VOL: 97, ISSUE: 43, PAGE NO: 36
Wendy Murray, PGDip (health visiting), BSc, RGN, RM, RHV, is nursing officer
Helen Glenister, PhD, MBA, BSc, RN, is nursing director of the Medical Devices AgencyUnfortunately, when using medical devices, things do sometimes go wrong - and the outcome can be fatal. Last year, the Medical Devices Agency (MDA) received 7,249 adverse incident reports, of which 824 involved serious injury or fatality. The consequences of these incidents can be devastating for patients and their families, as well as for the health care professionals involved.
Unfortunately, when using medical devices, things do sometimes go wrong - and the outcome can be fatal. Last year, the Medical Devices Agency (MDA) received 7,249 adverse incident reports, of which 824 involved serious injury or fatality. The consequences of these incidents can be devastating for patients and their families, as well as for the health care professionals involved.
We all assume that in the event of an emergency, equipment will operate as we expect it to. However, this is not always the case.
One incident reported to the MDA in March this year highlights the importance of checking equipment regularly to ensure that it is working correctly. The report came from an ambulance driver who had experienced problems with a suction pump unit during a resuscitation procedure. Possibly because of the displacement of a reusable suction canister, the unit failed to produce adequate suction. This may have been due to the canister being moved or knocked.
This incident shows that after the initial assessment of any medical device (see last week's article, 'Safety tips', October 18, p24), regular checks need to be carried out to ensure the device is functioning correctly and to find out whether reassessment is required.
Nurses must ask themselves two important questions when assessing devices. First, is the device doing what the manufacturer intended it to do, and, second, is it safe? Establishing these two points is vital if adverse incidents are to be avoided (Box 1). There have been a number of incidences where these simple questions could have avoided tragic incidents.
Knowing what to check
It is also important that nurses understand the instructions which accompany medical devices. If they misinterpret the manufacturer's instructions, they may unwittingly cause serious injury.
For example, the MDA recently received reports that the prolonged use of pulse oximeter probes and the tape used to hold them in place had led to tissue necrosis in infants (MDA, 2001a).
The manufacturer's instructions stated that the site should be inspected every four hours. The manufacturers had assumed that the inspection would result in a change of site. However, nurses inspecting the site believed they were doing so simply to check that the pulse oximeter was still in situ. To avoid confusion in future, revised instructions suggest that the site should be changed at least every four hours.
Knowledge of the device being used
Health care professionals need to be familiar with the devices they are using and should not attempt to operate any device they have not been fully trained to use.
Reports to the MDA have included incidences where over-infusion of intravenous drugs has occurred because nurses did not follow the prescription, and administered them too quickly. Investigations revealed that in some cases the device had been over-infusing for some time without action being taken, despite written records clearly identifying over-infusion at the time (Glenister, 2000).
There is ongoing confusion over two commonly used models of syringe pump: the Graseby Ambulatory MS16 and MS16A (which are set at mm per hour) and the MS26 (which is set at mm per day). There have been a number of cases where confusion has led to over-infusion and caused the death of patients.
The range of medical devices available is enormous and it would be impossible for nurses to be adequately trained to use of them all. The MDA has published comprehensive guidance on rationalising a number of different devices (MDA, 1998a), and encourages limiting the number of devices used. At least one hospital has opted to use only one type of syringe pump, despite having both available.
This appears to be an ideal solution, although it may have cost implications. In the long term, costs can be reduced through collective ward or unit purchasing power. Purchasers should ensure staff training is included in any package.
Failing to take action
Another issue nurses must consider is what is being monitored by a device and why. There is no point monitoring something if no action is going to be taken when things go wrong.
The question all nurses should ask themselves is: 'Are the results within recognised limits?' If they are not, take action. Do not just continue to monitor the situation. There have been incidences reported on labour wards where cardiotocograph recordings have indicated problems in labour but action was taken too late, resulting in stillbirths (MDA, 1998b).
Using devices correctly
Patients' needs can change, sometimes gradually but often very quickly. It is important that patients are reassessed regularly to ensure that their needs are still being met by the devices being used. This provision should ideally be made at the outset of treatment in the patient's care plan.
If there are problems with any device, steps should be taken immediately to rectify the situation. Replacement equipment should be obtained if necessary, and faulty devices returned for repair through the appropriate channels. There have been occasions where devices removed from one incident were used again through failure to follow the correct procedure.
It is not the correct procedure to put the device in the corner and wait for someone else to sort it out. There is no excuse for the reoccurrence of an incident involving a device that is already known to be faulty.
Sometimes devices that would appear to be harmless can in fact be lethal if used incorrectly, especially where there is a change in circumstances.
There have been a number of incidents reported to the MDA where children have been injured, even killed, through the inappropriate use of a medical device. In one incident reported recently, a young child was trapped under an electric bed. When the bed was lowered, the child's skull was crushed.
This is where education and continual reassessment play an important part.
Any device-related incidents should be reported as soon as possible to the MDA to allow for any necessary follow-up. This also allows for trends to be identified and again, where indicated, further action to be taken.
It is now possible to report these incidents quickly and easily via the MDA's website at: www.medical-devices.gov.uk
It is essential, as in any health care intervention, for accurate documentation to be maintained (Box 2). Records should identify the device and provide evidence that it has been maintained in good condition. This includes recording the device's identification details, for example, manufacturer, model and serial number. Health care professionals should know who they have to report incidents to.
Incident reports to the MDA highlight that the routine servicing of devices in some areas does not take place. It is acknowledged that servicing can be difficult, especially in community settings when devices are sometimes located in remote places. However, it is the health care professional's responsibility to ensure that any equipment has been regularly serviced in accordance with the manufacturer's recommendations before it is used.
With technology changing faster than ever before, it is increasingly difficult to keep track of instructions on the use of medical devices. This has serious implications for users. Ideally all instructions should be available at all times, if necessary by keeping them securely attached to the device.
Nurses' responsibility does not end when their patient is no longer using a device. It is their individual responsibility to ensure that the correct procedures are followed when disposing of the device.
There should be a standard method for the return, disposal or cleaning of all devices (Box 1). An example where this works effectively is the disposal of syringes in sharps boxes.
Where there is a need for decontamination, servicing or repair, procedures are a little more involved. An assessment of the equipment should be conducted, and if there are any faults or damage these should be dealt with. This should be done in accordance with the manufacturer's instructions.
Reuse of single-use devices
The reuse of medical devices supplied for single use is a serious concern. Nurses are often involved in this practice without having considered the full consequences of their actions. The MDA has received calls from health care professionals concerned that they are encouraged to reuse devices designed for single use only.
The MDA has published guidelines that clearly state that devices designated for single use must not be reused under any circumstances (MDA, 2000). Nurses who do not adhere to these guidelines are putting their patients and themselves at unnecessary risk.