Select Page

Author: Tim Gee

Methods to Access Alarm Data for Analysis

Difficulty getting access to alarm data is the elephant in the living room in the house of alarm fatigue. There are lots of conference presentations, webinars and papers about analyzing medical device alarm data. What’s missing are detailed discussions on how to get to the actual alarm data in the first place. This post will present a framework for the hardest part of alarm analysis:  getting access to alarm data so it can be analyzed. We’re going to define the kind of data we’re seeking, where it can be found, the various ways to get access to said data and finally, analytical tools....

Read More

HIMSS16 Recap

It was great to see so many blog readers and old friends at HIMSS this year. For those who downloaded my list of connected health exhibitors, how did the list work for you? I found sorting by booth number really cut down on running back and forth across the show floor. The exhibits are always the big draw for me at HIMSS, and this year was no exception. Where else can you meet with companies ranging from embedded system medical devices to digital health to horizontal market IT solutions? This year I visited and talked with 45 companies, all...

Read More

4 Ways Health Care Is Different

As a $1.7 trillion market with $3.24 trillion in health care expenditures in 2015, the US health care market can be a pretty tempting target to companies, entrepreneurs and investors outside of health care. There’s a lot of opportunity (not to mention needs) in health care, yet the track record of non-health care companies (including startups with non-health care management) is poor – especially when it comes to big companies. Last week I came across an article that touched on the source of a lot of griping by health care outsiders, the increased level of regulations in health care compared to other big verticals....

Read More

HIMSS16 Preview

It’s back to Las Vegas for HIMSS16 in a bit more than a week, which begs the question, what’s going to be theme of this year’s show? There’s typically very little data to apply to questions like that, until now. Drew Ivan, Healthcare Solutions Strategist with Orion Health, wrote a post on LinkedIn on HIMSS16 trends – with data! There’s a great diagram that compares the number of presentations under educational session categories have changed between 2015 and 2016. As an example, here are the top 5: Care Coordination and Population Health – up substantially over last year Process Improvement, Workflow, and...

Read More

4 Models for Alarm Vigilance

The method of arranging medical devices and those that recognize and respond to alarms is fundamental to alarm safety. The following are the 4 models or methods for alarm vigilance and notification in use today. These models are: line of sight,out of sight, monitoring techs, and automated notification. Let’s look at each one in turn. LINE OF SIGHT Back in the day when electronic medical devices were first used in hospitals, patient care areas were organized as wards. Patients were arranged in beds around the perimeter of a larger room with caregivers stationed somewhere along the perimeter or in the center...

Read More

Monitoring for Deteriorating Conditions

Monitoring patients at risk of a deteriorating clinical condition (DCC) is a growing patient monitoring need in almost every hospital. Here’s why…  For many years, the need to monitor patients outside traditional high acuity units has been a growing requirement in hospitals. Signs of this growing need have been evident in a number of areas: Years ago, a common hospital patient flow bottleneck was the telemetry unit. This was often because patients who did not meet admission criteria were placed in that unit because the attending felt the patient was at risk of deterioration and telemetry was the lowest acuity...

Read More

FDA Issues Draft Guidance on Cybersecurity

The FDA sets manufacturer’s expectations on what is expected to address data security threats in medical devices. This draft guidance (pdf download) applies to conventional embedded system medical devices with embedded software (firmware or programmable logic) and software products regulated as medical devices. Think about that for a few seconds and let the scope of impact become clear in your mind. The FDA press release hits the high points. Perhaps the biggest is this statement (emphasis mine): For the majority of cases, actions taken by manufacturers to address cybersecurity vulnerabilities and exploits are considered “cybersecurity routine updates or patches,”...

Read More

Interview with Sailesh Chutani, CEO, Mobisante

My first exposure to Mobisante and their disruptive diagnostic ultrasound system was the mHealth Summit in November of 2010. At that time, the consumerization of medical devices had been gaining traction, mostly in the physician office market. Consumerization offers medical device manufacturers advantages in lower design costs, shorter time-to-market, lower product costs, increased usability and lower training costs. I recently got Sailesh Chutani, co-founder and CEO of Mobisante, on the phone and we discussed their product strategy — a software based diagnostic ultrasound that runs on a variety of consumer electronics platforms. Your product is clearly a diagnostic ultrasound...

Read More

FDA Takes Step Backwards with New MDDS Guidance

This summer, FDA proposed lifting regulations from certain currently regulated medical devices. This unprecedented policy shift targets devices known as Medical Device Data Systems (MDDS) and is intended to benefit the mobile app industry and companies like Google, Apple and others. The current regulatory burden for MDDS devices is Class I, 510(k) exempt. This means manufacturers have to follow a basic quality system (i.e., design controls) on par with ISO9001, and report instances of patient injury or death in addition to any product recalls to FDA. The following is a guest blog post embodied in an abridged version of...

Read More

Inaugural Clinical Alarm Safety Symposium

Clinical alarm safety can be hard to achieve, and once attained, a struggle to maintain. There are so many challenges: False/positive and non-actionable alarms; Optimizing default alarm limits across patient populations and for individual patients; Spread out nursing units with high patient-to-nurse ratios; Numerous alarm notification methods – audible signal amplification, monitor techs and alarm notification systems; And the constant threat of complacency and alarm fatigue. The inaugural Clinical Alarm Safety Symposium, November 20-21, 2014, will delve into these issues and more to provide attendees with actionable information that can be later applied in your institution to ensure continued...

Read More

Recent Tweets