Healthcare Technology Management Research Articles

A meta-analysis of technology acceptance in healthcare from the consumer’s perspective

Consumer-oriented health care technologies are increasingly available and transforming global health delivery systems. However, there is a paucity of research that systematically investigates health care technology acceptance from the consumer’s perspective. This study conducts a literature review and meta-analysis to examine consumers’ adoption intentions toward health care technologies. The findings suggest that technology acceptance models are transferable to health care technology with modifications, and factors such as perceived risks, technology performance expectancy, consumer trust, and habit significantly correlate with consumers’ adoption intentions. This study provides valuable insights into health care technology management and practical implications for health care service designers, providers, and regulatory authorities.

What Is Healthcare Technology Management?

What Is Healthcare Technology Management?

Pediatric Characteristics Associated With Higher Rates of Monitor Alarms.

Background: Continuous physiologic monitoring commonly is used in pediatric medical-surgical (med-surg) units and is associated with high alarm burden for clinicians. Characteristics of pediatric patients generating high rates of alarms on med-surg units are not known. Objective: To describe the demographic and clinical characteristics of pediatric med-surg patients associated with high rates of clinical alarms. Methods: We conducted a cross-sectional, single-site, retrospective study using existing clinical and alarm data from a children's hospital. Continuously monitored patients from med-surg units who had available alarm data were included. Negative binomial regression models were used to test the association between patient characteristics and the rate of clinical alarms per continuously monitored hour. Results: Our final sample consisted of 1,569 patients with a total of 38,501 continuously monitored hours generating 265,432 clinical alarms. Peripheral oxygen saturation (SpO2) low alarms accounted for 57.5% of alarms. Patients with medical complexity averaged 11% fewer alarms per hour than those without medical complexity (P < 0.01). Patients older than 5 years had up to 30% fewer alarms per hour than those who were younger than 5 years (P < 0.01). Patients using supplemental oxygen averaged 39% more alarms per hour compared with patients who had no supplemental oxygen use (P < 0.01). Patients at high risk for deterioration averaged 19% more alarms per hour than patients who were not high risk (P = 0.01). Conclusion: SpO2 alarms were the most common type of alarm in this study. The results highlight patient populations in pediatric medical-surgical units that may be high yield for interventions to reduce alarms. Most physiologic monitor alarms in pediatric medical-surgical (med-surg) units are not informative and likely could be safely eliminated to reduce noise and alarm fatigue.1-3 However, identifying and sustaining successful alarm-reduction strategies is a challenge. Research shows that 25% of patients in pediatric med-surg units produce almost three-quarters of all alarms.4 These patients are a potential high-yield target for alarm-reduction strategies; however, we are not aware of studies describing characteristics of pediatric patients generating high rates of alarms. The patient populations seen on pediatric med-surg units are diverse. Children of all ages are cared for on these units, with diagnoses ranging from acute respiratory infections, to management of chronic conditions, and to psychiatric conditions. Not all patients on pediatric med-surg units have physiologic parameters continuously monitored,4 but among those who do, understanding patient characteristics associated with high rates of alarms may help clinicians, healthcare technology management (HTM) professionals, and others working on alarm management strategies to develop targeted interventions. We conducted an exploratory retrospective study to describe patient characteristics associated with high rates of alarms in pediatric med-surg units.

The Role of Healthcare Technology Management Professionals in Adverse Event Reporting

Healthcare technology management professionals play a key role in the medical device environment. By sharing their insights and expertise on medical devices issues with the US Food and Drug Administration, healthcare technology management professionals help the agency resolve medical device safety concerns and help improve patient safety. This article presents two real-world case study examples in which medical device reports containing critical healthcare technology management input were submitted to the US Food and Drug Administration's MedSun (Medical Product Safety Network) reporting program and helped contribute to 2 recalls. The details in the reports, provided by the hospital reporting team, offer a unique perspective for identifying the device concern and greatly contribute to the investigation and resolution of the reported device safety issue.

Two New Partnerships for International Healthcare Technology Management

Two New Partnerships for International Healthcare Technology Management

Addressing Burnout among Healthcare Technology Management Professionals.

This article suggests ways in which healthcare delivery organizations (HDOs) may address and mitigate burnout among healthcare technology management (HTM) professionals. Burnout is defined as a state of emotional and physical exhaustion resulting from workplace stressors. Although not intended to be a fully comprehensive empirical analysis of causes of burnout, this article discusses four likely causes for burnout that are particularly relevant to HTM professionals in HDOs: (1) gaps in developing a trained and sustainable workforce, (2) growing demand for HTM expertise across knowledge domains, (3) increasing occupational stressors related to patient safety, and (4) perceived lack of understanding of employee needs. Next, based on existing literature, the article proposes four possible solutions in response to each of these issues: (1) developing human resource planning and mentoring to ensure adequate transfer of skills and knowledge, (2) implementing ways to accomplish knowledge filtering, (3) integrating HTM workers in quality improvement initiatives, and (4) implementing employee voice practices. The article concludes by discussing the possible benefits that may be derived from implementing these solutions.

Benefits of Healthcare Technology Management Input in Medical Product Safety Network Reports

Healthcare technology management professionals play an important role in reporting medical device adverse events to the Food and Drug Administration by helping to identify and report device concerns, providing critical context to medical device reports, and mitigating safety concerns. The expert opinions and insights shared by healthcare technology management professionals are beneficial to the Food and Drug Administration and help the agency mitigate device-related problems and improve patient safety. This article is a case study that discusses how a medical device report involving infusion pump controllers was submitted to the Food and Drug Administration's Medical Product Safety Network reporting program and contributed to a voluntary class I recall affecting more than 800,000 devices nationwide. The details and context provided in the medical device report by the reporting team helped inform the investigation into, and resolution of, a device safety concern.

Overview of the US Food and Drug Administration's Medical Device Databases and Applications for Healthcare Technology Management Professionals

Healthcare technology management professionals play a role in assisting hospital leadership teams to make informed decisions related to the purchase, maintenance, and management of medical devices and other healthcare technologies. To do so, they use various resources both internal and external to their organization. One such external source is the US Food and Drug Administration databases. The intent of this article is to provide an overview of US Food and Drug Administration's medical device databases that may be relevant to healthcare technology management professionals and an explanation of how healthcare technology management professionals can leverage this information during their day-to-day operations.

TECHNOLOGY MANAGEMENT IN HOSPITALS

Advances in technology assumes a significant part in medical care, and their compelling administration is critical to the acknowledgment of quality medical care provided. Medical services changes decisively due to innovative technological developments, from sedatives and anti-toxins to attractive reverberation imaging scanners and radiotherapy. Health technologies are utilized to cure disorders ranging from the most basic to the most advanced. It creates and maintains essential operational frameworks for health services and technology that are both safe and dependable. To reduce asset downtime and streamline maintenance workflows, most hospital healthcare technology management (HTM) departments now employ a Healthcare Computerized Maintenance Management System (CMMS). The goal of HTM is to make sure that the right technologies are used to solve healthcare problems with acceptable, cost-effective, safe, and functioning equipment that poses the least amount of danger to users, patients, and the environment. This paper illustrates the importance of Technology Management in Hospitals.

Analysis of Medical Device Reports Involving Ventilator-Related Incidents in a Clinical Setting

Continuous ventilators are a critical resource for the treatment and management of respiratory diseases, particularly in the midst of the COVID-19 pandemic. Healthcare technology management professionals (HTMs) are instrumental toward protecting the safety of patients by ensuring that ventilators and ventilator accessories (ventilator-related medical devices) remain functional during their lifetime. This article discusses a retrospective analysis on the failure modes described in ventilator-related medical device reports that were submitted to the US Food and Drug Administration Medical Product Safety Network (MedSun). In addition, the article also examines MedSun case studies, obtained from medical device reports, to provide HTMs with a comprehensive analysis of the lifecycle of a safety signal and how their input is essential to improve the safety and effectiveness of medical devices. Postmarket medical device surveillance in a constantly changing medical device ecosystem benefits from the first-hand knowledge that HTMs contribute to the cross-functional collaboration between the clinical community, medical device manufacturers, and the US Food and Drug Administration.

Resource Depletion Risk for Medical Equipment: Embracing the Circular Economy.

As healthcare technology management (HTM) managers and clinical engineers, it is our responsibility to anticipate the market and understand risks, including considering the sustainable use of nonrenewable resources. Unexpected events that disrupt the supply chain seem to be happening more frequently, and these challenges are making it more difficult to ensure the sustainable availability of medical equipment and parts. Is this truly just a short-term result of the pandemic, or is it a sign of other underlying issues?As described by the Brundtland Commission in 1987, sustainable development “meets the needs of the present without compromising the ability of future generations to meet their own needs.”1 Medical equipment can do amazing things—and we expect that to continue forever—but we live on a planet with a limited amount of economically recoverable natural resources. Obtaining the needed nonrenewable mineral and energy resources to manufacture and operate this equipment will become more challenging in the decades ahead.At the 2021 International Conference on Medical Device Standards and Regulation,2 a panel titled Navigating the Pandemic: Ensuring Continuity of Patient Care was held. The panel sought to review the challenges facing the medical device sector as a result of the COVID-19 pandemic; evaluate the efforts of regulators, industry, and clinicians to respond to those challenges; and discuss future actions that the industry may consider to prepare for the next critical event or pandemic. In addition to discussing supply chain issues related to the pandemic, the conversation addressed other challenges including the wildfires in California, Hurricane Ida, the freeze in Texas, and semiconductor shortages.The Food and Drug Administration (FDA) has developed a new Resilient Supply Chain and Shortages Prevention Program, with the aim of establishing a permanent device shortages program that will help ensure access to critical medical devices while reducing U.S. dependence on devices from other nations.3 Although these discussions appeared to be focused on short-term shortages, considering long-term (i.e., decades) resource risks also is important.The global medical devices market was valued at $432 billion in 2020 and is expected to reach $628 billion by 2028, at a rate of increase of 5.4% from 2021 to 2028.4 This segment of healthcare requires enormous mining and energy demands, typically has a relatively short life span, and can be difficult to recycle, thereby resulting in a large carbon footprint and waste.The world's reliance on natural resources has continued to accelerate during the past two decades. In 2019, for the first time ever, the amount of material consumed by our global economy surpassed 100 billion metric tons, of which only 8.6% was cycled back into the economy.5 In The Sustainable Development Goals Report: 2020,6 the United Nations stated, “Urgent action is needed to decrease our reliance on raw materials and to increase recycling and ‘circular economy' approaches to reduce environmental pressure and impact.”According to Hagen,7 “If the global economy continues to grow at about 3.0% per year, we will consume as much energy and materials in the next ~30 years as we did cumulatively in the past 10,000.” As I will describe, this is unlikely to happen.Other industry shifts, such as transitioning to clean renewable energy and electric vehicles, will involve competition with the medical equipment industry for the same resources. Long development times for medical equipment will require us to be looking decades ahead to anticipate the market.Throughout the medical equipment life cycle, many opportunities exist to reduce energy and resource consumption while, in many cases, also reducing cost. This article will describe the “limits to growth” concept, resource depletion, and our current situation, as well as discuss the circular economy and its potential application to the management of medical equipment.In 1972, a book titled The Limits to Growth was published by researchers from the Massachusetts Institute of Technology.8 Their work involved using computers to model several possible future scenarios. Limits to growth include both the material and energy that are extracted from the Earth and the capacity of the planet to absorb the pollutants that are generated as those materials and energy are used.In the “business-as-usual” (base) scenario shown in Figure 1, which originally appeared in The Limits to Growth, we can see that since 1900, the per-capita food and industrial output (gross domestic product) has increased dramatically alongside population and pollution.8 Also, during that time, we have depleted about half of our economically recoverable resources. As described in the next section, the remaining resources will be more difficult and costly to extract, which, according to this scenario, eventually will cause food and industrial output to decline, followed by pollution and population.The Limits to Growth study was not intended to be exact in its timing or to show what would happen after collapse. Rather, it sought to show the potential interrelationship among key variables and to illustrate that limits to growth do in fact exist. This year (2022) will be the 50th anniversary of the report, with the model it describes having been supported by 20-, 30-, and 40-year follow-up studies.Figure 2 shows a resource pyramid depicting the size and quality of our energy and mineral resources. This example uses oil for energy and copper for minerals, but the same principle applies to all nonrenewable energy and mineral resources. One hundred years ago, we were at the top of both pyramids. Today, however, much of our extraction is occurring at the bottom levels.The mining of mineral ores requires enormous energy, which only increases as the concentration decreases. Thus far, we have been able to increase the use of relatively inexpensive fossil fuels to keep up with it, but fossil fuels also are degrading and depleting at the same time. Although we will never run out of resources, a point will be reached where the cost to extract will exceed the value of the ore. At that point the resources will no longer be available and therefore effectively gone.9As the population and consumption of our resources continue to grow in the coming decades, it will become increasingly difficult not only to maintain products but also to improve them in the face of declining availability of mineral resources.10As described by Michaux et al.,11 “The current economic paradigm is that global resources are infinite and that there are no limits on growth.” Predictions for resource availability have, to a large part, been based on supply and demand rather than geology. If something is not available, the market will increase prices and drive further development. This concept has worked well for the last 200 years, but as we approach the limits to growth with depleted quality and quantity of resources, the law of supply and demand begins to erode. “The rules of industrialization and the sourcing of raw materials are changing into a new era of business model. Change is happening, whether we are ready for it or not,” said Michaux et al.It's not a matter of if, but when, certain nonrenewable resources will become uneconomical for mining. It won't be a sudden collapse of everything, but it will gradually affect segments of the supply chain much like the availability of semiconductors following the pandemic. It will take years to develop the processes, methods, and products to begin making equipment that can be fully recycled. As I understand it, it then takes on average seven years to develop and bring a medical device to market. If we want to continue to have resources available for medical equipment, then we need to make some changes now—we can't wait until we run out before we find solutions.In our traditional linear economy, nonrenewable resources are extracted to make “stuff.” When the stuff is no longer wanted, it is disposed of. In the circular economy, the goal is to reduce the amount of resources extracted using renewable energy and to recycle resources from unwanted stuff.The circular economy diagram shown in Figure 3 illustrates the ideal life cycle for medical equipment. The image displays biological materials on the left and technical materials (e.g., minerals) on the right.The circular economy involves three core elements and five enabling elements.12 The core elements that form the basis for successful implementation are to (1) prioritize regenerative resources, (2) stretch the lifetime, and (3) use waste as a resource. These core elements are made possible through the following enabling elements: (1) rethink the business model, (2) team up to create joint value, (3) design for the future, (4) incorporate digital technology, and (5) strengthen and advance knowledge.The technical information report, AAMI TIR65:2015, Sustainability of medical devices—Elements of a responsible product life cycle,13 is an excellent resource, though having been developed almost 10 years ago, it is not rigorous enough to address the needed changes. The AAMI Sustainability Committee is currently balloting whether TIR65 should be renewed and/or a standard developed. The best way to enable and ensure a successful transition to the circular economy is to develop a standard.What can we do as HTM departments and healthcare organizations? The following section describes opportunities to reduce resource consumption in medical equipment. Many of these solutions will also reduce expenses for organizations.In the acquisition and replacement of equipment, power consumption should be examined as part of the prepurchase evaluation. Inefficient old equipment should be replaced when possible. In addition, if appropriate, less power-consumptive technologies, or even manual equipment, can be considered.For equipment in use, evaluate the cost/benefit of the application and make sure the equipment is still needed. Identify opportunities to reduce the in-use time. For example, by changing processes, certain equipment (e.g., lab equipment) may be able to be shut down periodically. Finally, evaluate redundant equipment to ensure it is still appropriate. If equipment has standby power levels, are they enabled? Evaluate whether equipment can be shut down when not in use and, if possible, unplug the equipment to eliminate standby power.Embedded energy is the total energy required to manufacture equipment, from mining to arrival at your site. You can help reduce this during acquisition by considering the embedded energy in prepurchase evaluation. Although this information may be difficult to obtain at that point, I suspect it will become more important in the future. Question whether alternative technologies exist that consume fewer resources. Also, include the operational embedded energy of consumables in the prepurchase evaluation.Reduce capital expenditure and your inventory by using location services (radio-frequency identification) to minimize the overpurchasing of equipment. If possible, share equipment rather than purchase additional items. Obtain or purchase used equipment.Finally, extending the life of assets is probably the greatest opportunity to reduce embedded energy, and HTM is a key partner in enabling this to happen.Through the management of replacement parts, you can reduce energy by stripping parts from retired assets for reuse, purchasing used/refurbished parts when possible, using ground shipping whenever possible, and optimizing parts stocking to reduce shipping costs and emissions. You can also reduce the energy intensity of field service maintenance by maximizing the in-house HTM service and combining service jobs when traveling.Because of their weight and frequent replacement, batteries are the biggest opportunity to reduce not only embedded energy but also shipping. The frequency of battery changes can be determined based on data and risk analysis, rather than blanket time periods. In addition, because batteries typically are replaced during scheduled preventive maintenance, there is plenty of time for ground shipping.You can maximize the value of your disposition program by working with the HTM department, local recycling vendors, and manufacturers. Reuse of equipment within your organization is the best use, not only for reducing energy but also for capital avoidance. If you can't reuse equipment, then remove the protected health information (PHI) and, in order of preference, trade it in, sell it, salvage parts (if needed), donate it, or recycle it properly.The biggest problem contributing to the early disposal of equipment is software obsolescence. Manufacturers need to make their systems less dependent on the software version, and the FDA needs to make it easier for manufacturers to upgrade operating system software versions.Donating equipment that is not functional or supportable is not a circular economy activity. In the case of overseas donations of what is essentially junk, a health and hazardous waste problem is created, as the recipients of the equipment frequently do not have the processes to properly recycle equipment. The results of one survey showed that in 2019, only 17.4% of electronic equipment waste in the world was collected and recycled.14Work with manufacturers, allied staff, and vendors to bring awareness of the need to conserve and recycle resources in the circular economy. This can be accomplished by sharing data and knowledge with peers/industry through white papers, conference presentations, and articles and publications, as well as conveying information to internal customers (hospital staff) via, for example, posters. Conducting energy audits of departmental or laboratory equipment is another opportunity to touch base with your customers and educate them.The greatest onus will be on the manufacturers to build equipment that lasts longer and can be fully recycled at end of life. Even in the best case, it will take years to develop these manufacturing processes and materials before they will begin to be reflected in new products. Various manufacturer practices will need to change, ranging from the raw materials they use, to the packaging and distribution of products, and potentially to the refurbishing of equipment. Other issues include end-of-life software and the removal of PHI. A comprehensive list of best practices is included in TIR65.Although it will transform our industry, incorporating the circular economy into healthcare can reduce the consequences of our current system.15 This transformation will require changes in user demand, new business models, and favorable regulatory action. This will need to exist in a “professional environment that values public health and sustainability as highly as individual patient safety,” said MacNeill et al.15The U.K. government is establishing regulations for “environmental sustainability and public health impacts, this includes the raw materials used and the recycling or disposal of medical devices.”16 Between climate change and resource depletion, these issues are not going away and need to be addressed in the U.S. more aggressively. The current article illustrates that this is not a fringe concern but is recognized by a wide variety of experts.Readers are encouraged to consider volunteering for the AAMI Sustainability Committee, to develop presentations on this topic for the AAMI eXchange annual conference, and to consult TIR65 for guidance.To continue to provide cost-effective diagnostic and therapeutic care for our patients, we need to embrace the circular economy for medical equipment. This will involve ensuring that resources are available both in the near term and for generations to come. As HTM managers and clinical engineers, hospital leadership expects us to be aware of potential future risks when they turn to us for guidance.As noted by Hagens,7 “We will not plan for this outcome—but we could react to it with airbags, social cohesion, an ethos and prepared blueprints based on intelligent (and wise) foresight.” We need to start developing the airbags and blueprints now—we can't afford to wait until the potential constraints in resource availability appear.

Context-Rich Medical Device Reports

Healthcare technology management (HTM) professionals and other clinicians can provide critical information to help the Food and Drug Administration (FDA) understand serious device issues from the hospital's perspective. By reporting context-rich adverse events to the FDA, HTM professionals help ensure that medical devices remain as safe and effective as possible throughout their use across the continuum of patient care. The medical device reports discussed in this case example were submitted to the FDA by HTM professionals and incorporated additional clinicians' observations. Key context in the medical device reports indicated the scope and relative degree of health hazard of a recurrent device malfunction and informed a class I recall classification for the device.

Survey: Open Positions and Untapped Diversity for Healthcare Technology Management

Survey: Open Positions and Untapped Diversity for Healthcare Technology Management

The Case for Medical Device Cybersecurity Hygiene Practices for Frontline Personnel

As medical devices and systems became more sophisticated over the past two decades, they began incorporating microprocessors, software, sensitive data, and connections to networks (including some to the Internet). These changes provided more features and greater versatility, collectively improving patient care, but they also resulted in a growing number of devices and systems with security vulnerabilities. Cyber adversaries simultaneously have become more sophisticated and more effective at taking advantage of these vulnerabilities with their attacks.Regulators, standards organizations, and industry expert groups all have been focused on developing the regulations, standards, guidelines, and tools necessary to identify and manage these new security risks. Examples of the aforementioned organizations and groups include the Food and Drug Administration (FDA), National Institute of Standards and Technology (NIST), MITRE, Healthcare Sector Coordinating Council (HSCC), Center for Internet Security (CIS), Health Information Sharing and Analysis Center (H-ISAC), Association for the Advancement of Medical Instrumentation (AAMI), International Organization for Standardization (ISO), American National Standards Institute (ANSI), International Electrotechnical Commission (IEC), and National Electrical Manufacturers Association (NEMA). Consequently, a wealth of resources are available on how medical device manufacturers and healthcare delivery organizations can adopt one or more frameworks to drive various aspects of their medical device/system security risk management programs.1However, one area that still gets little attention is the need for frontline staff (i.e., those who operate and those who provide technical support to medical devices/ systems) to know and exercise safe security practices. In fact, the greatest security exposure for the installed base of medical devices and systems is in how the medical device owners, operators, and technical support staff acquire, care for, operate, maintain, support, and eventually dispose of those devices/systems.Therefore, a critical element in any effective medical device security management program is the engagement of appropriate stakeholders in cybersecurity practices, education, and training.2Collectively, the cybersecurity practices followed by device owners, operators, and technical support staff are commonly referred to as cybersecurity hygiene (or cyber hygiene). Medical device/system cyber hygiene is defined as those practices that maintain security and reduce the device's/ system's and the organization's security risk and exposure. Cyber-hygiene practices are integrated into the organization's security management program through the establishment of policies, procedures, education programs, and compliance audits that are targeted at the organization's frontline staff.The following is a fairly comprehensive list of 20 interdependent practices that should be understood and followed by most frontline personnel involved in either the operation or support of medical devices and systems. If adhered to, these cyber-hygiene practices can go a long way toward preventing security-related compromises. Of note, although this list represents what are considered “leading practices,” any first-time implementation of a new process, practice, or tool should always be preceded with an assessment to verify whether the security benefit gained by the implementation is not offset by the introduction of significant care delivery, workflow, or safety risks.These cyber-hygiene leading practices (followed by the rationale supporting them) include: Keep any device operating system (OS), application software, third-party software, firmware, and security related configuration (e.g., antimalware software) up-to-date (i.e., use the latest version and vendor-recommended configuration).Outdated software with unpatched vulnerabilities represents one of the most commonly exploited vulnerabilities. Work with manufacturers to ensure available patches and updates are vetted by the manufacturer and that the patches/updates are overseen by healthcare technology management (HTM)/information technology (IT) security.Do not connect new memory devices (e.g., USB, SD cards, CDs, removable drives) to a device without first scanning them for potential security compromise.Malware inadvertently has been installed in medical devices because the media with the update also contained malicious code. Media should not be attached to or installed on a device without first scanning with a security application with up-to-date malware definitions to ensure the media is free from malicious code. Some organizations may choose to limit the use of external storage to sanctioned devices.Do not attach peripherals (e.g., storage devices, displays, chargers, printers, mobile phones) unless approved by the manufacturer and/or HTM/IT security.Peripherals can contain application code (including malicious code) that could install itself on a device. Installation of a peripheral or any code (particularly malicious code) from a peripheral can affect a medical device's performance adversely unless the device was specifically designed to attach to that peripheral.Do not install applications (e.g., music, games, utilities) on device unless approved by the manufacturer and/or HTM/IT security. This also includes applications and agents that are commonly used for IT endpoint management purposes but may not be approved/appropriate for use on the medical device.Medical devices often use modified versions of OSs and software. Installation of applications not designed for a medical device can add vulnerabilities and cause unintended and unexpected results when installed on a medical device running a modified OS or software. Installation of applications not designed for a medical device also can significantly increase exposure to security risks, as well as compromise the device's performance.Do not use email applications (including web-based email) or other communication applications on devices unless the manufacturer intended the device for email or communications use. If the manufacturer intends the device for email use, do not open mail, mail attachments, or URLs from unknown sources.Opening mail from unknown sources, opening unknown attachments, or clicking on URLs to unknown locations can result in the download of malware that exfiltrates sensitive data, destroys data, or encrypts data for ransom on the device and potentially on its connected network or that hijacks the device's operation.Do not use browsing applications on a device unless the manufacturer intends the device for browsing or the browser is required for operation of the device (e.g., accessing operating instructions). In addition, when the manufacturer intended the device for browsing, do not visit websites (URLs) unless approved by the manufacturer and/or HTM/IT security.Surfing the web and visiting unapproved websites can result in the download of malware that can exfiltrate sensitive data, destroy data, or encrypt data for ransom on the device and potentially on its connected network or that can hijack the device's operation.Do not connect to unknown or unsecured networks (wired or wireless) without using a VPN (virtual private network) application (or other secure connection technology) or obtaining approval from HTM/IT security.Connecting to an unapproved or unknown network can expose the medical device to device hijacking or introduction of malicious code.Use unique and strong passwords (never default or common passwords) for each individual user and use multi-factor authentication when possible or when required (e.g., for remote access or high-privilege access). Coordinate password change processes with HTM/ IT security and relevant stakeholders.Continued use of default passwords after initial installation and configuration can lead to use by unauthorized individuals who have looked up the manufacturer default. The use of shared or common passwords contributes weak security— where someone who is no longer authorized can still use the common password. Strong, unique passwords with multifactor authentication (e.g., use of a token or texted “security code”) are ideal.Limit device access to only authorized personnel and use role-based access to limit authorization to personnel based on the level of their need to access device functions.Use- or role-based access ensures that clinicians can only access “clinical” functions, technical support can only access “diagnostic/troubleshooting” functions, and administrators can access the master controls for security (e.g., creating roles, assigning users).Backup data, applications, and configurations regularly and verify the integrity of those backups.Data and applications can be lost due to device failure, corruption, erasure, malicious encryption (e.g., ransomware). Backing up frequently and staggering backups can protect data from catastrophic loss and can speed up recovery. Verifying the integrity of backups ensures data are, in fact, backed up properly and suitable for restoration. Backup processes should be compliant with all relevant recovery, privacy, and data retention requirements.Use a strong encryption protocol for data “in transit” (e.g., WPA3) and data “at rest” (e.g., on storage media) whenever possible. Prior to the initial implementation of any encryption protocol, confirm that it does not affect workflows or system performance unacceptably.Use of “strong” encryption can prevent compromise of sensitive data.Segregate vulnerable systems on to separate (isolated) networks and use firewalls (for network segments and/or individual devices as appropriate).Segregating medical devices (particularly those with significant vulnerabilities) on networks that have firewalls and fewer vulnerability exposures (based on the nature of other devices on the network and other network elements).Lock down, disable, or physically block hardware ports (e.g., USB, SD, HDMI, ethernet, proprietary test ports) and network ports (e.g., TCP/UDP ports) not needed for intended use on the device or system.Unused ports can be exploited by an attacker or by malicious code. Unused ports should be physically locked or configured as unavailable.Physically secure devices by locking away or “permanently” mounting to prevent theft of a device or the sensitive information (e.g., protected health information [PHI], individually identifiable health information [IIHI]) it may contain.When possible, medical devices accessible to unauthorized personnel should be physically locked away to prevent unauthorized use or, where appropriate, physically mounted to prevent theft.Use a real-time location system (RTLS) to track and locate devices containing sensitive information (e.g., PHI, IIHI) where appropriate.RTLSs can track and locate medical devices within and potentially outside a facility. For particularly sensitive and “portable” devices, a tracking/locating system can help in quick retrieval.Consult with HTM/IT security before selecting and acquiring a new medical device that utilizes microprocessor(s) or runs software.Security issues should be considered prior to acquiring new microprocessor-based medical devices. HTM/IT security should be given the opportunity to obtain an MDS2 (Manufacturers Disclosure Statement for Medical Device Security) form and ensure the new device can securely operate in the planned environment.Do not connect a new device (e.g., purchased, leased, loaned) or a device returning from a repair provider to the network until that device has been configured for secure operation and scanned for malware.Devices that have not been in continuous possession of the organization may not have an optimum security configuration and therefore may be more vulnerable to compromise. Those devices may also have acquired malware and should be scanned by HTM/IT security before connecting to the network.Discontinue use, discard, or replace (with HTM/IT security's support) any devices/systems with known vulnerabilities when they can no longer be updated or patched in a manner that eliminates or sufficiently reduces those vulnerabilities (or if external protective measures, such as network segmentation or firewalls, are not practical or sufficient).Some devices may have significant vulnerabilities that cannot be easily or effectively mitigated. Eventually, these devices will likely have to be removed from service, discarded, and potentially replaced.Remove sensitive data (e.g., PHI, IIHI, personally identifiable information, user and network credentials, research data) from any devices before discarding or transferring to new owners and document any data removal.Prior to disposal or transfer of devices, any sensitive data must be permanently removed by a process approved and overseen by HTM/IT security.Report unusual or unexpected device operation to HTM support services.Any unusual or unexpected device operation should be reported immediately to HTM services to determine whether there is a technical problem with the device—or whether there may be a cyber compromise.The security of medical devices will remain a major focus of healthcare providers for the foreseeable future. To remain relevant, all medical device owners, operators, and technical support staff must stay up to speed on the concept of medical device cybersecurity and associated cyber-hygiene practices.Although the importance of these medical device/system cyber-hygiene practices cannot be understated, their existence will have little effect unless all appropriate stakeholders (e.g., device owners, operators, tech support) are educated on and adopt them. The security chain is only as strong as its weakest link, and it only takes one stakeholder's one-time failure to learn and practice appropriate cybersecurity to result in a major cyber compromise.Cyber vulnerabilities and threats continually evolve, which means cyber-hygiene practices must also evolve to address those vulnerabilities and threats. Any new cyber-hygiene practices must also be passed on to and practiced by relevant stakeholders. Therefore, the process of updating cyber-hygiene practices, educating stake-holders, and auditing their compliance must remain ongoing.If you haven't already realized it, the security of medical devices will continue to be a major focus of healthcare providers for the foreseeable future. For any device owner, operator, or technical support professional hoping to remain relevant, this is the time to ensure you are up to speed on the concept of medical device cybersecurity and associated cyber-hygiene practices.

Ten Lessons Learned During the Pandemic From the Healthcare Technology Management World

Ten Lessons Learned During the Pandemic From the Healthcare Technology Management World

Assessment of Computerized Medical Equipment Management and Maintenance System From Health Technology Assessment (HTA) Perspective: Need and Approach

Appropriate management of medical equipment is of crucial importance for providing quality healthcare. A computerized maintenance management system (CMMS) is a computerized program used by healthcare technology management (HTM) systems as an instrument for maintaining, organizing, storing, and reporting the data related to medical technologies in health facilities. Though CMMS is introduced as a beneficial and flexible tool for transforming the management of biomedical equipment, but no evidence of the same has been documented yet to highlight the efficacy of CMMS in the Indian context. CMMS, an e-Health system used by HTM programs, is a relatively new technology being adopted by various states of India. Such systems are vital to judging whether the system is operating and delivering the effects as desired. Assessment not only can inform policy-makers about what is known about the technology, but it also provides a better knowledge of the strengths and weaknesses of the intended technology. Health Technology assessment (HTA) is a systematic process designed to synthesize and evaluate the prevailing evidence for treatment or health delivery innovation. So considering the HTA perspective, an assessment approach to CMMS could be planned. Systematic reviews and empirical frameworks that have been used for understanding and assessing e-health programs can be used for evaluating technologies. Assessment of CMMS from a HTA perspective should be vital to the implementation of HTM systems by healthcare agencies.

Healthcare Technology Management Professionals Are Influential for Device Safety and Reliability

Healthcare Technology Management (HTM) professionals are key stakeholders in the medical device ecosystem. When HTMs report medical device concerns to Food and Drug Administration (FDA), they contribute to patient safety, as FDA ensures that medical devices remain safe and effective throughout their use across the continuum of patient care. The HTM's perspective provides valuable context and insights to medical device problems and can lead to device improvements. We present a device concern reported to FDA by HTMs and analyze the strengths of each report. The HTM's perspective, shared clearly and thoroughly, resulted in improvement to the device design to mitigate a recurrent malfunction.

US Food and Drug Administration Seeks Input From Healthcare Technology Management Community on Medical Device Supply Disruption During COVID-19 Pandemic.

The US Food and Drug Administration (FDA) is currently seeking information from the clinical community about existing and anticipated disruptions in the supply of medical devices related to COVID-19. This information is important to FDA's fulfillment of its mission to ensure that healthcare providers and patients have continued access to safe and effective medical products. Insights from the clinical community, including clinical engineers and biomedical equipment technicians, bring device supply issues experienced on the front lines to FDA's attention so that the FDA can develop effective strategies to prevent and mitigate medical device supply concerns in its continued response to the COVID-19 public health emergency. Here, we describe the public health impact of the clinical perspective and the type of information that the FDA is seeking regarding current or anticipated medical device supply concerns. Information about how to have your voice heard on this important matter is included at the end of this article.

Bright Ideas: HTM Team Realizes Major Time Savings by Devising the AEM 'Holy Grail'.

Alternative equipment maintenance (AEM) is supposed to make the lives of healthcare technology management (HTM) professionals easier. In hospitals, where tens of thousands of devices need to be monitored and maintained, AEM strategies help busy staff save time and focus on what matters: ensuring the efficacy of devices and safety of patients. However, therein lies the rub with adapting any AEM strategy: In a busy hospital environment with countless devices, when will managers have time to build a new strategy from the ground up, let alone implement it?Blake Collins, director of clinical engineering at ChristianaCare in Newark, DE, pulled off just that. The secret, he said, is to “shamelessly borrow” great ideas and, with help from the right people, make them shine even brighter.Collins has been fascinated by alternative maintenance strategies for a long time.“If you remember, airplanes were dropping out of the sky in the 1960s and -70s. It was alarming! So, airlines created what is called reliability centered maintenance,” he said.In the early 1960s, airlines and the Federal Aviation Administration launched an intensive assessment of aircraft servicing practices. They discovered that many of the “lifetimes” for parts that had been outlined by aircraft manufacturers and their design engineers were wildly inaccurate. It was also suspected that much of the regularly scheduled maintenance that was being done at the time was causing more harm than good. The result was a transition to less frequent but far more informed and effective maintenance. Suddenly, far fewer commercial jets had problems.This real-world lesson stuck with Collins, who saw parallels between the maintenance practices of yesteryear's airlines and the hospital HTM practices of today.“A good example is an oto/ophthalmoscope,” said Collins. “There's a basic electrical safety check, which was pushed by National Fire Protection Association 99, that everyone does to ensure you don't get shocked when you pick up the device. But the thing is, there's no need to continue doing that kind of maintenance anymore because advancing technology has eliminated that risk.”Collins pointed out that, although the result is not as dramatic as planes falling from the sky, unnecessary or excessive maintenance on a medical device takes up time and creates new risk. Every time the device is taken apart for routine maintenance, there is a risk that a part will fail or a mistake will be made.Thankfully, risk assessment is what AEM is all about. Instead of relying solely on a manufacturer's recommendations, AEM strategies consider a hospital's unique risk factors before choosing to follow those recommendations or change the strategy for how a device is maintained.“With enough data, you can account for your own inventory, your own environment, and your own maintenance-related failures to determine the risks you take with each device. Based on that, you come up with your unique maintenance schedules,” Collins said.Of course, this is easier said than done. Another Collins, National Institutes of Health Director Francis Collins, pointed out that thanks to modern technologies, “we're all struggling with the wonderful problem of having too much data.”1When data from tens of thousands of medical devices are being generated every day, how do you distinguish the meaningful from the noise? How do you account for it all?“I can't take credit for this part of the idea at all,” said Collins, laughing. “I went with my team to a conference sponsored by AAMI where Matt Baretich and Frank Painter were talking about AEM. Matt had recently published this new guideline, and he and Frank were answering all the questions we had been struggling with.”Baretich, president of Baretich Engineering, has been consulting on HTM-related matters for more than three decades. Painter, a retired program director and adjunct professor at the University of Connecticut, has likewise spent decades focusing on improving the education and workflow of HTM professionals. Painter received the AAMI Foundation &amp; ACCE's Robert L. Morris Humanitarian Award earlier this year.2 The duo spent the greater portion of 2019 running AEM workshops to help trepidatious directors like Collins make sense of AEM factors and terminology.“When I first started thinking about AEM programs a few years ago, I was—to put it bluntly—not impressed,” Baretich, recently admitted in an AAMI blog post.3When he began researching AEM, Baretich quickly discovered several different interpretations for what even the acronym AEM stood for. It was a bad first impression for an already confusing topic.“When Steve Campbell, AAMI's chief operating officer, asked me to write what became the AEM Program Guide, I agreed because I like the idea of trying to make sense out of nonsense,” Baretich said. “Then I fell in love. Not head-over-heels in love, but step by step. … I fell in love with the idea that sound AEM principles, carefully considered, really do give us tools for evidence-based maintenance—that holy grail we've been seeking lo these many years.”After learning about it, the AEM Program Guide4 became the foundation for Collins' personal HTM holy grail.“Matt's guide is a simple form that breaks down the whole process,” said Collins. “It frames this concept of risk assessment into a series of check boxes and a quick mathematical formula. It's pretty incredible!”However, even with the mysteries of AEM solved, Collins and his team were still in a bind. ChristianaCare is no small entity. It consists of three hospitals and a free-standing emergency department. Collins said that he and his team manage nearly 40,000 medical devices, “and that's just a ballpark figure. We have new devices being added fairly frequently.”To adapt to an AEM program, Collins and his team had to come up with classes and subclasses for every piece of equipment. Likewise, they had to repeatedly plug years of data points into Baretich's formula. They had a plan, which was an enormous step forward, but they still expected it to be many months before they would have a fully optimized AEM strategy ready for all their eligible equipment.“We had long meetings lasting a couple of hours scheduled every week between all the supervisors and managers, just to sort through all our department's maintenance reports,” Collins said.They were preparing for a long haul—the better part of a year. And yet, only a couple of months later, Collins and his team had a fully automated AEM system at their disposal.A watershed moment occurred when Collins was thinking about a different workplace update.“Timing and opportunity played a part,” Collins said. “We were in the middle of updating our computerized maintenance management system (CMMS) database when I thought, ‘Why don't I see if we can build a new risk system with them? Since we're already gathering all this data and defining asset types or model, maybe I can cascade all of that down and put it into Matt's formula with the push of a button.'”Kyle Holetz, an advisory solution consultant for Nuvolo, was helping ChristianaCare set up its new CMMS when Collins pitched his idea.“At first, I thought it may be a bit too much to manage as simply as Blake made it seem,” Holetz admitted. “But we were able to break each element of the AEM decision tree down into bite-sized pieces and brought them into the product in a connected and streamlined fashion.”Holetz realized that Collins wasn't trying to reinvent the wheel. With Collins' preexisting close codes (representing the results of finished maintenance), he and the Christian-aCare team were able to prioritize the kinds of AEM decision making that could fit snugly into the configurations of Nuvolo's out-of-the-box workplace platform.“This let us think creatively about the problem and how to operate an AEM program from the tool, while avoiding costly and hard-to-maintain custom development,” Holetz said.The result was an extremely streamlined way to keep all of the data necessary for evidence-based maintenance decisions up to date at regular intervals—and all with the push of a button. Heidi Horn, vice president for global enablement-healthcare at Nuvolo, was particularly impressed.“By utilizing AAMI's AEM Program Guide as an accepted process and automating the required analysis within Nuvolo, Christian-aCare was able to implement a fully compliant AEM program that requires minimal administrative work to manage,” she said. “Nuvolo also thought it was a great initiative, so with some enhancements, we've now made this functionality core in our product so that our other clients can more easily implement an AEM program.”For Collins, he and his team finally have the AEM “holy grail” others dream about.“I was doing some of the legwork for the manual strategy, and I've got to tell you, it was painful,” said John Learish, a manager in the clinical engineering department at Christian-aCare. “Going through countless work orders and individually trying to understand them and categorize them was immensely time consuming. Now, it's just the click of a button and you're off and running. Then, we can monitor the decisions being made based off the system's risk scores.”That, of course, is still an important duty. For all his love of AEM, Collins was quick to point out that it's not always appropriate for a piece of hardware. Imaging radiology devices, for instance, have strict regulations in place for how they are safely maintained. Collins' team must manually exempt these devices from being placed on an AEM schedule.The time they're saving has also allowed the ChristianaCare HTM staff to stay at the top of their game. Lisa Carr, a supervisor in the clinical engineering department, spoke of a recent merger with Union Hospital in Elkton, MD, as a prime example of this.“When you take a new building with new staff into a system, they have their own way of doing things. We have to translate what they're doing into our system before we can optimize their maintenance schedules,” she explained. “With everything automated, that process has become much more streamlined.”Instead of requiring Union's staff to slowly scrub through years of data, manually making sense of their old reports in the lens of an unfamiliar AEM formula, Collins' staff was able to extract the data that were needed. They fed it wholesale into the new automated system for risk evaluation and maintenance scheduling.“Suddenly, the new staff is facing fewer time constraints. That frees them up for training and improved performance,” said Carr. “That's how we're putting value back into the tank.”“People always like to say that nurses have to work at the top of their license,” said Collins. “I want my folks to work at the top of their skill set, their certification, and really drive improvement for patients, physicians, nurses ... everyone.”

Ask The Joint Commission.

The sterile supply and equipment spaces in our ambulatory surgery center (ASC) currently are experiencing growing pains due to our success. We do not have enough space for the extra sterile supplies or equipment we acquired in the last two years. Therefore, we are looking into extra space in our office building for storing equipment, extra custom packs, and medical supplies. This space will be dedicated for storage and will not be in the ASC footprint; therefore, it mainly will be a warehouse area. Do any concerns exist for keeping product off site?As long as the organization meets the design requirements of the local authority and maintains the proper ventilation requirements for sterile storage, they will be considered compliant.What is required to be presented regarding X-ray equipment during a TJC survey?Typically, on day one of the survey, the surveyor will provide a list documents for review. Be sure to respond exactly as requested. Your medical equipment management plan, equipment inventory, and maintenance history records should always be ready for review. Because most records are now electronic, be sure that more than one person can run all your management reports. You want to avoid a citation for lack of documentation due to one person being unavailable.For several reasons, alternative equipment maintenance (AEM) is not being accepted at our facility to the extent that it should. For example, legal said “no way” because they are hesitant to depart from manufacturers' recommendations. This is not a valid or quantifiable reason. Some third-party companies see AEM as revenue reduction. What are your suggestions for changing this?A successful AEM program requires acceptance and “buy-in” from your key stakeholders. A data-driven proposal, including a risk assessment based on your historical services records or from another credible source, may help to support your argument. Your AEM strategy must not reduce safety and must be based on accepted practice standards. Your challenge is to prove this to key stakeholders with a defensible program.Why do TJC surveyors not follow the tracer methodology when end users report to a surveyor that “a device is broken and healthcare technology management (HTM) hasn't fixed it”? We have had several surveys where TJC surveyors are told a device is “broken” and that “it has been broken for a long time”; however, no surveyor has taken down the HTM control number for the device and either requested the repair history records or gone to the HTM department to ask questions specific to the repair of that device (e.g., Was a work request submitted? Was a work order created? What was the resolution?). Usually, the report is returned to leadership with a “finding” noted and a description along the lines of “the infusion pump in inpatient was reported as broken and not being repaired,” with no reference as to which one of the hundreds of portable infusion pumps was allegedly at issue. This prohibits HTM staff from appropriately researching and responding to the alleged problems and/or providing documentation regarding the allegation that the device is not being maintained/repaired.The tracer methodology is the process used during the on-site survey to analyze an organization's systems or processes for delivering safe, high-quality care by following an individual patient or resident through the organization's care process in the sequence experienced by each individual. Feedback received from staff is recorded as an observation of finding. Depending on the severity of the comment, the surveyor may or may not choose to investigate further. During the course of a survey, organizations may address the circumstances surrounding the discovery of an item that is out for repair.In this department, The Joint Commission (TJC) answers questions posed by AAMI members. Become part of the discussion by visiting www.aami.org/communities and joining AAMI's Joint Commission Discussion Group, which is open to all AAMI members. Some of the questions and answers may have been edited for space, style, and clarity.