Intended for healthcare professionals

Letters

Not again!

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7285.548 (Published 03 March 2001) Cite this as: BMJ 2001;322:548

Designing safer medical devices requires financial and political support

  1. Philip J Bickford Smith (bickford.smith{at}bradfordhospitals.nhs.uk), consultant anaesthetist
  1. Anaesthetic Department, Bradford Hospitals NHS Trust, West Yorkshire BD9 6RJ
  2. Ysbyty Gwynedd, Bangor LL57 2PW
  3. Queen Mary's Sidcup NHS Trust, Sidcup, Kent DA14 6LT
  4. Mill Stream Surgery, Benson, Oxfordshire OX10 6RL
  5. Department of Diagnostic Imaging (Radiology), Royal Hospitals NHS Trust, London E1 1BB
  6. Patient Concern, PO Box 23732, London SW5 9FY

    See pp 501, 517, 562, 563

    EDITOR—Berwick emphasises the need to redesign medical devices to help avoid errors.1 In the European Union a task group from the European Standards Organisation (CEN) reported on ways to reduce the incidents of accidental misconnection of lines to patients.2 It identified a need to differentiate between connectors used in lines and syringes for enteral feeding, vascular access, and administering and sampling gases in the respiratory system, including a risk analysis of the results of misconnection.

    The report was not welcomed by EUCOMED, which represents several European medical device manufacturers, because its proposals create more hazards for users and increase costs in a highly competitive sector of the medical device industry with high volume, low cost products. The Japanese government changed the design of connectors on syringes and enteral feed systems in less than a year because of an associated death, but none of the standards bodies in the European Union has so far volunteered to develop new standards for connector systems, as recommended by the task group. Central funding from the European Commission has been sought, but the work is effectively now on hold.

    Many non-interchangeable keyed connectors are manufactured, mostly for specialised applications. Those that are not patented are freely available and could be fitted on to hypodermic syringes and lines, allowing differentiation of line or syringe by function—for example, respiratory, vascular, enteral, or neuraxial. A separate key for intrathecal needle and syringes is possible and would require the drugs to be supplied by the pharmacist in a specialised syringe. At least one connector system incorporates an anti-tamper lock, preventing unintended disconnection. Differentiation of connector is one prompt to increase safety, differentiation by size and shape of the drug container is another. Thus intravenous drug infusions should always be supplied with an intravenous giving set pre-attached, and intrathecal drugs with a spinal needle. However, unless all access points are sealed off, drugs in an intravenous bag could be accessed by even a specialised intrathecal needle and syringe.

    Currently, medical hypodermic syringes have only one permitted type of connector in two types. 3 4 Since medical hypodermic syringes and lines are ubiquitous, the task of developing a global standard for a series of non-interchangeable connector systems for syringes and small bore tubing is daunting. Not having the correct type of syringe available in an emergency would create its own hazards. Clearly, any new designs would need to be widely tested, a task meriting a multidisciplinary approach, with support from technical, psychological, and risk analysis experts. The Department of Health has promoted the reduction of accidents5 and could take the lead here. Financial and political support, from both the medical profession and government, is urgently needed.

    Footnotes

    • PJBS is the clinical expert from the United Kingdom on the CEN Forum Task Group, “Luer Connectors.”

    References

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    Erroneous intrathecal injection results from a problem with protocols

    1. J R C Seale (jim.seale{at}nww-tr.wales.nhs.uk), consultant haematologist
    1. Anaesthetic Department, Bradford Hospitals NHS Trust, West Yorkshire BD9 6RJ
    2. Ysbyty Gwynedd, Bangor LL57 2PW
    3. Queen Mary's Sidcup NHS Trust, Sidcup, Kent DA14 6LT
    4. Mill Stream Surgery, Benson, Oxfordshire OX10 6RL
    5. Department of Diagnostic Imaging (Radiology), Royal Hospitals NHS Trust, London E1 1BB
    6. Patient Concern, PO Box 23732, London SW5 9FY

      EDITOR—The erroneous intrathecal administration of vincristine to 13 patients (many of them children) in 15 years is not just a problem arising from inadequate time, training, and supervision of medical staff; neither can it be confidently prevented by modifying the equipment used.1 Though I have not had access to the various investigations, I am confident that most of the vincristine given had been labelled correctly and been prescribed for intravenous use in the patients who received it intrathecally.

      The accidents all occurred for the simple reason that the national protocols for treatment of childhood acute lymphoblastic leukaemia and the various derived regimens for adult leukaemia and lymphoma require that intrathecal methotrexate and intravenous vincristine be given on the same day. This is particularly convenient for patients and their families and carers, but the resulting 10 deaths and three cases of paralysis ought to prompt a review by the bodies issuing the protocols (the Medical Research Council and others).

      I know of no pharmacological reason why these two agents have to be given together, whether they are being given to induce remission or as maintenance treatment. The repeated disasters, despite the problem being well recognised by all those (senior and otherwise) involved in intrathecal treatment, surely point to the need to design the problem out of the system: give the intrathecal drugs on a separate visit to the intravenous ones. Local protocols specifying the use of the agents in separate rooms are not failsafe and not necessarily applicable or enforceable in every institution.

      References

      1. 1.

      National guidelines are urgently needed

      1. Saad M B Rassam, consultant in haematology and oncology
      1. Anaesthetic Department, Bradford Hospitals NHS Trust, West Yorkshire BD9 6RJ
      2. Ysbyty Gwynedd, Bangor LL57 2PW
      3. Queen Mary's Sidcup NHS Trust, Sidcup, Kent DA14 6LT
      4. Mill Stream Surgery, Benson, Oxfordshire OX10 6RL
      5. Department of Diagnostic Imaging (Radiology), Royal Hospitals NHS Trust, London E1 1BB
      6. Patient Concern, PO Box 23732, London SW5 9FY

        EDITOR—Berwick rightly points out that mechanisms are needed to prevent tragedies such as the erroneous intrathecal injection of vincristine from happening.1 With the changes in cancer management after the Calman-Hine report, this issue needs to be urgently looked at and nationally agreed guidance issued.

        At Sidcup we have been consciously aware of such errors and have for many years introduced practical steps to prevent this error from happening. The central chemotherapy manufacturing unit labels intrathecal treatments “for intrathecal use only” and vincristine injections “fatal if given intrathecally.” The drugs are delivered in separate envelopes that are clearly marked for intrathecal or intravenous use. We separate the intravenous from the intrathecal treatment in that specialist chemotherapy nurses give the intravenous, and haematology doctors the intrathecal treatments. Intrathecal follows intravenous treatment, so vincristine is given first. Most importantly, no junior doctor is allowed to give intrathecal treatment without one of the haematology or oncology consultants supervising the procedure. The drugs are collected from the pharmacy by the specialist chemotherapy nurses and handed to the consultant or to juniors in the consultant's presence. The consultant checks the injections with the administering doctor and the electronic prescription chart is signed by both.

        The problem arises not because of negligence but from lack of experience and lack of seniority. By introducing such steps we not only protect patients but raise awareness and highlight to junior doctors the fatal risk that comes from the simple switching of syringes.

        References

        1. 1.

        Only ocular treatments should be packaged like eye drops …

        1. Tim Wilson (twilson{at}rcgp.org.uk), general practitioner
        1. Anaesthetic Department, Bradford Hospitals NHS Trust, West Yorkshire BD9 6RJ
        2. Ysbyty Gwynedd, Bangor LL57 2PW
        3. Queen Mary's Sidcup NHS Trust, Sidcup, Kent DA14 6LT
        4. Mill Stream Surgery, Benson, Oxfordshire OX10 6RL
        5. Department of Diagnostic Imaging (Radiology), Royal Hospitals NHS Trust, London E1 1BB
        6. Patient Concern, PO Box 23732, London SW5 9FY

          EDITOR—Just as I was penning a letter about how medical errors are portrayed in the media, Berwick has said it all.1 My letter was not about a case reported in the Daily Mail, however, but about a case reported in the BMJ.

          I stared in disbelief at the picture in Minerva on 20 January 2001.2 Why would a medical company be allowed to produce a bottle of stoma deodorant that so closely matched a bottle of eye drops? I expected the authors to point this out and perhaps suggest that the Medicines Control Agency have a system for controlling the packaging of products like these. The agency has, for example, made strides in the packaging of paracetamol to reduce suicide rates. 1 3 Instead, the authors wrote (and the BMJ published), “Great care must be taken when patients need ocular treatments in addition to other treatments contained in dropper bottles”—as if the staff on the ward somehow did not try to take great care. Even Berwick returns his videos to the wrong store: he should take more care and be less human.

          Once again healthcare workers are being exhorted to avoid an accident waiting to happen. Furthermore, such an accident is likely to happen again—on wards, in homes (where patients with poor sight using eye drops might have problems)—until someone says that only ocular treatments should ever be put in packages that look like eye droppers.

          References

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          … and packaging of lignocaine must be changed

          1. Anmol Malhotra, radiology registrar,
          2. Mathew Matson, radiology consultant,
          3. Otto Chan, radiology consultant
          1. Anaesthetic Department, Bradford Hospitals NHS Trust, West Yorkshire BD9 6RJ
          2. Ysbyty Gwynedd, Bangor LL57 2PW
          3. Queen Mary's Sidcup NHS Trust, Sidcup, Kent DA14 6LT
          4. Mill Stream Surgery, Benson, Oxfordshire OX10 6RL
          5. Department of Diagnostic Imaging (Radiology), Royal Hospitals NHS Trust, London E1 1BB
          6. Patient Concern, PO Box 23732, London SW5 9FY

            EDITOR—Further to Berwick's editorial on the erroneous intrathecal injection of vincristine1 and the picture in Minerva in the same issue on the packaging of lignocaine,2 we report a pertinent incident.

            Figure1

            Three of four flushes were 1% lignocaine instead of normal saline on 31 January 2001

            In 1994 our risk management department was made aware that the containers and boxes containing 0.9% sodium chloride (normal saline) and 1% lignocaine were almost identical and that these solutions were being used side by side in the radiology department. The potential for a serious incident of mistakenly administering lignocaine as a flush was identified. No action was taken.

            In 1999 a child was administered lignocaine as a flush during an interventional procedure. The child required urgent medical attention but did not develop long term adverse effects. The incident was again reported to risk management, but no further action was taken to reduce the risk of recurrence. In April 2000 the danger of giving lignocaine for normal saline was again highlighted at a risk management meeting; no action was taken.

            On 31 January 2001 four flushes were drawn up before computed tomography (figure). Three of the four flushes were 1% lignocaine. This was noted before injection and a near miss has been recorded and reported to risk management.

            With the increasing cost of payments made by the NHS for medical negligence it is time to change the packaging of lignocaine.

            Footnotes

            • GraphicPlus ça change. Dr R E Ferner of the West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital NHS Trust, Birmingham B18 7QH, has reminded us that he highlighted the problem of misleading drug packaging over five years ago (BMJ 1995;311:514). He showed how labels for lignocaine and normal saline were identical apart from the lettering and suggested that diversity could mean the difference between life and death.

            References

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            Patients must be properly informed to agree to or decline treatment

            1. Roger M Goss (rogerconcern{at}hotmail.com), director
            1. Anaesthetic Department, Bradford Hospitals NHS Trust, West Yorkshire BD9 6RJ
            2. Ysbyty Gwynedd, Bangor LL57 2PW
            3. Queen Mary's Sidcup NHS Trust, Sidcup, Kent DA14 6LT
            4. Mill Stream Surgery, Benson, Oxfordshire OX10 6RL
            5. Department of Diagnostic Imaging (Radiology), Royal Hospitals NHS Trust, London E1 1BB
            6. Patient Concern, PO Box 23732, London SW5 9FY

              EDITOR—Obviously errors will always occur in health care.1 Unfortunately, the medical profession has traditionally kept quiet about this sad fact of life—and death.

              Doctors have considered it inappropriate to tell patients that mistakes, let alone their consequences, can all too easily occur during the course of a procedure. Therefore, patients have not had the requisite information on which to make fully informed decisions.

              The motives for this secrecy have doubtless been honourable. But the desire to spare patients the additional trauma of being reminded that we are all fallible can easily slide into the suppression of crucial information about the risks associated with an intervention.

              Giving patients all the information necessary to agree to or decline treatment, without generating numerous refusals, is the challenge implicit in a meaningful doctor-patient partnership.

              References

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              View Abstract