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. 2001 Mar 3;322(7285):548.
Not again!
Designing safer medical devices requires financial and political
support
See the referenced article in volume 311 on page 514e.
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.
2.CEN Forum Task Group, “Luer Fittings.”. Luer connectors—a report to CEN. London: British Standards Institution; 2000. . (PD CR13825:2000.) [Google Scholar]
3.British Standards Institution. Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment. Part 1. General requirements. London: BSI; 1994. . (BS EN 20594-1:1994.) [Google Scholar]
4.British Standards Institution. Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment—lock fittings. London: BSI; 1997. . (BS EN 1707:1997.) [Google Scholar]
5.Department of Health. An organisation with a memory; report of the expert group on learning from adverse events in the NHS chaired by the chief medical officer. London: Stationery Office; 2000. [Google Scholar]
BMJ. 2001 Mar 3;322(7285):548.
Erroneous intrathecal injection results from a problem with
protocols
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.1-1 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.
Editor—Berwick rightly points out that mechanisms are needed to prevent
tragedies such as the erroneous intrathecal injection of vincristine
from happening.2-1 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.
Editor—Just as I was penning a letter about how medical errors are
portrayed in the media, Berwick has said it all.3-1 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
2001.3-2 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.3-1,3-3 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.
Editor—Further to Berwick's editorial on the erroneous intrathecal
injection of vincristine4-1 and the picture in Minerva in
the same issue on the packaging of lignocaine,4-2 we report
a pertinent incident.
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.
Plus 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.
Editor—Obviously errors will always occur in health care.5-1
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.
