Chapter 2 LITERATURE

Figure 5: Major phases in the life span of a medical device and associated stakeholders,
adapted from (Cheng 2003)

Any of these phases can affect the safety and performance of a medical device, and this risk
is shared between the manufacturer, vendor, government, user and the patient/public
(Cheng 2003). Given that the purchasing stakeholders interact closely with those involved
in the latter steps of this life span („Advertising‟ onwards), this risk is also shared with
purchasing stakeholders, and the changes of each process are inevitably linked. It also
means that system changes in either arena can trigger systems changes in the other.

Not all guidelines appear from regulation and some literature from the management
sciences also highlights similar principles. The concept of analytic hierarchy process is
emphasised (Sloane 2004) because “in the case of a medical technology decision, there is
an ethical obligation to try to honour the patient‟s needs and beliefs first and foremost, but
other stakeholder perspectives and needs must also often be considered… Few business
school researchers understand the medical field, but it has been encouraging to see how
often they can quickly identify and apply their portfolio of well-documented tools and
techniques once they understand a healthcare problem.” (Sloane 2004)

Literature from other international sources speak about the more generic term Healthcare
Technology Management (HTM) as follows (Poluta et al. 2005), described as:

Planning; Acquisition; Utilisation I (Asset Management); Utilisation II (Risk

Management); Utilisation III (Maintenance)

The use of Human Factors Engineering (HFE) has also been encouraged in selecting
devices, particularly for infusion devices which appear frequently in medical error
published literature (Lin et al. 1998; Zhang et al. 2003; Ginsburg 2005; Gagnon et al.

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