MEET REGULATORY REQUIREMENTS
WITH THE DIR

Dentist Office

MEET TGA REQUIREMENTS

MEET AHPRA REQUIREMENTS

Is your Dental Practice meeting AHPRA and TGA regulatory requirements regarding patient records?

If you work with dental implants in any capacity, current AHPRA regulations / ADA guidelines stipulate that patient records of all components for therapeutic devices (including dental implants & abutments) need to be accurately recorded and stored for a minimum 7 years.

 

  • This includes, but isn't limited to, the implant or abutment Lot/Batch and Reference numbers

  • TGA regulations even require personalised medical device (such as customised abutments and prostheses connected implants) records to be retained for 15 years

 

Furthermore, these details must be provided to the patient at their request at any time in the future. The Office of the Australian Information Commissioner indicates that patients should receive their information within 30 days.

 

Another mandatory requirement by the TGA is relating to high risk endosseous implants (such as zygomatic implants and osseoframes) that require patients to receive a Patient Implant Card (PIC). This is a physical/digital card that must be filled in by your practice and given to the patient.

 

To easily meet all your regulatory requirements, consider using the Dental Implant Registry (DIR) in your Practice. The DIR helps your Practice by:

 

  • Keeping accurate, accessible and long-term storable records

  • Giving patients access to their own implant records

  • Reducing your data entry and storage burden

  • Reducing your legal risk regarding record legacy requirements (particularly when you retire or move clinics)

 

The TGA even suggests including information about dental implant devices in a registry such as the Dental Implant Registry

 

The DIR is entirely free to use for Dental Practices, and you even receive a rebate for data entry!

YES I WANT MY PRACTICE TO MEET REGULATORY REQUIREMENTS

IMPROVE YOUR PATIENT RECORDS

By registering your patients implant components on the DIR, you are ensuring the information recorded is not only accurate, but also relevant and accessible for future treating dentists.

 

  • Are you currently recording the exact implant componentry you are installing including LOT/Batch and Reference numbers?

  • Does your practice regularly deal with patients who had dental implants placed years ago by a different dentist, that don’t have identifiable implant/abutment information?

 

Without knowing the implant component details, future treatment becomes difficult, and can potentially lead to complications.

 

  • If you don’t know the exact component that was installed, you won’t know which equipment (e.g. driver) to use to repair or maintain the implant/crown reconstruction

  • If you use the wrong tools and damage the componentry, you may have to replace the damaged components (free of charge to the patient in some cases)

 

There is a simple solution however to eliminate these issues:

 

  • Register your patients implant components on the DIR and ensure accurate records are kept for the patient’s lifetime

 

The DIR helps you record all this in one simple process via our online application, with registrations only taking 1-2 minutes. The registration then creates an easy-to-read PDF that can be accessed by the patient or their future dental professional, ensuring the best long term care!

 

Provide the best standard of care for your patients by using the DIR!

YES I WANT TO IMPROVE
RECORD KEEPING IN MY PRACTICE

ONE REGISTRATION HELPING MANY INTO THE FUTURE

Currently the estimation is that 15 million implants are placed worldwide every year, with this number growing at a rate of 10% per year. In Australia, over 200,000 implants are placed every year, so it is very likely that you will come across new patients with unknown implants.

 

Utilising the DIR in your Practice means not only helping patients improve their outcomes in the future (with accurate implant/prosthetic component identification), but also other clinicians that may have to deal with these patients with dental implants.

 

If the patient has their implant components registered on the DIR, it takes seconds for the treating dentist to identify their implants components. This results in a quick turn-around regarding admin and clinical time to treat said patient.

 

Not having access to the records without the DIR can mean several hours, days or even weeks can be spent trying to source the information from another clinic (if it’s available at all)!

The information from DIR registered patients is also utilised by the scientific arm of the registry which looks at two main factors:

 

  1. How do dental implant components perform in the Australian market

  2. How often do certain techniques caried out lead to success for patients

 

This information will be shared with clinicians on a yearly basis to help make informed decisions in your treatment planning. All data is anonymised for research purposes.

 

Utilising the DIR today means you are helping patients and their future treating dental professionals, and other dental professionals utilising the DIR today is helping you in the future.

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YES I WANT TO HELP WITH IMPLANT IDENTIFICATION IN THE FUTURE

BONE GRAFTING INFORMATION

Many patients who require a dental implant also require a bone graft. If your patient is a blood donor this can affect their ability to donate blood, either temporarily or even permanently!

Whether your patient is a blood donor should be a question every dental professional asks their patients prior to implant surgery (if bone grafting is required) to ensure you know the needs of your patient and do not affect their donation status. Failure to do so could result in legal issues.

Did you know the DIR also records bone grafting details with our implant registrations? This helps to assist your practice and patients by:

  • Providing a simple downloadable PDF that patients can present at any blood bank to help determine their eligibility

  • Ensuring the grafting material and implant details are kept together and securely stored for any future treatment

Ensure you are discussing with your patients, that require bone grafts, prior to implant surgery about their blood donation status, and ensure this data is accessible by third parties (with patient approval), such as the blood bank, by registering these details on the DIR today!
 

YES I WANT TO RECORD BONE GRAFTING DETAILS

IMPROVE DENTAL IMPLANT OUTCOMES FOR ALL

By utilising the DIR in your practice you are not only helping your practice and patient today, but also ensuring your patient receives the best care in the future as well.

 

Future treatment can be carried out safely and instantly as records are accessible by the patient and their treating dentist (privacy policy applies). This eliminates any worries about using the wrong tools and damaging the implant components. This also eliminates any future requests for implant records your practice will receive.

 

The DIR is also aiming to help all future dental implant patients by carrying out research that will help clinicians make informed decisions about treatment protocols and products performance. This is being achieved by using anonymised registry data in various research projects with the help of Australian universities.

 

The data you register today helps the whole industry in the future!

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YES I WANT TO IMPROVE OUTCOMES FOR ALL MY PATIENTS