established that the boundary for this research is the medical device as defined similarly to the EEC Directive earlier: any artefact designed and intended for use in a hospital setting and hence purchased by a hospital for providing clinical care. This would therefore include all devices falling under the „F-class‟ category as determined by PASA logistics (Table 1), but may include the pharmaceutical products if bought together with devices under „D-class‟ category, dental and optical equipment (I-class), and diagnostic imaging and radiotherapy equipment and services (J-class). However, given the hospitals own understanding of medical device to be mainly those under category „F‟, it can be assumed that these other categories were not taken into consideration by the respondents when providing responses.
continue to be addressed today.(Stafford 1978; Bauer & Clark 1975; Trafas 1980;
Lewis 1979; Harju 1984)
The role of the nurse in purchasing decisions has also been highlighted, given their central role in actually administering care using equipment (Carroll 1992; Raab 1984). But in practice, their role may also not be recognised and this also forms part of the observations collected in this study.
The importance of teamwork in purchasing decisions appears in later literature (Fahlstrom et al. 2006), highlighting the fact that decisions for devices require knowledge that sits in different areas of the hospital.
The Clinical Engineer as the Purchaser
“Biomedical engineers are often called upon to lead a procurement decision because of their knowledge of how medical technology works, technical problems with the current technology being used, requirements to maintain technology, what products are available on the market and their existing relationship with medical technology companies.”
(Cassano Piché 2005)
The role of the EBME in device selection process has continually been highlighted since the emergence of this discipline within a hospital (Moody 1965; Burton 1996; Draper 2004;
Whitworth 1979). More recently, the role of engineering and procurement in a hospital and at strategic level has been highlighted in international publications (Rothnie 2004).
Their role is seen as key decision-makers in buying equipment, since they work closely with clinicians and technicians and finance, and recognise that “various features and benefits are offset with risks and limitations”(Sloane 2004).
According to guidance given specifically to the EBME community, the role of the „EBME manager‟, whose role can be played by a senior clinical engineer, medical physicist, or clinical scientist, they are responsible also for:
1. Purchasing: “It is the responsibility of the EBME Manager to control the documentation and inspection of purchases. It is the responsibility of the Quality
Assurance Manager to ensure that this procedure is carried out.”(EBME, web source)
2. Stores procedures: “It is the responsibility of the EBME Manager to ensure that a list of all equipment used is maintained in the Department in a professional manner and to ensure that the stores are controlled and handled efficiently.”(EBME, web source)
The overlap between storage and maintenance, „estates‟, procurement, and EBME within a hospital, is therefore significant, making collaboration and communication between these departments a crucial feature to consider in this study. This stakeholder group is an essential subject for study in this research.
Equipment management
Guidance for equipment management as a whole is mostly found in regulatory literature, rather than published journals. The FDA has put together guidance on incorporating Human Factors Engineering (HFE) into risk management of devices, including aspects of usability testing (understanding a device in user environment), explaining what HFE means, what level of effort is required in implementing its principles, and implementing general risk management processes (Crowley & Kaye 2000). All of this guidance is readily available to download online. Similar guidance is available for medical device management from the British Standards Institute (BSI 2009). The criteria for appropriate risk management include:
1. Board level responsibility for medical device management 2. Medical device group, in accordance with MDA DB 9801
3. Comprehensive organisation-wide policy on management of medical devices including deployment, monitoring and control
4. Selection and acquisition of devices acquired in accordance with the MHRA and NAO recommendations
5. Access to manufacturer‟s instructions for end-users; statement signed to the effect that they have received instructions on the safe use of devices or equipment
6. All instructions supplier by the user organisation are evaluated for their adequacy 7. Acceptance checks on newly delivered medical devices
8. Devices designed for single use are not reused under any circumstances.
9. Information required to managed devices recorded on a suitable system 10. Adverse incident recording
11. Key indicators to show improvements in device management
All points highlight holistic, system-wide considerations for device purchasing and management. In particular, no. 4 points out the necessity to select devices appropriately.
Details on this point state that this should include “a properly planned approach to the purchase of medical devices, taking into account the needs and preferences of professionals and end-users whilst retaining consistency and control” (BSI 2009). This includes lease, renting, in-house manufacture, refurbishment of devices and very comprehensive criteria for choice of supplier as well. These criteria also show a heavy reliance on in-house processes, controls, checks, and improvements, rather than relying on the supplier‟s design of safe devices.
In academic journals, the focus is more on particular types of equipment that may highlight some of the challenges in implementing such guidelines. A small article published in an Accident and Emergency journal also gives these general guidelines to the
„purchasers‟ of equipment, aimed at management staff, within an A&E department. The same lessons are repeated: conduct regular/annual review of all equipment, maintenance contracts, service record, cost of maintenance vs. frequency of use and effectiveness. It also recommends building up good relations with charitable organisations, personal relationships with suppliers, and the importance of negotiation skills with suppliers and specialists within the particular unit (Oakland 1998). An interesting anecdote from this paper is the reference to capital funding allocations per department, speaking for their own department that the annual allocation for new and replacement equipment works like
“national lottery”, given the random allocations given per budget holder. Capital and revenue funding seems to be a large divide in deciding how devices are purchased and the amount of control adhered to the purchase. In this article, the thresholds are as follows:
<£300: Directly purchased from A&E budget
£300 - £5000: Purchased from revenue budget
>£5000: Purchased through business plan from capital budget
These figures are similar to those found in the Trusts in this study, and the challenges with such funding barriers are also addressed.