Patients told Hawke's Bay Hospital used inadequately sterilised surgical equipment
Originally published on Stuff
Three children under the age of 16 and four people over the age of 70 are among the patients potentially affected by a failure to properly sterilise surgical equipment at Hawke's Bay Hospital.
Surgical equipment that had not been fully sterilised was potentially used on 55 patients in Hawke's Bay.
Those patients will now be tested for blood borne viruses – including HIV and hepatitis B and C – but it would be 24 weeks before the patients could be given the all clear.
Of those, the greatest risk was of Hepatitis B and patients would be offered a vaccine for that.
The Hawke's Bay District Health Board admitted the mistake at a press conference on Wednesday morning.
There were 91 pieces of equipment that were cleaned and heated to high temperatures, but failed to go through the third and final stage of sterilisation overnight between February 1 and 2. That equipment was then distributed to clinics and used by district nurses before the mistake was discovered on Monday, February 11.
Up to 55 patients may have been affected by the mistake. Of those, 18 people were operated on in the main theatre block of Hawke's Bay Hospital.
A DHB spokeswoman said there were three children under the age of 16 and four people over 70 among those 18.
Packs were also sent to oral health and gynaecological clinics throughout Hawke's Bay.
The remaining patients were being identified.
The mistake was identified by a theatre nurse during a safety check on Monday. She discovered that a pack containing equipment was not marked as having been fully sterilised.
Each package has a label that changes colour, from green to black, when the sterilisation process is completed. In this case the nurse noticed the label was still black.
More than half the packs that were sent out were recalled before being used.
Chief executive Kevin Snee said there was an "extremely remote chance" patients may have been at risk of infection.
He apologised for any distress caused and said the main concern was identifying and contacting the patients involved.
"I take responsibility for this because I'm the head of the organisation," Snee said.
The DHB's clinical director of health improvement and equity Dr Nick Jones said "the risk was incredibly small but we couldn't not follow it up".
Bacterial infections could be ruled out given the sterilisation process, and patients would only be tested for viral infections.
Jones said the tests would be made available to anyone exposed, but not to their families as "there is no risk to them".
"The incubation period for all those diseases is many weeks," he said.
Those interested would undergo a series of blood tests; this week, in six weeks and again in 24 weeks.
They would not know conclusively until the last test if they had been infected.
A review of processes to date had shown that this was the only occasion where the sterilisation process had not been completed.
"In terms of who should be worried, the point is we know the names of everybody whose potentially at risk and we're contacting everybody. So there's no need for the general population who've had a procedure at Hawke's Bay Hospital to be concerned," Jones said.
Dr Colin Hutchinson, executive director of provider services said all patients would be invited to the hospital in the next few days to have care plans explained.
"At this stage we've found that the community we've reached out to have been very understanding," he said
A "very thorough" review was underway to find out how this event occurred.
Health Minister Dr David Clark said the incident was of concern "and I feel for the patients involved".
"It is good to see the DHB taking a proactive approach. I'm advised the risk to patients is very low but the DHB is contacting patients directly and arranging follow-up tests. That seems appropriate in the circumstances," he said.
"It's important that the DHB learns and shares any lessons identified as a result of this incident," Clark said.
BOARD CHAIRMAN 'DISAPPOINTED'
Hawke's bay District health board chairman Kevin Atkinson said he was "very disappointed this issue has arisen" and expressed his sympathy for those involved.
While the risk was low, how it happened had to be understood, he said.
"The Board will expect management to undergo a full and transparent investigation into the cause of the incident and report those findings as lessons learned so an incident like this can't happen again.
"However, I have been advised that management are confident that this has never happened before or since the incident, and relates to only one batch of equipment."
STERILIASATION A 'COMPLEX PATHWAY'
University of Otago professor Stephen Chambers said it was unlikely any patients would contract an illness from the equipment, considering only one step in the "multi-layered" sterilisation process failed.
"I'd personally be very surprised if anybody gets anything from this. But, when sterilisation comes in, no risk is the standard, and anytime we fall short of that's just not good enough."
Sterilisation of equipment was a "complex pathway" first requiring physical scrubbing of the equipment, and then computer controlled steam and pressure cleaning.
The overlapping measures make sure that any margin of error in any one method was eliminated.
"Often even one of those steps would work, but because we can't guarantee 100 per cent, there are other layers."
The concern over hepatitis B was due to it being a relatively robust disease compared to HIV and hepatitis C, meaning there was a greater risk of it surviving on poorly sterilised equipment.
Testing all three blood borne diseases was "pretty jolly brilliant", and patients could be assured any infection would not be missed. It was also possible to cure both hepatitises, and suppress HIV to the point that any infected patients would not have their lives drastically altered, he said.
The 24-week delay in test results was due to the time it takes for the diseases to multiply to a measurable level.
Hepatitis C and HIV reaches a testable level in the body within a couple of weeks, Chambers said, but hepatitis B takes considerably longer.
Associate professor Mark Thomas, a University of Auckland expert in infectious disease, said reports indicated the third and final stage of cleaning surgical equipment, a pressurised chamber called an autoclave, had failed.
He agreed it was unlikely a patient would contract a disease because "most bacteria would require relatively heavy contamination to then infect a person".
New Zealand Sterile Sciences Association president Shelagh Thomas said missing the final sterilisation step was an unfortunate accident.
"It was human error, someone didn't know that it hadn't been in the machine … It would happen to anyone in the country, at any DHB."
The DHB had invested in new sterilising equipment recently, and she was confident its facilities allowed practitioners to follow correct process.