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IP Stakeholders Series: Biomedical and Healthcare Technology


[To access the first installment of this series on the partnership between IPs and the C-suite, CLICK HERE]

By Kelly M. Pyrek

Healthcare technology that is poorly designed or implemented can contribute to patient harm, experts say, and health information technology (IT)-related patient safety events can go undetected.  As the adoption of healthcare IT becomes more widespread, clinicians must be on alert for increased risk of patient harm. One relationship that infection preventionists and other clinicians may not be cultivating as thoroughly as possible is with their healthcare institution's biomedical engineering and/or healthcare technology.

The timing is right to foster better relationships, as last month, significant changes to Joint Commission and Centers for Medicare and Medicaid Services (CMS) standards impacting the management and maintenance of healthcare technology in healthcare delivery organizations took effect. The changes impact preventive maintenance schedules and strategies, as well as the scoring of those activities by accrediting bodies, according to the Association for the Advancement of Medical Instrumentation (AAMI). The new Joint Commission standards were announced on July 1, 2014, and align with updated regulations from CMS issued on Dec. 20, 2013.

Stephen L. Grimes, FACCE FHIMSS FAIMBE, managing partner and principal consultant at Massachusetts-based Strategic Healthcare Technology Associates, LLC, explains that "Proscriptive clarifications (mandates) regarding medical equipment maintenance regulations were issued by CMS in December of 2013. TJC and other accreditors who have been given deeming status by CMS were subsequently obliged to change their standards to bring them in line with CMS. Evidence suggests these clarifications were made at the behest of an influential group of stakeholders. I have seen no credible evidence that suggests these 'clarifications' have any real impact on patient safety or quality of care."
In essence, acute-care hospitals must maintain an inventory of all medical equipment used in their facilities regardless of who owns it (rentals, loaners, etc.) and regardless of risk. As Grimes (2014) explains, "This will likely increase hospital inventories significantly, particularly as medical equipment is added that was previously considered of sufficiently low risk so as not to merit inclusion in a maintenance program."

Additionally, hospitals must follow medical equipment manufacturers' recommendations regarding maintenance procedures and frequencies if the equipment is diagnostic or therapeutic radiologic (including any ultrasound), if it is a medical laser, and if the hospital does not have access to detailed equipment service histories and has not analyzed those histories sufficiently to demonstrate a proposed change in maintenance procedures or schedules from manufacturer recommendations would have no adverse effect on patient or staff safety.

As Grimes (2014) notes, "Hospitals must obtain actual manufacturers’ maintenance recommendations for all medical equipment. These recommendations may not be immediately available in hospitals because they often previously relied on general industry guidelines and practices for their equipment maintenance methods. Hospitals must identify 'critical' or 'high-risk' medical equipment in their inventory (i.e., equipment where there is a risk of serious injury or death to a patient or staff person should the equipment fail). Focusing on 'critical' equipment, the new CMS and TJC requirements considerably broadens the number of equipment categories under special consideration."
Further, hospitals must obtain and monitor appropriateness of the credentials of all persons providing maintenance on medical equipment (including in-house staff and vendor and manufacturer staff) and for all persons (whether in-house or vendor) overseeing the hospital’s medical equipment management program.

As Grimes (2014) emphasizes, "It is extremely important hospital leaders and compliance officers become informed of these issues and work with those responsible for medical equipment management in their organizations to ensure an appropriate plan to achieve compliance is properly implemented. That plan should be comprehensive and include elements that help lay the necessary groundwork for compliance as well as guide the organization along a fiscally prudent and timely path toward that goal."

Stephen L. Grimes, FACCE FHIMSS FAIMBE, managing partner and principal consultant at Massachusetts-based Strategic Healthcare Technology Associates, LLC, says that "All stakeholders should constantly be reevaluating how each member of the healthcare team can allowed to maximize the benefit of their contribution to patient care." He adds, "The role that the new, often increasingly complex, technologies play in healthcare delivery suggests to me a rapidly changing environment where traditional relationships and ways of delivering care must be constantly reevaluated.  Through research and analytics, we are developing a much better understanding of underlying disease processes and developing technologies capable of more timely diagnosis and effective treatment. But this new knowledge and capability won’t have the desired effect if stakeholders haven’t developed a better understanding of how each member of the team can best use the technology and can best contribute to the delivery of quality and safe care."

Grimes says that while technology will continue to play a growing role in improving care, "the clinicians delivering direct care need to be encouraged to focus on care of the patient not worry about the various challenges associated with accessing and managing the technologies they’re dealing with.  It is the role of the healthcare care technology and information technology professionals to ensure those clinicians are getting the best technology support possible." He adds, "Healthcare technology management (HTM) and information technology (IT) professionals need to focus on ensuring clinicians delivering care have the right tools, for the right patient in the right place and at the right time."
Grimes emphasizes that when it comes to where clinical and health technology overlap, patient safety is everyone’s responsibility. "Healthcare is an increasingly complex environment. Safety and quality care are only possible when every member of the team collaborates on selecting, applying and maintaining today’s medical devices and when every member of the team also takes ownership of safety and quality issues. See something, say something!" 

That admonition is more critical than ever before, given the evolving sophistication of medical devices and equipment. "Medical devices are increasingly complex," Grimes says. "As with the evolution of mobile phones to today’s smart phone, medical devices have evolved to incorporate more capabilities and features and to increase connectivity. Patient monitors are capable of analyzing and displaying a wider range of parameters and are often connected to the hospitals electronic medical record. Surgical robots are capable of remote operation with extreme precision.  The proper use and operation of these medical devices can have a profound effect on patient care and safety. The increased complexity of new devices can also pose challenges to operators and those providing support services (like healthcare technology managers and IT). The operation of devices like these may not always be intuitive, new skills may be required of operators and supporters, and changes in workflow may be necessary if the devices are to be fully effective."

Regarding the new mandates, Grimes says clinicians can help by engaging healthcare technology management and IT professionals in decisions regarding the selection, deployment use and support of their medical devices. "Only through collaboration on these issues can today’s medical devices be safely and effectively applied," he says.
In early January, Grimes, along with George Mills from the Joint Commission, delivered an AAMI webinar, "Demystifying the Changes to Joint Commission and CMS Standards." During this webinar, Grimes and Mills helped participants understand the new requirements and share strategies for compliance. According to Grimes, the webinar provided participants with a better understanding of the new accreditation requirements associated with medical device maintenance as well as provided some guidelines on how best to meet those requirements through a thoughtful engineering approach.

In a 2015 Sentinel Event Alert, the Joint Commission underscored the safe use of health information technology, and outlined factors potentially leading to health IT sentinel events involving the following dimensions:
- Human-computer interface (33 percent) – ergonomics and usability issues resulting in data-related errors
- Workflow and communication (24 percent) – issues relating to health IT support of communication and teamwork
- Clinical content (23 percent) – design or data issues relating to clinical content or decision support
- Internal organizational policies, procedures and culture (6 percent)
- People (6 percent) – training and failure to follow established processes
- Hardware and software (6 percent) – software design issues and other hardware/software problems
- External factors (1 percent) – vendor and other external issues
- System measurement and monitoring (1 percent)

To address the problem, the Joint Commission advocates focusing on actions relating to three key areas: safety culture, process improvement and leadership. First, the Joint Commission (2015) advises healthcare institutions to create and maintain an organizational-wide culture of safety, high reliability and effective change management, with these characteristics:
1. A collective mindfulness focused on identifying, reporting, analyzing and reducing health IT-related hazardous conditions, close calls or errors.
2. A comprehensive systematic analysis of each adverse event causing patient harm to determine if health IT contributed to the event in any way.
3. Shared involvement and responsibility for the safety of health IT among the healthcare organization, clinicians and vendors/developers.
Second, the Joint Commission (2015) recommends the development of a proactive, methodical approach to health IT process improvement that includes assessing patient safety risks. To do so, the following elements can be used as part of a checklist to conduct a proactive risk assessment:
1. Make health IT hardware and software safe and free from malfunctions.
2. Make the use of health IT by clinicians, staff and patients safe and appropriate.
3. Use health IT to monitor and improve safety.
Third, the Joint Commission (2015) advises that hospitals enlist multidisciplinary representation and support in providing leadership and oversight to health IT planning, implementation and evaluation.


Grimes SL. New CMS & Joint Commission Regulations on Medical Equipment Maintenance: Taking the Smart Approach to Compliance. ABM Industries Inc. August 2014.

Joint Commission. Sentinel Event Alert: Safe use of Healthcare information technology. Issue 54. March 31, 2015.

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