Every sterilisation cycle prints a chart with a load number, a temperature and a hold time, and the chart is kept for eleven years because it is the evidence that an instrument set is safe. Autoclave 4 prints one a week that nobody put a load into.
I manage a hospital sterile services department. Twenty six years, the last twelve as manager.
What a cycle actually is, because the printout is the point.
A porous load autoclave runs a set programme: a series of vacuum pulses to get the air out, then steam to a hold at a hundred and thirty four degrees for three minutes, then a dry and a vent. Temperature and pressure are recorded throughout by an independent recorder, which prints the chart and stores it.
Each load gets a number from the tracking system. Every instrument set in it is scanned in, and every set carries that load number for the rest of its life, so if a problem comes to light in two years you can find every patient who received an instrument from that load.
The chart is signed by the operator who releases the load, against the parameters, and the chemical and biological indicators are checked.
Nothing is released on a machine's say so. A person releases it.
Autoclave 4 runs a cycle at about ten past three, most weeks, on a chamber that has been loaded with nothing and shut by nobody.
The printout is a perfect cycle. Three vacuum pulses, the hold at a hundred and thirty four point two for three minutes and eleven seconds, the dry, the vent, the parameters all in range.
The recorder is independent of the machine's own controller, which is the entire reason it exists. Both of them agree that a cycle ran.
The door is interlocked and it logs. The door log says it was shut at ten past three and open at half past.
What has been done.
The cycle counter. Every autoclave counts its cycles for maintenance intervals, and 4 is about fifty cycles a year ahead of its sisters, which is the number of these.
The controller was replaced in 2021 and the recorder in 2022, different manufacturer for the recorder.
The department is locked between eleven at night and six in the morning. Card access, logged. Nobody's card is used.
There is a camera in the corridor outside and it has been reviewed on four occasions covering nine of these nights.
Nobody goes in.
The load number, which is the thing I keep coming back to.
A cycle needs a load number and the tracking system issues them in sequence. If nobody scans a set in, there is no load number, and the machine is supposed to refuse to start.
These cycles have a load number.
It is in the right format and it is in the sequence for that night, and the tracking system has no record of issuing it, and there are no sets against it. Fifty a year of them since 2020.
I asked the tracking supplier to look. Their answer is that a load number can only be created by a scan, that no scan exists, and that the number on my printout must therefore have been entered manually at the machine.
You cannot enter one manually. There is no keypad on that autoclave that will take one, and I stood next to their engineer while he tried.
What we do about it.
The cycle is logged as an unattributed cycle in the machine's record, and I have written the same three sentences on the file every month for five years.
No instrument set has ever carried one of those load numbers, because no set was in there. Nothing has been released off one and nothing has ever gone to a theatre from one.
Our decontamination audit has been passed every year, including the year I put the unattributed cycles in the front of the file with the printouts attached, which was 2022, and the auditor's comment was that the record keeping was exemplary.
What I do.
I am the first in most mornings and the printouts are on the machines.
I read the chart on 4 the way I read all of them, and I file it, and I put a line through the release box because there is nothing to release.
The change I have made is that I do not do the six o'clock walk round on my own any more, and it is rostered as a two person task now, which I justified on manual handling grounds because the trolleys are heavy and they are.
In February 2021 I came in at ten to six and the department was empty and locked as it should be, and the chart on 4 was in the tray with a cycle on it from ten past three.
The chamber was warm, which it would be.
The door was open, which the log says it was.
And there was a set of instruments on the loading trolley in front of it, wrapped, sealed, with an indicator strip on it that had turned, and no label, and no load number, and I have worked in this department for twenty six years and I did not recognise two of the instruments in it.