunity for much more transparency, it would be how CDRH thinks about probability, including the term reasonable probability in its HHE and HRE process.

Don’t miss the candid discussion between FDA and industry stakeholders

What: HHE and Recalls/Global Recalls

When: May 10–12, 2016
Where: Washington, DC

Register now

MTI: Where do you see FDA’s approach to these procedures moving forward? Do you foresee more transparency and alignment?

Lorell: There are a couple of moving parts related to transparency. First, it’s a wait-and-see process. FDA recently convened working groups to address the current recall processes for medical devices, including a sub-working group intended to focus on HHE. Unfortunately, these working groups are operating behind closed doors. Many of us hope these working groups will become accessible to the public to afford broader participation and view points while still retaining the small core working groups that will do most of the heavy lifting in developing probable draft documents or whitepapers.

Second, conferences like the HHE conference next week are important because the topic of how to conduct an HHE is addressed in depth by FDA and industry participants. These discussions are critically important in moving the ball on transparency in both directions.  I’m hopeful that we’ll hear FDA give a high-level walk-through of how the center thinks about the HHE process, along with diverse case examples that will provide insight into the expectations on how it identifies the level of risk and the likelihood that the risk may occur if a patient is exposed to a defective device.

There needs to be an appreciation that there isn’t a single process of conducting an HHE that is the perfect and right fit for all medical device companies. Individual companies must have a lot of flexibility and resilience in how they approach the process.

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Maria Fontanazza, MedTech Intelligence