Law against home-made surgical tools has 'no teeth'

by Jessica McAllen / 24 August, 2017
RelatedArticlesModule - Surgical tools

Cost-cutting surgeons are using home-made and hardware-store-bought tools in our hospitals – so why doesn't the law stop it?

The people charged with keeping New Zealand surgery clean and safe can’t keep up. As soon as they get rid of one non-compliant piece of equipment, another almost immediately appears in its place.

By the end of last year, 112 medical devices had been officially removed from surgery at the Southern District Health Board, according to documents released under the Official Information Act. These devices weren’t registered with the Ministry of Health’s Wand (web-assisted notification of devices) database.

The database, run by Medsafe, identifies who is responsible for instruments, standardises cleaning instructions and, in the event of product recalls or questions about patient safety, helps officials track down the devices hospitals are using.

Failure to list a medical device with Wand within 30 days of becoming its sponsor (the exporter, importer or local manufacturer responsible for the device) is considered an offence. This is “punishable by a fine not exceeding $500 on conviction”, under regulation six of the Medicines (Database of Medical Devices) Regulations 2003.

Technicians blame budget pressures, a culture of bullying and the antiquated Medicines Act of 1981 as reasons behind the uphill battle to provide safe equipment. A lower North Island DHB technician manager says staff don’t want to “rock the boat” in the sector’s small employment market. “The pressure doesn’t come just from doctors. It comes from the nursing team, because they want happy doctors. There’s a lot of verbal bullying.”

Sterile-services staff are expected to “cut corners” in reprocessing medical devices because hospitals won’t provide enough instruments, yet they get the blame if an instrument is found to be a threat to patient safety.

“For years, [sterile-services] technicians have been at the lowest rung of the perioperative ladder. They have been ordered, threatened and verbally abused by surgeons and nurses demanding that they sterilise items that cannot be sterilised, are clearly defined as single-use items, or have been home-made in a surgeon’s or a friend’s garage. They are told that if they don’t do it, it will be their fault if the operation is delayed or cancelled.”

So how did 112 potentially dangerous items come to be circulated within the Southern DHB? Workplace culture played a role, the Listener’s source said. People got so used to creating and modifying equipment that they wouldn’t think to buy expensive surgical-grade items. “I look at the medical instruments and think, ‘My God, this can’t be used on people’,” he says. “It’s just incomprehensible.”

A pair of hardware-store vice grips attached to a slap hammer for use in orthopaedic surgery, for example, were not made from medical-grade material “or something that should have gone anywhere near the insides of a patient. This was of huge concern and risk to all involved – risk of instrument failure, infection and liability against Southern DHB – completely making us Third World. They are breaking the law. That’s all it boils down to. Hospitals think they are a law unto themselves.”

In late 2014, when technicians at Dunedin Hospital alerted authorities to the rusty vice grips, the items were promptly removed. A search for all DHB-manufactured or -modified instruments subsequently took place with the aim of replacing them with commercially made instruments as soon as possible. This unearthed dozens of medical devices that couldn’t be guaranteed to be properly cleaned. But it wasn’t until 2016 that many were removed, and sterile-services technicians are still finding substandard items.

In a leaked draft report from June 2016, the Southern DHB outlined the process that began once it recognised “in-house manufacturing of surgical instruments was an outdated practice that did not meet current standards”. Initially, in September 2014, 18 instruments were identified that were still in use, the report states. Another 20 instruments were identified the following year. Of those 38 instruments, 12 were immediately removed, one was kept in service as it was not a theatre instrument and three were added to the Wand database with relevant regulatory documents.

The other 22 instruments were kept in service until they could be replaced – nearly two years after the initial order to get rid of in-house-manufactured medical devices – in February 2016. The report says the process took “longer than anticipated” because of certain instruments being “essential for some surgical procedures” and others that were only used infrequently.

The report also confirms that staff felt unsafe about speaking up. “Work is required … to ensure that any staff member raising a flag for a patient safety concern (real or potential) is actioned … Poor behaviour was found to be a major barrier to a culture of safety for SDHB.”

PSA’s Julie Morton. Photo/Guy Frederick

Public Service Association southern region organiser Julie Morton says it’s difficult to measure the impact of unregistered and inappropriate items on patients. “You put absolute trust in the fact that the people treating you are doing it to the best standard they can – even with the best processes, people will still get post-op infections. The idea is to minimise it as much as possible.

“Having those instruments within the system is thumbing their nose at that.”

The manufacturing of medical devices used to be “more Wild West” 30 years ago, says Morton. “People had to think, ‘How can I make something that is going to work in this kind of surgery?’ Now you can get anything you like, but it’s costly because of the research and development and materials that go into it.”

She says clinicians can register an unsafe device on Wand and the law has “no teeth”. “So if it turns out to not be fit for purpose but you’ve registered it to Wand, then you’ve abided by the law.”

It’s not only the Southern DHB that has been shopping at the local hardware store. Sterile-services technicians at a lower provincial North Island hospital discovered old and rusting equipment that surgeons had been using – including a hardware-bought saw used for amputation. The orange paint on the saw was chipping off. It was in use until the end of 2015, says the technician.

A technician who used to work at the hospital says the facility also had a set of drill bits that were bought from an automobile parts supplier.

“I opened one up to have a look and the rust was falling off in chunks since it wasn’t surgical steel. They’re good for what you do in your car, but to put it in a patient’s leg and move about with that amount of rust? You could cause a horrendous infection.

“Fortunately, those have now been removed, but we don’t know the effect on patients upon whom they were used. The public would be horrified.”

Another technician the Listener spoke to, from a DHB in the upper North Island, says at one point his hospital was reusing single-use cutting clamps for umbilical cords. “For orthopaedic stuff, they go to Bunnings and pay $100 for a pair of bolt cutters instead of the stainless-steel sterilisable ones that are $1500-2000. The Bunnings bolt cutters don’t last as well because the steel chips.”

Nursing staff and doctors tend to overrule sterile-services technicians, he says, and it comes down to budgets rather than what is best for the patient.

Says one technician: “You have a nurse in theatre who is saying, ‘Well, I’m your manager, you do what I say’, when she has no qualifications to back her up in sterilising technology. Yet they are overriding what has been said about maintenance and upkeep of instruments just so they’re prepared and ready for a patient.”

Another remarks that doctors “compound the problem because they bring in instruments not fit for purpose and say, ‘This is what I want to use.’”

In-house made equipment began to be phased out last year, he says, after staff put their foot down. But sterile services have to remain vigilant as some doctors want to hang on to their favourite tools.

“We still have some vice grips being used that are not correct. They should be medical-grade stainless steel, but they’re just from a hardware shop and used in orthopaedic surgery.

“There’s still the odd thing floating around. They’ll use it in a rare operation so you won’t see it. All of a sudden, when there’s a complication, they bring it out and we’re like, ‘Wait, where did this come from?’”

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 

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