Comments of members of the USA Patient Network on Establishment of the Patient and Care-Partner Conn
The USA Patient Network is an independent group of patient advocates from across the country, working to ensure medical products are safe and effective for all patients. We are writing to express our views on the Patient and Care-Partner Connection Program.
We agree that incorporating patients’ perspectives in the development and evaluation of medical devices would be very valuable to patients, family members, caregivers, and the Center for Devices and Radiologic Health (CDRH). Our comments are focused on the issues of inclusion and barriers to participation, but also on the broader issue of making sure that patients’ perspectives are truly representative of all patients, and that issues of safety and effectiveness of medical devices are at the forefront.
Some of our members have benefitted from medical devices, and some have been seriously harmed by medical devices. When patients are harmed by medical products, they often do not know how to engage with the FDA. They don’t read the Federal Register and are not recruited by device companies to participate at FDA meetings. And, if they are seriously harmed, they may not be healthy enough or have the financial resources needed to go to FDA meetings, even when they know about those meetings. For that reason, when FDA reaches out to engage patients, they often hear from patient advocates that were recruited by and trained by pharmaceutical and device companies.
Unfortunately, even when patients harmed by medical devices have reached out to the FDA to share their perspectives, they often feel that their views are not taken seriously. At Advisory Committee meetings, for example, they are given 3-5 minutes to speak during a public comment period session, separated from Panel members by a red tape barrier, and almost never asked any questions by the Panel. After attending such a meeting at their own expense, often at considerable inconvenience, it is not surprising that many patient advocates are not interested in attending any other FDA meetings and would be difficult to recruit for this new CDRH program.
Our members tell us that in the past, it has seemed that CDRH is more interested in hearing from patients who have had good experiences with medical devices, rather than those who have been personally harmed or whose family members have been harmed by medical devices. This is especially true if those devices are still on the market. We hope that this newly proposed program will change that.
When patient advocates are recruited and/or trained by device companies, the views of those advocates tend to reflect the corporate view that FDA’s regulations are burdensome. We have a different perspective. Our members have met with staff from the FDA Patient Representative program and attended a Workshop where we were trained to understand the FDA approval process. We know that FDA’s mission is to protect patients from unsafe and ineffective medical products, and we want patients to help you achieve that by helping to explain what the risks and benefits of medical devices mean to patients. For example, if an adverse reaction to a product is pain, what does that mean in a patients’ daily life? If a benefit is a quicker recovery from surgery, how meaningful is that to most patients?
If this new CDRH program is to be a success, CDRH must ensure that the program is designed to include as many patients who were harmed as those who are pushing the FDA to approve devices more quickly. For true representation of patients’ perspectives, it is essential that the FDA recruit patients from organizations that are focused on safety, even if those organizations have not previously had much contact with the FDA.
Device Events, a company that helps businesses and organizations extract and understand adverse event reports for medical devices submitted to the FDA, has reported more than 635,000 injuries and 43,000 deaths from high-risk devices in the past 20 years. Of course, many “moderate-risk” devices, such as power morcellators, mesh, hip replacements, spinal implants, and cardiac devices, have also harmed hundreds of thousands of patients. The views of those patients and those family members are essential if CDRH is to succeed in truly representing patients’ perspectives.
It will be a challenge for CDRH to create a Patient and Care-Partner Connection Program that is not influenced by the medical device industry. We are happy to help CDRH achieve that goal.
CDRH should make sure that patients and family members can make informed decisions based on scientific evidence of the likely risks and benefits of medical devices. The Patient and Care-Partner Connection Program should empower patients by helping them understand evidence regarding medical devices, while also asking patients to help CDRH provide understandable, user-friendly information to other patients on the FDA website, and via labels, patient booklets, and other materials.
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