research articles about medical technology

• Research article
• Open access
• Published: 26 February 2018

The use of advanced medical technologies at home: a systematic review of the literature

• Ingrid ten Haken 1 ,
• Somaya Ben Allouch 1 &
• Wim H. van Harten 2 , 3  

BMC Public Health volume  18 , Article number:  284 ( 2018 ) Cite this article

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The number of medical technologies used in home settings has increased substantially over the last 10–15 years. In order to manage their use and to guarantee quality and safety, data on usage trends and practical experiences are important. This paper presents a literature review on types, trends and experiences with the use of advanced medical technologies at home.

The study focused on advanced medical technologies that are part of the technical nursing process and ‘hands on’ processes by nurses, excluding information technology such as domotica. The systematic review of literature was performed by searching the databases MEDLINE, Scopus and Cinahl. We included papers from 2000 to 2015 and selected articles containing empirical material.

The review identified 87 relevant articles, 62% was published in the period 2011–2015. Of the included studies, 45% considered devices for respiratory support, 39% devices for dialysis and 29% devices for oxygen therapy. Most research has been conducted on the topic ‘user experiences’ (36%), mainly regarding patients or informal caregivers. Results show that nurses have a key role in supporting patients and family caregivers in the process of homecare with advanced medical technologies and in providing information for, and as a member of multi-disciplinary teams. However, relatively low numbers of articles were found studying nurses perspective.

Conclusions

Research on medical technologies used at home has increased considerably until 2015. Much is already known on topics, such as user experiences; safety, risks, incidents and complications; and design and technological development. We also identified a lack of research exploring the views of nurses with regard to medical technologies for homecare, such as user experiences of nurses with different technologies, training, instruction and education of nurses and human factors by nurses in risk management and patient safety.

Peer Review reports

As a result of demographic changes and the rapidly increasing number of older patients, there is a need for cost savings and health reforms, which include an increased move from inpatient to outpatient care in most industrialized countries over the last 10–15 years [ 1 , 2 ]. As a consequence, the transfer of advanced medical devices into home settings was considerable and it is expected that there will be a further increase in the near future [ 1 , 2 , 3 , 4 , 5 , 6 , 7 ].

When ‘an increase’ in the number of medical technologies used at home is mentioned, it is not clear which and how many technologies are involved. Today, there are an estimated 500,000 different kinds and types of medical devices available on the world market [ 8 , 9 ]. The European Commission (EC) publishes data regarding legislation and regulations for medical devices, but the actual figures for medical technologies in outpatient practice are not available [ 10 ]. The U.S. National Center for Health Statistics (NCHS) stated that technologies have shifted from hospitals into the home, but it too does not illustrate its findings with statistics [ 11 ]. We searched for data with regard to the actual number of medical technologies used in home settings and it proved difficult to find any systematic data sets available throughout the international landscape.

An important condition for the application of medical technology in the home setting is that quality of care and patient safety must be guaranteed [ 6 ]. From a historical perspective medical technologies were designed for hospital settings [ 12 , 13 ]. This means that specific factors regarding the implementation and use at home now need to be taken into account [ 7 , 14 , 15 ]. In general, risks with medical technologies can be classified regarding (a) environmental factors; (b) human factors and (c) technological factors [ 16 ]. Human factors, however, are very important in patient safety in both hospital and in home settings [ 1 , 6 , 12 ]. For example, a major risk factor is the number of users and handovers in the chain of care. In home settings, a sometimes impressive number of different users of medical technology, often with various levels of training, instruction or education, are involved. Although patient empowerment moves control to the patient and/or relatives, an important user group is that of professional nurses. Understanding user experiences and information about adverse events and near incidents are important aspects for developing knowledge regarding implementation and use in home care setting. Sharing this knowledge can support patients and caregivers, and especially nurses in their professional work and will also contribute to patient safety and quality of care.

Therefore, there is a need to address the question first, which types of technologies are used at home; second, how frequently are they used and third, what trends can be distinguished. Additional research questions are whether there are any scientific data regarding particular user experiences; training, instruction and education; safety and risks, and finally, what can be concluded about the role of nurses in using medical technologies in the home environment. The objective of this paper therefore is to present a systematic literature search on the international state of art concerning various aspects of the use of advanced medical technologies at home.

Definitions

First, we want to clarify some definitions. In general, ‘health technology’ refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life [ 17 ]. The World Health Organization [ 8 ] uses the definition of ‘medical device’ as ‘An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose …….’. A specification for a home use medical device is: ‘A medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes’ [ 18 ].

The landscape of medical devices is diverse with technologies varying from relatively simple to very complex devices. Wagner et al. [ 19 ] stated that ‘high-tech dependency’ (for children) matches with ‘technology-dependency’ if it concerns ‘a medical device to compensate for the loss of a vital bodily function and substantial and ongoing nursing care to avert death or further disability’. ‘The needs of these patients may vary from the continuous assistance of a device and highly trained caretaker to less frequent treatment and intermittent nursing care’ [ 20 ]. Although patients dependent of advanced medical technologies at home are often medically stable, they sometimes have high technical needs and may be expected to need long-term recovery. They also require skilled nursing [ 21 ] and a considerable degree of advanced decision making, planning, training and oversight [ 22 ]. An overall definition of ‘advanced medical technology’ is: ‘Medical devices and software systems that are complex, provide critical patient data, or that directly implement pharmacologic or life-support processes whereby inadvertent misuse or use error could present a known probability of patient harm’ [ 23 ]. Examples of advanced medical technologies used at home include ventilators for respiratory support, systems for haemo- or peritoneal dialysis and infusion pumps to provide nutrition or medication.

In the Netherlands, the National Institute for Public Health and the Environment (RIVM) [ 24 ] uses the following definition:

Advanced medical technology or high-tech technology in the home setting is defined as technology that is part of the technical skills in nursing and meets the following conditions:

technology that is advanced or high-tech, for example equipment with a plug, an on/off switch, an alarm button and a pause button;

technology that had been applied formerly only in hospital care, but that is now also often applied in home settings;

technology that can be categorized as ‘supporting physiological functions’, ‘administration’ or ‘monitoring’.

Within the Dutch classification of advanced medical technologies 19 different devices are identified (see Table  1 ), which will be used in this review as a basis to categorize the technologies. It is a classification format in which specific advanced technologies are defined. Terms as ‘advanced medical technology’ (from now on abbreviated as AMT) will be used consistently as synonyms for ‘complex medical technology’ and ‘high-tech medical technology’. The term ‘technology’ will be used in the meaning of ‘device’ or ‘equipment’. The target is on technologies that are instrumental and ‘hands on’ use by nurses in the care for patients. This means that information technology (IT) based technologies as domotica (automation for a home) are not part of the study.

Eligibility and search strategy

The systematic review of the literature was conducted early 2016. Key concepts for the review were ‘medical technologies’ or ‘medical devices’, and ‘home settings’. The concept of ‘home settings’ is related to the terms ‘home nursing’ and ‘home care service’, of which the stem is ‘home’. Combining the key concepts provided the search string: (‘medical technology’ OR ‘medical device’). As domotica is not part of the study, the search string was extended with: AND NOT (eHealth OR telecare OR telemedicine). The exact search string is (“medical technology” OR “medical devices”) AND home AND NOT (ehealth OR telecare OR telemedicine). Online databases MEDLINE, Scopus and Cinahl were searched electronically using the search string to obtain data.

Inclusion and exclusion criteria

Criteria for selection were defined prior to the search process. General criteria for inclusion were:

Year of publication: 2000–2015.

An abstract or an article (with or without abstract) has to be available, containing reference to AMT information.

The article is published in English, German, French or Dutch/Flemish language.

If medical technology is cited, it has to conform to the definition of ‘advanced medical technology’ [ 24 ].

The abstract or the article has to contain empirical material. For the purpose of this review, ‘empirical material’ has been defined as: AMT which is designed for the home setting, or where the design or choices took into account the setting of the home, or where the medical technology has been tested for the home or if the medical technology is already on the market and being used in the home setting.

For further selection, inclusion criteria related to the key concepts for title and abstract were applied, such as ‘advanced medical technology’, ‘high-tech medical technology’, ‘home-centred health-enabling technology’ and ‘care at home’. The classification of the RIVM (see Table 1 ) has been taken as a basis to categorize technologies in this review. Domotica and telemonitoring technologies scored under ‘monitoring’, such as fetal cardiotocography, and respiratory and circulatory monitoring, were left out. If the abstract or article was about electronic health records, ‘smart home’, ambient intelligence, pervasive computing, software of devices, smartphone or surgical robots, the article was also removed from selection. Technologies as ‘VAD (ventricular assist device)’, ‘dental devices’ and ‘AED (automatic external defibrillator)’ were not seen as part of the technical nursing process and these records were left out as well. Studies conducted in the hospital, hospice or nursing home settings were also excluded. An overview of all inclusion and exclusion criteria can be found in Table  2 .

Screening process

The search in the online databases using the search string, identified a total of 1287 references. After checking for duplicates, 1070 articles remained. Those articles were reviewed by a reviewer for titles and abstracts on basis of the inclusion and exclusion criteria. A double check was performed by two reviewers, who independently screened random samples of 20% of the articles. There was an initial agreement of 88%. In case of disagreement about the inclusion of an article, the decision was based on a joint discussion by all three reviewers to an agreement of 100% and the resulting screening policy was applied to the rest of the abstracts. Based on the selected titles and/or abstracts, articles were retrieved or requested in full text and assessed for eligibility. Some articles were excluded from further study, for reasons of ‘full text not available’ or the article contained no empirical material. Finally, 87 studies remained which were included in the analysis (see Table  3 ). A graphical representation of the screening process has been included in Fig.  1 .

PRISMA flowchart

Appraisal of selected studies

To conduct the systematic literature search on the international state of art concerning various aspects of the use of advanced medical technologies at home, several sources are consulted. To guarantee a scientific standard, only articles were retrieved from academic databases. MEDLINE refers to journals for biomedical literature from around the world; Cinahl contains an index of nursing and research journals covering nursing, biomedicine, health sciences librarianship, alternative medicine, allied health and more. These databases related to discipline have been supplemented with Scopus, which is considered to be the largest abstract and citation database of peer-reviewed literature. Grey literature, such as national and international reports on regulations and safety of medical technologies, is also used to illustrate the background of the problem statement and describe definitions. The Classification of advanced medical technologies in the Netherlands according to the National Institute for Public Health and the Environment (RIVM) has been used as a framework to categorise the medical technologies in the selected articles. No methodological conditions of selected studies were applied in advance and the quality criterion we applied was that of the article had to contain empirical material, as we wanted to obtain an comprehensive overview of published studies of any design and to get insight in a variety of contents.

Categorization of included articles

The characteristics of the included articles are outlined in Table  3 . All included articles were categorized by year of publication and the type of research, like the designs, methods and used instruments in the studies. Research features were synthesized where possible into overarching categories. For example, ‘systematic review’ and ‘narrative review’ were scored as ‘review’ and instruments as ‘semi-structured interview’ and ‘in-depth individual interview’ were both assigned to the category ‘interview’.

For each study, the medical technology or technologies on which the study was based was scored. The categorization was in accordance with the classification of AMTs (see Table 1 ). For example, the devices ‘continuous positive airway pressure (CPAP)’ and ‘negative pressure ventilation (NPV) have both been categorized as ‘respiratory support’; and the devices ‘jejeunostomy tube’ and ‘gastronomy tube’ as ‘enteral nutrition’. With regard to the category ‘dialysis’, further subdivision was made by using ‘haemo dialysis’ and ‘peritoneal dialysis’. If in an article a medical technology was mentioned as an example, but was no subject of study, then the technology was not scored.

‘Medical diagnosis (or diagnoses)’ as mentioned in the studies, was included in the analysis only if it was related to the medical technology as the subject of study, not if it has been mentioned as an example. In some cases, an underlying cause of diagnosis was indicated. For example, ‘chronic respiratory failure due to congenital myopathy’, in itself a neurological disorder, has been scored as ‘neurological disorder’. Diseases or disorders have been classified as much as possible under the overarching name. For example ‘pneumonia’ and ‘cystic fibrosis’ are categorized under ‘respiratory failure’, and ‘gastroparesis’ and ‘Crohns disease’ under ‘gastrointestinal disorder’. The category ‘other’ contains diagnoses which occur only once, such as ‘chromosomal anomaly’, or which are not yet determined, like ‘chronic diseases’ or ‘congenital abnormalities’.

In relation to the research questions, articles were classified regarding one of the following categories and, where appropriate, into subcategories:

User experiences

Training, instruction and education, safety, risks, incidents and complications.

From an analysis of the articles, additional categories of content emerged:

Design and technological development

Application with regard to certain diseases or disorders, indication for and extent of use

Policy and management

Types of medical technologies used, frequency of use and trends.

In four of the 87 articles (5%) there were no specific medical technologies mentioned as a subject of study (see Table  4 ). Almost half of the studies (45%) considered medical technologies for respiratory support and 39% devices for dialysis, either haemo- ( n  = 18), peritoneal- ( n  = 15) or dialysis not specified ( n  = 1). Of the studies, 29% reported on devices for oxygen therapy. In addition, there has been relatively more research conducted on equipment for ‘infusion therapy’ ( n  = 19; 22%), parenteral nutrition and enteral nutrition with a score of 20% each ( n  = 17). Relatively little research has been carried out on suction devices (8%), external electrostimulation (5%), nebulizer (5%), insulin pump therapy (3%), sleep apnea treatment (2%), patient lifting hoists (2%), vacuum assisted wound closure (1%) and continuous passive motion (1%). None of de studies considered medical technologies with regard to decubitus treatment, skeletal traction or UV (ultraviolet) therapy.

Table 4 shows that on the years 2000 and 2001 no relevant articles on the subject were found. Over the period 2000–2005, 17 articles were published, the same number over 2006–2010, and there has been a substantial increase in the number of publications to 54 over the years 2011–2015. In general, it can be concluded that more frequent investigated technologies show a fairly even distribution of publications over the years 2000–2015. Technologies, on which little research had been done, except for nebulizers, have been mainly investigated since 2010. An increase of published articles over the years 2000–2015 is apparent particularly for haemo dialysis and to a lesser extent, for devices for enteral- and parenteral nutrition. As mentioned before, several studies reported on the increase of the number of medical technologies used in home settings, but concrete data are not available. However, the number of studies and the visible trends may be indicative of the frequency of use.

In 63% of the cases ( n  = 55), a medical diagnosis (or diagnoses) was mentioned in the article. Where a diagnosis has been mentioned, in almost half of the studies ( n  = 26; 47%) it concerned diagnoses in the field of respiratory failure (see Fig.  2 ). This is not surprising, since ‘respiratory support’ is the medical technology most commonly found in the articles, similarly ‘oxygen therapy’ has also been considered relatively often. Diagnoses with regard to neurological disorders occurred in 42% of the studies ( n  = 23). Just over a quarter of the studies (27%) considered diagnoses ‘other’, such as ‘sepsis’, ‘chromosomal anomaly’ or other not specified medical disorders, nearly a quarter (24%) considered ‘cancer’ and 22% kidney disorders ( n =  12).

Number of medical diagnoses mentioned in articles on AMTs ( n  = 87, multiple answers possible)

An analysis of the used research designs identified that 64% ( n  = 56) of the studies used an observational (non-experimental) design and only a small part of the studies ( n  = 5; 6%) used an experimental design, such as a Randomized Control Trial (RCT). Of the included studies 19 were reviews and 8 were essays. A quantitative design ( n  = 37) was used more frequently than a qualitative design ( n  = 25); and only one study applied ‘mixed methods’ (quantitative and qualitative). Just over one-third of the studies (35%) used a descriptive design, and a similar number used a cross-sectional study (36%). Case series were used in 12% of the articles and a cohort-study in 9%. A phenomenological approach was applied in 16% of the records. Research instruments most frequently used were interviews (33%) and survey/questionnaires (21%). In 10% of the cases other instruments were used, including different types of assessments or tests.

With regard to the categories of content, most research has been carried out on ‘user experiences’ (see Fig.  3 ): just over one-third of the articles ( n  = 31; 36%) focused on this topic. Of these articles almost all studies focused on experiences of patients or informal caregivers ( n  = 29) and only a small number ( n  = 2) considered the user experiences of nurses or other professionals (see Table  5 ). More than half of the studies ( n  = 19) used a qualitative research design; of these 13 used a phenomenological approach. The goal of these studies was to elicit the essence of human phenomena as experienced by the users. Seven studies used a quantitative design and one an integrated mixed method. Three of the studies applied a grounded theory approach and two an experimental design (randomized controlled trial). The research instruments in this content category to collect data were interviews, either semi-structured or in-depth, and a survey. About two-thirds of the articles regarding ‘user experiences’ were published in the period 2011–2015, with an accent on the psychosocial impact of patients or informal caregivers.

Number of articles on AMTs with main content categories ( n  = 87)

Relatively little research was found on ‘training, instruction, education’ ( n  = 7), for the use of AMTs in home settings. It was remarkable that all the studies identified as focusing on this topic, concentrated on one category of AMT. Respiratory support was the subject of study in four instances and in the other three, the focus was on technologies for enteral nutrition, haemo dialysis and external electro-stimulation. Four of the seven articles utilized quantitative methods, among which three of them used an observational non-experimental design and one was an experimental randomized double-blind clinical trial. Another study within the initial seven articles used a qualitative observational non-experimental design, one was a review and another was in essay format.

In total, 22% of the articles discussed topics on safety, risks, incidents and complications ( n  = 19). In the majority of cases ( n  = 13) general aspects about the subject, for instance safe use, factors affecting safety, a safe transfer of the equipment and monitoring of assessing safety were considered. One article described technological factors with regard to safety, three articles reported on environmental factors and two explored human factors. Safety aspects were explored over a wide range of medical technologies. Five articles were reviews and one an essay. Quantitative methods were used in ten of the cases, particularly for monitoring, evaluating and assessing safety, technological and environmental factors. Only three studies used a qualitative design. Retrospective chart reviews or case series were used to collect data in some cases of unforeseen events. Table 5 shows about a doubling of published articles in the period 2011–2015 regarding this content category, compared to the previous period 2000–2010.

Approximately 20% of the selected articles considered the content category ‘design and technological development of the medical device’ ( n  = 17). The studies each focused on only one type of AMT and treated a relative wide range of eight different categories, such as ‘respiratory support’, ‘oxygen therapy’, ‘haemo dialysis’, ‘infusion therapy’, ‘insulin pump therapy’ and ‘enteral nutrition’, but also ‘external electrostimulation’ and ‘patient lifting hoists’. Interestingly, in this group of articles, relatively often ( n  = 6) no medical diagnosis was mentioned. Around half of the studies ( n  = 8) referring to this topic were in review or essay format. All other studies used a quantitative research design and throughout the search no application of qualitative designs were found. Two studies used an experimental study design (randomized crossover trial) to obtain data and two described a prospective cohort study. The majority of papers ( n  = 11) were published in the period 2011–2015 and six in the preceding period up to and including 2010.

Seven articles concerned the application of AMTs, all of them devices with regard to at least respiratory support and/or nutritional support. Five studies used a non-experimental quantitative design including the analysis of clinical data, such as record reviews or cohort studies, and two articles were reviews. Most articles on this subject ( n  = 5) were published in the period 2012–2015.

Six articles described policy or management systems in different countries regarding the use of AMTs at home. The majority of the articles ( n = 4 ) were in essay or review format. The other papers concerned a qualitative cross-sectional case study analysis and an observational quantitative study in which data are collected prospectively using a database. The categories of content will now be discussed in greater detail.

Content description and trends to secondary research questions

In this category, 22 articles described the psychosocial impact on patients or informal caregivers from the use of medical technologies at home. Living at home with the assistance of medical technology needs a range of adjustments. Fex et al. [ 25 , 26 ] state that self-care is more than mastering the technology, in terms of the health-illness transition, it requires ‘…. an active learning process of accepting, managing, adjusting and improving technology’. When it comes to children, they have to learn to incorporate disability, illness and technology actively within their process of growing up [ 27 ]. It seems that the use of medical technologies in the home can have both a positive and a negative psychosocial impact on patients and their families, which in turn causes ambivalence in experiences [ 27 , 28 ]. On the one hand, patients in general gain more independence, an enhanced overall health and a better quality of life [ 29 , 30 , 31 , 32 , 33 , 34 ]. On the other hand, for some patients the experience is one of dependency on others for executing daily activities, and these circumstances, to some extent, a social restricted live and perceived stigmatization [ 29 , 30 ]. The situation in which patients need to use medical technology at home also affects family functioning and requires next of kin responsibilities [ 35 , 36 , 37 ]. As a result, next of kin caregivers are frequently faced with poor sleep quality and quantity, and/−or other significant psychosocial effects [ 38 , 39 , 40 , 41 ]. Nevertheless, family members had a positive attitude to the concept of bringing the technology into the home [ 42 ]. Knowledge of how to use the technology and permanent access to support from healthcare professionals and significant others, enabled next of kin caregivers to take responsibility for providing necessary care and to facilitate patients learning to provide self-care [ 25 , 36 , 42 , 43 , 44 ]. Bezruczko et al. [ 45 , 46 ] developed a measure of mothers’ confidence to care for children assisted with medical technologies in their homes. To provide high quality sustainable care, nurses have to recognize and understand the psychosocial dimensions for both patients and family members which arise as a result of changing role and providing care for the patients. The need to provide emotional support and support with appropriate coping strategies is a key professional role [ 25 , 26 , 47 ]. Insight into the psychosocial effects on those involved can be used to assist designers of medical devices to find strategies to better facilitate the integration of these technologies into the home [ 28 ].

Seven articles reported on the usability, barriers and accessibility experienced by patients or informal caregivers. Findings in these studies showed that several technologies were rarely perceived as user-friendly and that home medical devices inadequately met the needs of individuals with physical or sensory deficits [ 48 , 49 ]. An accessible design which meets the diversity of individual user needs, characteristics and features would be better able to help patients manage their own treatment and so could contribute to the quality of care and safety of patients and lay users [ 50 , 51 ]. Munck et al. [ 52 ] stated that restricted patients were reminded daily of the medical technology and were more dependent on assistance from healthcare professionals than masterful patients.

In contrast to the group of patients or informal caregivers, only two papers in this content category focused on the user experiences of nurses or other professional caregivers. The review demonstrates that to maintain patient safety, more education on application of medical devices for users is needed together with improved awareness and understanding of how to use the medical technology correctly in a patient-safe way [ 53 , 54 ]. More collaboration between all involved ‘actors’ in the process of care is also requisite. Continuity among carers, trust between patient and carers and supportive communication between informal and professional caregivers are important factors for the successful implementation of medical technologies in the home environment while maintaining patient safety [ 44 , 51 , 53 , 54 , 55 ].

Three articles regarding this topic focused on nurses or other professionals and four on the patients or informal caregivers. The results showed that successful use of advanced medical technologies at home requires adequate staff education and training programmes. Although many topics in educational programmes are suitable for different types of professionals in care provision, the focus for the level and application of information can vary for Registered Nurses and unregistered care staff. In addition, for overall learning experiences to be of maximum benefit there is a need for a clear focus on the specific client groups [ 56 ]. According to Sunwoo et al. [ 57 ], in the case of home non-invasive ventilation the degree of clinical support needed is extremely variable given the mixed indications for this respiratory support. A relatively simple procedure, such as the replacement of a feeding tube, can be performed by nurses, the patient and informal caregivers, provided they are trained well [ 58 ]. However, several studies revealed the complexity of the education needed by patients and informal caregivers for the use of advanced medical technologies at home [ 59 , 60 ]. Nevertheless, the studies revealed that a structured education programme, specific training, or the support of a dedicated discharge coordinator has several advantages [ 59 , 61 , 62 ]. It was evident that good preparation by patients or informal caregivers may result in a shorter length of stay in hospital, a better performance with regard to the use of the equipment or less requests by patients and/or families for assistance.

Most articles regarding this topic ( n  = 13) reported on safety in general, like aspects of safe use, factors affecting safety, complications and prevention of incidents in the home. Some identified the risk factors and the complications that may arise [ 63 , 64 , 65 ], where Stieglitz et al. [ 66 ] also emphasize that human error is the main reason for critical incidents and that regular instruction for medical staff and patients is necessary. To prevent untoward and adverse events, evidence based guidelines, recommendations on the preferred methods for managing the equipment, troubleshooting techniques for potential complications and monitoring activities are necessary [ 67 , 68 ]. Faratro et al. [ 68 ] added that key performance and quality indicators are important mechanisms to ensure patient safety when using a medical device in the home. Methods to address or evaluate patient safety issues are for example, a home visit audit tool, a nationwide adverse event reporting system, programs such as the Medical Product Safety Network HomeNet, or, in the case of peripherally inserted central catheters (PICCs) a central catheter stabilization system [ 69 , 70 , 71 , 72 ]. However, a study conducted by Pourrat and Neuville [ 73 ] in France found that there are very few internal medical devices vigilance reports found within organizations that deliver devices for home parenteral nutrition and that safety management could be improved. The safe transfer of medical devices from a hospital setting to the home and vice versa, comes with several challenges regarding technological, environmental and human factors [ 14 ]. While many hospitals have developed policies to control the pathways of home-used devices in the hospitals, in case patients take them into the hospital when they are admitted for treatment [ 74 ]. Improvement of the safety of devices intended for use in home settings, implies also improvement of safety when their transfer to the hospital settings is urgently needed.

One article considered the technological factors, three the environmental and two the human factors. An example of research on the technological factors of safety related aspects of medical technologies used in home settings by Hilbers et al. [ 75 ] found that manufacturers pay insufficient attention to safety-related items in technical documentation for the use in the home setting. For instance, the environmental factor of electricity blackout leads to electrically powered medical devices failing. Studies show that this type of event causes a dramatic increase in appeal for access to emergency or hospital facilities, and that disaster preparation needs to include the specific needs of patients reliant on electrically driven devices [ 76 , 77 , 78 ]. Regarding human factors impacting on safety aspects, one article assessed the suitability of a particular theoretical framework for understanding safety-critical interactions of patients using medical devices in the home [ 79 ], while Tennankore et al. [ 80 ] described adverse events in home haemodialysis by the use of patients. It was remarkable that none of the articles focused on human factors with regard to the use of medical technologies at home by nurses or other professional caregivers.

Of those articles that focused on this topic, ten reported on the comparison between different types of medical technologies, or their advantages and disadvantages. The comparison of different devices for oxygen therapy was made by two articles [ 81 , 82 ] and one reported on the comparison of two types of enteral nutrition tubes [ 83 ]. Some studies regarding respiratory support considered the process of making a choice between different types of devices [ 84 , 85 , 86 ] while one paper considered the conditions for home-based haemo dialysis [ 87 ]. A minority, explored the individual characteristics and the clinical applications of several devices for respiratory support [ 88 , 89 ] and one considered devices for insulin pump therapy [ 90 ]. Seven papers discussed the technological development or effectiveness of medical technologies. The testing of devices for external electro-stimulation was described in two papers [ 91 , 92 ], with the testing of a new design patient lift was subject of one study [ 93 ]. Hanada and Kudou [ 94 ] explored the current status of electromagnetic interference with medical devices in the home setting, an issue of importance as more devices are considered for home use. The technological development of respiratory support for home use was part of one study [ 95 ], as were the possibilities of solar-assisted home haemo dialysis [ 96 ]. While the study by Pourtier [ 97 ] describes the advantages of analgesia pumps that can be read remotely by nurses, but also emphasizes the central position of a professional nurse in the transfer of information within a multi-disciplinary team.

Application with regard to certain diseases or disorders, indications for and extent of use

All articles described several aspects that need to be considered for use, such as clinical characteristics of the patients, indications for the use in the home setting, the technical availability of devices, the extent of their use at home or eventual complications and morbidity. It was important to note that all but one article ( n  = 6) were about children or related to adults with what are usually regarded as paediatric diseases. Results show that the use of AMTs at home among children after hospital discharge is common (in 20%–60% of cases), or is standard for patients with some disorders [ 98 , 99 , 100 , 101 ]. The timely application of advanced home medical technology benefits patients and can help to reduce respiratory morbidity [ 102 ]. Nevertheless, the rate of death of patients with Möbius syndrome using the devices at home was high (30%) [ 98 ], as was that of patients with intestinal failure dependent on home parental nutrition therapy in Brazil (75% for 5 years) [ 103 ]. The average cumulative survival of children needing home ventilation was found to be between 75 and 90%, depending on the medical diagnosis [ 104 ].

Three of the papers were concerned with costs and/or reimbursement. The application of medical technologies in the home environment can be cost-effective when compared to institutionalized care [ 22 , 105 , 106 ]. Nevertheless, successful employment of medical technologies in the home necessitates medical guidelines for the indicators for use, careful identification of patients as well as careful planning and attention to details [ 105 , 106 , 107 ]. Two studies concerned the dilemma’s for implementation of the technologies in home healthcare and emphasized the importance of cooperation in the chain of key stakeholders to maximize efficiency of high-tech healthcare at home, one with regard to the purchasing policy of medical technologies [ 108 ] and one with regard to the interventions of local community service centres and hospitals supporting optimal use of these technologies in the home setting [ 5 ].

The use of medical technologies in the home setting has drawn increased attention in health care over the last 15 years, as the feasibility of this type of medical support has rapidly grown. This article systematically reviewed the international literature with regard to the state of the art on this subject, in order to provide a comprehensive overview.

Trend analysis over the period 2000–2015 shows that most research has been conducted about respiratory support, dialysis and oxygen therapy; relatively little about vacuum assisted wound closure and continuous passive motion, and no about decubitus treatment, skeletal traction and UV therapy. A substantial increase in publications was found in the period 2011–2015. Although the number of studies on technologies is indicative of the extent to which they are used in home settings, however, no firm conclusions can be drawn about this.

This review also identified that most research is conducted with regard to ‘user experiences’ of medical technologies in the home, ‘safety, risks, incidents and complications’, and ‘design and technological development of medical technologies’. There have been relatively few studies which have explored the topic of training, instruction and education. Content analysis showed that the use of AMTs in the home setting can have both a positive and a negative psychosocial impact on the patients and their families, and that it has become part of self-management and patient empowerment. Successful use of advanced equipment requires adequate education and training programmes for both patients, informal caregivers and nurses or other professionals. When trying to maximize or assure safety, technological, environmental and human factors have to be taken into account, and it is evident that human factors are the main reason for critical incidents. Studies on the design and technological development of medical technologies emphasize that research is necessary to improve its possibilities and effectiveness. The research found on the application of the technologies focused predominantly on children and the results indicate that the rate of the use of home medical devices among children after hospital discharge is common. Also that when compared to institutionalized care, the application of medical technologies in the home environment can be cost-effective. Much is known, but information on several key issues is limited or lacking.

An important finding was that in almost all the reviewed articles, the study subjects were patients or informal caregivers with very few studies focused on the role and activities of nurses or other professionals as users. This was unexpected as nurses are the main group of users of AMTs at home and they have to transfer knowledge and skills on how to use the devices to patients and other caregivers. Nurses also have a key role in setting up and maintaining collaboration between all actors involved in the process of care with regard to the use of home medical technologies and in giving support to patients and family members in this respect. There is need to initiate further in depth research on AMTs use at home focusing on the role of specifically nurses.

Another interesting result was that, despite the fact that most adverse events with AMTs at home are caused by human factors, hardly any studies conducted on this subject were found. None of the articles focused on related human factors regarding the use by nurses or other professional caregivers, although this is the main user group. Research on this area could contribute to improved patient safety and quality of care. The results also revealed the tension between the advantages and disadvantages of medical technologies as experienced by patients at home. Important aspects needed to promote the benefits include improving the user-friendliness of the devices and attuning their designs for the use in home settings. This emphasizes the importance of professionals (and patient groups) working together with the designers with regard to sharing knowledge and user experiences of the use of AMTs at home in order to improve quality of care and patient safety. This collaboration emerged as of key importance in the successful use of AMTs in the home as well.

Although all included articles were retrieved from academic databases and served our purpose, there was considerable heterogeneity of quality of the studies. Most of the studies have explicitly described their research design, albeit to a greater or lesser extent. On the other hand, there were a few studies that did not even mention their methodological approach, though it could be derived from the description. Most included reviews are of moderate quality. Although findings are almost always described clearly, the search strategy and selection criteria used are often lacking. The quantitative studies are generally well described in different methodological aspects, such as selection of respondents, research design, data collection methods and analyses. Studies of qualitative nature show more variation in the depth with which the design is described. However, almost all qualitative studies have described the research instruments very well, such as semi-structured interviews or questionnaires. Despite the varying quality of the studies, we believe that the whole of different methodological approaches and the relatively large number of included studies ( n  = 87) has yielded a fairly reliable overview on the international state of art concerning various aspects of the use of advanced medical technologies at home. For future research, we recommend to emphasize the development of a more detailed methodological design, zooming in on specific technologies, using large databases or conducting large surveys, and focusing on specific groups of respondents. Both in quantitative and in qualitative studies, a good definition of the research question(s), selection of respondents, development of instruments and analysis of findings, contributes to validity, consistency and neutrality.

Some limitations do have to be taken into account with this review. Although we used the RIVM-definition of ‘advanced medical technology’, not all devices are considered as ‘complex devices’ by nurses in practice. For example, the use of an anti-decubitus mattress in the context of ‘decubitus treatment’ and ‘patient lifting hoists’ are considered by nurses as being of less or lower complexity. However, overall the RIVM-classification was found to be a good starting point, and provided a practical and useful framework from which to work to gain an insight and overview of available medical technologies. Of some of the chosen technologies defined using the RIVM-classification of AMTs, questions do have to be asked as to whether they really are part of the technical skills in nursing process. For example, ‘external electrostimulation’ and ‘continuous passive motion’ are mainly applied by physiotherapists, although with appropriate training nurses can apply them. Then too, devices regarded as only ‘monitoring’ were excluded from the review.

This systematic review study was designed to fill a gap in the current research by investigating what is known about different aspects of medical technologies used in the home. From the results it is obvious that a wide and growing range of medical technologies are used at home. Different types of technologies have been subject of study, increasingly –also in scope- over the period 2011–2015.

Professional nurses have a central role in the process of homecare which has to be recognized when considering use of AMTs at home. Nurses have to support patients and family caregivers and in consequence have a key role in providing information for, and as a member of multi-disciplinary teams. Closer collaboration by all actors involved in the process of care and feedback of user experiences to the designers is essential for the provision of high quality of care and patient safety.

This review also identified a lack of research exploring the perspectives of nurses in the processes involved in introducing and maintaining technology in homecare. Most of the research has been conducted regarding the experiences of patient experience and how informal caregivers perceive their role in using medical technologies at home. The few studies that were found, demonstrate the need for more research focused on the experiences of nurses working with advanced technologies in the home. The same applies to research on training, instruction and education to use medical technologies, as in these areas too, there was limited available research so here again there is need for further research. Despite the fact that most adverse events with medical technologies in home settings are caused by human factors, our findings also identified a lack of research in this area for nurses.

This study demonstrates that, although there is increasing attention on and recognition of the need for the use of medical technologies in the environment of the home, the research has not kept pace with the advances in care. Subjects such as user experiences of nurses with different technologies, training, instruction and education of nurses and human factors by nurses in risk management and patient safety urgently need to be investigated by further research.

Abbreviations

Automatic external defibrillator

Advanced medical technology

Continuous positive airway pressure

European Commission

Information technology

National Center for Health Statistics

Negative pressure ventilation

Peripherally inserted central catheters

Randomized Control Trial

National Institute for Public Health and the Environment

Ultraviolet

Ventricular assist device

World Health Organization

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The authors thank Ronnie van de Riet, head of the Medical Technical Care Team of the hospital ZiekenhuisGroep Twente, for his time and commitment to this project.

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Ingrid ten Haken is researcher in the research group Technology, Health & Care at Saxion University of Applied Sciences, Enschede, The Netherlands. Somaya Ben Allouch is head of the research group. Wim van Harten is professor at the University of Twente, Faculty Behavioural, Management and Social Sciences, department Health Technology & Services Research and CEO of Rijnstate general hospital, Arnhem, The Netherlands.

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ten Haken, I., Ben Allouch, S. & van Harten, W.H. The use of advanced medical technologies at home: a systematic review of the literature. BMC Public Health 18 , 284 (2018). https://doi.org/10.1186/s12889-018-5123-4

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The machinery of medicine: how technology influences medical research and clinical care

• Features The machinery of medicine From raw idea to finished product The artificial pancreas If you have a lemon, make lemonade The tools of medicine Human body as machine Keeping the “Goldilocks” organ cool New artery? We can print that A hunch leads to an anti-HIV compound Not by the numbers Greek drama’s lessons for veterans
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Since Neolithic humans fashioned the first scalpel out of stone, new machines and methods have changed the way we practice medicine and learn about the human body. Physicians moved on from those early scalpels to stethoscopes, X-rays, and MRIs, the better to understand the workings of the human body. With these new understandings has come translational research that transfers findings from the lab into new, more effective treatments and medicines. Dean Robert J. Alpern, M.D., Ensign Professor of Medicine, discussed basic science and advances in clinical care; technology and patient care; and the role of serendipity in research with Yale Medicine .

What have been some of the key inventions or discoveries that have advanced clinical care and medical research? In the past 50 to 100 years, there have been so many advances that it’s hard to rank any one above the other. Obviously, some come to mind—the discovery of the structure of DNA, recombinant DNA, electron microscopy, knockout technology. The new gene editing technology, CRISPR, is really going to transform research. It’s important to point out that the major advances in health care have been based on basic scientific findings. DNA technology and the structure of DNA were basic science findings that now drive clinical genetics. The understanding of how cells grow has transformed cancer care. Basic understandings of the immune system have led to immunotherapy for cancer.

How do physicians integrate new technologies into medicine while maintaining the doctor-patient relationship? Technology is always good for improving what physicians can do, but you run the risk that doctors won’t hone their clinical skills as well as they could because they know that the technology will end up defining the diagnosis. There needs to be a combination of the two. I don’t see technology replacing the need for outstanding clinicians. Technology should enhance clinical skills, not replace them.

How important is serendipity in scientific discovery? There are stories of serendipity, but the best investigators always appear to have good luck. The best investigators are asking the right questions, the important questions. It’s a matter of staying knowledgeable about all of the technologies, including those from other fields, and thinking about how to apply them to your field. When you ask the right question and use the right technology, serendipity falls upon you.

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How advanced medical technologies are changing the healthcare landscape.

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By James McDonough, a dad, explorer and entrepreneur who is expanding human health potential at EDISON BIO .

For most people, including busy entrepreneurs, the concept of “taking care of your body” has usually meant visiting a doctor once a year and going over some routine lab results. However, advancements in medical technology are rapidly and drastically changing the healthcare landscape to go well beyond this elementary approach.

Today, settling for a quick five-minute annual with a physician is no longer the only option. Genomics, cancer blood tests, MRIs, sleep analysis and many other innovations now allow patients to gain the most comprehensive picture of their health ever available. As a result, these advancements in technology are revolutionizing the healthcare system to become more proactive, personalized and convenient than ever before. 

Proactive 

Traditional healthcare systems are often criticized for their reactionary approach to medicine; health issues are addressed only once they’ve developed enough to become problematic. 

But the development and increased accessibility of medical technology give patients the chance to treat diseases at their onset, giving them a higher chance of successful recovery. 

For example, some healthcare innovators have begun offering full-body MRI scans as part of their executive health exams — exams designed for high-achievers such as entrepreneurs, CEOs and senior executives. These safe and painless procedures can detect multiple abnormalities before the onset of symptoms occurs, including brain tumors, spinal deterioration, pulmonary lesions, heart disease and more. Similarly, new cancer blood tests can test a patient’s blood sample for over fifty different kinds of cancer in their body at once. With these technologies, patients can be more confident that diseases aren’t growing in their bodies undetected.

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It’s not new knowledge in the healthcare community that treating diseases earlier is better. However, with the advancements in medical technology in the last few years, it is now more possible than ever to invest in proactive care that empowers patients to do just that. 

Personalized

Because advancements in medical technology allow for more testing opportunities, healthcare companies can now capture billions of data points for an individual patient and use them to provide more personalized care. 

For example, quantitative data from biomarker and genomic testing can be aggregated and analyzed to uncover an extensive and comprehensive understanding of a patient’s health. And by looking at a patient's entire health story and health history, providers are then able to provide more personalized care. 

This incorporation of data collection into medicine underscores the shift toward a more holistic and individualized approach to healthcare. It is no longer one-size-fits-all when it comes to a patient’s wellness and health outcomes. Innovation in technology allows doctors to not only understand their patients more comprehensively than ever, but also to provide them with personalized care like never before. 

As an entrepreneur, you know that time is money. And technology has allowed healthcare to become incredibly more convenient for those who need it most. 

Long gone are the days of wasting time driving to and waiting around in a physician’s office. Instead, the innovation of telemedicine allows for patients to receive care through their phones or computers in real time. 

Some advanced healthcare companies even offer to come to their patient’s home or office for any testing that needs to be completed — saving the patient time and hassle. Online portals also make the patient’s health data easily accessible, giving them the ability to share that data with specialists, trainers or even family members. 

No longer is the healthcare landscape marked by wasted time and piles of paperwork. Telemedicine gives patients the ability to seek care on their own time and access their health information all in one place. 

The Future Of Care

As advancements in technology continue to develop, so will the ways that we care for our bodies. Patients will continue to turn to companies whose incorporation of technological innovation into medicine allows patients to take control of their health like never before. Increasing longevity and improving performance has never been easier with a healthcare system that is changing to become more proactive, personalized and convenient for you.

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5 innovations that are revolutionizing global healthcare

Technological advances are starting to revolutionize the healthcare sector. Image:  Pexels/Chokniti Khongchum

.chakra .wef-1c7l3mo{-webkit-transition:all 0.15s ease-out;transition:all 0.15s ease-out;cursor:pointer;-webkit-text-decoration:none;text-decoration:none;outline:none;color:inherit;}.chakra .wef-1c7l3mo:hover,.chakra .wef-1c7l3mo[data-hover]{-webkit-text-decoration:underline;text-decoration:underline;}.chakra .wef-1c7l3mo:focus,.chakra .wef-1c7l3mo[data-focus]{box-shadow:0 0 0 3px rgba(168,203,251,0.5);} Stefan Ellerbeck

.chakra .wef-9dduvl{margin-top:16px;margin-bottom:16px;line-height:1.388;font-size:1.25rem;}@media screen and (min-width:56.5rem){.chakra .wef-9dduvl{font-size:1.125rem;}} Explore and monitor how .chakra .wef-15eoq1r{margin-top:16px;margin-bottom:16px;line-height:1.388;font-size:1.25rem;color:#F7DB5E;}@media screen and (min-width:56.5rem){.chakra .wef-15eoq1r{font-size:1.125rem;}} Innovation is affecting economies, industries and global issues

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Stay up to date:.

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• Healthcare innovation is accelerating at an unprecedented scale, particularly in the digital sphere, the World Health Organization says.
• Advances such as artificial intelligence and gene editing are transforming the way diseases are detected and treated.
• Here are 5 innovations that are pushing boundaries in healthcare.

Suppose you or someone you know needs surgery or treatment for an illness or disease. In that case, it’s increasingly likely that advances in medical technology will improve the chances of a successful outcome.

Medical innovations have occurred throughout history, continually advancing our ability to treat complex diseases. These include the first vaccine for smallpox in the 18th century, the development of antibiotics in the 1920s and the world’s first organ transplant three decades later.

However, the 21st century is bringing even more progress, with technological advances revolutionising the healthcare sector. The World Health Organization says innovation, particularly in the digital sphere, is taking place at an unprecedented scale.

Innovations that are transforming the global healthcare industry

Here are five innovations that are pushing even more boundaries in healthcare.

Artificial intelligence (AI)

The use of algorithms and machine learning in detecting, diagnosing and treating disease has become a significant area of life sciences. Some believe it is the biggest healthcare revolution of the 21st century.

AI can detect diseases early and make more accurate diagnoses more quickly than conventional means. In breast cancer, AI is enabling mammograms to be reviewed 30 times faster with almost 100% accuracy , reducing the need for biopsies.

Meanwhile, a deep-learning algorithm developed by health-tech company Qure.ai is enabling the early detection of lung cancer . The firm says a study demonstrated a 17% improvement when using AI to interpret chest x-rays compared to conventional radiology readings. It has formed a partnership with drug giant AstraZeneca that aims to scale up the technology to reduce lung cancer mortality rates around the world.

3D printing

The use of 3D printing techniques in healthcare is growing rapidly. More than 110 hospitals in the US had facilities for point-of-care 3D manufacturing in 2019, compared with just 3 in 2010, according to data provided by Statista.

Number of US hospitals with a centralized 3D printing facility

The technology is being used for creating dental implants, replacement joints, as well as for made-to-measure prosthetics. Research into using 3D printers for manufacturing skin tissue, organs and even medication is also underway.

One of the main benefits of 3D printing is that it greatly accelerates production processes and, therefore, also reduces the cost of traditionally manufactured products. The technology has reduced the time it takes to produce hearing aids from more than one week to just one day, according to the American Hospital Association.

CRISPR gene editing

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene-editing technology can potentially transform how diseases are treated. It could help make significant advances against killer diseases like cancer and HIV in a matter of years.

The technology works by “harnessing the natural mechanisms” of invading viruses and then “cutting out” infected DNA strands . By altering cell mutations, CRISPR also has the potential to transform the way rare conditions like cystic fibrosis and sickle cell disease are treated.

However, ethical concerns around its use need to be addressed, as its potential ability to change genomes in children has been raised. A team of scientists was prosecuted in China in 2020 after they claimed to have created the world’s first “designer babies” using CRISPR.

The Global Health and Strategic Outlook 2023 highlighted that there will be an estimated shortage of 10 million healthcare workers worldwide by 2030.

The World Economic Forum’s Centre for Health and Healthcare works with governments and businesses to build more resilient, efficient and equitable healthcare systems that embrace new technologies.

Learn more about our impact:

• Global vaccine delivery: Our contribution to COVAX resulted in the delivery of over 1 billion COVID-19 vaccines and our efforts in launching Gavi, the Vaccine Alliance, has helped save more than 13 million lives over the past 20 years .
• Davos Alzheimer's Collaborative: Through this collaborative initiative, we are working to accelerate progress in the discovery, testing and delivery of interventions for Alzheimer's – building a cohort of 1 million people living with the disease who provide real-world data to researchers worldwide.
• Mental health policy: In partnership with Deloitte, we developed a comprehensive toolkit to assist lawmakers in crafting effective policies related to technology for mental health .
• Global Coalition for Value in Healthcare: We are fostering a sustainable and equitable healthcare industry by launching innovative healthcare hubs to address ineffective spending on global health . In the Netherlands, for example, it has provided care for more than 3,000 patients with type 1 diabetes and enrolled 69 healthcare providers who supported 50,000 mothers in Sub-Saharan Africa.
• UHC2030 Private Sector Constituency : This collaboration with 30 diverse stakeholders plays a crucial role in advocating for universal health coverage and emphasizing the private sector's potential to contribute to achieving this ambitious goal.

Want to know more about our centre’s impact or get involved? Contact us .

Virtual reality (VR)

The VR and AR (augmented reality) market is booming worldwide , and both technologies are being used increasingly in healthcare applications. The technology can be deployed in various ways , such as performing more advanced surgery, helping with pain relief, and treating mental health conditions.

Surgeons can also use a VR helmet to rehearse procedures, as well as to have full sight of the inside of a patient's body. And the technology can help people to "unlearn" chronic pain by retraining the brain, Forbes says.

VR can also help people with mental disorders overcome their fears by providing them a controlled environment for social interactions. Two hours of exposure to treatment for fear of heights cut patient anxiety by an average of 68%, according to Forbes.

Smart bandages

A bandage that uses sensors to monitor wound healing has been developed by researchers in the US. It “promotes faster closure of wounds, increases new blood flow to injured tissue, and enhances skin recovery by significantly reducing scar formation”, according to the Stanford University team behind it.

A thin electronic layer on the bandage has temperature sensors that monitor a wound. If necessary, they can trigger more electrical stimulation to accelerate tissue closure.

“With stimulation and sensing in one device, the smart bandage speeds healing, but it also keeps track as the wound is improving,” said Artem Trotsyuk, co-author of a study of the bandage.

The device needs to overcome cost and data storage issues before going into mass production. However, it could eventually offer significant help to people with suppressed immune systems and diseases like diabetes, who often suffer from slow-healing wounds.

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Potential for GPT Technology to Optimize Future Clinical Decision-Making Using Retrieval-Augmented Generation

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Advancements in artificial intelligence (AI) provide many helpful tools for healthcare, one of which includes AI chatbots that use natural language processing to create humanlike, conversational dialog. These chatbots have general cognitive skills and are able to engage with clinicians and patients to discuss patients’ health conditions and what they may be at risk for. While chatbot engines have access to a wide range of medical texts and research papers, they currently provide high-level, generic responses and are limited in their ability to provide diagnostic guidance and clinical advice to patients on an individual level. The essay discusses the use of retrieval-augmented generation (RAG), which can be used to improve the specificity of user-entered prompts and thereby enhance the detail in AI chatbot responses. By embedding more recent clinical data and trusted medical sources, such as clinical guidelines, into the chatbot models, AI chatbots can provide more patient-specific guidance, faster diagnoses and treatment recommendations, and greater improvement of patient outcomes.

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• The Regulatory Review In Depth

The Future of Technology in Health Care

Alyson diaz , julia englebert , and carson turner.

Scholars discuss the need for federal regulations to combat risks associated with technology in health care.

Most U.S. adults use technology to improve their health—nearly 60 percent browse the Internet for medical information, and over 40 percent obtain care through telemedicine .  Despite technology’s health care potential, however, six out of ten Americans are uncomfortable with their health care provider relying on AI to diagnose diseases and recommend treatments.

AI can enhance quality of care by helping physicians verify their diagnoses and detect diseases earlier. For example, researchers have found that AI technology can help predict a patient’s risk of breast cancer. Similarly, a combination of physician expertise and AI algorithms can increase the accuracy of diagnoses.

Yet, AI systems can fail, and if humans rely too much on software, an underlying problem in one algorithm can injure more patients than a single physician’s error. In addition, AI algorithms incorporate biases from available data. For example, Black patients receive , on average, less pain medication than white patients. An algorithm trained to recommend pain treatment from these health records could suggest lower doses of painkillers for Black patients, irrespective of biological needs.

At the same time, technology can help underserved communities gain access to health care. These communities often experience shortages of trained practitioners and standard health care facilities, resulting in higher risk of disease and misdiagnoses. Telehealth, as one example, increases access to quality care by allowing patients to meet with doctors online or have their vitals monitored remotely.

Currently, no federal law regulates the use of AI in health care. Although the U.S. Food and Drug Administration (FDA) reviews most products using technology or AI software on patients, it does not currently make determinations as to whether uses of AI in health care are safe for patients. Instead, FDA approves AI-enabled devices through a process known as 510(k) review . During a 510(k) review, a manufacturer must show that its technology is “substantially equivalent” to a product already available in the market. The process allows AI-enabled devices to be approved without clinical trials proving their safety or accuracy.

Last year, the Biden Administration pledged to oversee the responsible development of AI, including in health-related fields. President Joseph R. Biden’s executive order on the subject includes requirements for health care providers to inform users when the content they provide is AI-generated and not reviewed by a physician. In addition, providers are responsible for mitigating potential risks posed by the technology and ensuring that it expands access to care.

Health professionals have also expressed concern about adolescents self-diagnosing medical conditions discussed by influencers who promote telemedicine on social media. Currently, FDA does not require telemedicine companies to disclose information about potential risks of services, and companies receive free speech protections as “advertisers.”

Advocates for stricter regulation of technology in health care point out that telehealth providers escape regulation by classifying themselves as communication platforms that connect patients with doctors, and not as providers of medical services. Telehealth companies maintain their independence from medical providers, allowing them to avoid legal liability for those providers’ actions.

In this week’s Saturday Seminar, scholars offer varying suggestions on regulating the use of technology in health care.

• AI algorithms are inherently biased, yet no federal regulation addresses the risk of biased diagnostics when AI is used in health care, recent Seattle University School of Law graduate Natalie Shen argues in an article in the Seattle Journal of Technology, Environmental & Innovation Law . Shen explains that in the absence of federal action, states have taken the lead in passing laws to address automated decision systems such as AI in health care. By analyzing New Jersey’s and California’s approaches, Shen recommends improvements to future state legislation, including extending any future law’s coverage to the private health insurance sector, and imposing continuous assessment requirements as AI technology evolves.
• In an article for the Virginia Law Review , Berkeley Law Schools Khiara M. Bridges argues that educating patients about the risk of race-based algorithmic bias should be a prerequisite before using AI in health care. Bridges explains that people of color are more likely to distrust physicians and health care institutions and thus, are likely to be skeptical of medical AI. Furthermore, medical algorithms are developed based on a primarily white “general population,” reducing their predictive accuracy for communities of color, Bridges notes . She argues that disclosure of AI-related risks would foster patient-physician dialogue in communities of color, encouraging more patients of color to use the technology and ultimately remedying existing algorithmic biases.
• Regulation of AI-enabled health tools must include pre-market authorization and continued performance monitoring processes, urge Joana Gonçalves-Sá of Complexity Science Hub and Flávio Pinheiro of NOVA Information Management School in an chapter in Multidisciplinary Perspectives on Artificial Intelligence and the Law . Gonçalves-Sá and Pinheiro propose improvements to FDA’s pilot program, Total Product Lifecycle , which tracks the safety risks of AI. Under the program, an AI company can achieve “precertified status” if it can demonstrate that it develops high quality algorithms and continues to monitor their effectiveness after market entry, Gonçalves-Sá and Pinheiro explain . FDA should also investigate the reliability of datasets and engineers that train AI tools, Gonçalves-Sá and Pinheiro recommend .
• Regulators should lower legal barriers that prevent community organizations such as Black churches from helping poor and marginalized people to gain access to telehealth services, argues Meighan Parker of the University of Chicago Law School in a recent article in the Columbia Science and Technology Law Review . Parker notes that although community organizations such as Black churches could help some people to overcome mistrust of health care providers, involving them could cause conflicts between the churches’ beliefs and patients’ medical needs, or open the churches to malpractice liability. In response, Parker proposes softening or adjusting regulatory barriers to ensure that churches will not face ethical conflict or legal liability for connecting people with needed telehealth services.
• In a note in the Washington Journal of Law, Technology & Arts , Kaitlin Campanini , a student at Pace University Elisabeth Haub School of Law , argues that the U.S. Drug Enforcement Administration’s lax regulation of telehealth providers has worsened inadequate mental health treatment and increased excessive drug prescriptions. Although telehealth providers’ business models can render treatment more convenient and affordable, the expedited treatment model they offer “blurs the line between offering health care to patients and selling controlled substances to customers.” This is because such companies fall into a regulatory gray area. They disclaim providing medical services by maintaining that they are independent from providers. Yet they aggressively market stimulants to consumers and facilitate questionable prescriptions after short, virtual evaluations.
• In a recent note in the Belmont Law Review , J.D. candidate Nora Klein argues that regulators should close legal loopholes that allow direct-to-consumer (DTC) pharmaceutical companies to unfairly influence social media users. Klein notes that DTC pharmaceutical companies have avoided FDA advertising regulations in part by labeling themselves as entities over which FDA has no regulatory authority. Accordingly, these entities are only subject to FTC advertising regulations, which are difficult to enforce, Klein observes . She argues that the DTC model is harmful because it leads to misdiagnoses and patient complications more often than traditional health care services. To address the problem, Klein proposes that FDA require DTC pharmaceutical companies to disclose important drug information to consumers.

The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week,  The Regulatory Review  publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.

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Access to medical technology saves lives. How can we make it more accessible in low- and middle-income countries?

Zhendong song.

The medical device sector is large, diverse, competitive, and highly innovative, but these devices are not reaching people around the world equally. From wheelchairs to blood tests, ultrasound machines and more advanced imaging tools, availability is often highly limited in low- and middle-income countries, putting another barrier in front of people’s ability to access impactful health care.  

As governments, development organizations, and other stakeholders focus on what’s needed to reach the UN Sustainable Development Goals for health, part of success requires identifying what’s undercutting access to affordable health care—including medical devices that make lifesaving diagnoses—and putting in place a strategy for overcoming this.

Why access to medical devices matters

Making medical technologies more widely available is a necessary part of making health care accessible and effective.

Take diagnostics, for example: Only 19% of the people in low-income and lower-middle-income countries have access to the simplest of diagnostic tests. The Lancet Commission has estimated that 1.1 million deaths in these countries could be avoided just by improving diagnostics for six conditions: diabetes, hypertension, HIV and tuberculosis in the general population, and Hepatitis B virus infection and syphilis among pregnant women.

What is the impediment to expanding access?

One reason is that in many countries, these devices must be imported -- often from the US, Europe Japan, and China – making them more costly because of the added expenses of transportation, distribution, and limited access to hard currency. Depending on imports also puts health systems in developing countries at risk during times of crises, when countries may keep supplies for themselves or when supply chains break down, as happened during the COVID-19 pandemic.

When equipment is available, keeping it working can be challenging because of a lack of trained staff, replacement parts, or repair technicians. In addition, complex machines designed for the temperature-controlled comfort of developed nations may not work as well in the heat, humidity, and other challenging conditions in poorer regions.

Finally, not all developing countries have the necessary regulations for using advanced medical equipment from other countries. According to Global Health: Science and Practice , because many African countries don’t have the resource and knowledge to regulate certain medical devices, countries often rely on European or US regulatory bodies’ approvals or clearances, which were not designed to meet local needs and issues, and the compliance costs can be prohibitive for local manufacturers.

Solutions for local needs

Overcoming these challenges requires a multidimensional approach, but identifying routes for investing in the local manufacture of medical devices should be a first step. Localizing production – which can include setting up regional production centers that can be supported through diverse and closer supply chains – is a necessary part of improving access to care in lower-income countries. Expanding production in these markets also helps support local research and development, which can spark new solutions that directly target local clinical and market needs.

The path isn’t straightforward and there are numerous complexities, which is why IFC, together with the World Bank, is working with partners, among them the World Health Organization, to help public and private stakeholders identify what’s needed to support regionalized solutions. A big challenge is that complicated technology often requires long lead times and major commitments of research and development dollars. And manufacturers setting up locally will need to know that there is an ongoing market for these devices.  

This does not mean that investors and manufacturers need to wait. The initial focus can be on producing less complex products, such as personal protective equipment and other medical consumables. Items like syringes and bandages, offer the most direct opportunities for scaling up local production and improving supply chain security. Revital Healthcare, a Kenyan medical supply manufacturer launched about 15 years ago, is now one of the continent’s largest manufacturers, employing more than 650 workers and producing 45 different devices, some for export.

Another route is to focus on assembly of products. High demand for medium-complexity devices such as patient monitors and electrocardiogram machines offers opportunities for moving the final steps to emerging markets. Recently, Ethiopia launched the first ultrasound assembly plant in Africa. Besides local assembly, there are market opportunities via technology transfer, joint ventures, and foreign investments that could further help develop local capacities.

It should come as no surprise that the World Health Organization has issued an urgent call to action: Governments and private entities must work closer and coordinate their efforts to improve and invest in the local production of health supplies and medical technology.

Here at the IFC, we’re urging stakeholders to collaborate and discuss the challenges they face in localizing production and the solutions needed, so we can help bring about sustainable and resilient health systems. We cannot wait until the next crisis. We must act now. 

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Senior Industry Specialist for Medical Devices, International Finance Corporation

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New research shows microevolution can be used to predict how evolution works on much longer timescales

by Nancy Bazilchuk, Norwegian University of Science and Technology

Ever since Charles Darwin published his landmark theory of how species evolve, biologists have been fascinated with the intricate mechanisms that make evolution possible.

Can mechanisms responsible for the evolution of a species over a few generations, called microevolution, also explain how species evolve over periods of time extending to thousands or millions of generations, also called macroevolution?

A new paper, just published in Science , shows that the ability of populations to evolve and adapt over a few generations, called evolvability, effectively helps us understand how evolution works on much longer timescales.

By compiling and analyzing huge datasets from existing species as well as from fossils, the researchers were able to show that the evolvability responsible for microevolution of many different traits predicts the amount of change observed between populations and species separated by up to one million years.

"Darwin suggested that species gradually evolve, but what we found is that even though populations rapidly evolve over the short term, this (short-term) evolution doesn't accumulate over time. However, how divergent populations and species are, on average, over long periods of time still depends on their ability to evolve on the short term," said Christophe Pélabon, a professor at NTNU's Department of Biology and senior author of the paper.

Big datasets from living creatures and fossils

The ability to respond to selection and to adapt, the evolvability, depends on the amount of heritable (genetic) variation. The researchers conducted their analysis by first compiling a massive dataset with measures of evolvability for living populations and species from publicly available information. They then plotted evolvablity against population and species divergence for different traits such as [bird] beak size, number of offspring, [plant] flower size and more.

They also examined information from 150 different lineages of fossils, where other researchers had measured differences in morphological traits in the fossils over time periods as short as 10 years and as long as 7.6 million years.

What they saw was that traits with higher evolvability were more divergent among existing populations and species, and that traits with higher evolvability were more likely to be different from each other between two consecutive fossil samples.

Conversely, traits with little evolvability or little variability didn't change very much between populations or between successive fossil samples

Environmental fluctuation is the key

Traits with higher evolvability change rapidly because they are able to respond to environmental changes more quickly, Pélabon said.

The environment—things such as temperature, the type of food available, or any other characteristic important for the survival and the reproduction of the individual—is the driving force of evolutionary changes because populations try to adapt to their own environment. Typically, environments are changing from year to year or decade to decade, fluctuating around stable means. This generates fluctuation in the direction of selection.

Highly evolvable traits can rapidly respond to these fluctuations in selection and will fluctuate over time with high amplitude. Traits with little evolvability will also fluctuate but more slowly and thus with lower amplitude.

"Populations or species that are geographically distant from each other are exposed to environments whose fluctuations are not synchronized. Consequently, these populations will have different trait values, and the size of this difference will depend on the amplitude of the trait's fluctuation, and therefore on the evolvability of the trait," Pélabon said.

Consequences for biodiversity

The researchers' results suggest that selection and therefore the environment has been relatively stable in the past. With climate change , things are rapidly changing, and mostly in one direction. This may strongly affect patterns of selection and how species can adapt to environments that are still fluctuating but around optima that are no longer stable even over periods of time of a few decades.

"How much species will be able to track these optima and adapt is uncertain, but most likely this will have consequences for biodiversity, even on a short timescale," he said.

Journal information: Science

Provided by Norwegian University of Science and Technology

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Should You Buy GigaCloud Technology (GCT) Ahead of Q1 Earnings?

GigaCloud Technology Inc. ( GCT Quick Quote GCT - Free Report ) will report its first-quarter 2024 results on May 9, before the bell.

Let’s check out how GCT is currently doing.

Stock Looks Cheap Despite Massive Price Rise

The stock has gained a massive 100% year to date, significantly outperforming the 13.1% rally of the industry it belongs to. But GCT is still trading at a forward sales multiple of 13.8X, significantly below the industry’s 39.41X.

Company Well Poised on Recent Acquisitions

In late 2023, GCT completed the acquisitions of Noble House and Wondersign, significantly advancing its position as a full-service end-to-end B2B solution provider in the large marketplace. The buyouts have empowered the company to enhance its footprint across various geographies, diversify its product range with premium stock-keeping units, integrate cutting-edge technology, and extend its business network, all contributing to its strengthened presence and capabilities.

Sales Healthy on Strong Demand

GCT integrates its supplier-fulfilled retailing business model with research and development aimed at harnessing advanced algorithms to further refine its strong cloud infrastructure. This strategic fusion enables the company to provide a superior B2B selling and sourcing experience for all involved in the marketplace. Addressing the rising demand for large parcel merchandise, GCT has witnessed notable growth in GigaCloud Marketplace GMV, sales volume, and the number of buyers and sellers. Sales surged 95% year over year in the fourth quarter of 2023.

Sales and EPS Growth Prospects Strong

The Zacks Consensus Estimate for revenues in the to-be-reported quarter is pegged at $235 million, indicating a more than 83.9% increase from the year-ago quarter’s actual figure. The consensus estimate for the bottom line is pegged at 51 cents per share, indicating 30.8% year-over-year growth. The estimate for EPS has remained unchanged over the past 30 days.

The consensus mark for GCT’s 2024 sales stands at $1.11 billion, suggesting year-over-year growth of 57%. The estimate for EPS has remained unchanged over the past 30 days at $2.98, suggesting year-over-year growth of 29.7%.

GigaCloud Technology Inc. Price and EPS Surprise

GigaCloud Technology Inc. price-eps-surprise | GigaCloud Technology Inc. Quote

To Conclude

GCT looks like a compelling buy ahead of its first-quarter results as it is trading dirt cheap when compared to its industry, and both top and bottom-line growth prospects look healthy for the current year.

GCT currently sports a Zacks Rank #1 (Strong Buy). You can see  the complete list of today’s Zacks #1 Rank stocks here .

Recent Earnings Snapshots of Some Service Providers

Omnicom ( OMC Quick Quote OMC - Free Report ) reported impressive first-quarter 2024 results, wherein both earnings and revenues beat the Zacks Consensus Estimate.

OMC’s earnings of $1.67 per share beat the consensus estimate by 9.9% and increased 7.1% year over year. Total revenues of $3.6 billion surpassed the consensus estimate by 1.6% and increased 5.4% year over year.

Equifax ( EFX Quick Quote EFX - Free Report ) reported mixed first-quarter 2024 results, wherein earnings surpassed the Zacks Consensus Estimate, but revenues missed the same.

EFX’s adjusted earnings were $1.5 per share, ahead of the Zacks Consensus Estimate by 4.2% and up 4.9% from the year-ago quarter. Total revenues of $1.4 billion missed the consensus estimate by a slight margin but increased 6.7% from the year-ago quarter.

ManpowerGroup ( MAN Quick Quote MAN - Free Report ) reported mixed first-quarter 2024 results, with earnings beating the Zacks Consensus Estimate but revenues missing the same.

Quarterly adjusted earnings of 94 cents per share surpassed the consensus mark by 4.4% but declined 41.6% year over year. Revenues of $4.4 billion lagged the consensus mark by 0.6% and fell 7% year over year.

See More Zacks Research for These Tickers

Normally $25 each - click below to receive one report free:.

ManpowerGroup Inc. (MAN) - free report >>

Omnicom Group Inc. (OMC) - free report >>

Equifax, Inc. (EFX) - free report >>

GigaCloud Technology Inc. (GCT) - free report >>

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