1.4 Practitioners’ Implications
One can distinguish the following groups of stakeholders in MCPS:
MCPS developers, including manufacturers of medical devices and integrators of medical information technologies
MCPS administrators—typically clinical engineers in hospitals, who are tasked with deploying and maintaining MCPS
MCPS users—clinicians who perform treatment using MCPS
MCPS regulators, who certify the safety of MCPS or approve their use for clinical purposes
In the United States, the FDA is the regulatory agency charged with assessing the safety and effectiveness of medical devices and approving them for specific uses.
All of the stakeholder groups have a vested interest in MCPS safety. However, each group has additional drivers that need to be taken into account when designing or deploying MCPS in a clinical setting. In this section we consider each group of stakeholders and identify specific concerns that apply to them as well as unique challenges that they pose.
1.4.1 MCPS Developer Perspective
Dependence of MCPS on software, as well as complexity of software used in medical devices, has been steadily increasing over the past three decades. In recent years, the medical device industry has been plagued with software-related recalls, with 19% of all recalls of medical devices in the United States being related to software problems [Simone13].
Many other safety-regulated industries, such as avionics and nuclear power, operate on relatively long design cycles. By contrast, medical device companies are under intense market pressure to quickly introduce additional features into their products. At the same time, medical devices are often developed by relatively small companies that lack the resources for extensive validation and verification of each new feature they introduce. Model-based development techniques, such as the ones described in Section 1.3.3, hold the promise of more efficient verification and validation, leading to shorter development cycles.
At the same time, many medical device companies complain about the heavy regulatory burden imposed by the FDA and similar regulatory agencies in other countries. Formal models and verification results, introduced by the model-based development approaches, provide evidence that MCPS is safe. Combined with the assurance cases that organize this evidence into a safety argument, these rigorous development methods may help reduce the regulatory burden for MCPS developers.
1.4.2 MCPS Administrator Perspective
Clinical engineers in hospitals are charged with maintaining the wide variety of medical devices that constitute the MCPS used in patient treatment. Most clinical scenarios today involve multiple medical devices. A clinical engineer needs to ensure that the devices used in treating a patient can all work together. If an incompatibility is discovered after treatment commences, the patient may be harmed. Interoperability techniques, described in Section 1.3.4, may help to ensure that more devices are compatible with one another, making the job of maintaining the inventory and the assembly of clinical scenarios easier. This, in turn, reduces treatment errors and improves patient outcomes and, at the same time, saves the hospital money.
1.4.3 MCPS User Perspective
Clinicians use MCPS as part of delivering patient treatments. A specific treatment can, in most cases, be performed with different MCPS implementations using similar devices from different vendors. A primary concern, then, is ensuring that clinicians are equally familiar with the different implementations. The concepts of clinical scenarios and virtual medical devices, introduced in Section 1.3.4, can help establish a common user interface for the MCPS, regardless of the specific devices used to implement it. Such an interface would help to reduce clinical errors when using these devices. Furthermore, the user interface can be verified as part of the analysis of the MCPS model, as suggested by [Masci13].
MCPS development must take existing standards of care into consideration. Clinical personnel need to be involved in the analysis of the scenario models to ensure that they are consistent with extant clinical guidelines for the respective treatment and are intuitive for caregivers to use.
A particular challenge in modern health care is the high workload faced by caregivers. Each healthcare provider is likely to be caring for multiple patients and must keep track of multiple sources of information about each patient. On-demand MCPS have the potential to control cognitive overload in caregivers by offering virtual devices that deliver intelligent presentation of clinical information or smart alarm functionality. Smart alarms, which can correlate or prioritize alarms from individual devices, can be of great help to caregivers, by giving a more accurate picture of the patient’s condition and reducing the rate of false alarms [Imhoff09].
1.4.4 Patient Perspective
Of all the various stakeholder groups, patients stand to gain the most from the introduction of MCPS. In addition to the expected improvements in the safety of treatments achieved through higher reliability of individual devices and their bedside assemblies, patients would get the benefit of improvements in treatments themselves. These improvements may come from several sources.
On the one hand, MCPS can offer continuous monitoring that caregivers, who normally must attend to multiple patients as part of their workload, cannot provide by themselves. Clinical guidelines often require caregivers to obtain patient data at fixed intervals—for example, every 15 minutes. An MCPS may collect patient data as frequently as allowed by each sensor and alert caregivers to changes in the patient’s condition earlier, thereby enabling them to intervene before the change leads to a serious problem. Furthermore, continuous monitoring, combined with support for predictive decision making, similar to the system discussed in Section 1.3.5, will allow treatment to be proactive rather than reactive.
Probably the biggest improvement in the quality of care for patients will come with the transition from general guidelines meant to apply to all patients within a certain population to personalized approaches, in which treatment is customized to the individual needs of the patient and takes into account his or her specific characteristics. Personalized treatments, however, cannot be effected without detailed patient models. Such models can be stored in patient records and interpreted by the MCPS during treatment.
1.4.5 MCPS Regulatory Perspective
Regulators of the medical devices industry are tasked with assessing the safety and effectiveness of MCPS. The two main concerns that these regulators face are improving the quality of the assessment and making the best use of the limited resources that agencies have available for performing the assessment. These two concerns are not independent, because more efficient ways of performing assessments would allow regulators more time to conduct deeper evaluations. The safety case technologies discussed in Section 1.3.7 may help address both. The move toward evidence-based assessment may allow regulators to perform more accurate and reliable assessments. At the same time, organizing evidence into a coherent argument will help them perform these assessments more efficiently.