Search Results for: mdds

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....

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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...

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FDA Issues Draft Guidance on Cybersecurity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 This draft guidance (pdf download) applies to conventional embedded system medical devices with embedded software (firmware or programmable logic) and software products regulated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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Challenges Using Patient Generated Data for Patient Care

When I do presentations on the use of standards, I invariably have a slide which defines interoperability as "the ability of a system or a product to work with other systems or products without special effort on the part of the customer." My second slide then defines syntactic and semantic interoperability. Syntactic interoperability occurs when there are two or more systems capable of communicating and exchanging data and this is usually attainable with the use of physical standards, data standards, and messaging structures. Semantic interoperability is defined as the ability to automatically interpret the information exchanged meaningfully and accurately...

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Health Care Messaging Vendor 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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A Medical Device Recall of an EHR-like Product

The recent recall (links below) for McKesson’s Anesthesia Care system raises interesting questions about potential information system failure modes as well as what system/software functions cross the imaginary line between unregulated EHRs and regulated medical devices. First the facts. The FDA announced McKesson’s voluntary recall of its Anesthesia Care system in several on-line (here, here and here)  postings. This trio of postings is interesting because the first links only to the second, the second does not link to either of the other two. The third also does not link to the other two, and was not part of any of the announcements, but it is the most complete. The statement of the reason for the recall is that, “There was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record (ACR) in that it included data from another case." It was further noted that, "Use of this affected product may cause serious adverse health consequences, including death.”  In the third link the FDA identifies the product as, "...a computer based system which collects, processes, and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at...

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HIMSS 2014 in Review

The HIMSS conference is so big, with so many different kinds of attendees and exhibitors that it's almost impossible to have one big theme for any given year. Yet the question of theme for any given HIMSS is something we all talk about. The themes one perceives are at least partially defined by our own interests and area of focus. Consequently, the #HIMSS14 themes for me were: The shifting product and value proposition focus of many of the vendors I track, The tension between spot solutions and enterprise solutions, and The big buzz word of the show, population health....

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Defining the Point of Care Market

It's useful to segment and analyze markets for developing company and product strategy or analyzing competitor's actions. Such an exercise helps illuminate why companies and markets do what they do - and what they might do in the future. In getting ready for this year's HIMSS in Orlando, I've been thinking about the point of care (PoC) market. At the first Medical Device Connectivity conference in 2009, I defined the PoC market as the workflow and data associated with direct patient care in nursing units, the ED, surgery and related areas. This contrasts with EMRs managing orders, diagnostics, capturing...

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Patient Context Workflow

Connectivity enabled medical devices send patient data right out of the medical device to a network, be it a body area network, cellular broadband network, home or enterprise network. The network then conveys this medical device data to databases and applications that store, display and manipulate the data. When a medical device is directly attached to a patient, there is no question as to which patient the device data belongs. As soon as the data leaves the actual medical device via the serial port or a network connection, the association of that data with a particular patient is no longer obvious. Much of the data used in establishing and maintaining patient association or patient context comes from, or is stored in, the patient management database. Patient management workflow is an important enabling component in the overall connectivity solution and key to patient context management. It is critical to reliably know that the data from a medical device belongs to a particular patient. If the data is not associated with any patient it's worthless; should the data be associated with the wrong patient it could be deadly. When patient data from patient A is misidentified as belonging to patient B, patient A can miss out on a life saving clinical intervention that is mistakenly applied to patient B. In this example, patient A may die due to a lack of...

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