The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document that addresses the information accompanying (active) implantable medical devices, including patient information leaflets and implant cards. The present article is dedicated to the latter and describes the regulatory requirements applicable thereto.
It is important to mention that the guidance document issued by the TGA provides non-binding recommendations and could be subject to changes in response to respective changes in the underlying legal framework.
First, the TGA outlines the scope of responsibilities of medical device manufacturers and sponsors. In this regard, the document refers to the Essential Principles and general regulations on medical devices. The authority additionally emphasizes the importance of ensuring the medical device in question is duly included in the national register of healthcare products approved for marketing and use in the country – the Australian Register of Therapeutic Goods (ARTG). The scope of regulatory requirements medical devices should comply with in order to be approved for marketing and use includes the requirements for patient information materials.
According to the document, the responsibilities could be divided into the following way:
- Medical device manufacturers should ensure the content of patient information materials is complete and accurate and complies with the applicable requirements; while
- Sponsors shall have all important information about the medical device in place or duly implement procedures allowing them to obtain all necessary information from the medical device manufacturer in a timely manner.
According to the applicable legislation, implantable medical devices and active implantable devices should be accompanied by patient information materials. The relevant regulation entered into force on December 1, 2018; however, the appropriate transition period applies.
The authority further provides the definitions of both implantable medical devices and active implantable devices and also states that the requirements described herein are also applicable for absorbable devices, as well as implantable custom-made devices and patient-matched devices. At the same time, the TGA also mentions that certain implantable medical devices are explicitly excluded from the scope of requirements addressed in the document. Excluded devices include such devices as sutures, staples, wedges, dental fillings, tooth crowns, screws, pins, and connectors. However, even though the devices described above are excluded from the requirements for patient information materials, the regulating authority still encourages medical devices manufacturers and other parties responsible for these products to provide patient information materials in order to ensure the persons using these devices (including healthcare professionals and patients) have sufficient information about the products to be able to make informed decisions.
The TGA additionally emphasizes that patient information materials should not be used for marketing and promotional purposes. In order to avoid situations when such materials are used to promote and advertise medical devices, the manufacturers shall:
- Provide all information related to the (active) implantable medical device in a neutral and informative manner;
- Avoid providing information that describes the device in question as the best option;
- Avoid making comparative statements when providing information regarding the performance of the device;
- Make sure the patient information materials are not used in promotional activities.
Patient Implant Cards in Detail
The second part of the TGA guidance addresses the matters related to the patient implant cards. According to the document, patient implant cards are intended to provide patients with information about the medical device after the latter has been implanted. It is stated that the purpose of patient implant cards is to ensure that patients are aware of the details of the device that they have been implanted with and that health practitioners can also identify particular devices. The authority also states that patient implant cards could also be used to improve the general traceability of medical devices and facilitate post-market activities related to the safety issues associated with implanted medical devices, including safety warnings and recalls.
The document further describes the applicable regulatory requirements a patient implant card should meet. As in the case with patient information leaflets, information materials of this type should be supplied with the medical device and provided in English (however, the information contained therein could be additionally provided in other languages). Patient implant cards could also contain schemes and drawings or standardized symbols. According to the guidance, the scope of information a patient impact card should contain covers the following elements:
- The name of the device;
- The model of the device;
- The batch code, lot number or serial number of the device;
- The unique device identifier (UDI) of the device (if any); and
- The manufacturer’s name, address and website address.
The TGA also states that even though it is not explicitly required under the applicable legislation, the information outlined above could be supplemented with the details about the medical device’s sponsor and/or safety warnings that could be important for the patient (especially those related to possible interactions with electronic equipment).
How Implant Cards Should be Provided
As of today, the regulating authority encourages the use of patient implant cards in physical form as in this way the information contained therein would be easily accessible for health practitioners and other parties involved in operations with medical devices. Apart from the elements listed above, a patient implant card could contain blank fields intended to be filled with the following details:
- The name of the surgeon; and
- The name of the hospital where the procedure was undertaken.
Additionally, medical device manufacturers are allowed to use bar codes, as long as such bar codes are placed on stickers that are durable enough to remain clearly visible and readable and contain all necessary information.
As in the case with other patient information materials, patient implant cards could be provided in electronic format as well. In such a case, the medical device manufacturer shall ensure the important information related to the device is easily accessible.
Another important aspect addressed in the present guidance relates to the role of the TGA as a regulating authority in ensuring all patient information materials comply with the applicable regulatory requirements. It is stated that such materials would be subject to review during the ordinary procedures carried out by the authority, such as:
- TGA’s conformity assessments;
- Application audits; and
- Post-market reviews.
If the device in question is included in the appropriate conformity assessment certificate issued by the TGA, the entity responsible for such device should duly submit patent information leaflets and patient implant cards for review.
In summary, the guidance document issued by the TGA provides additional clarifications regarding the regulatory requirements patient implant cards should meet. The guidance outlines the scope of information to be included in a patient implant card and also describes the way such card should be provided (including the use of an electronic form).
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