Pharmacy purchasing is quite separate from the devices in terms of involvement in decision making.
PHA_C
Summary of learning about stakeholders
The key learning from this section is summarised in these bullet points:
The different roles played by the stakeholder group groups in each purchasing process step were assigned (Table 18).
The results strongly suggest that not everyone involved in the process has a clear understanding nor consensus about who makes decisions and who is involved.
Patient involvement is device-dependent. This gives us clues about who is perceived to be an 'end user' when it comes to purchasing. And also, who is perceived to be a 'purchaser'. To some, this means the administrative tasked assigned to the person making the order. To others, this is a collective term.
There is an inconsistency of interpretation of roles in medical device purchasing among different stakeholders
Clinical input is divided from the rest of process, but is present at the start (except for pharmaceutical products, where „risk department‟ is involved)
There is less involvement of patients for infusion device purchase, but acknowledgement of necessary involvement of Nurses and EBME (more than Clinicians and Purchasing) for decision-making.
resources referred to are those in the second question of the questionnaire in Appendix II.
The results are summarised in Table 19.
Table 19: Number of respondents who used or are familiar with available resources
Table 19 highlights some key observations:
„Regulatory‟ guidance, such as that from MHRA and NICE, all are guidance with which they were familiar, but guidance from PASA or Royal colleges varies.
Purchasing documents (e.g. Pre-purchase questionnaire, PASA documentation, BIME device evaluation data) are almost unknown to pharmacy respondents.
The differences in resources used give another indication of the separation of maintenance/engineering staff and those based more on the front-end or pharmaceutical management.
Drivers for making individual purchasing decisions
These responses correspond to the fourth question on the questionnaire in Appendix II.
The results are not statistically valid, and there were also differences in interpretation in many of the phrases used in the questionnaire. However, the key findings are shown here as they did show a few trends worthy to note:
„Device history‟, „quality‟, „safety‟, „robustness‟, „ease of use‟, „after sales support‟
and „reliability‟ ranked high no matter what the role Supplier image or brand generally not important
Technical/engineering staff recognise importance of working relationship with sales representative
Below are some of the sample comments that illustrate these findings:
I would always concentrate on the user first rather than the design. I compare medical devices to cars, and I've my car in the car park now and the car park is not doing anybody any harm, it‟s only likely to do any harm when I get in the car and drive it.
ENG.snr_C2
CE marking doesn't give any indication of quality or safety or reliability.
RISK_C
If we have two products then one we have experience with working with the company and we've got on OK with … we'd like to use them again.
TRAIN.tec_D
I wouldn‟t go with a company if it didn‟t give me any training.
TRAIN.tec_D
During these responses, some further comments were made that did not relate directly to the questions asked during the interviews, but served to highlight issues further and provide insights into the situation.
Firstly, the knowledge of the resources available was not common to all, as pointed out earlier.
I'm aghast at how many people have not seen MHRA guidelines… it's the ward level people who don't know.
ENG.snr_C1
A member of the risk department points out the intrusion made by sales representatives on their control processes:
We want purchases to be independent and neutral and want to avoid reps coming and building…I don‟t like reps going in and having too much influence on the process.
RISK_D
Medical device coordinators are not used by all Trusts but can play a key role in establishing links between the clinical and technical considerations of device purchase and use. They usually purchase “for the Trust” and have a particularly holistic understanding of device needs. However, respondents were not always sure who this medical coordinator was for their own Trust, and different names were given for the same role.
Device committee that‟s me, and…[Engineer‟s name]
ENG.snr_C1.
Maybe it is him…
TRAIN.tec_B
We do not have one medical device coordinator, it's coordinated by the MD committee.
PHA_B
I think there is a committee… you'd have to ask [ENG.snr_C1]
RISK_C
Medical device coordinator comes under the realm of clinical engineering team RISK_D
Culture and mindsets
The questionnaire also invited respondents to comment on changes in the NHS, and changes to purchasing practice. This was to elicit the attitudes and mindsets of current stakeholders with regard to current practice, and gauge willingness or need for improvement further.
Respondents were first asked whether or not change was necessary, and the response was overwhelmingly positive, although some claimed the changes have already occurred and safety is being taken into account in decisions, from their personal perspective:
I disagree that it would require significant cultural change. I think it should be relatively straightforward.
PHA_B
We do have some quite well defined procurement processes and I think increasingly they are taking safety into consideration which is good…
ENG.snr_C
National awareness campaign is hugely important to raise awareness. To engage people and recognising that there are significant benefits in taking a national approach [or] a sub-standardised approach at things.
PHA_B
We almost need to identify champions across the NHS who can actually support the NHS Trust with a lot of these things, so we've got a sort of patient safety coordinators in each of the regions… actually working with individual Trusts to try and support the introduction of new equipment or help us with business cases...
PHA_C
Using collaborative procurement hub is good way to assess risk…
PHA_C
[Conferences] enables the targeting of key people.
RISK_C
An online resource kit and to bring together many of the aspects that you would have, and I suppose want to use these tools to measure and help plan the next processes out.
RISK_C
[We need] more about PASA structure because Trusts do try and comply with those things, people who are looking after patient safety have to compete with the Board's attention, finance...which has much higher national priorities.
TRAIN.tec_D
I think we need more honest thorough the whole NHS (honestly admit when we are having a hard time implementing good practice)
RISK_D
I'll tell you what you need; you need purchasing for safety champions - -individuals in Trusts who can engage people in a tradition, working in a clinical area where they can influence the vision.
PHA_D2
Summary of learning on decision-making influences
The key learning from this section is summarised in these bullet points:
Dispersed use of any national guidance among the stakeholders but heavier reliance on internal policies, measures, and human resources to control the management of devices.
Not all „purchasers‟ are familiar with all guidance available, and this varies according to Trust area
What “purchasers” rank as important for making purchasing decisions relates mostly to the training and maintenance given by the supplier. Little value is given to the internal capacity of their workforce to comply with training and usability requirements. The expectations lie slightly more with the supplier.