Healthcare workers are demanding answers after NSW’s patient safety agency banned hospitals from using eco-friendly medical supplies in favour of single-use products that end up in landfill and cost taxpayers millions of dollars each year.
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that → demand → dollars
Clinicians have accused the NSW Clinical Excellence Commission (CEC) of siding with a multibillion-dollar manufacturer of disposable medical devices that would lose money if the sustainable products were widely adopted.
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products → accuse → money
The stoush revolves around remanufactured materials, which are formerly single-use items that are reprocessed into new products approved by the Therapeutic Goods Administration (TGA) and used daily in every other state and territory.
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that → revolve → state
These materials include patient transfer mattresses, compression sleeves, tourniquets and blood pressure cuffs.
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materials → include → mattresses
The CEC, in a letter to the TGA, said the commission was concerned about infection control, traceability issues, a risk of expansion into more critical care items, and the potential for the materials to mislead doctors and patients.
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materials → say → doctors
But a NSW Health employee who has researched the issue extensively said the CEC’s position is not backed by research.
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position → research → research
“Their concerns are not evidence-based, they’re not valid, and we can answer all those concerns with evidence we have specifically gone and sourced ourselves,” said the employee, Charlie*, who spoke on the condition of anonymity for fear of repercussions.
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who → base → repercussions
The chief executive of the only locally based third-party remanufacturing company, Medsalv, said they had spent two years asking the CEC for further clarification on the ban, but the commission had been reluctant to engage.
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commission → base → ban
“I’ve engaged with them a number of times,” Medsalv chief executive Oliver Hunt said.
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Hunt → engage → times
“[I’ve tried to] explain how the regulations relate to medical devices and remanufactured devices specifically.
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regulations → try → devices
It hasn’t identified a patient safety issue here, so the question is, what is it doing here?
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it → identify → what
Medsalv supplies more than 170 hospitals across Australia and New Zealand and has partnerships in every Australian state and territory except NSW.
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Medsalv → supply → NSW
Hunt said that Cardinal Health – one of the largest suppliers of medical devices in Australia, which booked a $US2.6 billion profit last year – had a pattern of intervening in Medsalv’s commercial relationships with hospitals across Australia.
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which → say → Australia
The Herald has seen correspondence in which Cardinal Health representatives have lobbied in NSW hospitals to block Medsalv from collecting discarded medical products.
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representatives → see → products
This includes alleging that Medsalv was sending materials it had collected for remanufacturing straight to landfill, which Medsalv denies.
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Medsalv → include → which
Cardinal Health has announced plans for its own remanufacturing facility.
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Health → announce → facility
In the letter to the TGA, the CEC advocated a regulatory distinction between remanufacturing by a third party (such as Medsalv) and by the original manufacturer (such as Cardinal Health), citing concerns about intellectual property rights.
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CEC → advocate → rights
“Remanufacturers do not hold the IP or technical specifications,” the letter said, contributing to the CEC’s “significant concern” about third-party remanufacturing.
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letter → hold → remanufacturing
The letter said that third-party remanufacturers may have “inadequate decontamination procedures”.
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remanufacturers → say → procedures
The CEC did not respond to questions about how intellectual property concerns were within its scope as a patient safety agency, or about its relationship with Cardinal Health.
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concerns → respond → Health
“It asserts that third-party remanufacturing is somehow inferior,” Hunt said.
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Hunt → assert → ?
“I think that it’s concerning to have a public official providing correspondence to a federal regulator without any evidence to support that position.”
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official → think → position
The CEC has also raised concerns that remanufactured products could be repackaged and sold as new items, with no disclosure to patients or treating health workers.
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products → raise → patients
“That is categorically untrue,” Charlie said.
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Charlie → say → ?
“All the devices are barcoded, so they’re trackable through the system: Where they go to, how many times they’ve been through.
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they → barcode → Where
“Original devices don’t have any such system, so it’s arguable that the remanufactured devices are actually safer, and easier to track.”
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devices → have → system
In a statement, a CEC spokesperson said it was awaiting updated guidance from the TGA, which was expected by the end of the year.
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which → say → year
“Patient safety systems are working at their best when they identify and mitigate risks before patient harm occurs,” the spokesperson said.
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spokesperson → work → risks
A TGA spokesperson said that all manufacturers – remanufactured or otherwise – must hold evidence demonstrating compliance with regulatory requirements.
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manufacturers → say → requirements
“Remanufactured medical devices supplied in Australia must meet the same requirements for safety, quality and performance as other medical devices,” the spokesperson said in a statement.
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spokesperson → remanufacture → statement
Charlie has spent two years advocating for remanufacturing in collaboration with colleagues.
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Charlie → spend → colleagues
When they explain the stoush to outsiders: “People go, ‘Is it really that high risk?
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it → explain → outsiders
Are you trying to put implantable devices from the bin into a newborn baby?’
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you → try → baby
[and] We go, ‘No – it’s a tourniquet’.”
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it → go → ?
Remanufactured medical devices are commonplace in Britain, the US and Europe, but are relatively new to the Australian market.
“
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devices → remanufacture → market
In the US, it’s a multibillion-dollar industry,” said Forbes McGain, the University of Melbourne’s associate dean for healthcare sustainability and a physician who uses remanufactured devices in his practice.
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who → ’ → practice
“Reprocessing has been shown to be safe over many years in the US, under the watch of the FDA, [which] approved it long ago.”
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which → show → it
Hunt said that his company cleans and tests all devices in its Geelong facility – they check if they’re inflating or stretching, if their clips work – before repackaging them and selling them back to hospitals.
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clips → say → hospitals
He said that single-use devices are often labelled as such for commercial rather than safety reasons.
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devices → say → reasons
“Big [healthcare] companies tend to want to make things in a low-wage economy somewhere … ship it along a long supply chain, chuck it into a high-wage economy, and sell it for as much money as they can, and they really don’t mind what happens after.”
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what → tend → money
…and 11 more, not listed.
The Aporia
