August 18, 2021
National Center for Health Research’s Public Comments on the FDA Discussion Paper Regarding Conveying Materials Information About Medical Devices to Patients
We are writing to express our views on the discussion paper regarding how to convey information to patients about medical devices intended for long-term use. As stakeholders who work directly with thousands of patients to help them understand medical information, we appreciate the opportunity to provide our comments.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Medical devices can improve patients’ health and even save their lives, but like all medical products, they have risks. Unlike drugs, most medical devices on the market are not approved based on clinical trial data; they are cleared based on substantial equivalence to other devices that may be made of different materials. It is therefore essential that patients are well informed regarding all materials used in devices and the potential short- and long-term risks they may pose.
The problem in communicating this information starts but does not end with the lack of information about materials on device labeling. Labeling is crucial in order to equip patients with the information that allows them to provide informed consent, and labeling must be informative rather than a symbolic gesture. However, the labels on most implanted devices are seen by the surgeon, not the patient. So, the first step is that the label should be made available online and in-person to patients as well as physicians, as an early step in the informed consent process, and as a source of information if adverse events occur. Patients tell us that information about medical devices is often only made available to them in the minutes prior to surgery; that is not acceptable. Information about materials should be made available prior to making the appointment for surgery, preferably as a checklist for patients and their physicians to sign. In addition, many surgical procedures include small implanted devices, such as staples, rings, and tiny metal markers placed during a biopsy, which patients do not learn about prior to surgery. The information about the potential effects of materials should be accessible in the AccessGUDID public database and accessible using the FDA website search engine when searching by the name of the product. Patients and physicians should be provided with a link to these databases, making it known and accessible to all.
When the information is made available as described above, it should be as short and easy-to-understand as possible. It should also be straight-forward, as a simple alphabetical list of materials within a material type category, using commonly known names that are easily understood by a lay audience. All materials contained within the device or included in the processing and preparation should be listed. Possible trace materials should be included, regardless of safety thresholds, with information about the levels of risk and exposure from the device when that is known. If a device has multiple parts, the materials in each of the parts should be listed separately (as shown in Appendix B of the FDA document). All materials and their potential risks should be listed; none should be held under the justification of “trade secrets.” Patients deserve to know, in information understandable to the lay public, how much of each material is present in a given device.
We support the suggestion to explicitly name device components in terms that are accessible to the layperson, such as using the term “gold” instead of only using the scientific label “Au.” Similarly, chemicals’ trade names or other commonly used names should be used alongside or instead of their scientific names, since those are the names that patients may be most familiar with. For example, different types of silicone materials should be listed as silicone (not as silicon or as polysiloxane) with specific types of silicone included in parentheses.
Labeling should be comprehensive regarding every potential allergic and autoimmune reaction, such as all known risks for a given metal or alloy, as well as the potential risks that may continue even after the device has been explanted. Further, labeling needs to be clear and transparent with respect to animal-derived components, such as explicitly stating the use of pig skin collagen, rather than only using the term “collagen” without specifying the source.
Labeling that is widely available to inform patients about all potential risks of the materials of a device can also contribute to scientific knowledge. Patients who are aware of a potential side effect should be encouraged to report it to their doctor and to the FDA if it occurs, to add to FDA’s information about the frequency and severity of such adverse events. Patients would otherwise be unlikely to realize that the systemic problem they are experiencing is related to their device.
Some patients are aware of their sensitivity to certain metals, dyes, or other materials, while others are not. Every patient deserves to be notified of materials prior to scheduling surgery, and warned about all of the risks of a medical device in order to be able to properly provide their informed consent for its use. Labels on packaging that the patient never sees, or sees only after the implant is in their body, are not sufficient. In addition to online access described above, FDA should require a list of all materials in an implant made publicly available online on the product’s website and manufacturers should also provide a hard copy to patients, preferably as part of a patient checklist, before a nonrefundable deposit has been made for surgery. As noted above, all information about these materials should be listed in an understandable and accessible way for all devices – even tiny ones that are not the major focus of a surgical procedure – so that patients can make informed choices about their medical care. Moreover, it should never be “buried” in a long patient booklet or label in ways that reduce the chances that a patient will read it.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.