Participant characteristics
A total of 17 participants took part in the interviews: 88% were female and 12% male. In the majority of cases, the homecare team operated as an independent organisation separate from a hospital. To a lesser extent, the homecare team had a collaboration with one or more hospitals, or was a component of a hospital. These and additional participant characteristics are shown in Table 1.
Table 1
Participant characteristics at time of interview.
| Participant | Gender | Type of organisation* | Position in the organisation | Years of experience |
| P1 | F | A | Nurse in a medical technical homecare team of a homecare organisation. | Over 20 years in care and quality management. |
| P2 | M | A | Quality advisor at the organisation for elderly care. | 30 Years in quality management, of which 13 years in healthcare, before that in industry. |
| P3a P3b | F F | B | P3a: Manager in a cooperative for medical technological homecare of 3 organisations for residential and homecare, and a hospital. P3b: Clinical physicist for MT in hospital and homecare. | P3a: About 25 years in quality management. P3b: One year in a hospital and before 4 years during education. |
| P4 | F | C | Coordinator MT for 3 hospital locations and 17 centra for residential and elderly care. | One year and a half in this position and before a PhD-research project in biomedical technology into safety of medical technology. |
| P5 | F | C | Nurse in a medical technical care team for homecare. | 8.5 Years in this position. |
| P6 | F | A | Senior nurse in a mobile care team for high- and low-complex care in outpatient and eventual inpatient care. | 15 Years in the mobile care team. |
| P7 | F | A | Nurse in a medical technical care team for homecare. | 5 Years in quality management. |
| P8 | F | A | Specialized nurse in a medical technical care team. | 4.5 Years in this team. |
| P9 | F | A | Homecare nurse for medical technical care. | 26 Years in homecare. |
| P10 | F | B | Policy advisor quality within a homecare organisation. | Almost one year. |
| P11 | F | A | Nurse in a medical technical care team in a cooperative of 4 care organisations for specialized care. | 22 Years in MT. |
| P12 | F | A | Nurse in medical technical care in a homecare organisation | 18 Years in MT. |
| P13 | F | A | Project leader care technology. | 22 Years in care and 2.5 years as a project leader. |
| P14a P14b | F F | A | P14a: Nurse specialist and project employee in a homecare organisation. P14b: Nurse specialist and project employee in a homecare organisation. | P14a: 11 Years as a nurse in homecare, of which 5 years as a nurse specialist and 1 year as project employee. P14b: 9 Years as a nurse in homecare, of which 5 years as a nurse specialist and 1 year as project employee. |
| P15 | M | A | Nurse in a medical technical care team in a homecare organisation and chairman in the Shared Gouvernance Group medication safety. | About 5 years in the Shared Gouvernance Group. |
| *A: The homecare team is an independent organisation separate from a hospital |
| B: There is a collaboration with one or more hospitals |
| C: The homecare team is a component of a hospital |
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Quality management systems and quality frameworks/guidelines
All participants confirm the presence of a QMS in their respective organisations, with the utilization of one or more national systems (see Table 2). However, three participants are unaware of the specific national QMSs being employed. National QMSs predominantly serve for periodic audits, as well as external accreditation or certification. Homecare teams affiliated with hospitals generally adopt the hospital’s QMS.
Approximately half of the participants are uncertain about their organisation’s existence of a plan for AMT quality and safety. Six participants acknowledge the presence of such a plan exists, while two assert its absence, ‘….as the technologies are owned by the supplier, they are responsible that those devices are safe’ (P2). When present, these plans are usually integrated into another policy documents or annual plans. These plans encompass quality assurance measures for AMT, referencing user protocols, or the training for professional users. The practical implementation of the AMT quality policy is delegated to various departments within the organisations, e.g. the technical homecare team itself, specific colleagues, expert teams, the coordinator or policy advisors for AMT, or the ‘Quality department’.
Few participants are acquainted with the ‘Covenant on the safe application of MT in specialist medical care’ [7], a mandatory systems for Dutch hospitals. Among those familiar with it, two explicitly indicate its integration into their organisation’s QMS. These organisations maintain collaborations with, or are components of a hospital.
About a quarter of the interviewees confirm the involvement of a clinical physicist in their organisation’s AMT quality process. Within the network of other disciplines, a pharmacist’s involvement is often standard practice. Additionally, the prescriber or ultimately responsible physician, as well as ad hoc individuals like producers or suppliers (e.g. Mediq), the general practitioners, regional hospitals and a technician play a role. One participant emphasizes:
‘Of course, there is regular consultation….. However, not only when an issue arises, but also for the purpose of improvement. It doesn’t always have to be a problem. Sometimes, certain matters are arranged in a cumbersome manner. You might not have an issue, but there’s room for enhancement or acceleration. These are also instances, of course, to convene’. (P8)
Table 2
National QMS used by organisations (multiple answers possible).
| Abbreviation QMS | Used by number of organisations | Spelled out or translation | Type of system |
| ISO | 8 | International Organisation for Standardization | Quality standards |
| INK/EFQM | 2 | Dutch Institute for Quality | Management model |
| NIAZ | 1 | Dutch Institute for Accreditation of Hospitals | Accreditation/certification system |
| CBO | 1 | Central Guidance Institute for Peer Assessment (Quality Institute for Healthcare) | Quality guidelines |
| HACCP | 4 | Hazard Analysis and Critical Control Points (Nutrition/Kitchen) | Quality codes and instructions |
| HKZ | 7 | Foundation for Harmonization of Quality Policy in Healthcare Sector | Accreditation/certification system |
| TNO QMT | 1 | The Netherlands Organisation for applied scientific research– Quality for MT | Quality system |
| Other: | | | |
| TÜV | 1 | Association for Technical Inspection | Accreditation/certification system |
| JCI | 1 | Joint Commission International | Accreditation/certification system |
Procedures regarding the introduction and the use of AMTs
Nine participants affirm that their organisation possess procedures linked to the introduction of AMTs. In several instances, the initiation stems from the medical technical care team, often upon the request of a hospital or a physician. These teams independently order the technologies, with or without managerial consultation. In other cases, suppliers take the lead in proposing new technologies, and the team decides whether to adopt them or not. Four participants describe an inclusive bottom-up process across the organisation before transitioning to new technology.
Half of the participants indicate that their organisations lack a product file for AMTs. Some are uncertain, while others confirm the presence of such files. As one participant put it:
‘Yes, of course, we have a collection of the products and materials we work with, and you could call that a file, indeed. However, it’s…. We don’t officially refer to it as such, but it’s essentially a file containing everything we work with. We can rely on it for information. And, well… It might not be named that way, but practically speaking, that’s how it functions’. (P1)
Three interviewees confirm the utilization of product files in their organisations, incorporating requirement programs and risk analysis; these organisations are affiliated with hospitals.
When asked about procedures related to AMT use, participants refer to the national Vilans Protocols1 [19] and some organisations employ hospital procedures. Supplier manuals of guidelines are also frequently cited as procedural references. One participant is uncertain about their organisation’s user protocol description: ‘…..at least, I have never seen them’ (P11). Typically, users have access to information about technologies, including protocols, through the organisation’s document management system, intranet, or an app.
Evaluation of AMT use is primarily not conducted according to an established plan to ascertain proper device functioning, but often occurs ad hoc in practice. In a few organisations, AMT use is systematically evaluated as part of internal policy, whereas in others no evaluation occurs.
‘No, we do not evaluate that. We assume that the supplier has this in order. The pumps also have to meet all kinds of quality requirements before they can even come on the market ……..We are not going to ask him about ‘Does the pump meet the quality requirements that the pump must meet?’ I’m assuming it’s been thought through. I trust that, we just trust that. Otherwise it gets complicated’. (P11)
Procedures regarding the maintenance and malfunctions of AMTs
In terms of AMT maintenance, all organisations adhere to the supplier’s guidelines and protocols. For hired equipment, the supplier usually initiates maintenance, conducts checks, and replaces devices if needed. Equipment owned by organisations also undergoes scheduled checks, for example indicated by stickers on the devices, specifying the maintenance date and the due date.
‘Upon receiving a device, the ‘Healthcare Technology department’ assesses whether maintenance is required and how frequently. This assessment is guided by the associated risk score of the device. .… Subsequently, a decision is made regarding the necessity and frequency of maintenance. Of course, the supplier’s instructions and recommendations are also taken into account. This is recorded in our management system, Ultimo, where the equipment is logged, and maintenance is scheduled’. (P3b)
Additionally, organisations use procedures for cleaning, disinfection and sterilization, e.g. suppliers protocols to clean pumps after each patient use. Due to the COVID-19 pandemic, two interviewees note heightened attention to hygiene and specific manufacturer-provided enhancements.
While one-third of the participants state their organisations lack procedures for addressing AMT malfunctions, all know what to do in the event of a malfunction. Nurses initially attempt to resolve malfunctions themselves. If unsuccessful, nurses can contact a 24/7 breakdown service, often provided by the supplier.
‘No, we don’t have a procedure for that. It’s actually something we’ve figured out within the team itself. It’s more a mental process rather than being documented on paper. We always try to resolve it ourselves based on our knowledge. If we don’t know, we call [the supplier] where we got the pumps from’. (P5)
Two homecare teams affiliated with hospitals may avail the hospital’s technical service, while two other hospital-affiliated teams are referred to external services for malfunction.
Competence of the users and environmental conditions
Various, often combined methods are employed within organisations to ensure nurses’ competence in using AMT at home. Organisations offer tailored training programs, involving testing of knowledge and skills. Formal registration of nurses’ competence is required according to participants, though one acknowledges not all nurses adhere to this. Peer review is utilized by a few organisations, and new employees may follow an onboarding protocol including testing. While nine participants note organisation initiate nurses’ competence, three organisations see it as nurses’ personal responsibility. Periodic retraining is common in the majority of organisations; typically every three years. Often a periodic test is mandatory. However, some participants mention retraining occurs occasionally or upon team request.
For new technology, training is provided by organisations with mandatory testing in some of them. Conversely, participants indicate competence is not tested, and testing is not always obligatory.
‘It is not subjected to testing in that way, but it is evaluated. So, as I mentioned, through evaluation questionnaires, they assess whether the implementation [of a new device] is successful and running smoothly. They also gauge whether people have enough confidence to work with it’. (P15)
Other methods employed to try to ensure the competence of the nurses include team discussions about new technology, practice sessions in the office, or to observe a colleague’s performing the skills on a patient.
Patient and/or informal caregiver(s) operation of devices is typically allowed, with the attending physician’s permission. The nurse ensures these users are competent by instructing them and supervising their skills. When deemed safe by the nurse, these users may perform tasks independently.
Organisations have requirements for the homecare environment, albeit often undocumented. These requirements include a safe, clean environment suitable for responsible care. Nurses assess this on-site and discuss it with clients and/or informal caregiver(s) when necessary. In extreme cases, patient transfer to a hospital or nursing home may be considered. However, a participant elaborates on a practical experience:
‘No, it [the homecare environment] is not screened. I don’t think it’s ensured either. Currently, the priority is more about ensuring that if, for instance, infusion therapy is prescribed, it simply takes place. We sometimes work in very unsanitary environments. We do try to be cautious with pets in such situations and might take it outside the room, but sometimes you can’t avoid a house being very dirty or excessively damp. There are cases where you have very little space to work in a clean environment. I’ve never experienced AMT being cancelled or postponed because of this’. (P8)
Incidents, knowledge management and patient safety culture
In the event of an incident, professionals have the option to submit a ‘MIC-report’, either through a separate form in the electronic client file or, in some cases, via a distinct reporting system outside the patient file. There are no specific incident reporting procedures for AMTs. In one organisation, professionals can use a transmural incident report system, which allows chain partners such as pharmacists, suppliers or hospitals to be informed. Patients or informal caregivers are typically advised to discuss incidents with nurses, who then initiate the reporting process. In some cases, informal users can also use forms in the patient file to report incidents or are directed to file complaints.
‘We don’t perceive incidents and complaints as shortcomings in our work, but rather as opportunities for improvement. This applies to client and family complaints as well; we are very receptive to them. We also encourage our staff to be very open about it and invite clients and families to voice their concerns wherever they’re not satisfied’. (P2)
After reporting an incident, each organisation follows its own procedure for addressing it. Generally, incidents are discussed within the team, either periodically or on an as-needed basis.
‘Most often, they are user errors related to equipment, and as a team, we can generally identify those ourselves and propose corrective measures’. (P3a)
Incidents are discussed in incident or quality committees, shared governance groups, or expert teams. In three cases, reported incidents are sent to the supervisors or heads of departments, and a quarterly report is sometimes submitted to management. There is a distinction in three organisations between serious and less serious incidents. Serious events often entail thorough investigations carried out by special teams, with findings shared more broadly within or outside the organisation. Some participants note that incidents are not discussed outside the team, and there is no comprehensive overview of incidents in these organisations.
PRISMA method is predominantly used for analyzing most incidents, although one participant specifies its use for only very serious incidents. Six participants are unsure about the method used for incident analysis. In one organisation no method for incident analysis is employed. One participant mentions that her organisation investigates if trends can be identified from incidents.
The interviewer informed participants about a previous study that indicated substantial underreporting of incidents involving AMT following organisation’s protocol. Three participants do not recognize the low reporting rate of 16%.
‘To my knowledge, optimal use is made of it, a formal report …….. Of course, I don't know what I don't know, but to my knowledge we are honest about it’. (P1)
However, twelve participants acknowledge significant formal underreporting in their organisation. One participant observes differences between teams in terms of reporting frequency:
‘…..which does not mean that more mistakes are made or quality is lower there. It is known that if the team makes zero reports, it can be assumed that there is underreporting’. (P14)
Most participants who acknowledge underreporting do not have precise estimates, while others suggest that a quarter of incidents are reported, half of the incidents or that the average over the teams indeed will be about 16%. Nearly all participants note actions are taken within their organisations to increase protocol-based reporting. About half of these organisations receive central-level messages, such as communications from quality committees or official announcements, special meetings, or intranet news items. Reporting is also promoted during team meetings and sometimes included on the agenda. Two respondents report increased reporting since the introduction of these measures.
Participants were presented with descriptions of a culture ladder from the ‘Instrument for Self-Evaluation of Patient Safety Culture’ (IZEP) [20]. This instrument is used by Dutch hospitals to self-evaluate patient safety culture across various dimensions. Interviewees were asked to identify which situation most closely aligns with their organisation’s patient safety culture in terms of ‘reporting, evaluating and learning from incidents’. Half of the participants identified situation D as the closest match (see Table 3). When values are assigned to the situations (situation A = 1,...., situation E = 5), the average score is 3.8 situation C, towards D.
Table 3
Culture ladder in IZEP [20]
| N (%) | Explanation |
| 0 | Situation A Denying Why waste time on safety; we provide good care. - Incidents are rarely reported in our department. - It is common to hide mistakes and no learning takes place. - Management and healthcare professionals do not want any hassle but want to get back to work as quickly as possible. |
| 0 | Situation B Reactive We take action after every incident. - Although there are formal agreements in place covering the reporting of incidents, healthcare professionals are reluctant to report incidents, neither are they stimulated to do so. - In the main, only serious incidents are reported but there is rarely any feedback on a report. - Serious incidents temporarily put patient safety on the agenda. An improvement is then devised ad hoc that will not be followed for long. |
| 5 (33,3%) | Situation C Calculating We have systems to manage all risks. - There is a reporting system, but healthcare professionals do not feel secure enough to report all types of incidents. - The incidents are discussed at a department level. The emphasis is more on analyzing and less on seeking improvement. - Management is primarily interested in registering the number of reports. |
| 8 (53,3%) | Situation D Proactive We are alert to risks. - Most healthcare professionals report almost all types of incidents. Many incidents without harm to the patient are also reported. - The incidents are discussed at a department level. Improvements are introduced with the aim of preventing recurrence. - Improvements are actively sought to prevent the incidents reported (both within and outside of our own department) in the future. Patients are typically involved. |
| 2 (13,3%) | Situation E Progressive Safety is an integral part of everything we do. - Healthcare professionals are aware of their responsibilities and report all incidents to help prevent recurrence. - They provide quick and targeted feedback on the reported incidents. Improvements are fed back and monitored. - All those involved in the care process are constantly alert to risks, make improvements and share good practice with the rest of the organisation. |
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