A poor workman always blames his tools

Medical equipment and devices are often blamed for adverse incidents. Sarah Whitehouse investigates how and why mistakes occur in medicine – and the link between medical device error and human error

“The team was only able to locate two fully-functioning infusion pumps (stored in a linen room).”¹

This extract, taken from the Healthcare Commission’s investigation and subsequent report into the poor standards of care at Stafford Hospital in the UK, shows only too clearly that a lack of vital medical equipment – fully-functioning, well-maintained, and stored in the correct place – damages patient safety.

A medical device is anything other than a medicine or prescription drug that is used in diagnosis, treatment or surgery, ranging from the everyday, eg, syringes, needles, dressings and examination gloves, to the more specialised, eg, anaesthetic equipment, defibrillators, endoscopes and implants.

Worldwide, approximately 14,000 firms produce more than 100,000 different brands of medical device, and they can all go wrong in a number of ways.² Dr Susanne Ludgate, Clinical Director for Devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), explains: “The higher risk the device, the more likely it is to go wrong.”

What can go wrong?

There can be something wrong with the device itself or, more commonly, a user-device interface problem. The device could be difficult to use, instructions for use might not be available or be very clear for the user (or they might not use the instructions), it might be stored incorrectly, or the packaging could be faulty.

The MHRA suggests that errors may be partly (or wholly) due to deficiencies in the design of the device or instructions for use.³ Whether as a result of design deficiencies, or more human fallibilities, the World Health Organisation (WHO) states: “Within the clinical engineering community it is widely believed that user-error underlies at least half of all medical device-related injuries and deaths.”⁴

Device error - and human error

The holes in the Swiss cheese represent failures in a system’s defences that allow a hazard to pass through. A critical incident occurs when all of the holes line up

Cognitive psychologist Dr James Reason used a Swiss cheese model to explain human fallibility. The holes in the Swiss cheese represent failures in a system’s defences that allow a hazard to pass through.⁵ A critical incident occurs when all of the holes line up. Some of the holes in a system could be down to human factors, including: 

• Fatigue 
• Hunger
• Lack of concentration 
• Interruptions or distractions 
• Poor communication 
• Lack of training 
• Lack of information 
• Unfamiliarity with workplace 
• Other – illness, influence of drugs, alcohol, etc.

Devices that have not been standardised, or do not work or look alike, increase the likelihood of operator errors.⁶ Research into high levels of adverse incidents in anaesthesia criticised equipment manufacturers for producing different designs of machine, similar except for one key difference – the valve controlling anaesthesia turned either clockwise or anticlockwise. Anaesthetists became confused about which model they were working on.⁷ Standardising the machines led to a significant reduction in adverse incidents.

Incorrectly using medical devices can have devastating consequences. In Singapore, MPS medicolegal consultant Dr Lawrence Ng recalls a coroner’s case where a patient died of brain hypoxia from an anaesthetic oxygen tube that did not deliver oxygen, as the valve was placed the wrong way round. He explains: “The case was recorded as misadventure as it could not be identified who placed the valve that way. The tubes were washed by hospital attendants and recycled for use after sterilisation.”

Pushing the boundaries

Dr Ludgate suggests that some of the problems we see with devices are because doctors are pushing boundaries. “For example, a surgeon might trial a coronary stent in a big vessel with a large lesion, and then start pushing it into small vessels and multiple lesions. Pushing the boundaries is often understandable as you can’t always do clinical trials in circumstances that do not happen very often.”

However, if a doctor is pushing boundaries in their use of a device, they should always work within the limits of their own competence and if the procedure is really “off label”, they should discuss their proposals with the medical director first, and the patient should be fully aware.

Training

If you are using new equipment, you must ensure that you have received appropriate training and are adequately supervised

Problems with medical devices also arise when there has been inadequate training and inadequate mentoring. MPS has been contacted about a number of cases where inexperienced chest draining has taken place.

“If you are using new equipment, you must ensure that you have received appropriate training and are adequately supervised,” warns Dr Jayne Molodynski, MPS medicolegal adviser. Ensure you are familiar with any equipment, and, if you are in any doubt, ask for advice from colleagues. Don’t be afraid to say you are unsure of how something works. The UK’s General Medical Council (GMC) advises: ”You should recognise and work within the limits of your competence.”⁸

If you are using a new piece of equipment or a device for the first time, patients should be appropriately advised and consented for procedures in which new techniques are being used.

The simplest of problems can lead to complaints – eg, severe bruising or the trauma of a difficult venesection, if a patient feels the individual carrying out the procedure was not capable of doing it competently.⁹

Maintaining medical devices

It is often not enough to simply have the correct equipment or training in place; checks need to be made to ensure that the equipment continues to be fully-functioning.

A case would usually be indefensible if faulty equipment was not properly checked prior to use

This, of course, comes with additional costs. Dr Nancy Boodhoo, MPS Head of Operations in the West Indies and Bermuda, explains: “In the developing world, hospitals may have the resources to buy equipment, but do not have a maintenance agreement for the equipment that they buy.”

In some instances in the West Indies, private hospitals have written contracts that require a doctor to be responsible for equipment. Limited access, or delays in accessing, MRI scans or x-ray machines can have serious consequences – leading to a missed or delayed diagnosis, and possible complaints or claims to the doctor handling the treatment.

MPS has seen a number of claims involving anaesthetic machines, where anaesthetists have failed to check they are working properly. Dr Molodynski adds: “A case would usually be indefensible if faulty equipment was not properly checked prior to use.”

Misusing or reusing equipment can endanger patient safety. Infection control can often be a problem, particularly when poor sterilisation takes place, or disposable equipment is reused to save resources. There should be proper maintenance logs for all equipment.

In the UK, the GMC states: “If you have reason to think that patient safety is or may be seriously compromised by inadequate premises, equipment, or other resources, policies or systems, you should put the matter right if that is possible.” If not, you should report the matter to your employing or contracting body.¹⁰

Instructions for use

To ensure a high-quality standard of care, doctors should be fully competent and cognisant of manufacturers’ guidance for use and maintenance

In the UK, the Medical Devices Directive, as part of the MHRA, handles medical device alerts, and similarly, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) issues device notifications. In New Zealand, Graseby MS-series syringe drivers, used to provide continuous ambulatory infusion of medicines, should be removed from clinical use by 30 June 2010.¹¹

There are often concerns about Instructions for Use associated with medical devices, which are becoming longer and increasingly difficult to read. Clinicians often worry where liability would lie if something went wrong with the use of a medical device that they should have known about because of the instructions.

This, however, is more of an anxiety in the minds of clinicians rather than a pressing medicolegal issue, in the experience of MPS. To ensure a high-quality standard of care, doctors should be fully competent and cognisant of manufacturers’ guidance for use and maintenance. However, the manufacturer also has the responsibility to bring to the medical professional’s attention any changes in Instruction for Use.

“If a doctor had received a medical device alert and they were aware of it, or should have been aware of it, then generally they would be liable,” says Dr Ludgate, but in many cases, doctors might not be aware. “Manufacturers may change the Instructions for Use without flagging up to clinicians that they have done so. You cannot expect clinicians to re-read the Instructions for Use before every procedure.”

General practice risks

MPS Educational Services conducts Clinical Risk Self-Assessments (CRSAs) at GP practices throughout the UK and Ireland. Sometimes, practices have used equipment that is past its expiry date. A number of CRSAs found GP practices had a defibrillator and it was not known who was responsible for maintenance checks, or not all staff had been trained to use it. Recommended actions included designating a member of staff to check regularly that defibrillators are in correct working order and record the check is complete. GP practice nurses often monitor and record medical device alerts, even recording nil returns if the alerts are not relevant to the practice.

Problems were also noted with vaccine refrigerators and temperature control errors. It is a good idea to ensure that the minimum and maximum temperatures are recorded daily, and to date and sign that this has been undertaken. vaccine refrigerators should be clearly labelled and should not be used to store food.

Reporting concerns

Doctors in South Africa have voiced concerns over their ethical and legal liabilities regarding actual and potential errors arising from infrastructure difficulties within the National Health Laboratory Service (NHLS).

If you have concerns that patient safety is endangered due to a lack of basic equipment, materials, or properly-trained personnel, you should report this appropriately. The Health Professions Council of South Africa (HPCSA) states that you should: “Always regard concern for the interests or wellbeing of your patient as your primary professional responsibility”, and, additionally, you should “Deal responsibly with scarce healthcare resources”.¹²

Being open

When things go wrong it is easy to apportion blame to individual error, but closer analysis of the incident may reveal other underlying causes

When things go wrong it is easy to apportion blame to individual error, but closer analysis of the incident may reveal other underlying causes. The information from adverse incident reports can help identify faults with medical devices and may prevent similar incidents happening again. Once an incident is reported, an investigation can take place to attribute human or device error, or, more likely, a mixture of both.

In the UK, the MHRA’s newly updated online reporting system for medical device users was implemented in November 2009. In Ireland, the Department of Health and Children’s Building a Culture of Patient Safety (2008) provides details on incident reporting systems.

If an adverse event does occur, it is important to be open and honest, and explain what went wrong to friends and relatives of the patient.

Learning lessons

A lack of standardised and well-maintained equipment, deployed without comprehensive training, can lead to equipment not being adequately checked or being used incorrectly. Device users are often blamed as the main factor in device-related adverse incidents, yet there is a complex inter-relationship between how a device is intended to be used, and how it is used in practice.

Keeping up-to-date with regulatory device alerts and with manufacturers’ changes to usage, combined with regular training and support, can help guard against the potential pitfalls relating to user error, and reduce the likelihood of device-related adverse incidents.

References

1. Healthcare Commission, Investigation into Mid-Staffordshire NHS Foundation Trust, p41 (March 2009)
2. Ward J and Clarkson P, An Analysis of Medical Device-related Errors: Prevalence and Possible Solutions, Journal of Medical Engineering and Technology, 28 (1): 2-21(2004) 
3. MHRA, MHRA Device Bulletin: Reporting Adverse Incidents and Disseminating Medical Device Alerts, p8 (February 2010) 
4. WHO, Medical Device Regulations – Global Overview and Guiding Principles, p6 (2003) 
5. Reason J, Human Error: Models and Management, BMJ, 320: 768-770 (2000) 
6. Corrigan J, Donaldson M, Kohn L, To Err is Human: Building a Safer Health System, Institute of Medicine, p62 National Academy Press (1999) 
7. Vincent, C (Ed), Clinical Risk Management: Enhancing Patient Safety, p118 BMJ (2001) 
8. GMC, Good Medical Practice (2006) 
9. Cowan J, Clinical Risk – Minimising Harm in Practical Procedures and Use of Equipment, British Journal of Clinical Governance, 5 (4): 245-249 (2000) 
10. GMC, Good Medical Practice, p9 (2006)
11. Medsafe Statement – Graseby MS-Series Syringe Drivers – Extension of Deadline (December 2009) 
12. HPCSA, General Ethical Guidelines for the Health Care Professions, Booklet 1 (2008)