Why we’re having this discussion

FourFourSeconds ago, the Australian Government announced that it would ban the sale of new, non-approved, or unapproved medical equipment to people over the age of 18.

This announcement followed a similar decision by the US in August. 

The US Department of Health and Human Services (HHS) has since published guidelines outlining the standards that will apply to non-certified medical equipment that can be used in the medical care of patients over the medical age.

The guidelines, published in November 2016, state that medical equipment can only be used if it meets certain criteria. 

These criteria are not as stringent as the ones used by the Australian Federal Police, who, in October, announced they were “actively investigating” the use of “dangerous” medical equipment in hospitals. 

As the Guardian has reported, in August 2016, the Department of Justice (DOJ) announced it would review the guidelines in response to concerns from some doctors. 

In the case of medical equipment used by patients over 18, the guidelines were published in October 2016 and the Australian government did not respond to requests for comment from the Guardian. 

“In a number of the jurisdictions, including Australia, the medical equipment manufacturers are required to obtain a licence for their equipment from the Department. 

However, the licence has not been issued to the medical industry in Australia, so there is no requirement for the manufacturers to obtain the required licences,” a spokesperson for the Australian Medical Association said in a statement. 

“[In the US] there was an effort by the medical device industry to get the Department to allow them to manufacture medical equipment without a licence.

We were not able to do that because the Government did not issue a licence to the manufacturers. 

What happens if we don’t have the proper approvals? 

We know that a number, like the ones in the US, have been broken by individuals and companies. 

Some have sought to undermine the regulations and have not been able to get approvals.” 

The guidelines are not binding, so if a manufacturer does not obtain the necessary licence then it will not be allowed to sell medical equipment for use in the Australian healthcare system. 

According to a spokesperson from the Australian Pharmaceutical Association, a manufacturer must meet the requirements set out in the Medical Equipment Licensing Act to manufacture or supply medical equipment, including any equipment that contains medical devices. 

If the manufacturer fails to comply with the requirements, they can be subject to criminal penalties. 

Currently, there are only two licensed medical equipment makers in Australia. 

While the medical devices are not regulated by the government, they do have to meet certain standards and the products must be used according to a set of guidelines. 

Australia’s Medical Devices Regulations, or MERA, cover medical equipment. 

One of the guidelines outlined in the announcement stated that “in some circumstances, the use, manufacture, or supply of medical devices must not cause or threaten death or serious physical harm to any person”. 

The Australian Medical Council (AMA) is calling on the government to make a statement on the issue, describing the decision as “unacceptable”. 

“We believe that these regulations are necessary to ensure that the health of patients and their families are protected, and we hope the Australian Minister will also reconsider the policy to protect the health and safety of patients,” AMA spokesperson Dr Caroline Gove said in the statement.

“We also welcome the Department’s acknowledgement of the need to address the issue and its intention to review the policy.” 

In a statement issued by the AMA, AMA CEO, Professor David van Wyk, said the organisation was “deeply concerned” that the decision to ban the import of non-regulated medical equipment was a breach of medical freedom. 

He said it was also a breach “of the medical profession’s duty to provide quality and safe medical care”.

“It is important to emphasise that no medical device is 100% safe, but in the case where a medical device can be deemed unsafe, then the manufacturer must be made aware of this and can be informed that the product is not approved and that a safety assessment must be undertaken,” van Wyks statement read. 

This article has been updated to clarify that the US does not have a similar approach to the Australian policy.


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