Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common name. What if the FDA required the same for certain medical devices? He can soon.
On May 24, 2021, the FDA’s Center for Devices and Radiological Health (CDRH) released a discussion paper detailing a proposed framework for including specific information on materials used in the labeling of medical devices. The framework proposed by the CDRH is similar to that used for ingredient lists on food labels and would label certain medical devices to identify “ingredients” that are designed to be in contact with the patient for more than 30 days. The CDRH has asked stakeholders to provide comments on its proposed framework by July 19, 2021. This alert summarizes the labeling framework proposed by the CDRH, including its importance, and the potential implications of litigation for manufacturers. of devices.
How can device labeling change?
The CDRH is considering requiring that the labeling of healthcare providers include (1) specific information on the material composition of a medical device; and (2) recommendations on how to counsel patients about device materials. Since not all devices designed for long-term use have patient labeling, the CDRH is also considering requiring manufacturers to provide patient labeling, which may include, among other things, ” basic description of the device and a list of the patient contact material of the device in an easy to understand manner.
Which medical devices can be subject to the proposed changes?
All medical devices that may be in contact with a long-term patient (> 30 days).
Why is the CDRH considering integrating these labeling requirements for certain medical devices?
According to the CDRH, “several high-profile safety issues associated with certain long-term exposed medical devices” have sparked “a discussion within the stakeholder community about the materials used in these medical devices and their potential association with adverse events. reported to the FDA. “In 2019, the CDRH responded by completing a review of the scientific literature on metal-containing implants and holding an advisory committee meeting to discuss potential immunological responses to metal-containing implants. One of the CDRH’s teachings is the advisory committee meeting is that “it is important and beneficial for patient safety that the packaging and labeling of the device include a list of the basic composition of the device”.
The CDRH believes that this information will help patients and providers in two key ways: (1) it will enable them “to make more informed decisions about which medical devices may or may not be most appropriate for an individual patient”; and (2) it “will facilitate identification whether immunology / hypersensitivity to any material in a device has been the cause of adverse health consequences experienced by the patient in whom the device has been used”.
What factors has the CDRH taken into account in developing the proposed changes to the labeling of devices?
The CDRH has identified the following factors as being important for its consideration of whether and how to include a list of medical device materials in labeling for patients and healthcare providers:
- Duration of implantation – The CDRH believes that permanently implanted devices may present additional risks, such as the need for surgical removal
- Contact durationt – The CDRH indicates that generally devices with a longer duration or repeated contact are more likely to cause an adverse reaction (for example, more than 30 days)
- Usefulness of labeling – The CDRH wants information on materials to be easily usable and understandable by stakeholders to inform decision-making and
- Diversity of devices – The CDRH does not believe it is practical or necessary for manufacturers to include material information for all devices, especially those that pose a low risk.
What materials of the device would be listed in the labeling?
For all devices designed for long-term use, the CDRH plans to identify all materials that could reasonably come into contact with human tissue. This means that some device materials may not need to be listed if, for example, they are in a housing or have a protective coating designed to prevent tissue exposure. The CDRH proposes to list the constituents of the following materials: (1) metals, (2) polymers, (3) ceramics, (4) materials of natural origin: animal sources; (5) materials of natural origin: non-animal sources; (6) composites; and (7) manufacturing residues.
How would device materials be listed in the labeling?
The CDRH suggests that the way materials are listed in the labeling may vary depending on the type of material involved. It offers for each type of material:
- Metals: The CDRH proposes to classify metals by their elemental name (eg nickel) in decreasing order according to their prevalence in the alloy. The CDRH is also studying the advisability of including trace elements.
- Polymers: The CDRH is considering requiring that polymers be listed both by their trade name and their chemical name, as well as by any coloring additive. Additional specificity may be required for polymers or their components which present known toxicological risks (eg, residual catalyst, monomer, impurity). He also identified some polymer products that may warrant providing additional information such as lubricants and over-the-counter devices. designed to degrade in situ.
- Ceramic: The CDRH plans to list the elementary names of materials in descending order according to their prevalence in ceramics.
- Materials of animal origin: For material of animal origin, the CDRH is considering identifying the animal, tissue type, material purity and chemical names and other information on processing reagents.
- Non-animal material of natural origin: For materials of non-animal origin, the CDRH suggests including the type, species of material, material purity and chemical names and other information on processing reagents.
- Composite materials: The CDRH defines composites as being made up of two or more independent materials which maintain the phases of the material. The CDRH suggests identifying each material as described above.
- Manufacturing residues: The CDRH raises a concern about devices that are processed in the presence of other materials of manufacture or processing aids which could result in contamination of the device materials to toxicologically significant levels. If residual chemicals are not removed during the cleaning process, CDRH suggests identifying residual chemicals.
What is the potential significance of these proposed labeling changes?
Providing information that can help patients and healthcare providers make an informed decision about medical devices is generally a good thing. But while the ingredient list in food products may help consumers make better dietary decisions, it is questionable whether a similar framework will help healthcare providers and patients make better device decisions. Some potential drawbacks of the proposed framework are as follows:
- The choice of materials is not always an option: While consumers can look at an ingredient list and decide to avoid a food that contains a known allergy or other health problem, patients with a medical device often do not have this option. Without adequate guidance from healthcare providers, some patients may forgo necessary medical attention due to concerns about device materials that are not supported by evidence. In addition, it is not clear that the labeling proposed by CDRH for patients would address the results of clinical studies and biocompatibility tests, which are much more indicative of the safe and effective use of a device.
- A list of materials is insufficient to assess potential risks: To list materials in descending order according to their prevalence in the component is insufficient to understand their potential for toxic effects on health. To understand the toxicity risks of a material, a reader must know the rate at which the material escapes from the device relative to the health protection values for that material.
- A list of materials can give a false sense of security: CDRH suggests that a detailed list of device materials can help healthcare providers make better decisions about which medical implants are best suited for a particular patient. But we still don’t know if this is true. In fact, at the 2019 Advisory Board meeting, discussed above, panel members acknowledged that it is currently not possible to prospectively identify patients who are at risk of developing an allergic or immune response. to a particular material in a device. In the case of metal allergy, for example, case-control and prospective studies have shown that even a history of metal contact dermatitis or a positive patch test cannot predict whether a patient will develop contact dermatitis or not. other complications from metal joint implants. In addition, there is currently no known causal relationship between certain device materials and autoimmune disorders. Therefore, while it may be helpful for patients and providers to discuss the materials contained in a device, it may be too early to suggest that taking this information into account will lead to better patient outcomes. health.
What are the potential implications of litigation for medical device manufacturers?
Manufacturers could experience an increase in reports of adverse events and associated litigation when a material listed in the device receives media attention for unrelated health concerns. The proposed labeling requirements will likely provide complainants with new theories of liability regarding whether a manufacturer correctly listed the materials needed on the label. They could argue, for example, that an omitted material should have been listed because it was reasonably likely to come into contact with human tissue or that a manufacturing residue should have been disclosed because it existed at levels toxicologically significant. Such theories would once again test the defenses of preemption.