When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred.
Several considerations come into play during an HHE, and the final decision of whether an action must be taken should be made by a qualified internal team that has defined procedures and responsibilities. This team will be looking a several key factors, but much of the focus during the process should be on the patient that might be exposed to a hazard and any complaints associated with the product in question.
“An HHE is a clinical analysis of the potential harm that may occur to your patients,” said Beverly Lorell, MD, senior medical and policy advisor at King & Spaulding’s FDA & Life Sciences Practice Group. “Create a culture where the focus is consistently on the patient.” Lorell, industry stakeholders, and FDA officials debated how to approach and use an HHE as an escalation tool during a conference held by Medical Device Summit this week in Washington, DC.
The consensus among many of the experts was that the management of complaints, and strong documentation of those complaints, plays a critical role during an HHE. “The best data you can have is in the complaint box,” said Thomas Morrissey, MD, vice president, quality assurance advanced technology/product safety at Edwards Lifesciences. “Your health hazard [evaluation] is only as good as your complaints management team.” He added that FDA will always tell companies that the level of its investigation should be directly proportional to the complaint.
When conducting an HHE, companies need review these product complaints in detail. This includes assessing communications with users to identify any trends. The more data that a company’s complaints management team can provide during the process, the easier it will be to make an informed decision. “When I’m looking to try to assess the risk of an issue, typically there are complaints that are involved in the issue,” said Morrissey. “To go back into those files and see that [companies have] done an adequate investigation and asked follow-up questions—maybe they’ve requested x-rays, etc…[they] got the product back, got the lot number—[they have] all that information and are able to tie that together. That makes my job a lot easier and I feel I can give a better assessment of the risk if I get those complete files.”
For more on the discussion at this event, read about Beverly Lorell’s take on FDA transparency and the challenges that device manufacturers are facing related to next steps once a product recall decision is made