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Submissions received: Proposed refinements to the requirements for medical device patient information materials
The TGA thanks respondents who provided a submission to the public consultation: Proposed refinements to the requirements for medical device patient information materials - Australian Government Department of Health .
This consultation related to the implementation of the requirement for sponsors of implantable medical devices, to provide patient information leaflets (PIL) and patient implant cards (PIC) about their medical device. The requirements commenced in late 2018, with a gradual implementation over three years.
During the implementation phase, we received feedback from consumers, health care professionals, surgeons, hospitals and medical device companies of some impracticalities and challenges with the implementation. We therefore sought submissions through this consultation on potential refinements to the existing regulatory requirements for patient information materials.
Two refinements were proposed:
- Offering more flexibility in how, when and in what format the patient information leaflet and the patient implant card could be provided by the sponsor; and
- Whether there were additional devices that could be exempt from the requirements due to the nature of certain devices.
Summary of feedback
Almost all respondents, including the consumers, agreed with the proposals for providing information in a range of formats. This would allow information to be recorded in electronic formats such as electronic patient records and MyHealth records. Although, several respondents considered that regardless of how the information is kept, patients should also have the option to receive a hard copy. Most were in favour of flexibility in the way information is provided. There were also suggestions for providing patient information materials in different languages and in audio form. The medical device industry respondents noted that electronic formats would reduce cost and some health care providers considered that costs are offset by benefits. However, there were several concerns raised about the burden on hospital staff and administration times if the system is too demanding or complex.
The majority of respondents agreed that it is unnecessary to provide patient implant cards if the device is going to be absorbed by the body within a certain timeframe. Those that stated they did not agree had concerns over delayed reactions to such implants. The suggested timeframes varied from days to 2 years, but the majority of those who responded opted for periods of 3 to 6 months.
The strong majority of respondents agreed that it is unnecessary to provide patient implant cards for pedicle screws, given that many types of screws could be used in one surgery. There were suggestions that a system implant card is sufficient (that covers all implanted devices from one system), or that a generic patient information leaflet could be provided. In general, the responses indicate that it is unnecessary to provide patient implant cards for each screw or component, but the requirement for a patient information leaflet should be retained.
Although only a few respondents had comments on other devices which could be exempt from the requirements, there was strong representation for exempting reloads with staple line reinforcement, sutures with pledgets, and pledgets alone from requiring patient implant cards. There was also a recommendation to ensure alignment with the European requirements by exempting spinal rods, suture anchors, wedges (augments), laminar hooks, non-expandable cages, interspinous spacers, and bone screws.
There were also some questions about certain devices such as coronary stents and dental crowns, which indicated that there was still some confusion about the regulatory requirements for these devices.
It was noted that there was a need for increased communication about the implementation including education for hospitals, procurement officers and clinicians in relation to the provision of these materials.
Based on the outcomes from the consultation, agreement will be sought from the Government to consider refinements to the Regulations. These refinements would:
- allow more flexibility in how patient information materials can be provided including in a range of formats such as electronic format and at either pre or post surgery (i.e. not necessarily supplied with the device in the packaging);
- exempt devices absorbed by the body within a defined time period from the requirement for a patient implant card but maintain the requirement for a patient information leaflet;
- exempt pedicle screws from the requirement to have a patient implant card. The requirement for a patient information leaflet will be retained, but could be incorporated into a system patient information leaflet where appropriate; and
- create the power for a TGA delegate to consider exempting other devices where clinically appropriate to ensure alignment with Europe, where possible.
Guidance documents will be updated to address other concerns raised in the consultation. Continued education will also be provided, including clear messages to relevant groups such as hospitals, surgeons, clinicians and procurement officers in relation to the implementation of patient information materials.
Guidance will be further updated following a decision from the Government on the proposed refinements.
A total of 34 submissions were received with more than half of the submissions from health care professionals and hospitals who are responsible for providing information to patients. Submissions were also received from consumers, professional health related societies and the medical device sector.
All submissions that gave permission to be published on the TGA website are available below in PDF format. Nine respondents did not give permission for their submission to be published.
- Consultation submission: Anonymous 01 (pdf,25kb)
- Consultation submission: Anonymous 02 (pdf,24kb)
- Consultation submission: Anonymous 03 (pdf,28kb)
- Consultation submission: Anonymous 04 (pdf,25kb)
- Consultation submission: Anonymous 05 (pdf,25kb)
- Consultation submission: Anonymous 06 (pdf,24kb)
- Consultation submission: Anonymous 07 (pdf,24kb)
- Consultation submission: Anonymous 08 (pdf,25kb)
- Consultation submission: Anonymous 09 (pdf,29kb)
- Consultation submission: Anonymous 10 (pdf,25kb)
- Consultation submission: Anonymous 11 (pdf,24kb)
- Consultation submission: Anonymous 12 (pdf,25kb)
- Consultation submission: Anonymous 13 (pdf,25kb)
- Consultation submission: Anonymous 14 (pdf,26kb)
- Consultation submission: Anonymous 15 (pdf,31kb)
- Consultation submission: Anonymous 16 (pdf,24kb)
- Consultation submission: Anonymous 17 (pdf,25kb)
- Consultation submission: Anonymous 18 (pdf,24kb)
- Consultation submission: Day Hospitals Australia (pdf,24kb)
- Consultation submission: Dental Implant Registry (pdf,27kb)