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Our Commitment to Quality

3 April 2013

The medical device industry has seen its fair share of community discussion regarding the safety and effectiveness of therapies available in Australia and New Zealand over the past 12 months. Yet, the fact that these notifications have taken place doesn’t necessarily mean that there is a fundamental problem with safety and regulatory systems in Australia.

The nature of medical devices means that often advances in technology take place very quickly and that clinicians look to adopt these technologies early as a way of helping improve health outcomes for their patients. The key however, to providing access to medical devices whicMedtronic Operations - Manufacturing facilityh have the potential to save and enhance lives, is not only through rigorous research and development, but through seeking reliability and quality in these devices once they come to market.

Every Medtronic employee plays a role in product quality and our commitment to the improvement of products and services. Whether it be reporting, researching or acting upon information, our staff are regularly trained on the correct process for quality control and complaint handling. Carefully controlled quality measures include; testing and monitoring of products; formal reporting measures; as well as post-market surveillance.
At times, we identify, or are notified about potential improvements to our products. We take this insight very seriously, engaging in a number of steps to help address them. These steps include:

  1. Collection and investigation of feedback;
  2. Device assessment by laboratory technicians and expert engineers regarding devices returned by clinicians and patients for damage or malfunction;
  3. Compliance with local authorities such as the Therapeutic Goods Administration and Medsafe to inform them of product issues and action as appropriate.

Medtronic proactively monitors the complaint rates of all reported complaints and determines if any further corrective / preventive action is required. If a field corrective action is deemed necessary, then Medtronic communicates with the local authority and dependent upon all other factors relating to the complaint, local authorities classify the matter as either;

  • A safety alert: advice regarding a specific situation with respect to a therapeutic good which, whilst performing to meet all specifications and therapeutic indications, might present an unreasonable risk of harm if certain specified precautions in regard to its use are not observed.
  • A hazard alert: involving the issuing of precautionary information about an implanted device.
  • A product notification: the issue of precautionary information about a therapeutic good, in a situation that is unlikely to involve significant adverse health consequences.
  • A product recall: product recalls do not always mean that all therapeutic good need to be removed from the market. Recalls vary in the risk they pose to safety. A recall can occur because of simple problems, such as labelling or packaging errors or more serious problems.

It is important to understand that not all of these actions may relate to the malfunction of a medical device. Sometimes, notifications relate to changes in software settings, product packaging, or updated product information which accompanies the device.

Dedicated to transparent communication and keeping customers informed, Medtronic always provide information to healthcare professionals within a timely manner. In addition to the clinical information for doctors, Medtronic also provide information for patients, to be distributed at the healthcare professional’s discretion, as per Australian and New Zealand law, and in some cases provide this information on our website.

In 1983, Medtronic instituted the industry’s first product performance reports by publishing data on our chronic lead studies. Pacemakers and other devices followed as our performance reporting has constantly evolved based on customer need and feedback. One thing has been a constant. It is our sincere commitment to communicate clearly, offering timely and appropriate product performance data and reliability information. This has always been and will continue to be our goal.

If you would like to learn more about Medtronic’s commitment to quality, please visit Medtronic.com.au.

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