On June 7th, 2013 the Texas Children’s Hospital and Smith Seckman Reid are producing an educational workshop on medical device connectivity. Nursing is the predominate perspective explored in this event. (One of my pet peeves is all the focus physicians get from vendor’s marketing departments. Yet, when it comes to systems in hospitals, the predominate user – by far – is nursing.)
TCH, an early adopter of clinical documentation into EMRs and alarm notification, has some of the most extensive experience with medical device connectivity in the US. They’re hosting and presenting at this one day seminar. Here’s the blurb on the event, with links to where you can register. Besides the great content, the next best thing is the cost – free. The only downside is there’s room for just 150 attendees.Read More
Last month I spoke at the first CIS Qatar International Conference in Doha Qatar. My topic was the Importance of Enterprise Wide Medical Device Integration in CIS workflow. You can download a copy of my presentation here.
This was the first such conference in Qatar with over 1,500 people attending. The ballroom only had capacity for 1,200 so they had remote screens and audio for the 300 overflow attendees. Several hospitals in Qatar are in the process of implementing Cerner’s EMR, so there is a lot of keen interest in all things EMR.Read More
On April 8, 2013, the Joint Commission published a Sentinel Event Alert on medical device alarm safety in hospitals. Once again, alarm hazards tops the ECRI Institute’s 2013 Top 10 Health Technology Hazards. Alarm fatigue is unfortunately a topic that is evergreen because it has plagued hospitals for many years and shows little sign of abating. A search of the literature will show the most common consequence of alarm fatigue is a failure to rescue adverse event (in which
the vast majority 80% of patients die). A secondary consequence is on patient satisfaction; constant alarms audible throughout the unit make it difficult for patients to sleep.
There are currently several private entities that seek to certify medical apps, connectivity solutions, EHR record exchange, and other products, services and people in our sphere of interest. Given the ongoing proliferation of private certifications, there is a growing need to evaluate them, judge their relative costs and benefits, and determine which – if any – are worth adopting as either the one certified or as the consumer of certified products or services.
These private activities are usually distinct from governmental requirements (e.g. FDA or FTC compliance, or state licensing), although in the case of EHR Meaningful Use (MU) certification, private entities function on behalf of the federal government to certify compliant EHRs. Note here that compliant EHRs are those that are capable of achieving MU. Purchasing a product that is thus certified is a prerequisite for a provider then achieving MU.Read More
The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials.
As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose intended use “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”. As stated in the FDA’s Draft Guidance, omitted from this definition, and therefore not medical devices, are apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”Read More
In preparing for my presentation on Stage 2 Meaningful Use (MU) requirements for the November, 2012 Fourth Annual Medical Connectivity Conference I had the opportunity to delve further into the question of what had to be connected to what, and interoperable with what, in order for providers seeking EHR incentive payments to satisfy their MU obligations. (I ended up making this presentation by phone from New York to Boston because of the lack of transportation out of New York post hurricane Sandy.)
Stage 2 of the federally defined Meaningful Use (MU) is now upon us (details here), and a recurring theme is clearly interoperability. But what this means, and to whom, has not always been clearly presented. In this regard there has been occasional talk from the medical device engineering side of the room that MU requires that a variety of “traditional” medical devices must be able to send data to the EHR.Read More
Since my last blog post here at Medical Connectivity there have been some mHealth updates that may be of interest to the blog readers.
USA and FCC
Just this week the FCC released its task force findings on mHealth. The overarching goal given to the task force was: “By 2017 mHealth, wireless health and e-Care solutions will be routinely available as part of best practices for medical care.” They were to produce actionable recommendations that could be taken by the FCC, other regulatory agencies and industry to reach this goal. The FCC committed to implementing five specific actions in the list produced by the task force:
a) Immediately recruit for an FCC Medical Director position
b) Develop and execute a health care stakeholder outreach plan to promote greater collaboration between the FCC and the health care sector on policies at the intersection of communications and health.
c) Direct the International Bureau to work with FCC counterparts in other countries to encourage them to make spectrum available for MBANs and to discuss possible spectrum harmonization to allow for medically safe cross-border patient travel and better economies of scale for device makers.
d) Consider an Order by the end of this year to comprehensively reform and modernize the Rural Health Care Program, and
e) Consider an Order by the end of this year to streamline our experimental licensing rules to promote and encourage the creation of wireless health “test beds” to permit easier testing of mHealth devices.
Those of us engaged in medical devices and their connectivity often (or perhaps not often enough) look to the FDA for regulation and guidance. In these pages there has been discussion of FDA regulation generally (here), as applied to Medical Device Data Systems (MDDS) (here), medical device mobile apps (here and here), and clinical decision support systems (here)
We sometimes remember that there are also other government agencies that may have impact on what we do. For examples the role of the FCC has been discussed here with respect to medical device wireless applications, and more recently the prospect of the FCC taking away part of the Wireless Medical Telemetry Spectrum (WMTS) has received attention in clinical engineering circles (while no one else seems to care). CMS is always of interest with respect to medical device reimbursement, and more recently with respect to meaningful use of electronic health records (EHR), which may or may not be medical devices. Advertising of medical devices is regulated by both the FDA and the FTC, and some over-the-counter devices bridge the FDA and Consumer Products Safety Commission divide. The FTC (but curiously not the FDA) has previously gone after smart phone acne treatment apps because of their “baseless claims.” When there is dual authority and a need for regulatory action I have wondered if having two responsible agencies is worse than having just one (leading to some new math such as 1+1 < 2, and might even be <1).Read More
I commonly receive requests for information about connectivity and enabling technologies like indoor positioning systems. Here’s an example:
…I am currently undertaking research into RFID technologies and WLAN to use within a hospital. In particular I am interested in implementing the use of patient/infant tracking tag, panic tag or status tag, asset tag and also temperature control tags, all of which are working with a WLAN.
Is there any information that you are able to share with me please.
While I don’t normally provide services for free (I have bills to pay like everyone else), I have no problem providing some initial information or value to get to a place where an actual project can be considered. So, in that spirit, here’s my reply:
I would be glad to share some info with you. From your email it appears you have a number of different indoor positioning applications which you want to undertake. The key to RFID is that there is no one best system or technology for all applications. You have to match the requirements of your positioning applications to the various capabilities of different systems, and many hospitals end up with more than one RFID system as a result.Read More
Today, July 11, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act. Applauded by big pharma, the American Medical Association, the National Organization for Rare Disorders, and others, this new legislation reauthorizes various user fees, and revises regulations in an effort to address problems around drug shortages, the paucity of therapies for rare diseases, and improving availability of pediatric drugs and devices. For regulatory geeks, there is also new language around the “least burdensome standard,” modification of de novo application process, reclassification procedures and more. You can see a bill summary of the legislation here, and download the actual law here (pdf).
Unique Device Identifier
Two things in the FDASIA (pronounced “F-D-A sigh”) jumped out at me: unique device identifier and health information technology. Section 614 directs the Secretary of HHS to issue proposed unique device identifier (UDI) regulations by December 31, 2012, and to finalize the proposed regulations not later than 6 months after the close of the comment period.
In general, the UDI is a good thing in that it will likely contribute to improved supply chain efficiency. All the claims about improved post market surveillance, patient safety and quicker, more reliable recalls are considerably beyond the ability of what is really just a hopped up serial numbering scheme. To achieve the widely trumpeted safety benefits would require the wide adoption of an information system that does not yet exist. There are a lot of cool ways such an information system could come into being – the feds, some outfit like the ECRI Institute, or an open source software project driven by hospitals. And of course, you’d have to get health care providers to, you know, actually use the software.
Needless to say, the easy part with be getting the UDI onto products (and that’s taken years).
The big news for many folks is that there is now a legislative mandate to regulate HIT.Read More