Have you ever heard of IRIS?

We asked numerous doctors and nurses if they’d heard of IRIS – none had.

We couldn’t access IRIS through the NSW Health Intranet.

IRIS is hidden, disconnected, and consequently ineffective. This is unfortunate given it is vital for patient safety.

IRIS stands for Incident Reporting & Investigation System – the Therapeutic and Goods Administration (TGA) rely on it to review medical equipment. The TGA are the only regulatory body in Australia who can effectively remove hazardous products from our hospitals.

Front line staff are well aware of their own states incident reporting systems (IIMS in NSW, VHIMS in Victoria, CIMS in WA, SLS in SA).

However, we’ve become aware that statewide incident reports aren’t forwarded to the IRIS system – this is a great concern.

We’ve previously provided the TGA with an extensive list of cases of accidental chlorhexidine administration causing death or serious injury (see here). This was the TGA’s response:

the report by you regarding indistinct chlorhexidine is the only report we have received for this issue

Their decision not to ban indistinct chlorhexidine is heavily based on lack of reports in their IRIS system.  They go on to cite several policies indicating how to avoid inadvertant injection (see here).

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Indistinct chlorhexidine (centre of image) has been mistaken for other colourless solutions leading to patient deaths and injury. It could be replaced by distinct versions (on right) already used at many hospitals.

We’ve started contacting state reporting systems requesting a database review for cases of accidental chlorhexidine administration. We’ve discovered new cases of arterial injection, intravenous PICC line injection, and accidental administration into a cerebral ventricular drain. We’ll forward these to the TGA.

We hope the TGA recognise IRIS is desperately impaired and develop links with other reporting systems.

Just as seat belt laws didn’t lead to an increase in unsafe driving, introduction of safety measures won’t make healthcare staff less likely to follow policies.

Front line staff want to work in an environment safe for patient care. Over 250 people have signed the petition to ban indistinct chlorhexidine (sign here).

Your support is driving change – Sydney Local Health District has replaced indistinct chlorhexidine with a more distinct solution – we hope others will follow suit.

Patient safety may improve when:
– we accept an error by one person is something we could all make,
– we learn how to effectively prevent these errors leading to adverse outcomes
– and we have the tools to put this learning in place.

7 thoughts on “Have you ever heard of IRIS?

  1. Totally agree with the thrust of your post.

    There is little doubt that the worst possible outcome of a preventable incident in which a patient is harmed is to let it happen again. Sadly, this occurs almost all the time – for reinforcement of this, see the latest report of the Victorian Institute of Forensic Medicine on recent coronial inquests involving central venous lines – no new issues there, just the same issues over and over. We are failing to learn from our mistakes.

    Osler is creating a community of patient-safety focussed clinicians who believe that we must learn by recognising our mistakes and improving our systems accordingly. Part of this solution is to bring clinicians world wide together, and create a healthcare alert system that works for clinicians, not administrators.

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  2. Fascinating and horrifying in equal measure. Just clicked through to DAEN (http://apps.tga.gov.au/PROD/DAEN/daen-report.aspx) where only one incident related to tinted pink chlorhexidine is found… and yet you suggest that many incidents (serious ones!) are known to state reporting systems?! So, the reporting and the investigation system don’t seem to be talking to one another. That’s a real worry!

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  3. I agree these are serious concerns. Not familiar with IRIS, but very involved with IIMS in NSW during my tenure in a major university teaching hospital in Sydney. Had been involved with a number of IIMS cases relating to CVC-related issues. This is where closed-system chlorhexidine skin preparation delivery systems would reduce the risk of accidental injection/ingestion through open-bottle dispensing of solution in poorly lit areas. Chloraprep has been registered with the TGA since 2014 (in Australia) and has been successfully accepted for skin antisepsis in many countries for years as the preferential skin preparation for invasive and surgical patient procedures. I also reviewed the DAEN searching for Chlorhexidine Gluconate 2% and Chlorhexidine In Alcohol 70% from 1971 – 2016. Only 3 pertinent episodes isolated from the data report – 1 cardiac arrest and 2 anaphylactic/anaphylactoid style reactions, however none of these cases had any mortality-based outcome reported by the TGA. Most were skin reactions/uticaric-style site reactions and one episode of paraesthesia documented.

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    1. Thanks Tim,
      How many near misses and adverse events do patients need to be subjected to when suitable alternatives already exist and are well accepted. It is very unfair on patients and front line staff that the systems in place to improve safety rarely introduce effective solutions – instead they opt for reminders, alerts, policies. We look forward to the change.

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      1. Agreed, and the minimization of these risks with reduce adverse events, however, there also needs to be a greater understanding that closed systems of this type of antiseptic solution delivery is now the “standard of practice” in most countries. Decanting of solutions is fraught with danger and the fact that the current state of practice in Australia is to LABEL a solution only that is decanted; no one will follow this practice, if at all, very few, still exposing patients to greater risks.
        I welcome the change to a closed system delivery method – take away the middle processes of reminder, alerts and labelling pens! Policies are still very effective to enforce compliance within practice, as it puts clinicians at risk of disciplinary actions if an adverse event happens from non-compliant practice. It is essential that policy is clear and also effective to outline the process to use the equipment properly and safely.
        Patient safety should always be a number one focus for all healthcare clinicians..

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