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Michael G Scott, PhD FPSNI
Head of Pharmacy and Medicines Management,
Antrim Hospital Site,
A medical device means any instrument, apparatus, appliance, material or other article whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used by human beings for:
Furthermore, a medical device is an instrument which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
They are dealt with under the EU directive 93/42/EEC1 and subsequent updates2 which cover the placing on the market and putting into service of medical devices. Products included in the directive are extremely diverse and include, for example, first aid bandages, tongue depressors, breast prostheses, X-ray equipment, giving sets etc. In addition, devices are also sub-divided into Classes I, IIa, IIb or III depending on how they are intended to be used.
The market is increasingly subject to regulation and, while products are not licensed, they must have the CE marking of conformity when they are placed on the market.
The merger of the Medicines Control Agency and the Medical Devices Agency to form the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK further emphasised the significant degree of conformity between the products that they regulate; the prime function being to promote and protect public health.
In relation to safety with regard to medical devices, in 2009 the MHRA received 9,099 adverse incident reports involving medical devices, 21% more than in the previous year. This total also represents an increase of 37% over the 6,610 reports received ten years ago in 1999.3
The adverse incidents may arise due to defective products on the one hand and incorrect use or maintenance on the other, and thus these issues must be addressed in terms of risk potential at the outset. Due to the diverse nature of the market, it is important that robust specifications to meet clinical need are balanced against risk management considerations. The MHRA recognises the importance of pharmacy in these elements in both primary and secondary care.
There is a significant and ever-increasing spend on disposable medical devices, with this particular class of product accounting for about 30% of the total pharmacy spend – i.e. finance main code 50 – within an NHS trust. In addition, there is also further spend relating to medical and surgical devices that are re-usable (surgical instruments), as well as clinical equipment, which also have associated maintenance and consumable costs.
Clearly, given the scale of the spend on these clinical items, there is a requirement to manage that expenditure and ensure optimal value for money for the health service. However, such issues must be consistent with the paradigm that:
This requirement demonstrates the synergy with the process associated with the management of medicines.
Pharmaceutical clinical technology
The rationale for the involvement of pharmacy has been outlined by Wertheimer.4 He defined pharmaceutical clinical technology as the “rational, effective, safe and economic use of medical technologies (e.g. devices, instruments, single-use items, biotechnology and diagnostics) and medicines used in the prevention, diagnosis and treatment of disease”.
Heller explained that there is a requirement for health professionals to “systematically consider the clinical rational use, technology information analysis, patient safety, epidemiological, economic and managerial issues for clinical technologies and drugs used in medication”.4
Evidently, the application of these skills will provide a high level of patient care. Increasingly, it is the case that clinical technologies are becoming more varied and complex and generally overall management is poor. In essence, pharmaceutical clinical technology is an evolution of what pharmacy already does in the care process.
The marketing of these products follows similar patterns to that of both drugs and dressings, with sales representatives promoting their products utilising promotional material, product specifications and characteristics (CE marking).
In relation to studies, there is significantly less data available in either peer-reviewed or non-peer-reviewed published literature. Consequently, there is a need for objective evaluation of such data to produce an enhanced assessment of these pharmaceutical clinical technology products as is undertaken for both drugs and dressings. This information should be carefully evaluated and evidence-based, so that rational, informed clinical and economic decisions can be made. The skills required are part of the routine armoury of the pharmacy team.
In effect, pharmaceutical clinical technology (PCT) takes account of:
The NHS Information Authority has established a comprehensive dictionary of medicines and devices (dm+d) that provides for unique inventory classification as well as linkage between categories of products and a basis for IT management.
This is very important for future procurement processes and governance arrangements, whereby the linkage of these products enables patient therapy to be compared against the recommended best practice.
The term ‘expert purchaser’ relates to expertise that is a function of a number of elements and in the context of pharmaceutical clinical technology is defined as:
The single common denominator is pharmaceutical expertise drawn from pharmacists working in clinical areas, quality control, governance (risk management), medicines information and procurement.
Thus the wider pharmaceutical team is not only central but critical to the specification of the technical need, understanding the nature of the commercial market in which that need is presented, the application of the technology in the clinical setting and the economic analysis of achieving best value under given clinical conditions.
The role of pharmacy, together with clinicians and clinical engineering, in this area of health technology assessment has also been recognised in other European countries such as Switzerland, Belgium and Italy.5,6,7
Further, the management of centralised decontamination units by pharmacists to deal with surgical instruments and the adherence to all relevant standards only serves to reinforce this point.
It is therefore apparent that the management of devices is an area in which the pharmacy team can effectively work, as they possess the necessary skill set.
In Northern Ireland at a regional level, there has been an eight-strand programme in place for the last six years, namely the Pharmaceutical Clinical Effectiveness Programme (PCEP). Pharmaceutical clinical effectiveness is here defined as the outcome of the application of pharmaceutical skills directed to providing a systematic approach to rational product selection and use, consistently applied across secondary and primary care, taking account of clinical need, evidential product clinical performance, product presentation, safety characteristics and economic factors.
The clinical procurement has been undertaken using STEPSelect (Safe, Therapeutic, Economic Pharmaceutical Selection), which is a matrix-based methodology.8,9 It recognises that such procurement is quite unlike that associated with general goods and services such as plastic bags and jam, and that different expert skills are required. The complete process is clinician-driven, with the expert groups comprising all appropriate healthcare professionals from both primary and secondary-care sectors.
This step-wise process is based on safety and quality and was successfully applied to medicines in the first instance, but subsequently wound dressings and topical negative-pressure systems and now other medical and surgical disposable devices.
Whilst there is less evidence with regard to products in the latter categories when compared to medicines, it is still essential that all available data is presented for the expert group’s consideration to ensure optimal product selection.
The pharmacy team plays a key role on these groups via the application of both the evaluation and clinical skills of the clinical ward/departmentbased pharmacists and technicians in conjunction with consultants and theatre nurses. In addition, locally, there is a course that is specifically geared to pharmaceutical procurement, which ensures that the pharmacy team can maintain and update their skills.10
Trust structure and process
Due to the varied nature of medical devices, the governance arrangements required have to be both broad and interlinked, and in the Northern Health and Social Care Trust the following system operates (see Figure 1).
The key purposes of these committees are as follows – all of which are either chaired by or have pharmacy representation:
Point of Care Committee
To manage point-of-care testing effectively and limit risks associated with its use.
Surgical and wound dressings
To provide advice to the trust on all aspects of surgical dressings and wound product utilisation.
Clinical Procurement Advisory Group
To advise the trust on all matters relating to the use of medical and surgical disposable products and contribute as required to the overall trust strategy and operational requirements for medical devices.
Medical Devices Committee
To advise the trust on all matters relating to medical and devices equipment. To contribute as required to the trust strategy and operational requirement for devices.
Infection Prevention Control and Environmental Hygiene and Decontamination Groups
These groups have an important role to play in terms of appropriate medical device selection and use from their respective perspectives of infection control and decontamination.
Clinical Capital Scrutiny Group
This relatively recently formed group draws up prioritised lists of clinical capital requirements for the trust based on a matrix format.
Thus this committee structure can oversee all aspects of the use of medical devices within the trust, maximising the introduction of new devices, standardisation of products and optimising value. In addition, regarding safety, pharmacy quality assurance may be involved as well as the medicines governance pharmacist in incidents relating to disposable medical devices.
At an operational level, the pharmacy team manages the medical and surgical disposable items, including in vitro diagnostics, in the same way as for medicines and dressings, utilising the traditional top-up system.
This, therefore, brings the same rigour of logistics to these items, including a review of regular usage, stock management – for example replacement of a superseded medical device, with a newer model – and electronic ordering and invoicing. A lead technician oversees the ordering and management of the devices.
In conclusion, it can be seen that the pharmacy team, both pharmacists and technicians, are best placed to manage medical and surgical devices, given the requirements of both clinical and procurement expertise to ensure the safe, high quality use of these products thus driving both health gain and efficiency for the patient population and healthcare economy.
1. Council Directive 93/42/EEC on medical devices
2. Council Directive 2007/47/EC on active implantable medical devices and medical devices
3. Adverse Incident Reports 2009, MHRA DB 2010 (03) April 2010
4. Mason P. Pharmaceutical Journal 2003;271:428-9
5. Snackers F. The Medical Equipment Committee. EJHP 2004;4:56
6. Grimm E. The use of medical devices. EJHP 2004;6:55
7. Scroccaro G. Clinical Pharmacy in Italy. An increasing role in health technology assessment. EJHP 2004;6:92
8. Scott MG et al. EJHPP 2010;16:2010-3
9. Expert Opinion on Pharmacotherapy 2007;8: S1–S69 10. Mairs J et al. HPE July/August 2006;39-41