Cover Story: ECRI’s List of Tech Hazards

Posted By: K. Richard Douglas on: April 10, 2016 In: Cover Story, Feature Slider, Magazine

By K. Richard Douglas

A January 2015 article in USA Today detailed several incidents of fatal illnesses in Seattle, Pittsburgh, and Chicago related to a superbug bacteria known as Carbapenem-resistant Enterobacteriaceae (CRE). The bacteria is of real concern to medical professionals because it resists even “last defense” antibiotics, according to the story. In each case, the investigation of the source of the deadly bacteria turned out to be a specific type of Endoscope used on a half million patients annually.

Conventional cleaning of these endoscopes proved to be insufficient to remove all bacteria. This problem leads ECRI Institute’s list of the “Top 10 Health Technology Hazards for 2016.” ECRI points out that flexible endoscopes, and duodenoscopes in particular, are constructed in such a way that makes thorough cleaning difficult. The proper reprocessing of these scopes is critical to the well-being of patients. Biologic debris must be removed prior to sterilization or disinfection. The need for this pre-cleaning step is just one area of concern identified by ECRI Institute in this year’s list.

ECRI Institute’s Health Devices Groups says that the list “identifies the potential sources of danger that we believe warrant the greatest attention for the coming year.” ECRI points out that the list does not necessarily reflect the most frequently reported problems, or those with the most severe consequences, but instead those issues demanding the most immediate attention.

Besides the concerns about flexible endoscopes, the list also includes:

  • Missed Alarms Can Have Fatal Consequences
  • Failure to Effectively Monitor Postoperative Patients for Opioid-Induced Respiratory Depression Can Lead to Brain Injury or Death
  • Inadequate Surveillance of Monitored Patients in a Telemetry Setting, May Put Patients at Risk
  • Insufficient Training of Clinicians on Operating Room Technologies Puts Patients at Increased Risk of Harm
  • Errors Arise When HIT Configurations and Facility Workflow Do Not Support Each Other
  • Unsafe Injection Practices Expose Patients to Infectious Agents
  • Gamma Camera Mechanical Failures Can Lead to Serious Injury or Death
  • Failure to Appropriately Operate Intensive Care Ventilators Can Result in Preventable Ventilator-Induced Lung Injuries
  • Misuse of USB Ports Can Cause Medical Devices to Malfunction

“Some of the most obvious resources for addressing these concerns are the hospital IT and biomed/clinical engineering departments. If the concerns and steps listed previously are going to be addressed and utilized, these two departments are going to need a good working relationship.”

The ECRI Institute considers several criteria when forming its list. Those criteria include severity, frequency, breadth, insidiousness, profile (is it publicly known) and preventability. Nominations for the list come from ECRI Institute’s own engineers, scientists, clinicians and other patient safety analysts.

These experts base part of their nominations from investigating incidents, testing medical devices, speaking with other health care professionals, observing operations, assessing hospital practices and reviewing the literature, according to ECRI.

There should be a preventable element to any item that makes it on the list. ECRI also says that the absence of a topic from a previous year should not be perceived as any indication that it is a hazard that no longer deserves attention.

Continue reading …

Evidence-Based Maintenance Is CE’s Moonshot

Published on April 8, 2016

Binseng Wang

A little over 50 years ago, reacting to the Soviet lead in the space race, President Kennedy decided to rally the nation with the moonshot. He justified his decision to the American public by stating, “We choose to go to the moon in this decade and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win, and the others, too.”1

While landing a man on the moon in itself did not yield many tangible benefits aside from a psychological win for the American public, the moonshot brought an unprecedented advance in science and technology, as well as economic growth. Almost everything that we consider indispensable today can be traced back to the moonshot—such as solid-state electronics, satellite communications, and GPS, as well as most medical monitoring, telemedicine, and imaging technologies.

Today, the clinical engineering (CE) community faces a similar challenge. After decades of effort in dispelling the initial false alarm of electric shocks and developing rational methods to improve equipment maintenance at lower costs, CE professionals were able to attain a much lower maintenance-related failure rate than the Six Sigma quality level sought by world-class manufacturing companies.2 Yet, in 2011 the Centers for Medicare & Medicaid Services (CMS) released a new set of maintenance requirements with little, if any, rationale, demanding blind adherence to manufacturers’ recommendations.3

As a token of recognition to the CE community’s achievements and after intense lobbying, CMS agreed in 2013 to allow us to adopt an alternate equipment management (AEM) program for certain equipment (except lasers, imaging, and “new” equipment) if the hospital can provide evidence that it is “safe and effective.”4 Ironically, such a requirement does not exist for equipment manufacturers. While the Food and Drug Administration (FDA) does require manufacturers to prove their products are safe and effective before marketing, it does not require their maintenance recommendations be proven “safe and effective.” FDA only requires that “[w]here servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.”5

Since the publication of the CMS mandates and subsequent revision of the standards by its accreditation organizations, including The Joint Commission (TJC), many organizations adapted their “risk-based criteria” to fit the new requirements and redefining risk to conform to the terms “critical” (or “high-risk,” per TJC). In doing so, some CE departments even continued to exclude “low-risk” equipment from their maintenance inventory, in spite of the explicit requirement from CMS to include all equipment.4 Few have thought about how to collect evidence to prove that their AEM programs are safe and effective. Two data-based methodologies have been developed that can prove alternative maintenance strategies are as safe and effective as those recommended by manufacturers. They are reviewed below.


  • Reliability-Centered Maintenance

  • Introducing EBM

Continue reading. . .

Source: 24×7 Magazine

Healthcare Technology Management Week

2015 HTM Week Winners
The Healthcare Technology Management Team at the Ann & Robert H. Lurie Children’s Hospital of Chicago are the 2015 HTM Week winners.

This annual celebration is designed to promote the awareness of—and appreciation for—the critical work of biomedical equipment technicians (BMETs), clinical engineers, and other members of the healthcare technology management (HTM) field.

So how can you celebrate? As you make plans for 2016, check out these ideas developed by AAMI’s Technology Management Council (TMC) to help you mark this appreciation week in your community or at your workplace.

  • Contest—Every year we host a contest for the best celebration of HTM Week.  Meet the 2015 winners on the right.
  • Free Posters Offered —Choose your favorite! Here are the posters offered in 2015.
  • Creative Ideas —A few ideas for celebrating HTM Week where you work.
  • Resources—These tools will help you get the festivities started.


Sponsored by the Technology Management Council


Two Generations, Two Unique HTM Perspectives


Healthcare technology management isn’t just one area of study, nor is it a single profession. The term includes hospital roles such as biomedical equipment support specialists, clinical engineers, and medical maintenance technicians. That said, we wanted to get two different perspectives on ever-widening field of HTM, and also showcase the diversity in field of engineering. Luckily we have just that with Baby Boomer Al Gresch and Millennial Alyssa Merkle.







Alan Gresch is VP of Client Success at Mainspring Healthcare Solutions. He has over 30 years of technology management experience in multi-hospital health systems, leading both clinical engineering and corporate system logistics teams. Before Mainspring, Gresch was the Corporate Director of Clinical Engineering at Aurora Health Care. Living in Wisconsin, he’s the father of six and grandfather of 10, who owns an RV and bleeds green and gold as a season ticket holder with the Green Bay Packers.

Alyssa Merkle interned at Mainspring Healthcare Solutions, graduated from the University of Connecticut with a BS in biomedical engineering, and is currently enrolled in UConn’s clinical engineering master’s program. Merkle has also been inducted into the Biomedical Honors Society (Alpha Eta Mu Beta). Originally from New Jersey, Merkle is a New England Patriots cheerleader, and in that role tipifies the saying, never judge a book by its cover.


How and when did you know you wanted to study biomedical engineering, what drew you to the field?

Merkle: My uncle, an electrical engineer, had always given me great advice. I sat with him one night and we just talked about my interests and what jobs I could see myself enjoying. He knew I was good at math and science so he immediately brought up engineering. Then we brought up the fact that I love helping people, and the field that emulated that trait of mine was biomedical engineering. After doing research about the field, I decided I wanted to try it in school and when I got to UConn and started learning more, I knew I had chosen the correct major. It combines the things I like doing best and it’s a field that will continue to grow, so I can continue to learn and develop with it throughout my career.

How has the HTM field changed since you first started your career, what was it like then versus now?

Gresch: Early in my career we were much more involved in the actual clinical application of technology. Fields like electrophysiology and cardiology diagnostics were in their relative infancy so in addition to doing equipment repair we spent a lot of time on the research side of things helping develop diagnostic tools and being right next to nursing staff in setting up and connecting equipment to patients. Also, my first CMMS was in the form of data cards printed from our hospital’s data center! Today there is a much greater need to manage projects and utilization of assets to keep costs at a minimum and still deliver exceptional care.

You’ve just finished your undergrad and are headed to grad school in the fall. How has your experience been so far, and what are you most looking forward to about continuing your studies?

Merkle: My experience at UConn has been amazing in terms of enjoying my major as well as appreciating all the other opportunities available at the school. Moving forward is going to be just as much fun, as I am starting a new chapter with clinical engineering. I liked the biomedical major and loved that the clinical side of biomedical engineering is even more focused on closely helping people. I was recently accepted into UConn’s master’s program for clinical engineering. The thing I am looking forward to most, is starting a new journey in a field that I can continue to learn and help people to the best of my ability.

What’s one of the biggest misconception in hospitals about HTM departments?

Gresch: A big misconception is that HTM departments are just fix-it guys. Many organizations fail to take advantage of the business benefits this group can bring to things like Capital Planning and Asset Management.

How do you explain the clinical engineering and healthcare technology management (HTM) field to your friends?

Merkle: I had a few friends in engineering fields such as biomedical, electrical, and chemical engineering. Besides that, I had a few friends in the business school, a few friends in the education program, and my best friend was in the nursing program. When I was explaining clinical engineering and HTM to them in the simplest way, I would tell them that we are the people that are the liaisons between patient safety and the device manufacturers. Of course, it is so much more and we are the people that make the hospital workflows function as efficiently as possible through database cleaning, different committee meetings, learning hospital workflow by being present in the hospitals, and implementing new plans to create a more effective and efficient environment overall.

What advice would you give to young professionals like Alyssa starting out in the HTM field?

Gresch: Reach for the stars! Learn as much as you can about the challenges facing your organization and how you can help through effective technology management and integration. In addition to developing strong relationships with nursing, get to know your finance, accounting, and IT groups and learn how you can bring value to them as well.


Source: Mainspring