October 26, 2022
I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest.
My expertise is based on post-doctoral training in epidemiology and public health, my previous policy positions at Congressional Committees with oversight over FDA, my previous position at the U.S. Department of Health and Human Services, and as a faculty member and researcher at Harvard and Yale.
There are unique issues for the different types of wound dressings you are considering today, but they have some issues in common:
- They have been treated as 510k devices despite not being categorized as Class II or any other Class
- They have been used for years but FDA found very few studies pertaining to safety or effectiveness, and some were specific to particular types of surgery, such as diabetic foot ulcer care.
- The information from FDA’s AEs reporting on the MDR system is limited but the FDA has identified several potentially serious AEs, including toxicity, infections, and delays in wound healing. These are important because they clearly can interfere with the success of surgery.
- Most patients and surgeons assume that these products are proven safe and effective. They would be surprised to know how little scientific evidence there is regarding safety and effectiveness.
You heard testimony from Madris Kinard from Device Events this morning, and saw her excellent analyses of adverse events based on information from the FDA database. At our request, she also provided an analysis of wound dressings to our research center, based on the FDA total product life cycle database. The results indicated thousands of reports of contamination and problems with non-sterile packaging of wound devices on the FDA. Most were from the last 4 years. For the animal derived wound dressings, which are collagen dressings, there are 126 MDRs and 12 recalls.
FDA and other experts agree that MDRs are under-reported. It is a voluntary system, and as panel members mentioned this morning, it is difficult to distinguish between adverse events caused by the device vs. the procedure. We all know that surgeons are very busy and do not strong incentives to report adverse events if the causes are unclear. Keep in mind, for example, if a patient’s wound becomes infected, surgeons would not necessarily report it as an MDR for the wound dressing.
The FDA has delineated some very clear special controls for these devices if they are considered Class II and continue to be cleared through the 510k process. These are good efforts that would improve upon the current regulatory policies for these devices.
But the special controls have 2 major shortcomings:
#1: They don’t include inspections, which could reduce harm caused by contamination and non-sterile packaging.
#2: None of those controls will provide scientific data on the safety and effectiveness of any of these wound dressing products. And that is the one crucial type of information that is missing. Insufficient information is currently available, especially regarding which specific products are safest and most effective for which indications. The issue isn’t just different types of wound dressings, but the products made by different companies. It is likely that some are better than others. That is why I encourage you to urge the FDA to categorize wound dressings as Class III, so that we will finally have well designed clinical trials to determine safety and effectiveness.
What about registries? Registries can collect important information. But as you consider all the medical devices being discussed today and tomorrow, please remember that registries are controlled by medical societies and as such the data from them are not available to the public or the FDA, except for the information that those medical societies choose to make public. So unfortunately, we can’t rely on registries to provide objective, comprehensive information about safety or effectiveness to the FDA or the public.