Managing medical devices is a complex but important element in the delivery of high-quality care and has considerable effect on the financial bottom line of health care providers [1,2]. If not managed well, there can be various downsides, such as health care organizations holding too many devices in relation to demand [3,4], physicians needing to wait for delivery of the devices they need urgently [5], nurses possibly not having enough time available for the direct care process [6], and using devices that do not comply with safety and hygiene standards [7]. Hence, health care organizations spend considerable time and resources on seeking solutions to mitigate these problems, such as opting for joint procurement, applying lean manufacturing principles, using tracking technologies, and outsourcing [2,8]. In this paper, we are especially interested in outsourcing as a potential route to better medical device management.

Achieving better management of medical devices is particularly challenging when one considers that health care providers are still working toward more integrated care delivery [9]. Although such integrated care developments seem promising, operational and organizational challenges are often encountered when operating across care disciplines [10,11]; for example, patients may appreciate being able to retain the same wheelchair when moving between care locations, but this creates additional logistics or administrative tasks for nursing staff. Furthermore, the stringent requirements on the traceability and safety of medical devices under the 2021 European Union (EU) Medical Device Regulation challenge manufacturers and care providers to improve their medical device management [12]. The outsourcing of logistics activities may address some of these challenges by reducing coordination and planning efforts and improving their results [13,14]. Whether such outsourcing solutions, in this case related to managing medical devices, would be perceived as acceptable by nursing staff and indeed improve care delivery need to be carefully assessed.

When pursuing integrated care delivery, supportive IT becomes pivotal, including in relation to medical device management [15]. Care professionals generally have a positive attitude toward the implementation of IT [16]. However, its implementation and adoption are complicated by the multistakeholder context involving patients, medical staff, and other organizational staff [17]. Previous studies have underlined the importance of the usability of technology in gaining the support of core medical staff, thereby contributing to a successful implementation and increasing the likelihood of a positive effect on care delivery and other outcomes [18,19]. In this study, we focused on the feasibility of using a web portal aimed at enhancing medical device management through outsourcing.

We conducted a mixed methods study to assess the feasibility of a logistical intervention, where a health care provider outsourced several noncritical reusable medical devices to a third-party provider and introduced a web portal to support medical device management. Feasibility is based on the extent to which an intervention is considered acceptable by the users; whether the intervention is successfully implemented; and, finally, the intervention’s preliminary efficacy. Our aims with regard to outsourcing were to reduce the (1) total utilization days of the medical devices; (2) delivery time; and (3) time and money spent on cleaning, maintaining, and internally transporting the devices. We aimed to achieve our goals by using a web portal that supports medical staff by reducing the time taken to order a device when needed and to deregister it when no longer needed and that provides them with easy insight into device availability from their own location. With this study, we provide practitioners and researchers with knowledge on the potential benefits of, and challenges related to, outsourcing medical devices, assisted by IT, in an integrated care provider setting.

The study took place between January 2019 and June 2022 in the context of a large regional health care provider in the Netherlands. The organization, which was established after a merger of a hospital, several nursing homes, and home care providers, consists of 1 hospital, 17 nursing homes, and 3 residential care centers; it also provides home-based care at several locations. Since the merger, the health care provider has moved toward becoming a more integrated care organization (eg, by implementing an organization-wide electronic medical record system). It was the first such organization to receive chain-wide accreditation worldwide from the Joint Commission International [20].

The Dutch health care system is organized around 3 domains, largely based on the principles of managed competition [21]. The curative care domain is regulated by the Health Insurance Act. Private health insurers compete for beneficiaries, whereas private not-for-profit health care providers compete for patients. The long-term care domain is regulated under the Dutch Long-term Care Act, with a national tax-based budget. Budgeting responsibility for long-term care is regionally executed by so-called care offices. The home care domain falls under the responsibility of local government, regulated by the Social Support Act. Given that the studied health care provider is active in all 3 care domains—hospital, residential, and home care—it has contractual agreements with all regional financing bodies: health insurers, care offices, and local government. This leads to a complex setting where the health care provider is required to determine which medical device is associated with which financing body and to understand the conditions that govern the use of these specific devices. Within this health care context, we focused on the management of noncritical reusable medical devices. Reusable medical devices are defined as those that health care providers can reprocess and reuse for >1 patient [22]. Typically, reusable medical devices require calibration, maintenance, repair, user training, cleaning, and decommissioning [23]. In our research, noncritical devices are typified by the fact that they are not invasive, such as wheelchairs and patient lifts. Critical or semicritical medical devices, such as surgical instruments or equipment for diagnostics [22], are beyond the scope of our research.

Before the intervention, on-site stocktaking showed that several medical devices were unused, and there was little insight into the actual stock held. Approximately 40% of the devices physically identified were not registered, whereas several devices registered as available on-site were untraceable. Exploratory meetings with staff and on-site observations indicated that the existing way of managing devices led to considerable time spent searching by employees, patients having to wait, and high inventory and management costs.

Our focus on reusable medical devices provides a setting demarcated by relatively low complexity in which to study how to structurally benefit from logistical solutions such as outsourcing and web ordering portals in a chain-wide provider.

The intervention consisted of 2 parts. The first part involved a transition to the full outsourcing of 8 types of medical devices: anti–pressure ulcer mattresses, bariatric care beds, bed trapezes, lifting slings, low-low beds, patient lifts, standard wheelchairs, and shower stretchers. Of these, bed trapezes, lifting slings, low-low beds, shower stretchers, and standard wheelchairs were largely (>90%) managed and owned by the health care provider before the intervention. Anti–pressure ulcer mattresses, bariatric care beds, and patient lifts were already outsourced for most care locations (>90% of the devices were outsourced). From April 2021 onward, all 8 device types have been fully outsourced. Since then, the health care provider has been paying a rental fee per device per day to a third-party medical device supplier that transports, stores, cleans, and maintains the devices. The second part of the intervention involved implementing a web portal for nurses to support and simplify the process of registering and deregistering an increased number of rented medical devices (implemented on September 1, 2021). Before the intervention, nurses ordered medical devices via telephone or email, either via the internal purchasing department or directly through an external device supplier. The portal provides a standardized system for ordering these devices and gives nursing staff insight into the number of devices ordered and the devices currently available on-site. Overall, the intervention aimed to unify the management of noncritical reusable medical devices across the entire organization.

This study can be typified as a mixed methods feasibility study. It is based on several data sources: medical device rental data, interviews, on-site observations, and a small-sample questionnaire. The study has a before-and-after design and addresses 3 of the typical goals of feasibility studies, as classified by Bowen et al [24]: whether the outsourcing of reusable medical devices and the introduction of a web ordering portal are acceptable, implementable, and effective.

In this paper, we focused on 2 types of devices: wheelchairs and anti–pressure ulcer mattresses. Each device type was exposed to different aspects of the intervention during our study: wheelchairs were undergoing the transition to outsourcing and the implementation of the web portal, whereas, for anti–pressure ulcer mattresses, the web portal was the main change in managing the devices. A comparison between these 2 types of devices thus enables a feasibility assessment of the transition to outsourcing separately from the implementation of the web portal. A schematic overview of the intervention is shown in Figure 1.

The utilization days of owned (wheelchairs) and rented (anti–pressure ulcer mattresses) devices before the intervention were compared with the situation after the intervention using stacked charts, showing the utilization of medical devices in days per month per care location. The stocktaking data provided the number of owned and rented devices present at each care location before the intervention. All the various device brands and models were clustered into basic types (wheelchairs or anti–pressure ulcer mattresses) to ensure comparability before and after the intervention. The number of owned devices was converted to utilization in days per month. Average rental time per newly rented device was calculated and analyzed for 4 care locations (rental data only). Total device utilization and average utilization time were analyzed by means of 2 linear regression models (Excel 2016 [Microsoft Corporation]). Table 2 provides an overview of the dependent and independent variables, which were defined before the analysis. Autocorrelation between outsourcing and the portal was checked based on variance inflation factors and was <3 in all models.

The questionnaire data were analyzed by distinguishing three user groups: (1) nurses who used the web portal for both wheelchairs and anti–pressure ulcer mattresses, (2) nurses who used the web portal for only 1 type of device, and (3) nurses who had never used the web portal or had stopped using it. The questionnaire responses were analyzed by comparing the average difference between reported ordering time and delivery time before and after the intervention and on the average score per item on questions regarding ordering satisfaction and the perceived effects of the intervention. Differences in average ordering satisfaction and perceived effects among the user groups were assessed by means of a 2-tailed t test (Excel 2016). Differences in the average reported ordering time and delivery time before and after the intervention were assessed by means of a paired 2-tailed t test.

The interview data were analyzed with the aim to thoroughly understand the challenges that emerged from the transition to outsourcing and the implementation of the web portal—and how the care provider dealt with these challenges—as well as to highlight the challenges that the intervention did not resolve. Led by the first author, we performed the analysis using ATLAS.ti software (ATLAS.ti Scientific Software Development GmbH) and Excel, following the 3-step grounded theory approach of Corbin and Strauss [25] as discussed in the study by Karlsson [26]. This process follows a cycle where categories are inductively formed from the data, followed by a deductive analysis where findings are refined and validated based on existing concepts. In the first step, open coding, the transcripts were summarized and short text codes assigned. In the second step, axial coding, we established more general categories related to typical characteristics, challenges, enabling conditions, and consequences related to medical device use within the health care organization. In the third step, selective coding, 2 typical patterns emerged that seemed to have an effect on the implementation process of the portal and the outsourcing contract. The first pattern related to the scale of uptake of the intervention, leading to ambiguity in the organization. The second pattern concerned the effect of market incentives, hampering suppliers in offering a wide product portfolio. The coding process and intermediate outcomes were frequently discussed between the first and second authors to achieve consensus in categorization and established patterns.

The data regarding rental of medical devices were routinely collected by the health care provider for administrative purposes and not linked to individual patients. The data processed in this study are not considered to constitute medical research involving human participants as defined in the 1964 Helsinki declaration. As such, the statutes of the institutional review board of the faculty of economics and business of the University of Groningen indicate that the study does not require ethics approval by a review committee. Nevertheless, all the methods described in this study were conducted in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

All interview and questionnaire respondents were informed about the purpose of the data collection and the data processing procedure, and they consented to participate.

The results are presented in 3 parts. In the first part, we evaluated the acceptability of the intervention by nursing staff. In the second part, we addressed to what extent the intervention was successfully implemented and what enabling or limiting factors have been established. Finally, in the third part, we offered a preliminary assessment of the efficacy of the intervention in terms of device utilization, costs, ordering and delivery time, quality of care, and compliance with safety and hygiene standards.

On the basis of comparing the use of wheelchairs and anti–pressure ulcer mattresses before and after the intervention, we now present the findings of our preliminary efficacy analysis.

This study addresses the feasibility of a 2-fold logistical intervention aimed at outsourcing the management of reusable medical devices and the introduction of a web portal facilitating the ordering and use of these devices. The findings show that, with respect to acceptability, user satisfaction with the ordering and delivery process was high. Concerning preliminary efficacy, a reduction in the required number of wheelchairs, which was significantly related to outsourcing (P=.03), was observed. The increase in the required number of anti–pressure ulcer mattresses stabilized after the introduction of the web portal. For both wheelchairs and anti–pressure ulcer mattresses, we found shorter reported ordering and delivery times, but rental times per device did not reduce. Hence, the web portal may support the ordering and delivery processes, but there is no indication that it triggers a more efficient use of devices. After the intervention, a higher degree of device certification was reported, thereby increasing compliance with safety and hygiene standards. In theory, these improvements should translate into better outcomes in terms of costs and the quality of care. However, based on the findings, we could not establish that a reduction in overall costs had been achieved, and nurses did not report improvements in safety and the quality of care. Although, for all 8 types of reported medical devices, the implementation of the intervention was successful, based on observations and interviews, several challenges were highlighted related to improving the chain-wide management of medical devices. These challenges relate to the diverse nature of the supply base and complexities with having multiple care financers. In essence, these findings show the difficulties of managing, and catering to, the various stakeholder interests involved in the care chain, and this will be more elaborately reflected upon in the following subsection.

This study assessed the feasibility of an intervention based on qualitative and quantitative data collected before and after the intervention. Several limitations warrant mention. First, although our data indicate clear improvements over time, there are several potentially confounding factors that have not been considered explicitly; for example, although care registration data did not indicate considerable changes in patient numbers or disease burden, this was not part of the statistical analyses. Other examples include developments in treatment methods that may affect device use as well as disruptions in the supply and care process, such as those seen during the COVID-19 pandemic.

Second, our study took place against the backdrop of the introduction of the 2021 EU Medical Device Regulation. This context places our results within a framework of heightened standards for the traceability and safety of medical devices and shows a glimpse of the complex landscape that health care providers must navigate within the newly imposed regulatory constraints.

Third and last, the questionnaire on user experience that provided relevant insights that add to the basic device data was sent out only after the intervention, and it was targeted at nursing staff and not at patients. As such, we lack firsthand experiences from the latter group. This is especially relevant because our respondents did not report any clear effects on patient satisfaction or any effect on care quality, which provides an important direction for further study. This again stresses the importance of measuring patient experiences and outcomes over time for both care and research purposes.

The integrated management of medical devices should lead to reduced costs and fewer required devices, higher quality of care, and reduced material waste. This feasibility study confirms this potential when it comes to acceptability, implementation success, and the preliminary efficacy of the presented intervention. Nevertheless, at a time when the integration of care chains is becoming more important, our research also highlights some of the difficulties when putting integration into practice; for example, in a health care system context that is based on market principles, it remains an immense challenge to achieve a more coherent way of managing medical devices, even for a single care provider when operating across traditional health care boundaries. In addition, the ongoing challenges in achieving transparency on prices and on the quality of care again prove key to measuring the efficacy of integrated medical device management which, in turn, is pivotal to achieving long-term implementation.