Vani Singhal, Esq.
When responding to a patient inquiry, whether from a telephone call or an email, a medical device manufacturer should frame the communication around the information contained in the device label. A manufacturer should develop and provide detailed and clear instructions on the safe and effective use of every device. The label, or a user guide or instructions for use (IFU), will serve as the manufacturer’s script when responding to patient queries. A manufacturer should not stray from these instructions to advocate an off label use, or give information or advice that could be construed as medical treatment.1 Device manufacturers should develop a protocol for a “Patient Assistance Line” utilizing the IFU as the guide.
An excellent resource for preparing a device label is the FDA Guidance on Medical Device Patient Labeling.1 The Guidance provides a suggested outline of information for the label, including examples of wording and format to make the instructions understandable for the lay user. According to the Guidance, two categories of information may be included in the label: 1) risk/ benefit information; and 2) instructions for use. See FDA Guidance. This article will summarize the second category, as the IFUs will provide the framework for responding to patient questions.
The intent of medical device patient labeling is to assure the safe and effective use of “therapeutic, restorative, diagnostic or cosmetic” devices. See FDA Guidance. Medical device labeling comes in different formats such as “patient brochures, patient leaflets, user manuals and videotapes.” Id. This information may accompany the device and many times is available on the manufacturer’s website, private medical websites and even YouTube; and may be given to patients with or without counseling from a health care provider depending on the device. Just like the label, any other form of communication with a patient should be geared towards promoting and assisting with the safe and effective use of the device.
IFUs are the “how to” for the device and provide the procedural steps to follow when a patient has control over the device and needs to set up, operate, clean, troubleshoot and store a device, such as pain or insulin pumps, physical therapy equipment such as heating pads or T.E.N.S. units, or even more complicated cardiac equipment such as the LifeVest. The FDA Guidance provides a detailed description of best practices in instructing patients step by step on: set up; operation (for example, description of the location of the on/off switch); maintenance (such as cleaning, changing batteries, using adaptors at home or when traveling abroad); storage; and disposal.
The FDA regulates and approves the information contained in the label. “When translating the professional label into lay language [for patients], take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or other parts of the professional labeling.” Id. Similarly, patient communications by telephone or email should align with the written instructions.
The FDA Guidance recommends the manufacturer include a section on troubleshooting to address common user issues and questions. This will likely be the section most helpful to the person responding to patient questions. The label, as well as the company representative, should “[i]nstruct users to call their health care professionals for emergency assistance if troubleshooting reveals a patient health problem rather than a device problem.” Id. This section should advise users on how to get help for problems with the device and include a customer assistance number. A manufacturer should consider setting up a website where patients may find the IFU and demonstration videos.
In responding to patient inquiries, a manufacturer should not offer information beyond the intended or indicated use provided in the device label. A manufacturer should develop a detailed but easy to follow Instructions for Use/User Guide to serve as a guide to not only patients but to the company representative who is charged with responding to patient inquiries. A manufacturer should not advocate off label use, provide information that is not accurate or outside the label, or give information or advice that amounts to medical decision making.
1 For more information on off-label promotion, see How to Avoid Off-Label Promotion.
2 Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA (April 19, 2001).
Vani Singhal, Esq. is Of Counsel at the Tulsa, Oklahoma office of McAfee & Taft, and a member of Medmarc's defense panel.
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