ANSTO suffers nuclear medicine meltdown

Serious problems have been revealed in Australia’s production of lifesaving aids.

Australia’s nuclear medicine industry is in crisis after years of accidents, delays and other setbacks.

The marketing material sent out by the Australian Nuclear Science and Technology Organisation was clear: its planned nuclear medicine facility, ANM, costing $169m and due by the end of 2016, was a big deal.

State of the art. World-class. A significant improvement on the existing facilities that already performed a lifesaving service, delivering thousands of doses of nuclear medicines to more than 250 hospitals and medical practices in Australia alone.

“ANM will position Australia as a global leader in the high-end manufacturing of nuclear medicine used in over 45 million medical procedures globally each year to diagnose cancers, heart disease and skeletal conditions,” ANSTO boasted.

But, three years later, Australia’s nuclear medicine industry is in crisis after years of accidents, delays and other setbacks. The saga has left patients exposed to a global shortage of molybdenum-99 (Mo-99) isotopes used to diagnose a wide range of illnesses, including cancer and cardiac, muscular and skeletal conditions

The shortages may have a lasting impact on what the medical profession does and how the system functions, experts say.

Charles Sturt University’s Geoff Currie, an associate professor in nuclear medicine, says providers have had to ration supplies and are trying to mitigate the impact of delays for referring doctors and their patients.

“We had days where there was 100 per cent disruption to supply, and there have been multiple days like that,” he says. “There have been weeks where 60 per cent of the Australian population had none or virtually none.”

As lobbyists and politicians call for nuclear energy to be part of the nation’s electricity future, it is perhaps worth noting how the existing nuclear industry has fared of late.

Atomic angst

Alongside Australia’s nuclear reactor in southwest Sydney are several buildings crucial to the production of nuclear medicine.

On the morning of August 22, 2017, around 7am, one of ANSTO’s quality control analysts dropped a vial containing a solution of the isotope Mo-99 in Building 23 at the reactor site. There, Mo-99 produced in another building is used to make Tc-99m generators for use in nuclear medicine.

Experts would later express alarm at what the worker had been required to do, likening it to “reaching around a tree truck with both hands, to perform a critical procedure” — using tongs to remove the cap from a small bottle. It was an accident waiting to happen.

Building 23 is an older facility, relying on manual labour more than automation, having originally been intended for research, not manufacturing. Even though the breakage was inside a fume cabinet it still contaminated the worker’s gloves — two pairs, worn as a precaution — and, worryingly, the skin underneath.

GRAPHIC: Ill health industry

A specialist oncologist determined the worker had been exposed to about 20 times the statutory annual dose limit of radiation. The Australian Radiation Protection and Nuclear Safety Agency deemed it a level 3 serious incident on the International Nuclear and Radiological Event Scale (INES) and notified the International Atomic Energy Agency. It was the first time ARPANSA had reported a level 3 incident, on a scale ranging from 0, where there are no safety implications, to level 7 events such as Chernobyl and Fukushima.

“The injury has caused skin blistering, erythema and desquamation,” ARPANSA reported to parliament in February last year.

“Recent medical observations dated January 2018 showed the tissue damage to the skin of both hands is ongoing. The healing will take months and there is a risk of longer term effects.”

ARPANSA found ANSTO in breach of legislation on the basis it “had many opportunities to prevent the accident or reduce the likelihood of occurrence and/or severity of the accident consequence” and had failed to act.

ANSTO vowed to do better. However, three further safety incidents, as well as a conveyor breakdown in Building 23 that halted production of generators, led ARPANSA to issue a rare formal direction to ANSTO demanding an independent review.

Staff under pressure

The review found culture and morale at ANSTO Health, its nuclear medicine arm, had “significantly deteriorated” under internal changes and constant pressure to do more with less.

Building 23, for example, had been slated for replacement for years but the government apparently didn’t have the money. Still, staff recognised the vital role they played in serving the health system and patients in need.

“The dedication of ANSTO Health staff to patient safety is admirable; however, there is a risk that production pressures will undermine this focus and ANSTO needs to be alert to this,” the review found.

“This level of commitment and passion also comes with a price: it means staff have higher expectations in terms of commitment of the organisation and the federal government to improvements. Repeated levels of expectation regarding the replacement of Building 23 have led to a level of frustration, disappointment and cynicism among all of the ANSTO Health staff interviewed that there is not an equivalent level of commitment at higher levels of ANSTO and the government.”

As the review was taking place, ANSTO was struggling to source a reliable, back-up supply of generators, having to trade away supplies of Mo-99 while workers tried to fix the conveyor.

Its domestic customers — nuclear medicine providers across Australia — were rightly frustrated. So were international customers in New Zealand and Southeast Asia.

Impact on patients

Dr Eva Wegner from Sydney’s Prince of Wales Hospital, the treasurer of the Australasian Association of Nuclear Medicine Specialists, says generators, isotopes and tracers are crucial in healthcare.

A delayed scan could lead to delayed treatment, with unknown consequences: “It’s not really an optional extra, we need to have a robust supply in Australia.

“Failures like these are not only inconvenient for patients, they directly impact patient care.”

The OECD Nuclear Energy Agency noted the ongoing delay with the ANM facility.

An associated liquid waste facility, known as SyMo, also was delayed, along with problems choosing a site for a radioactive waste dump.

Again, ANSTO vowed to do better and to work with government on options for Building 23, including a possible replacement building that would cost around $200m and take five to 10 years to complete.

By pure coincidence, at the end of last year the IAEA sent its own 20-member review team to inspect Australian facilities and, primarily, the regulatory system in which they operated.

Early this year they made a series of recommendations, including that the commonwealth “take actions with specific milestones to address decommissioning of facilities and radioactive waste management by assuring the strategies, programs, funding and technical expertise for safe completion are in place”.

It was clearly time for renewal. The ANM facility was needed not only to boost production of Mo-99 and generators but to usher in a wave of other developments and improvements.

In March this year the ANM facility’s time had come. Three of four hydrogen heaters, used to produce the Mo-99 for generators, failed in Building 54, leaving only one. ANSTO sought ARPANSA’s approval to bring the ANM facility into service earlier than its delayed commissioning schedule had intended.

ARPANSA would normally wait until ANSTO had responded to its previous concerns but it didn’t have much choice: Building 54 was barely satisfying domestic demand for Mo-99, let alone exports, with a heightened risk of complete and long-lasting failure.

And so the ANM facility was finally brought online. It was designed to produce much more Mo-99 than Building 54 but could not do so until the old facility was decommissioned. And Building 23 still had a role to play.

Workers exposed

However, in June, the ANM facility had to be shut down after the hands of three workers were exposed to radiation, two of whom received a dose that exceeded the recommended annual limit.

The incident was classified level 2, and ARPANSA last month again found ANSTO in breach. Building 54 was hastily reopened before the ANM facility was cleared to resume production.

Then, last month, the unthinkable happened: the ANM facility broke down due to a mechanical fault with a gate valve at the top of a dissolution cell.

Fixing it would be no easy task, made more complicated by the presence of radiation and the effort needed to contain it.

There were no immediate safety concerns for workers but ANSTO has been forced to import Mo-99 ever since.

Currie says importing Mo-99 at least involves less wastage than the previous scenario whereby Mo-99 was traded away for generators, both of which have a limited shelf life.

“It’s a worse solution in terms of cost and reliability but the actual overall delays are only in one direction,” Currie says.

“But, remember, the (ANM) facility is capable of producing 40 per cent of the world market for Mo-99, when you include Australia. There’s still value in us fulfilling the business model.”

Wegner says her association is working with ANSTO but has concerns about reliability.

“It appears that they have a number of single points of failure, and one after the other keeps going, and there is no redundancy in place,” she says.

“I think that’s quite problematic.”

Currie and Wegner say regional nuclear medicine providers have been most affected.

“When we face the patient and tell them we can’t do the scan tomorrow, or at all, that’s much more significant and would have a psychological impact on patient and professional,” Wegner says.

It is too early, Wegner says, to know the extent of the impact this crisis has had on clinical outcomes.

She believes doctors have been redirecting patients to have alternative scans and investigations, some of which may not be as reliable or involve side effects.

ANSTO has never revealed the full cost of the imports and other contingencies, but recently raised its prices.

Industry, Science and Technology Minister Karen Andrews hasn’t had much to say about all the problems but the government directed another $56m to ANSTO in the last budget.

Funding for new facilities has yet to be allocated.

Health Minister Greg Hunt, meanwhile, has had to modify Medicare to allow for alternative diagnostic methods in the wake of ANSTO’s latest setbacks.

Currie says the crisis in nuclear medicine is far from over.

“If there’s never another ANSTO issue then I’d think this industry is still facing a five or six-year recovery,” he says.

“But if there is a string of other shorter disruptions we’re going to have a 10 to 20-year recovery period because people have lost confidence in the industry.”