Even when the existence of unsuitable equipment is pointed out, it is not always acted on. At a MidCentral DHB hospital in the Palmerston North area, a kitchen spoon and sieve were being used in urology for prostate and bladder samples. In March 2016, the minutes of a sterile-services staff meeting recorded that “items that are non-medical – that is, [a] spoon” – were to be removed. More than a year later, the MidCentral DHB has confirmed to the Listener that they are still using the items.
In the Southern DHB area, ventouse handles (suction tools attached to a baby’s head to help in childbirth) made by a doctor at Dunedin Hospital were in use after the DHB had told the Listener all in-house-made equipment had been removed. According to a staff member, the handles were found and removed in November because they were too big and posed a risk of damage to a newborn’s brain.
Dr Marion Poore, medical director of the women’s health directorate at the Southern DHB, said the ventouse handles were no longer used. The DHB now uses the Kiwi Complete vacuum delivery system, which she says is “made of plastic and it is disposable, so it is not possible to dismantle it and it is not sterilised for reuse”.
Meanwhile, a nasal speculum (used to dilate nostrils) was found at Dunedin Hospital with blue tape plastered over the manufacturer’s engraved warning against reuse. Poore confirmed that “an outpatient department sent a nasal speculum for sterilising. The manager of sterile services immediately contacted the manager of the outpatient department, who in turn spoke to the staff concerned to ensure this practice was immediately stopped. The equipment was not sterilised and was not reused.” However, sterile-service technicians say the blue tape showed intent to disobey the hospital’s policy against reusing single-use items.
Then, in June, technicians discovered that a gynaecological surgeon had office thumb tacks at the ready to stop bleeding during rectal surgery, instead of the medically recommended titanium haemorrhage occluding pins. A technician ensured they weren’t actually used and they have been replaced. The tacks are intended to be “pushed through a vein into the spine and stay in the abdomen forever”, the technician said.
The Listener’s Southern DHB source provided photos of the tacks on their way to potentially be used in an operation. “What it proves,” the technician says, referring to the date – Wednesday, 25 – marked on the bag that held the pins, “is that the surgeon had intended to use them if necessary”.
Poore says that a “sterilised tack” was on standby should a “rare, life-threatening complication have occurred” but says it was never used.
At an upper North Island hospital, a sterile-services technician recently discovered a rusty spanner that he says was bought from a hardware store. The sterile services department was asked to sterilise it for use in surgery.
Mitre 10 communications manager Alison Rowland is surprised to hear that hardware-bought tools are being used in hospitals, and stores in the localities identified weren’t aware of DHBs buying items officially. She says it is best if the company doesn’t comment on whether its tools would be safe to use in surgery, but notes, “We’re not selling them with the intent for that.”
Jacqui Coombes, general manager of Bunnings New Zealand, says: “We supply a large number of commercial customers with home improvement and outdoor living products. We are not aware of the use of our products in a surgical environment.”
Afraid to speak out
The technicians who spoke to the Listener have, for the most part, been complying with the cost-cutting regimes despite their horror. They say they fear for their jobs if they speak out.
Technicians are obliged to meet an Australian and New Zealand (AS/NZS) standard that says all reusable medical devices must be supplied with the manufacturer’s instructions for decontamination and sterilisation and that the supplier of the instrument must declare the item is fit for purpose. Hardware stores obviously can’t guarantee an instrument is safe to be used in surgery, so hospitals that use these items aren’t meeting the standard.
But there is evidence that equipment intended for single use only or without cleaning instructions from the manufacturer is being reused. Items labelled as single use are intended to be disposed of after they have been used, because they are hard to clean or unable to be sterilised.
This is also covered by an AS/NZS standard, which says that a device labelled by the manufacturer as “sterile single use” or “single patient use” is intended for use on one patient only.
Some medical professionals are horrified by the thought. “Buying non-medical-grade devices for medical use is a no-no,” says one Auckland theatre nurse. “And this is right the way down to something as simple as the spoon – literally just a spoon – we use to transfer bone graft from a grinder to a bowl. They must be medical grade. It’s meant to be picked up in the purchasing or sterilising processes auditing when it happens.”
One technician who spoke to the Listener on condition of anonymity said the devices that DHBs buy from surgical suppliers are made to withstand the cleaning process and are usually made from quality surgical steel or titanium.
“Anything cobbled together by a surgeon or in someone’s garage is dangerous. What kind of metal is it? What has it been used for previously? How was it cleaned? Will the welds hold together or will bits drop off in the patient? Can water get inside it that will then harbour and grow bacteria and pass it from patient to patient?”
The technician referred to the danger posed by biofilms that can “get into your body [and] create disease”. Biofilm is a mass of bacteria and extracellular material tightly stuck to a surface and extremely difficult to get rid of. It can form in less than 30 minutes if instruments are not kept clean and moist in use before being returned to sterile services for cleaning. Sterile-services technicians have sprays to prevent the formation of biofilm and special detergents to break down the enzymes, but “once you’ve got biofilm, even if you scrub it off, there’s still a little bit there”, the technician said.
Introducing new hazards
It doesn’t sit well with another sterile-services technician manager, at a lower North Island DHB, when surgical staff think it’s okay to use something that could leave leftovers in a patient.
“They’re introducing a new hazard to a patient that they are completely unaware of. When they sign the [medical] consent, they are consenting to be made well again, not have something introduced that may affect their health down the track.”
A third technician, who works in the South Island, agrees. “The food industry has more regulations and control than a hospital does,” he says. “That’s how crazy it is.”
Timothy Blackmore, an infectious diseases specialist at Wellington Regional Hospital, says he wouldn’t allow in-house manufactured instruments because they could damage high-quality surgical items in the high-pressure, high-heat sterilisers known as autoclaves. A few years ago, the hospital had problems with cheap scissors going through autoclaves and staining other instruments. “It’s not really a debatable topic,” he says. “It completely wrecks all your other instruments.
“That steel isn’t of high-enough grade to go through autoclaves, so you get a lot of corrosion on the non-surgical steel. It will corrode and rust more quickly, speeding the pitting, discoloration and corrosion of the good steel instruments and the autoclave itself.”
It’s difficult to pinpoint the cause of post-operative infections influenced by medical devices, he says. “To show that instruments transmit infection is very difficult, because it usually has to be an outbreak of one thing, like a hepatitis virus or some sort of HIV, and those are reasonably easy to kill in an autoclave.
“It’s to do with standards. The air handling in a theatre, the washing of hands, the instruments, wearing masks … these are all things that bring down the rates of infection. It’s not hard to show that if one of them hasn’t worked, an infection will ensue. When there are problems with the cleaning processes, you end up with instruments that don’t work very well – scissors and clamps don’t open and close properly.
“I’d be far more worried that they would be impairing the performance of our other instruments. I’d be far more worried about having forceps and other simple instruments that are used all the time not working properly, because they’re the things they use to control bleeding during surgery.
“It’s a classic situation where the only reason people would do this is that they’ve got no money in their budget at the moment and so they’re making short-term decisions that are going to cost them more in the long run.”
A surgeon’s perspective
A Mitre 10 saw is okay for one-time use, but rust on equipment is an absolute no-no.
A North Island surgeon who has worked in rural and urban hospitals says doctors at cash-strapped district health boards are just trying to do their best.
The surgeon says the use of in-house-made equipment is the result of the high prices of medical-grade products, whose manufacturers charge “extraordinary amounts of money”. A pair of surgical pliers to remove a piece of wire that’s through a bone – a procedure done under local anaesthetic in a clinic – can cost $900-1000. “You can get the same thing for $30 from Mitre 10.
“You wouldn’t believe the mark-ups. An example is a set of little plastic tubes that we use for people who have strictures in their urethra after surgery or trauma – you stretch them up with plastic tubes over a guidewire. It’s basically a series of bent knitting needles – that’s all it is, plastic knitting needles. You think, ‘That must be $5-6 worth of plastic.’ They cost $900 for a set of five.”
In major abdominal surgery, a self-retaining retractor is used to hold the wound open so the surgeon can work. The gadget costs about $20,000, but the hospital he works at can make its own for several hundred dollars.
“It’s not actually as good,” the surgeon says. “It’s a slight nuisance, because we have to readjust sometimes as we’re operating, but when you’re talking about cost differences like that, you put up with it.”
The problem is complicated by the fact that some rural DHBs are facing a problem of a “dying breed of general surgeons”, he says, who prefer making their own equipment to buying new, expensive items.
“They’re the guys who do a bit of everything. The big stuff goes to the big centres, so they end up doing more basic stuff and might be a little set in their ways with how they do things or what they want. So you’ve got problems of not having a great budget for buying new equipment and guys who aren’t receptive to new technology and who are maybe a little out of touch with modern regulations.”
He understands the thought process behind the idea that if hardware-store equipment is used only once, it is okay (“we’re all trying to get as much bang for our buck as we can in the public health system”). But rust is unacceptable.
“You can sterilise just about anything. You can scrub off rust, put it through a machine, but if there’s still rust on it when you’re going in to operate, that’s a problem.
“If they’re getting a cheap saw from Mitre 10, it’s actually cheaper to use it once and then dispose of it,” he says, noting that “it would absolutely have to be sterilised first. I’m not advocating doing this but can understand the thinking behind it.
“It’s a shame. There are smarter ways of doing this. I sympathise with surgeons from small centres with no budget for equipment who need to get the job done and this is the only way they see to get through that. But obviously I’m not going to defend somebody using rusty gear.”
He says that sterile-services technicians can be strongly influenced by companies that make medical equipment and that they can be told they would be responsible for killing people if they let unsafe equipment be reused.
Rolling your own
There are pros and cons to DHBs making their own medical equipment.
Hospitals are allowed to make their own instruments, usually in a biomedical engineering lab. Of the country’s 20 district health boards, five – Canterbury, Counties Manukau, West Coast, Auckland and Capital and Coast – confirm they still manufacture or modify medical instruments in-house.
Counties Manukau DHB, which makes about 60 instruments a year, says in-house equipment can cost a third less than the commercial price. But Hawke’s Bay DHB says it doesn’t make equipment because “the cost to develop, test, manufacture and register a device is prohibitive”. Likewise, Waikato DHB says it is “not insured” to meet the “stringent standards” required for this kind of work.
Although there are benefits to hospitals making their own devices – Counties Manukau DHB, for example, says it can make items that aren’t commercially available – there can be risks.
A Southern DHB technician cites his employer’s approach as an example of in-house equipment not meeting standards. Instruments were sometimes made by modifying hardware-store purchases, by adapting existing medical-grade instruments using non-medical-grade metal or from scratch using metal that rusted and corroded. The welds and joins were poorly done. Rusty water could be seen coming out of the cavities created by poor welding, which also caused pitting that is a known breeding ground for infection-causing agents.
“There was visible evidence of rust, pits and discoloured fluids on the modified equipment. Why would a DHB be manufacturing or modifying equipment in-house when there are correct-grade versions available that have complied with all standards?”
The Listener asked all DHBs to provide lists of inappropriate surgical items that had failed or instances of reused equipment. Many were unaware of what was going on, which didn’t surprise sterile-services technicians.
One said when items were identified, they were removed without the find being reported.
In 2013, Pharmac’s role was expanded to include managing hospital medical devices. Communications adviser Anthony Bull says the organisation is phasing in changes that will ensure that “no matter which hospital you walk into, you’ll get the same device”, providing significant savings. A recent example: Pharmac negotiated a countrywide price of $4 a box for surgical gloves, doing away with variable pricing that meant some DHBs were paying $10.
Pharmac’s director of operations, Sarah Fitt, says most of the national contracts that have been negotiated are still optional. “Within that context, DHB hospitals can continue to tailor-make any devices to suit their needs.
“Pharmac has yet to determine its exact approach to how new technology [or specialist/novel technology] will be assessed, introduced and managed.”
Dated legislation is instrumental in our laissez-faire approach to medical devices.
There is no approval system for medical devices under the Medicines Act 1981, and the quality and safety of instruments isn’t assessed by Medsafe before use. Any item – no matter how faulty or unsafe – can be registered with Medsafe’s Wand (web-assisted notification of devices) database and they are removed only if failures become noticeable.
The Government is aware of the problem. Cabinet papers from Health Minister Jonathan Coleman say the Medicines Act is “dated and inflexible, reflecting policy and legislative drafting of the late 1970s”.
However, replacement of the Act with a proposed Therapeutic Products Bill, which is intended to modernise the regulatory framework for all therapeutic products, including medical devices, is behind schedule.
When Medsafe group manager Chris James was asked how many times medical devices made by DHBs had been found not to be Wand-registered, he replied via email that “Medsafe has no evidence that DHBs are using medical devices that have not been notified to the Wand database”.
When asked what inspections are done, he said: “There is no requirement for pre-market assessment or approval of medical devices in New Zealand, so there is no inspection process.
“New legislation is being developed that is anticipated to include a more robust regulatory framework for medical devices.” He noted that, at present, DHBs could “technically” register a hardware-store item with Wand.
A recent parliamentary select committee report in response to a petition by two women affected by surgical mesh said: “We believe that it would be highly desirable to introduce an assessment process before medical devices are used in New Zealand.”
All technicians spoken to for this story want Wand regulations to be tightened, welcome the overhaul of the Medicines Act and say they are speaking out to promote patient safety.
A Dunedin sterile-services technician says: “Whatever happens to me is nothing compared to the end result – we want a safe place for people to have surgery. An auditing system needs to be in place that includes robust accountabilty.”
- About 48,000 medical devices have been notified to Medsafe and 5000 are added each year.
- About 450 adverse events related to medical devices are reported each year, although this is generally accepted to be an under-reported area.
- Medical devices range from heart valves, ventilators and CT scanners to home pregnancy kits.
- DHBs spend about $1 billion a year on medical devices and costs have been rising faster than economic growth.
- The manufacturers (also known as sponsors) of medical devices are responsible for reporting on adverse effects of a device or withdrawing it if ordered by the Director-General of Health.
- About half the products on Wand are low-risk (for example, reusable surgical instruments); 10% are high-risk (for example, implantable pacemakers); 40% are medium risk (for example, hypodermic needles).
- Medical devices are not subject to an approval process of any kind, only a notification to Medsafe, irrespective of the risk level.
This article was first published in the August 12, 2017 issue of the New Zealand Listener.
In a Letter to the Editor, Southern DHB responds:
Readers of the story “DIY doctors” (August 12) could be excused for believing that the use of unsafe and unsanitary equipment is commonplace in New Zealand hospitals. This is not the case.
The article is a mix of anecdotes and the retelling of rare historical incidents, which paints an inaccurate picture.
There have been many safety improvements made in the healthcare sector over the years. Including some examples of these would have helped to make your story more balanced.
Patients should be assured that their safety is a priority for district health boards and DHBs will continue to improve services and reduce risk.
Dr Marion Poore and Dr Stephen Packer
Southern DHB medical director, women’s, children’s and public health directorate and medical director, surgical directorate, respectively