Department of Agriculture issued alert on 'stink bugs'
The Department of Agriculture has issued an alert that all incoming containers from Italy now have to be fumigated or treated to reduce risk of ‘stink bugs’ coming into Australia as per the following: www.agriculture.gov.au/import/industry-advice/2018/04-2018
We understand an exemption applies to “Fresh produce (including nursery stock and live plants); Live animals; Food for human consumption; Seeds for sowing”; and the pharmaceutical industry.
We are asking for an exemption for medical devices is based on the following:
- Medical devices are largely invasive ie. implanted in the human body or used directly in the body during surgical procedures;
- Medical devices are required to be manufactured, transported and stored with in tight environmental controls;
- The environment in which a medical device is manufactured, transported and stored needs to be validated to ensure any risks to patients are as low as possible and clearly characterised;
- Changes to that environment would need to be validated to ensure no detrimental effect to the finished medical device or transfer of contamination to the patient;
- The addition of a “chemical” to a medical device would need to be validated, prior to application, as an understanding of any residuals is required to ensure patient safety and device integrity;
- These residuals have not been evaluated from a toxicological risk point (across any medical device) and would therefore mean the product no longer conforms to the strict provisions under which it is approved to be supplied in Australia. Non-conformance results in the destruction of product – no Australian patient would receive the device;
- Many medical devices are provided sterile and if sterilised by a gas sterilisation process, there is a potential for any chemical to enter the sterile barrier which is designed to allow gas ingress;
- The controls on medical devices are critical to patient safety as any residuals may enter a surgical open wound site and/or used in patients who are immune compromised;
At this stage the Department is not willing to provide our industry with an exemption as it does not have enough evidence or understanding of our sector.
If you are impacted by this issue please contact MTAA so that we can put you in touch with the right people in the Department. We hope that by understanding and inspecting the goods the Department might be better placed to provide our sector with an exemption.