VOL: 101, ISSUE: 42, PAGE NO: 50
Trisha Weller, MHS, RN, DPSCHN (PN), CPT, is module and programme leader, National Respiratory Training Centre, Warwick
Because of concern about the cross-infection risks of reusing medical devices, European legislation has been introduced to counteract the risk. However, some placebo devices are being labelled for single-use only, which could, as Trish Weller explains, compromise patient care if supplies are limited.
Placebo inhaler devices are widely used in primary and secondary care to teach patients how to use their inhaler correctly without using active drug. The use of these devices helps health professionals to decide on the most appropriate device for the patient and prevents unnecessary ones being prescribed. However, the devices are becoming less easy to obtain as a result of European legislation, which aims to tackle concerns about cross-infection. Potential infections include: acquired immune deficiency syndrome; Burkholder cepacia; hepatitis B and C; methicillin-resistant Staphylococcus aureus; rhinovirus and other viral respiratory infections, and tuberculosis.
Infection risks also apply to spacer devices, inspiratory flow meters and peak flow meters. The latter are essential for monitoring chronic asthma and for the objective assessment and treatment of acute asthma.
Teaching patients to use their inhaler correctly is an important part of respiratory management. Good inhaler technique is essential to ensure effective delivery of inhaled medications. Ineffective inhaler technique can have serious consequences:
- Poor control of respiratory diseases such as asthma and chronic obstructive pulmonary disease;
- Potential ill health for the patient;
- Significant cost implications if they are not used correctly or prescribed appropriately.
Medical devices are regulated by European legislation (Medical Devices Agency, 1993). In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has statutory responsibilities to safeguard public health and safety. Consequently, National Health Service trusts are required to have a structure and system in place as part of their risk management strategy (DoH, 1999; DoH, 2004).
Peak flow meters are classified as medical devices because they are used for diagnosis and monitoring, but placebo inhaler devices are specifically excluded from the medical devices list (MDA, 2003).
Approval by the MHRA is not needed for placebo inhaler devices because they contain no active drug and are not subjected to clinical trials or drug licensing applications.
However, many placebos are labelled as single-use items by pharmaceutical companies. Re-using designated single-use devices has implications, because the legal responsibility then transfers from the manufacturer to anyone who re-uses a device (MDA, 2000).
Devices in practice
Nurses make a major contribution to patient care by teaching and checking inhaler technique, and the cleaning of placebo inhaler devices has been an on-going concern for many (Clancy, 2003). But there is little or no evidence that placebo devices and peak flow meters pose a significant cross-infection risk; the risk is theoretical (Kendrick et al, 2003). However, limited supplies of placebo devices and infection control policies can have a serious impact on the teaching and checking of inhaler technique, potentially compromising patient care. Legislation places NHS trusts and health professionals in an unenviable position, but there are also risks attached to not teaching or checking inhaler technique.
Practical recommendations for clinical practice
The National Respiratory Training Centre was commissioned by the British Thoracic Society Standards of Care Committee (2005) to examine and report on the issues concerning placebo devices.
A summary of the findings and practical recommendations for the use of placebo devices and peak flow meters are published on the web sites of both the British Thoracic Society (www.brit-thoracic.org.uk) and the National Respiratory Training Centre (www.nrtc.org.uk).
The document from the British Thoracic Society Standards of Care Committee (2005) has attempted to highlight the practical issues for those working with respiratory patients. In an ideal world, patients would always bring their inhalers and spacer devices with them when they attend for review, there would always be sufficient supplies of placebo devices, these would be easy to obtain and devices would never be used between patients.
Unfortunately, because this is not an ideal world, the British Thoracic Society has attempted to minimise harm to the patient and provide practical recommendations for acceptable standards of care.