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Author: Tim Gee

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...

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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...

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FDA Issues Draft Guidance on Cybersecurity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 This draft guidance (pdf download) applies to conventional embedded system medical devices with embedded software (firmware or programmable logic) and software products regulated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,”...

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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...

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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...

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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...

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Interview with Jim Welch, EVP, Sotera Wireless

This interview is with a long established thought leader in patient monitoring and alarm notification, Jim Welch. Jim has demonstrated a knack for bringing a fresh approach to long-term persistent problems in monitoring, nursing vigilance and patient care. At Sotera Wireless, Jim’s had a chance to re-imagine patient monitoring in low acuity settings with predictably innovative results. At the AAMI 2014 conference, I had the opportunity to attend the breakfast symposium where Jim presented, Transforming Care in Non-ICU Settings through Disruptive Continuous Monitoring Technology. The following discussion centers on patient monitoring data analytics, pioneered by Sotera Wireless. What is...

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Messaging Middleware Growth Strategies

Developing and launching a competitive product, and getting initial traction in the market are not inconsiderable milestones. And yet for the entrepreneur and their investors, this is just the beginning. What was record setting last quarter is barely acceptable this quarter, and next quarter had better be back on track. Developing a solid plan for growth depends on two things: a good understanding of the basic means to drive growth, and a deep understanding of the market. This post seeks to combine both of these in a brief survey of the key factors to drive messaging middleware revenue growth...

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Interview with Todd Dunsirn, CEO, True Process

A while back I had the opportunity to chat with Todd Dunsirn, the CEO of True Process. True Process provides products and services to both hospitals and various manufacturers. The company is focused on the point of care market offering a medication administration solution and a medical device data system. What was the genesis for starting True Process? I started the company in 2004. I have an engineering background, and had several other companies doing IT consulting and then web development, and application development. Then I had a friend contact me to develop a bar-code point-of-care simulation so that...

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Messaging Middleware Market Segmentation & Adoption

The previous post in this series suggested a set of characteristics to define the messaging middleware market and described the typical product architecture for these systems. In this post, we’ll look at ways the market may be segmented and how the market is adopting these systems. Market Segmentation Market segmentation is the dividing of a broader market into subsets of potential buyers who have common market requirements who then become the target for your product, sales and marketing. Using my favorite market adoption model, Geoffrey Moore’s Crossing the Chasm, this is the bowling alley strategy. Software developers in the...

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