November 16, 2016

0 Comments

William Hyman: What Do FDA Inspections of Hospitals for MDR Compliance Tell Us?

Medical device reporting (MDR) is mandatory for hospitals and others captured under the definition of “device use facilities,” which does not include physician offices. Also subject to mandatory reporting are manufacturers for which this is a well-entrenched activity. The three categories of device-related events that must be reported are deaths, serious injuries, and, for manufacturers, […]

Continue reading...

November 14, 2016

0 Comments

James Piepenbrink: I’m Not Just a Clinical Engineer; I’ve Been a Patient, Too

For 36 years, I worked at two major teaching hospitals in Boston. I have been on a cancer ward, in an infusion center, inside an MRI and CT scan, in the OR and PACU, the ER, the cardiac ward, the cath lab, and other diagnostic areas—not only as a clinical engineer, but as a patient. […]

Continue reading...

November 10, 2016

10 Comments

Donald Armstrong: What Makes a Great Biomed?

During a recent discussion with several respected biomed colleagues, the topic of certification came up. There was mix of certified and noncertified biomedical equipment technicians at the table, some with bachelor’s degrees and others with associate’s degrees. We considered a couple of questions: “Does being certified make you a better biomed?” Would you choose a […]

Continue reading...

November 7, 2016

2 Comments

Nancy Chobin: Understand the Difference between Certification and Competency

As the former executive director of the Certification Board for Sterile Processing and Distribution, Inc. (1988-2014), I had the opportunity to learn a great deal about certification and its impact on the safety of patients. Few can argue that there is a critical need for competent sterile processing personnel; they perform essential duties that can […]

Continue reading...

November 1, 2016

4 Comments

Carol Davis-Smith: The Value of Speaking Up

We are all faced with professional situations that sometimes don’t feel “quite right.” There’s an inner voice in all of us that calls us to action when these situations occur. But some people don’t speak up for fear of retaliation or even a fear of inaction (that is, if we do say something, nothing will […]

Continue reading...

October 31, 2016

0 Comments

Wil Vargas: Tackling the Tower of Babel with Health Software Defects

A security flaw is identified in another medical device, another set of patient data results is mixed up, configuration information is lost after a software update, another device fails to perform as intended. News stories continue to implicate software in medical device failures as the use of software in healthcare continues to grow. We don’t […]

Continue reading...

October 17, 2016

1 Comment

Kelvin Knight: Are You Cutting Stones or Building a Cathedral?

I walk through the hospital every morning on the way to my office and notice people along the way. There are families bringing children to clinic visits, navigating their way through the long corridors and crosswalks connecting buildings, sometimes escorted by volunteers or even an employee. Some employees walk briskly to their offices, eager to […]

Continue reading...

September 23, 2016

0 Comments

Fu, Halamka, Kufahl, and Logan: Hospitals Need Better Cybersecurity, Not More Fear

We’ve seen unprecedented attention to medical-device security after an unorthodox report was recently released by short-selling investment research firm Muddy Waters Capital and MedSec, which alleged security vulnerabilities in St. Jude Medical’s pacemakers. An independent research team subsequently raised doubts about some of the clinical claims made by the report. St. Jude Medical, meanwhile, has […]

Continue reading...

September 20, 2016

1 Comment

Matthew B. Weinger: Can We Make Patient-Centered Care Really Patient Centered?

If we are to move from our current provider-centered system toward a more patient-centered system of healthcare, we must understand the obstacles. The Institute of Medicine defines patient-centered care as “providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.” How […]

Continue reading...

August 30, 2016

7 Comments

Donald Armstrong: Report on Metrics that Matter to Your Hospital

As healthcare technology management (HTM) professionals, we routinely report on many items. I have reported to environment of care (EOC) committees for years, and it seems that we report the same old numbers, such as preventive maintenance (PM ) completion, unable to locate, and recall rates. And while these numbers are still very valid and […]

Continue reading...