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Year: 2011

Lessons from a Recent Recall

A recent Class I recall (not pictured) of a medical monitor with a hospital network connected central station stimulates some generalities about software, “fixes”, and connectivity. (Class I recalls are defined by the FDA as  a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.) The use of the product in question was given as: a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs Curiously only one customer was identified as having received the product, or at least this particular version of the product. While the manufacturer and product in question is a matter of public record, and available at the link, I chose not to include it here because my objective is not to repeat the recall information, but to suggest the reasons for the recall, an associated labeling issue, and offer some general lessons. The reason given for the recall had two seemingly separate parts. The first is that “The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage”. This sounds like a software problem yet the fix was not to “upgrade”...

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The IOM on EHRs

The   issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S. Department of Health and Human Services (HHS). This report expands the discussion beyond the EHR (used henceforth for both EHR and EMR) to include other related electronic information tools collectively called health IT. Health IT Risks The potential for health IT to improve both the quality and efficiency of medical care has been much noted to include more complete and timely records, ready exchange of information between providers, clinical decision support, and in turn a reduction in errors associated with the quality and availability of patient information. Efficiencies may arise from electronic capture of data which would eliminate manual entry, and time savings in accessing and reviewing patient information, and perhaps in passing information to third party payers. Additional public health value might accrue from the enhanced searchability of electronic records with respects to trends, treatments and outcomes. These benefits assume well designed, user friendly, compatible systems not withstanding that the U.S. model is to allow for numerous independent products that may or may not be able to exchange information nor display it in a consistent manner. Not surprisingly the report notes that the IT imperative will likely not be fruitful without associated attention to the people...

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Wi-Fi Capacity and New Devices

A recent NY Times article reported that hotel Wi-Fi capacity was again being challenged, this time by iPads and other tablets, or more specifically, tablet users.  The Times notes that these users may have a smart phone and laptop going at the same time they are sucking up streaming video. The high bandwidth demand of these devices, or more specifically, their uses,  is said to be reducing download speeds back to the good old days of dial-up connections. A likely solution will be a tiered charge structure, similar to the newest cellular data plans, with the result that you can waste bandwidth if you don’t care what it costs.  A more general report on current and future wireless demand versus capacity has been produced by the Global Information Industry Center at the University of California San Diego. A less foreboding report on medical uses of Wi-Fi has been produced by the Wi-Fi alliance. Smart phones have a prior history of  overwhelming cell phone networks, such that in dense environments someone can’t make a phone call because too many other people are watching reality show reruns and bad movies. Now some cellular devices have been looking at switching to Wi-Fi when it is available, as explained here. This leads to the conflict ridden situation of cellular wanting to use Wi-Fi to solve its capacity problems at the same time that Wi-Fi is being over loaded by...

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Call for Contributing Authors

Today I was contacted by a social media marketing firm working for a major MDDS vendor with an offer to contribute content that’s on topic for this site (that last part is important). I’m interested, and I imagine a lot of this blog’s readers will be too. As I will likely take them up on their offer, I want everyone to understand that there’s not any favoritism that plays into who gets to post on this site. So, the following describes the ground rules, the benefits of contributing, and issues an open invitation to contribute posts. We’ve been fortunate to have a number of terrific contributing authors over the years, and some of them have written posts that continue to be popular to this day. On the About This Site page is a long standing open invitation to anyone who wants to climb up on the soap box and spout off contribute to the conversation about medical device connectivity. I’ve also made contributing author offers personally to many folks on both the provider and vendor sides of the table. There are so many people who have incredible knowledge and experience to share. And most of these people don’t have the time or inclination to create their own blog. Now you have an outlet. Increasingly companies are adopting social media policies that establish ground rules for employees posting to blogs,...

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Hacked Insulin Pump

The fact that connectivity, and perhaps wireless connectivity in particular, allows for hacking for mischief, theft, politics, social protest and other forms and varying degrees of evil should surely come as no surprise. In turn, that a wireless medical device might be hackable should be somewhere on the mind of developers, users, and regulators. Thus the report from the recent Black Hat conference that someone hacked an insulin infusion pump (not pictured above), and in so doing was then able to alter its settings, should also not be particularly shocking, but should serve as yet another reminder, that security associated...

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Third Medical Device Connectivity Conference

This September 8-9, in Boston, will be the third Medical Device Connectivity conference. We’re returning to the Joseph B Martin Conference Center at Harvard Medical School – a really nice facility with great food. Of course, the ambiance and cuisine is secondary to what you’ll learn at this year’s conference – still the only event dedicated to medical device connectivity. Since last year’s conference so much has come to pass: The FDA published their final rule for Medical Device Data Systems, and signaled their intent to regulate health care providers who develop their own MDDS solutions. The FDA also published the long anticipated draft guidance on mobile apps, clarifying the boundaries around what is and is not regulated medical device software, and laying out a bit of the FDA’s enforcement strategy. The transition of health care technology from the hospital to home health has also received some attention from the National Research Council in their report, Health Care Comes Home: The Human Factors. An FDA Workshop on Medical Device Interoperability was held a few months after last year’s Medical Device Connectivity conference. This event was just part of an effort to develop a regulatory framework tailored to plug and play medical device interoperability. The group behind this event has published a number of important papers this year on interoperability, risk management and other topics. Founded in July of 2010,...

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Mobile Apps Guidance Q&A

On LinkeIn this morning, I came across a couple of comments about the FDA’s recent draft guidance on mobile apps. Thoughtful comments by David Doherty and Nathan Billing in a LinkedIn discussion prompted the following. My imperfect interpretation of their comments was the impetus for this post. David suggests that FDA regulation will stifle mobile app innovation, and observes that brand-name phone manufacturers are in a better position to shoulder FDA regulations than startups.  He further wonders why an App Store that takes a 30% cut of app revenue does not appear to draw any regulatory attention from FDA. Nathan agrees that over-regulation could stifle innovation and suggests that the regulatory burden should vary based on the intended user. Nathan implies, I think, that apps for health care professionals should face greater regulatory scrutiny than apps for use by patients. He also laments that FDA has not designated specific standards that would facilitate cross-vendor interoperability in the mHealth ecosystem. I don’t mean to pick on David and Nathan, it’s just that they raise some excellent points that I’ve seen repeatedly in other forms. The problem with many people’s constructive criticism of FDA’s draft guidance is that they are criticizing or suggesting things that lie outside FDA’s legal framework. Criticism that ignores this legal framework really barking up the wrong tree. Suggestions that go beyond the FDA’s legal framework are...

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FDA Addresses Mobile Medical Apps

As medical applications for mobile devices have proliferated,  regulatory questions have proliferated nearly as fast, at least in some quarters. The key questions are what kinds of apps are medical devices, and among those, which will the FDA focus on for regulatory action.  To date these apps range from home use  adviser’s, guides and “toys”, which may or may not have real health care implications, to serious medical devices which have clear health care functions, despite in at least some cases, pretending they do not really, perhaps in an attempt to avoid the FDA. On July 19, 2011 the FDA announced its proposed official action in this regard, including defining “mobile medical applications”  that are the subject of this action. (I will use the acronym MMA, although the FDA did not.) . This includes a new FDA web page for mobile apps (here), with links to a new Draft Guidance, information for consumers, and a press release. This action by the FDA has a parallel to the recent final rule on Medical Device Data Systems (MDDS), discussed by Tim here, which also addressed what is it, what is it not, and how that which is will be regulated. The Draft Guidance, dated July 21, 2011, defines an MMA as a “software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed...

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New National Research Council Report on Home Health Technology

This new report (download page) is focused on the factors that contribute to effective home health care: integrated and easy to use medical devices and information systems, and the physical characteristics of a home that is supportive (or at least does not present barriers) to home health care delivery. There is quite a mix of recommendations in this report, from the insane (numbers 6 and 7) to the most excellent (numbers 4 and 9). I came across this via a Modern Healthcare blog post by Joseph Conn. Like me, Conn was drawn to the first recommendation (from the NRC report): Recommendation 1. The U.S. Food and Drug Administration and the Office of the National Coordinator for Health Information Technology should collaborate to regulate, certify, and monitor health care applications and systems that integrate medical devices and health information technologies. As part of the certification process, the agencies should require evidence that manufacturers have followed existing accessibility and usability guidelines and have applied user-centered design and validation methods during development of the product. In his blog post, Conn quoted David Wegman, the chairman of the NRC’s Committee on the Role of Human Factors in Home Health Care, which produced the report, on the roles of the ONC and FDA as it relates to medical devices and HIT: “As it is now, the ONC has the responsibility for the credentialing and...

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Reporting from AAMI 2011

After missing last year’s meeting in Tampa, I’m back at AAMI – one of the two events that I try to attend every year. The focus on connectivity has increased as there is a full track devoted to the topic this year. One change this year, is that my blog posts from the conference will be appearing on the Medical Electronic Design magazine blog, found here. As usual, I’ll also be taking lots of photos, some of which may also be posted on the MED blog. Eventually most all the photos (the good ones that aren’t confidential) will be posted on my Flickr account,...

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