Medical Device Label
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.
Patient Assistance Line
- Designate a person(s) within the company to respond to patient inquiries. For example, a “patient liaison” or a “patient representative” who is trained in fielding and responding to communications from patients.
- Develop a template of potential questions and answers using the IFU.
- Set the days and hours the company representative will be available to field calls and include that information in the IFU. Similarly, if the representative or a website directs patients to an email address, provide the approximate timeframe within which the patient may expect an answer
- Consider reviewing emails and recording phone calls for quality assurance. Monitoring patient communications may provide the manufacturer with information about a potential device issue that may be helpful in developing modifications or improvements to make the IFU or the device itself more patient friendly.
- Complaints that implicate device safety are regulated and the representative should be familiar with the FDA’s reporting procedure, specifically if the device may have caused or contributed to a serious injury or death.
- The representative should not give information or advice that may be considered care and treatment, for example, recommending dosages for an insulin pump or usage times for devices such as heating equipment. The representative should refer the patient to the IFUs general recommendations for maximum safe usage, and refer the patient to the health care provider for patient specific usage information. The representative may even need to suggest the patient seek emergency medical care.
- Suggested language if the patient may reach a voice mail: “You have reached the patent assistance line for Life Science Company X. A patient representative is available to answer your questions Monday through Friday from 8:00 a.m. to 5:00 p.m. central standard time. If you have reached this message during those hours, we are on another line. Please leave a message with your name, phone number and nature of your question, and we will respond promptly. If you think you are having a medical emergency, call 911 immediately. If you have a medical question, please call your healthcare provider. You may also contact us through our website, www.lifesciencecompanyx.com.”
- For email inquiries, provide an approximate response time and consider the following disclaimer, “I understand that while my initial correspondence to Life Science Company X via this website is secure, your response will be via unencrypted email and that Life Science Company X cannot guarantee the security of email correspondence. I acknowledge I have been provided access to the Life Science Company X HIPAA Privacy Notice concerning the use and disclosure of my medical information.”
- A picture is worth a thousand words. A website with a downloadable IFU, a how to manual with photos, and videos depicting step by step use of the device can save a company representative time and potentially reduce telephone calls.
- A manufacturer should implement a protocol that is achievable and follow the protocol that is established.
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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