More than 2,200 people attended the 2016 Association for the Advancement of Medical Instrumentation (AAMI) Annual Conference and Expo that was held June 3-6 in Tampa. AAMI provides both national and international consensus standards for the medical device industry, and six of the most talked-about topics at this year’s event follow below.

Medical Device Integration (MDI):
With hospital mergers on the rise, cybersecurity and network integration are quickly becoming issues. Facilities that are expected to integrate their virtual environment often use different network coding systems, proprietary networks and, in some cases, outdated equipment not designed to support wireless data transfer. Addressing this means more uniform coding, adapting older technology that cannot be readily replaced with the most current one and using middleware to allow different systems to communicate with one another. This is an expensive and labor-intensive process.

MDI is crucial to creating a network of seamless patient data transfer among devices. Older equipment still in use is often analog or not designed for data transfer, and current-generation digital devices cannot communicate with one another due to network differences. Standardization of coding is underway, but it is a lengthy process involving hospitals, vendors and regulatory bodies. Hospitals will also need to consider that networks will be reaching capacity as new technology is added and integrated into the system. This will necessitate moving to the next generation of wireless communication technology, known as Li-Fi. This light-based transmission has speeds upward of 200 gigabytes per second, nearly 100 times faster than currently available Wi-Fi.

Optimizing the cost of medical equipment:
As health care systems operate under increasingly shrinking budgets, providers must be savvy about finding cost savings. When it comes to medical equipment, the cost-saving process starts well before anything is purchased. Careful assessment of repair costs, life expectancy of equipment and availability of replacement parts should be considered to determine whether it is time to repair or replace.

MD Buyline strongly recommends that health care facilities adopt request for information (RFI) and request for purchase (RFP) forms. Part of the RFI process is being specific about who is responsible for the interface, including software and hardware. Customers should demand detailed information from the vendor about the overall product cost throughout the product use. Repairs and scheduled maintenance, in addition to the final purchase price, need to be negotiated before the finalization of the purchase. If these terms are not satisfactory, options such as third-party servicing, certified pre-owned (CPO) or demonstration units, or buying directly from the manufacturer could offer savings.

A large number of third-party repair companies at the conference were offering a variety of services. These included a simple mail-in repair on an “as needed” basis, a subscription format with a fixed monthly cost and all-inclusive repair and exchange options, complimentary in-services and brand new OEM equipment sales. When trying to determine whether the cost for service is fair, one AAMI presentation targeted the average replacement value method, which divides the replacement costs by service cost and provides the user with a percentage with which to compare costs.


FDA Initiative on third-party repair: The market for third-party service and refurbishment vendors has grown steadily as providers look to cut costs. However, concerns have arisen throughout the years about just how qualified third-party organizations really are when it comes to servicing and repairing equipment. One study presented at the conference reviewed millions of MAUDE reports throughout the past 10 years and found very little data to support the concerns by original equipment manufacturers. However, the FDA has stated it plans to review the existing data in October 2016 and determine the appropriate course of action, if any, to take.

Flexible scope cleaning:
According to a study presented at the conference by the Osaka University Hospital and Tokyo University Hospital, flexible endoscopes, dental hand pieces and robotic instrumentation (e.g. EndoWrist) are among the most difficult equipment to clean properly. Because of this, the infection rate for these instruments is high.

This prompted the staff of the university hospitals to conduct a study to determine the culprit for the issue. The difficulty of cleaning is a well-known problem and resulted in a voluntary FDA recall of Olympus duodenoscopes in January 2016. Endoscopes’ inner channels are coated with polytetrafluoroethylene (PTFE) known as Teflon.

As the Japanese study trials showed, PTFE is highly hydrophobic and resistant to protein and carbohydrates adhesion. However, it does not prevent lipids from sticking. The design of the biopsy channel and tip elevator, along with inadequate personnel training, variability of cleaning solutions and automation of the cleaning process, contribute to poor disinfection outcomes. The findings of the Japanese trials serve to emphasize the need for proper manual cleaning with brushes by qualified and certified staff. They also suggest that the cleaning process should be taken one step further, from high-level disinfection to sterilization to optimize infection control and cross-contamination.

Alarm management:
Alarm management continues to be an ongoing problem for hospitals and health systems, and currently, the Joint Commission does not specify how best to achieve patient safety goals related to alarm management. It also does not specify or endorse a specific process or model, though various models exist that have guided facilities in framing their process to improve alarm management. These models include guidance on how to determine, apply, manage and measure the effectiveness of alarm settings embedded in medical devices.

However, due to a lack of evidence-based data, improvements are difficult to quantify and sustain. Changes in alarm settings are difficult to measure because capturing data is labor intensive and potentially costly when opting to integrate middleware. There is also little data to support staff in making decisions related to customizing alarm parameters.

The good news is that technology is emerging to capture alarm data to make patient care environments safer through an evidence-based approach. This new technology also has the capability to transfer alarm data directly to the caregiver for immediate awareness and action. These alarm metrics allow the multidisciplinary team to make evidence-based recommendations for changes in standardized alarm settings, which will, of course, vary by clinical unit.

However, technology is not the only component of alarm management. Major sociotechnical and cultural differences exist among health care providers, clinical support staff, patients and departments, such as biomedical engineering and IT. The Joint Commission expects hospitals to provide a systemic and multidisciplinary approach in framing and sustaining alarm management. Engagement and commitment at all levels of the organization, starting with executive leadership, are necessary for an effective alarm management program to flourish.


Bridging health care technology management (HTM) with IT and risk management:
The integration and interoperability of medical devices have created a need for an HTM-IT collaboration. Historically, these two have been separate and independent departments. With the increased complexity of medical device design and functionality, it is impossible to delegate the maintenance and repair to just one discipline. Biomedical engineers must have at least basic IT knowledge, and IT teams must be willing to take initiative to assist and guide the clinical engineers. Although there are college degrees available that combine the HTM and IT skill set, until these hybrids fully replace the current workforce, a new kind of working relationship and cultural change must take place to ensure a high-quality, cost-efficient and timely workflow to help improve patient safety.

Risk management also needs to develop a relationship with biomedical engineering and IT. The sheer amount and complexity of technology in daily workflow and patient care means there is an increased opportunity for technology and systems failure. This necessitates risk management, including HTM and IT in root cause analysis and failure modes, and effects analysis. The insight that could be garnered when including an engaged, eager biomedical team is invaluable. Although roles and scopes are departmentalized, it is crucial for executive leadership to set this cultural expectation, specifically through example, in order to eradicate cultural differences between departments that can directly and indirectly impede optimum patient care.

About the authors: Jamie Williams, BSN, RN, is a clinical analyst at MD Buyline with over 10 years of nursing experience in intensive care and post anesthesia care. James Laskaris, EE, BME, also works at MD Buyline as an emerging technology analyst with over 30 years of experience in the field of biomedical engineering and health care. Lidia Chelkowska, BSN, RN, is a clinical analyst with MD Buyline, specializing in surgical technology.