Malfunctions and Management of Home Medical Equipment in Visiting Nursing Stations and Collaboration with Clinical Engineers

Introduction

Home medical equipment is widely used in Japan, encompassing devices for health monitoring—such as those measuring vital signs—as well as life-support devices, including infusion pumps and respiratory devices. As medical technology has advanced, the number of patients using home medical equipment has increased in many countries. In Japan, the number of children using medical devices, such as mechanical ventilators, has approximately doubled to quadrupled over a nine-year period from 2010–2019.¹ Similarly, in the United States, the number of patients using oxygen concentrators increased approximately 2.9-fold over an 11-year period from 2008–2018.² Many patients who rely on life-support devices receive visiting nursing services under physician supervision. However, for the majority of the time spent at home, patients or their family members must perform the operation and maintenance of this equipment.^3,4 Inadequate operation or maintenance under these circumstances poses a significant risk to patient safety.⁵ In Japan, device-related errors accounted for 0.3% of 1937 adverse events reported during visiting nursing services in 2020.⁶ In the United Kingdom, of 606 incidents related to home infusion therapy devices reported from 2005–2015, 278 were identified as device malfunctions.⁷ Consequently, effective management of home medical equipment is crucial.

Typically, patients acquire life-support devices through medical institutions, which enter into contractual agreements with medical equipment vendors or manufacturers for equipment management. These agreements enable patients to access necessary devices, whereas manufacturers assume responsibility for maintenance, consumable supply, and troubleshooting of malfunctions. However, manufacturers are not licensed to perform medical procedures and are therefore unable to provide support that impacts the patient’s health status. However, when patients or their families lack sufficient knowledge or skills to manage the equipment safely, visiting nurses provide support. In many countries, visiting nurses cater to patients, operate, and troubleshoot equipment malfunctions.^7–10 However, visiting nurses are not equipment specialists. In home care settings, the type of equipment used by each patient varies according to the treatment policies of the attending physician, medical institution, and home care environment. Consequently, visiting nurses may face challenges in managing operations and malfunctions of all equipment types. Approaches to home medical equipment malfunction vary by country. In the United States, malfunctions are primarily addressed by durable medical equipment companies, with medical teams intervening via telehealth for complex settings adjustments.¹¹ In the United Kingdom and other European countries, external companies are responsible for inspections and repairs, while a team of healthcare professionals coordinates service requests to external companies and manages patient care.¹² In Japan, by contrast, visiting nurses and manufacturers are involved in equipment use. However, the relationship between equipment malfunctions and management practices at visiting nursing stations (stations) remains unclear.

In Japanese hospitals, clinical engineers (CEs) operate and maintain medical equipment. Under the direction of physicians, CEs perform operational and management tasks related to respiratory therapy, cardiopulmonary bypass, and blood purification therapy, collaborating closely with multidisciplinary teams. CEs support patient treatment through equipment management, ensuring that physicians and nurses can use equipment safely and effectively. Equipment management by CEs contributes to enhanced patient safety and improved quality of medical care.^13–16 Professions with roles similar to those of CEs exist in other countries. For example, in the United States, professionals such as biomedical equipment technicians specialize in the maintenance and repair of equipment, fulfilling responsibilities comparable with those of Japanese manufacturers. In Japan, tasks such as respiratory therapy that are performed by CEs are typically managed by specialized professionals, such as respiratory therapists, perfusionists, and hemodialysis technicians, with responsibilities clearly delineated by profession. Therefore, despite the similarities in the equipment management systems between Japan and the United States, notable differences exist in the allocation of roles. A distinctive feature of Japanese CEs is their capacity to manage a wide spectrum of medical equipment-related tasks.

The Japanese government is actively promoting the enhancement of multidisciplinary collaboration, aiming to establish a community-based integrated care system that transcends the various facilities and domains involved in home care.¹⁷ Currently, the activities of CEs are primarily confined to hospital settings.¹⁸ However, expanding the scope of activity to include home care, promoting collaboration in equipment management between hospitals and home care providers, and supporting patients through coordinated efforts with visiting nurses and other professionals are essential. Under the medical reimbursement system in Japan, visiting nurses can obtain reimbursement by providing regular management and guidance to patients using medical devices, where the fee is determined according to the type of device. However, CE activities in home care are not currently recognized under medical reimbursement schemes. This is particularly significant for patients who rely on life-support home medical equipment, where effective collaboration between visiting nurses—who deliver direct patient care—and CEs—who provide technical expertise—contributes to patient safety and quality of life at home. Therefore, by elucidating the perceived necessity of CEs within home care settings, we could better define the role of CEs in home care. However, no study has clarified the malfunctions occurring in home medical care in Japan, the relationship between equipment malfunctions and management practices at stations, or the perceived necessity of CE involvement in this setting.

Accordingly, this study aims to elucidate the relationship between equipment malfunctions and management practices at stations, as well as to assess the perceived necessity of CEs.

Methods

Participants

To clarify the nationwide situation in Japan, the target population for this study comprised 15,562 stations across all 47 prefectures as of 2024. Using the information publication system for long-term care services,¹⁹ 500 stations were selected through stratified random sampling. The sample size was determined based on an anticipated response rate of 20%. Survey respondents were the administrators of each selected station.

To analyze the relationship between home medical equipment malfunctions and management status, we calculated the sample size using G*Power 3.1. For the two groups—device malfunction and management status—parameters were set as follows: effect size ω = 0.3 for the χ² test, α err prob = 0.05, power (1 − β = 0.8, and DF = 1). The required total sample size was calculated to be 88.

Data Collection

A request for research participation and an anonymous, self-administered questionnaire were mailed to selected stations. The completed questionnaires were returned in dedicated anonymous envelopes. The return of a completed questionnaire was considered as implied consent to participate in the study. A preliminary survey was conducted with 11 visiting nurses to develop the survey items.

Operational Definitions

Device management in this study was defined in accordance with Article 1–11-3 of the Enforcement Regulations of the Medical Care Act in Japan.²⁰ This includes the implementation of education for safe and proper use, prevention of malfunctions, information management and collection, as well as maintenance and inspection activities. Device malfunction was defined as a condition in which the device is unable to perform its intended function owing to damage, failure, malfunction, or operational issues. Device anomalies refer to failures attributable to the equipment itself, including mechanical failure, component deterioration, or software errors. Human error refers to operational mistakes made by users, such as incorrect assembly, improper settings, or failure to follow operating procedures. In Japan, regular maintenance and inspection of medical devices is conducted annually. Therefore, the recall period for malfunction reporting covered malfunctions experienced during home visits within Japanese fiscal year 2023.

Measurements

Attributes and Recognition of CE Expertise

Several factors, including gender, age, years of experience as a visiting nurse and administrator, hospital work experience, experience collaborating with CEs, and awareness of CE expertise, were considered.

Station Overview and Device Management Status

The number of full-time nurses, hospital affiliations, and the registration of medical devices in management ledgers (pulse oximeters, medical electronic blood pressure monitors, electric suction units, and electronic thermometers). Additionally, we evaluated the development of operation manuals, implementation of training programs, designation of equipment educators, collection of safety information, recognition of the need for maintenance, and assignment of personnel responsible for device maintenance.

Occurrence of Device Malfunctions

Devices investigated for malfunctions were based on safety management concerns in home medical care, as highlighted in the National Research Council report.²¹ This report emphasizes that, although the use of home medical equipment is becoming widespread, malfunctions pose significant risks to patient life support.²¹ Accordingly, this study focused on six high-risk devices: infusion pumps, syringe pumps, electric suction units, oxygen concentrators, non-invasive positive pressure ventilation (NPPV), and tracheostomy positive pressure ventilation (TPPV). For each device, we investigated the occurrence of malfunctions, the nature and cause of these events, and the personnel involved in responding to them.

Collaboration with CEs at the Station

We evaluated the availability of CEs who can accompany home visits, respond to device malfunctions, and the perceived necessity of CE involvement in home medical care. Furthermore, we identified specific tasks that the station would like to request from CEs.

Survey Period

The survey was administered between September and October 2024.

Statistical Analysis

To examine the association between malfunctions of six device types and management practices, we employed the χ² test or Fisher’s exact test, as appropriate. Statistical analyses were conducted using SPSS Statistics ver. 23, with a significance level of 5%.

Ethical Considerations

This study was approved by the Medical Ethics Committee of Kanazawa University (No. 979–2). Participation was voluntary, and this was clearly communicated in the research invitation.

Results

Responses were obtained from 91 of the 500 stations, yielding a response rate of 18.2%. After excluding 15 stations with substantial missing data, 76 stations were included in the final analysis (valid response rate: 83.5%).

Demographics and Awareness of CEs

Among respondents, 90.8% were female. By age, 40.8% were in their 50s, and 34.2% were in their 40s. The average years of experience were 9.8 as a visiting nurse and 4.7 as an administrator. Nearly all respondents (98.7%) had prior hospital work experience (Table 1).

Table 1 Subject attributes and collaboration/ awareness of CE expertise

Regarding CEs, 55.3% of visiting nurses reported experience collaborating with CEs, and 97.4% acknowledged their expertise (Table 1).

Station Overview and Equipment Management

The average number of full-time nurses per station was 5.2. Hospital-affiliated stations comprised 28.9% of the total stations (Table 2).

Table 2 Overview of stations and equipment management practices

In terms of device management practices, 57.9% of the stations did not register devices in a management ledger. Furthermore, 73.7% had not developed operation manuals, and 64.5% did not conduct device training. Responsibility for device education was assigned to managers in 44.1% of stations, manufacturers in 32.3%, station colleagues in 20.4%, and CEs at 3.2%. In terms of safety, 53.9% of stations did not collect safety-related information. Although 94.7% recognized the importance of device maintenance, 56.0% were visiting nurses, 37.6% were manufacturers, and 6.4% were CEs (Table 2).

Status of Device Malfunctions

Infusion Pump

Malfunctions involving infusion pumps were reported at 27 stations (Table 3).

Table 3 Malfunctions of infusion and syringe pumps

The reported event was persistent alarms (13 cases). Device abnormality was identified as the primary cause in 20 cases, followed by human error by the user in 9 cases. Visiting nurses responded to 16 of these incidents (Table 3).

Syringe Pump

Syringe pump malfunctions occurred at 20 stations (Table 3).

Persistent alarms were reported in 14 cases. Device abnormality was identified as the primary cause in 18 cases, followed by human error by the user in 5 cases. Visiting nurses responded in 18 instances (Table 3).

Respiratory-Related Equipment

Electric Suction Unit

Malfunctions with electric suction unit were reported at 25 stations (Table 4).

Table 4 Malfunctions of respiratory-related equipment

Low or no suction pressures were reported in 21 cases. Device abnormality was identified as the primary cause in 20 cases, followed by human error by the user in 4 cases. Visiting nurses responded in 19 cases (Table 4).

Oxygen Concentrator

Oxygen concentrator malfunctions occurred at 20 stations, with persistent alarms reported in 10 cases. Device abnormality was identified as the primary cause in 18 cases, followed by human error by the user in 8 cases. Visiting nurses responded in 16 cases (Table 4).

NPPV

NPPV malfunctions were reported at 19 stations (Table 4).

The reported events included circuit leaks or damage in nine cases, poor mask fit in nine cases, persistent alarms in two cases, and assembly errors in two cases. Device abnormality was identified as the primary cause in 14 cases, followed by human error by the user in 5 cases. Visiting nurses responded in 12 cases, whereas manufacturers responded in 11 cases (Table 4).

TPPV

Malfunctions involving TPPV were reported at eight stations (Table 4).

The specific issues included persistent alarms in four cases, circuit leaks or damage in three cases, and power failures in three cases. Device abnormality was identified as the primary cause in 6 cases, followed by human error by the user in 2 cases. The manufacturer was the primary responder in four cases (Table 4).

Association Between Infusion/Syringe Pump Malfunctions and Management Status

Stations experiencing infusion pump malfunctions had a significantly higher proportion of hospital affiliation compared with those without malfunctions (χ² = 4.890, p = 0.027, ω = 0.254, 1 − β = 0.600) (Table 5).

Table 5 Association between Malfunctions of Infusion and Syringe Pumps with Management Practice

Regarding syringe pumps, stations that had developed operation manuals were significantly more likely to report malfunctions than those without such manuals (χ² = 7.852, p = 0.005, ω = 0.321, 1 − β = 0.799). Additionally, stations that collected safety information had a higher incidence of syringe malfunctions (χ² = 3.922, p = 0.048, ω = 0.227, 1 − β = 0.508) (Table 5).

Association Between Respiratory-Related Equipment Malfunctions and Management Status

No significant associations were observed between the occurrence of malfunctions and management status for the four types of respiratory-related equipment evaluated (Table 6).

Table 6 Association between Malfunctions of Respiratory-related Equipment and Management Practices

Collaboration with CEs and Perceived Necessity at Stations

Only 2.6% of stations had a CE available to accompany the visiting nurses. The percentage of stations with CEs available to respond at the time of a malfunction was 21.1%. However, 81.6% of stations recognized the necessity of CE involvement in home medical care (Table 7). The most frequently requested tasks for CEs included providing instruction and education on device usage (54 stations), maintenance execution (53 stations), and response to device malfunctions (53 stations).

Table 7 Collaboration status with CEs and their necessity in stations

Discussion

Prevention and Response to Malfunctions of Home Medical Equipment

Infusion Pump

Malfunctions were identified at 27 stations, with the most prevalent issue being incessant alarms, primarily attributed to equipment failure. In 2006, the National Institute for Public Health and the Environment in the Netherlands reviewed the technical documentation of 19 infusion pump models provided by manufacturers and identified 17 technical defects,²² all of which were indicative of equipment failure. These findings are consistent with the causes of malfunctions observed in home clinical settings in the present study, underscoring the need to enhance management strategies to prevent equipment anomalies.

Visiting nurses served as the primary responders to these malfunctions. Notably, incessant alarms can result not only from equipment failure but also from human errors, such as improper attachment of the infusion route or incomplete fixation of the door lock lever. Visiting nurses must identify the causes of malfunctions in collaboration with manufacturers.

Malfunctions were more frequent at hospital-affiliated stations compared with non-affiliated ones. Patients at hospital-affiliated stations were generally considered to have higher medical dependency, which may necessitate the use of different equipment models. However, this study did not investigate patient conditions and specific models, highlighting the need for further research in these areas.

Syringe Pump

Malfunctions were identified at 20 stations, with incessant alarms—again primarily resulting from equipment failure—being the most common issue, similar to those observed with infusion pumps. Few studies have investigated the malfunction of syringe pumps in home or hospital settings. In the UK, a 10-y investigation beginning in 2005 examined malfunctions of all infusion devices used at home; however, data specific to syringe pump malfunctions remain limited.⁷ A report from a hospital in Hong Kong documented wire breakage in the syringe size sensor of a syringe pump model used for inpatients,²³ further illustrating that component failures in syringe pumps can occur in home clinical settings.

Visiting nurses served as the primary respondents. The causes of incessant alarms included not only equipment malfunctions but also human errors, such as incorrect syringe settings or improper plunger installation. As with infusion pumps, visiting nurses need to identify the cause of malfunction in collaboration with the manufacturer.

Stations that experienced equipment malfunctions were more likely to have developed operational manuals compared with those without such incidents. This suggests that the occurrence of malfunctions may have prompted these stations to recognize the importance of standardizing equipment usage, resulting in the creation of manuals. Alternatively, the availability of an operational manual may have enabled stations to detect device problems at an earlier stage. However, the effectiveness of these manuals remains uncertain, and a thorough review of their content is warranted.

Similarly, stations with a history of malfunctions were also more likely to collect safety information. The experience of equipment failures may have motivated these stations to collect safety information from manufacturers and other sources. Alternatively, the availability of safety information may have enabled stations to detect device problems at an earlier stage. However, the effectiveness of this practice is unclear, and further consideration should be given to effective methods for sharing and utilizing safety information.

Respiratory-Related Equipment

Electric Suction Unit

Malfunctions were reported at 25 stations, with the primary issues being low suction pressure or inability to suction, primarily caused by equipment failure. An analysis of inspection data from 9631 units across 14 models used in home care settings in the US in 2008 and 2009 identified 233 malfunctions in which the suction pressure did not meet required standards. The most frequently reported causes were battery failure (126 cases) and switch failure (73 cases), both indicative of equipment failure.²⁴ The causes of malfunctions observed in this study were consistent with these findings.

Furthermore, low or no suction pressure could result from factors unrelated to equipment failure. Physical conditions, such as the consistency or moisture of airway secretions, can also contribute to reduced suction effectiveness. Human errors, including improper assembly of the suction bottle or a malfunctioning float, are also potential contributors. These factors may occur in combination with each other. Visiting nurses were the primary respondents. Inadequate suction pressure can increase patient discomfort and elevate the risk of complications. Therefore, visiting nurses must promptly identify the complex causes in actual clinical practice.

Oxygen Concentrator

Malfunctions were identified at 20 stations, with incessant alarms being the most common issue, primarily attributed to equipment failure. A 2010 study in Turkey surveyed 200 patients using oxygen concentrators at home and observed anomalies in the equipment of 44 patients, necessitating the replacement of compressors and filters.²⁵ Similarly, in the present study, equipment failure was a frequent cause of malfunction, highlighting the importance of daily management.

Visiting nurses served as the primary respondents. The causes of incessant alarms are multifactorial and may be influenced by the patient’s respiratory status, activity levels, and indoor environments, in addition to equipment-related issues. Moreover, because patients and families are responsible for the day-to-day management of oxygen concentrators, human errors—such as blocked intake or exhaust ports and clogged intake filters—are prone to occur. These malfunctions can adversely affect patient outcomes and require prompt resolution. However, the limited duration of home visits can make it challenging for visiting nurses to thoroughly investigate and resolve the underlying causes. Therefore, collaboration with equipment manufacturers is essential to ensure the timely identification and resolution of malfunctions.

NPPV

Malfunctions were identified at 19 stations, with issues including respiratory circuit leaks or damage, poor mask fit, incessant alarms, and incorrect circuit assemblies. The primary cause was equipment failure. A 2006 UK study analyzed 188 malfunctions among 1199 patients using home NPPV over six months, reporting 52 cases of ventilator malfunction and 43 technical issues, highlighting the prevalence of equipment-related failures.²⁶ Although NPPV performance has evolved over the past 18 y, effective management to prevent equipment failure remains crucial.

In the UK, external services and maintenance companies typically address malfunctions in home NPPV settings, and a system is in place to connect patients with a respiratory support team, including nursing staff, when necessary.²⁶ In this study, respondents included visiting nurses and manufacturers; however, the presence of an organized response system was not validated. NPPV malfunctions can pose life-threatening risks, with causes stemming not only from equipment failure but also from changes in the patient’s physical or mental status, environmental factors, and human error—such as poor mask fit or incorrect circuit assembly—which may trigger low airway pressure or circuit leak alarms. Manufacturers cannot intervene in clinical tasks, such as mask adjustment or circuit replacement. However, CEs can provide support for both equipment failures and safety assurance related to medical procedures. Therefore, establishing a response system that enables a specialized team, including CEs, visiting nurses, and manufacturers, to operate during NPPV malfunctions is essential.

TPPV

Malfunctions were identified at eight stations, with issues including incessant alarms, respiratory circuit leaks or damage, and power failures. The primary cause was equipment failure. A 1991 US study analyzed 189 malfunctions across four ventilator models used by 150 home TPPV patients over 1 y, finding that defective equipment or mechanical failure accounted for 73 cases.²⁷ In this study, equipment failure also emerged as a frequent cause. Although the performance of TPPV devices has improved over the past 33 y, the underlying causes of malfunctions remained consistent. Given that TPPV malfunctions are directly linked to life support, preventing equipment failure and ensuring a prompt response when issues arise are essential.

Manufacturers were the primary respondents during malfunctions. Therefore, the incessant alarms may not have been solely attributable to equipment failure. The underlying cause could not be identified in relation to changes in systemic conditions, including respiratory symptoms. Consequently, establishing a specialized team, including CE personnel, is essential. A robust system must be implemented to ensure daily equipment management and facilitate prompt collaboration during malfunctions.

Among the four types of respiratory equipment evaluated, no correlation was observed between malfunction occurrence and management status. Therefore, the management practices conducted at each station require further validation.

Collaboration Between Stations and CEs

Of the visiting nurses surveyed, 98.7% had prior hospital work experience, whereas 55.3% had experience collaborating with CEs. Additionally, 97.4% of participants recognized the expertise of CEs. Although relatively few visiting nurses have collaborated with CEs in the home care setting, their previous hospital experience may have provided opportunities to appreciate the value of CE expertise.

Stations with CEs available to accompany nurses accounted for 2.6% of the total. According to the Japan Association of Clinical Engineers, 2.1% of 1337 CEs performed home-care-related tasks,¹⁸ indicating nearly identical percentages. However, 21.1% of stations reported having a CE available to respond to device malfunctions. However, the actual CE intervention was validated in only a few cases: one infusion pump, one syringe pump, and two NPPV. Notably, no CE response was observed for TPPV malfunctions in this study. For TPPV in particular, preventing malfunctions and ensuring prompt identification and resolution of issues are crucial. Therefore, the construction of a system that enables collaboration with the CE was deemed necessary.

A significant majority (81.6%) of stations recognized the necessity of CE involvement in home medical care. The primary tasks that stations wished to request from CEs included instruction and education on device usage, implementation of maintenance and inspections, and response to device malfunctions. These findings demonstrate a clear demand for collaboration with CEs and elucidate the roles expected of CEs in the context of home medical care.

Hospital-affiliated stations are located within or near the hospital premises, providing an environment conducive to collaboration with hospital staff. If a collaborative system with hospital-employed CEs can be established, the scope of CE activities could expand from hospitals to home medical care. Furthermore, such systems are expected to facilitate collaboration with CEs even in non-hospital-affiliated stations. Establishing a robust collaboration framework between CEs and stations that support the lives and health of patients using medical devices is essential to ensuring patient safety.

Clinical Implications

This study identified key management system issues associated with six types of home medical devices. Addressing these challenges is expected to contribute to the overall improvement of device management systems across all equipment overseen by the station.

For the management of malfunctions related to NPPV and TPPV among the six types of home medical devices, this study proposes that visiting nurses, manufacturers, and CEs collaborate to ensure safety in malfunction management and medical procedures. For the management of malfunctions involving infusion pumps, syringe pumps, electric suction units, and oxygen concentrators, visiting nurses and manufacturers should continue to respond as usual (Figure 1).

Figure 1 Proposed collaborative framework between visiting nurses, manufacturers, and Clinical engineers for managing the malfunctions of six types of home medical equipment. Solid lines indicate the collaborating professionals involved in malfunction response for NPPV and TPPV. Dotted lines indicate those for infusion pumps, syringe pumps, electric suction units, and oxygen concentrators. Abbreviations: NPPV, noninvasive positive pressure ventilation; TPPV, tracheostomy positive pressure ventilation.

Limitations and Future Issues

The survey response rate was 18.2%, which provided a final sample size of 76. Therefore, the required sample size of 88 for the initial calculation was not satisfied. This weakens the confidence in significant associations. The patient disease severity, medical device usage status, device model, and service life may have influenced the association between equipment malfunctions and management practices. Therefore, future research should analyze the results of this study after adjusting for these confounding factors. The repeated testing across six medical devices may have increased the possibility of Type-I errors. Station administrators with a particular interest in device management or CEs may have been more inclined to participate, raising the possibility of response bias and self-selection bias. Data on device malfunctions and management practices were based on the self-reported evaluations by station administrators. However, objective assessments of device malfunctions and management status were not conducted. Additionally, the statistical power for analyses examining the association between infusion pump malfunctions and hospital affiliation, as well as between syringe pump malfunctions and the availability of operation manuals and safety information, was below 0.80. Therefore, these results should be considered preliminary. Future research with larger sample sizes is warranted to validate these associations.

Conclusions

We investigated device malfunctions among home care patients utilizing infusion pumps, syringe pumps, and respiratory care equipment. The findings revealed that device failure accounted for over half of all reported malfunctions. In the majority of cases, issues were addressed either by visiting nurses or manufacturers. Significant associations were observed between infusion pump malfunctions and whether the station was affiliated with a hospital. Similarly, a significant relationship was found between syringe pump malfunctions and the availability of operational manuals and safety information. Furthermore, over half of the stations recognized the importance of CEs in home care settings. However, these findings should be interpreted with caution given the low response rate, the limited statistical power of the analyses, and the cross-sectional study design. These results underscore the necessity of establishing a collaborative framework between stations and CEs to enhance patient safety.