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Every day, orthopedic device professionals face myriad regulatory and quality affairs questions that have no definitive right or wrong answers. Four orthopedic experts who know these gray areas well convened for a panel discussion at OMTEC to provide industry colleagues with advice on ways that they would manage real-life scenarios.
In this article, we will review two examples—complaint reporting and clinical evaluation reports. The panel included:
- Jeff Tyber, Founder, President and Chief Executive Officer, Tyber Medical (moderator)
- Dawn Norman, Executive Vice President, MRC-X
- Kimberly Light, Director of Regulatory Affairs, BioPro
- Ryan Belaney, Senior Director, Regulatory Affairs, Active Implants
Complaint Reporting: Should You or Shouldn’t You?
According to Tyber, much discussion still needs to take place to determine the difference between feedback and complaints. Varying opinions and multiple caveats illustrate that so much is situational, and that by adding new details to the same scenario, companies may choose to take different approaches.
In the common case of a fibula fracture with ankle instability, a syndesmotic screw is placed to stabilize the ligament to get it to scar over. In this case, the patient complained of pain six weeks post-operation, and as it turns out, the syndesmotic screw had fractured. A secondary operation occurred to remove the screw and the fragments, but the entire screw could not be removed. Do you file a report?
Kimberly Light said that with this information alone, she would absolutely put this in the complaint system.
“I would pull certificates, go through the lab records and learn everything I could about the device that broke,” Light said. “I lean toward reporting this because the situation required a second operation, which increases risk to the patient.”
However, when given more information about the scenario, the likelihood of reporting decreased. After her initial response, Tyber asked Light if her decision would change based on the following new information: In this scenario, surgeons plan for two operations because this specific screw fractures about 90% of the time. The second operation is planned because they anticipate the screw breaking. If a second operation is planned and it is considered typical for the procedure, how would that impact the decision of whether or not to report?
Light explained that given this new information, she would be less likely to report. The planned secondary surgery would serve as her justification for not doing so.
Belaney highlighted the importance of having a system in place to make sure that companies gather the necessary information in these situations.
“You need to be able to differentiate between what is feedback and what is an actual complaint,” Belaney said. “How you manage the gray area of measuring reportable or not reportable scenarios, aside from serious injury or death, will need to be substantiated by what is considered your normal procedure.
“Similar to this scenario, the plates placed in the spine are temporary until fusion has occurred,” Belaney continued. “So, what do you do if a plate cracks before the spine fuses? Do you report it? Do you review the history of the device to see if it’s a growing trend? What is the risk to the patient?”
According to Norman, “Whenever you’re used to breakage, it’s crucial that you are well-trained and know what to expect from the products you’re using. If something is going to require reoperation, both FDA and EU will be asking questions to make sure your results are matching their standards in their literature and to keep track of the results you are seeing, so trends can be identified.”
It’s also important that you consider the risk to the company if you choose to not report it. What is your company’s threshold for damage? With all of these factors to consider, the panel suggested:
- Make sure you gather enough information about the procedure and the devices before deciding whether or not to report the incident.
- Have a system in place that your team can follow to ensure consistency in your decisions about reporting complaints.
- Regardless of whether or not you report an incident to the regulatory body, log these events to substantiate data. You may identify a trend.
- Be consistent.
The panel also cautioned that reporting less is not the best way to avoid red flags from FDA. In fact, FDA is starting to track companies that are reporting fewer incidents more closely than others. This could increase your likelihood for further scrutiny and auditing.
Clinical Evaluation Reports – What Really Matters?
In this example, the panel discussed Ti-6Al-4V foot and ankle plates that have been on the U.S. market for three years, with indications for arthrodesis and fracture fixation. Who is the most appropriate expert to author the Clinical Evaluation Report (CER)?
According to Light, everyone who has written and reviewed CERs in the last three years has seen a dramatic change in what was previously acceptable due to the EU’s shift from the Medical Device Directive to Medical Device Regulation. Compliance standards are much more stringent than ever before. Another challenge is that different regulatory bodies will give companies different kinds of feedback. When dealing with data equivalent devices, we sometimes must rely on information from the published information from other companies, and it can be challenging to include other validations in new CERs.
Norman suggests early planning and collaboration when it comes to CERs and Postmarket Surveillance. “You need to start making some decisions and early planning of what you are willing to do and present to the notifying body,” Norman said. “You need to be able to prove you can collect enough data for you claims, because at the end of the day, that’s what they’re really looking for. If you feel stuck, don’t hesitate to reach out to regulatory bodies. They are there to help and are happy to do so.”
According to Belaney, the credentials of CER authors must be taken into account. “When you consider CER authors, look closely into your own company and be sure that the most appropriate person or people are participating in the process,” he said. “They may not be the person who first drafts the report, but they should definitely be a final approver before publication. A medical doctor would probably be most appropriate. If you don’t have one, don’t give this responsibility to a straight-out-of-school associate who is new to the industry. Your most senior associates need to oversee these reports and their processes, to ensure credibility.”
Kim Snell is an ORTHOWORLD Contributor.
