On August 6, 2013, FDA published modifications to the list of medical device related standards they recognize. News was made of the fact that additions to the recognized standards addressed areas such as cybersecurity and interoperability. While there were many revisions and some additions of a variety of standards, this blog post will focus on the news making standards related to medical device connectivity.
The published modifications are divided between two separate recognition lists, number 31 (pdf) and 32 (pdf). Here is the Federal Register version (PDF). Recognition list number 31 includes one standard under the Software/Informatics category: Laboratory Automation: Data Content for Specimen Identification; Approved Standard (NCCLS AUTO-7A). The 20+ standards listed in recognition list number 32 are all new additions under Software/Informatics and focus on the following topics:
- IT governance in hospitals for networked medical devices,
- Medical device connectivity and interoperability, and
These are all great standards (although they are of varying relevance and usefulness). So where is the confusion, you might ask?Read More
On August 14, 2013, AAMI reports that the FDA has, “issued a new guidance document on integrating RF technology into medical devices.” You can read the FDA blog post on this guidance here. The draft version of this guidance on RF wireless medical devices was published more than 6 years ago in 2007 (blog post here). At the time, I thought the draft guidance was not earth shattering but a solid example of the application of the Quality System regulation to wireless medical devices.
In order to effectively use this guidance, or the earlier draft guidance, one must have a working understanding of wireless technologies and the FDA’s Quality System regulations. Only then is there sufficient context to be able to properly apply the guidance to the design, manufacture, installation and support of wireless medical devices. Like many initial connectivity efforts, dealing with these wireless issues can be a case of not knowing what you don’t know.Read More
A while back I was provided with a review copy of the book, Electronic Health Record: A Systems Analysis of the Medication Domain, by Alexander Scarlat, MD. This book is intended to serve as a practical book about electronic health/medical records systems as used in acute care settings. (For the purposes of this review, the term EHR is intended to refer to both EHRs and EMRs.)
There are two audiences for the book. The first group includes clinicians with little or no expertise in information technology. There are plenty of books for clinicians that provide an introduction into the common capabilities of an EHR. Scarlat’s book goes a step further, providing the understanding and tools to be able to collaborate with the IT folks who are implementing an EHR so that clinicians can actively participate and communicate their needs and preferences in an unambiguous way. The second audience includes IT professionals who lack in depth knowledge and understanding of clinical workflows that are automated in the typical EHR. For them, the book details what is perhaps the most complex and challenging EHR application, medication ordering.Read More
On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.” We have discussed this draft and mobile apps generally here, here, and here. As with all draft guidance documents, following the release of the draft the FDA is supposed to receive and review comments (reported to be about 130), and then issue a revised draft, a final guidance document, withdraw the draft, or do none of these for an extended period, just letting the draft sit. The latter appears to be the fate of many drafts. The two years that this draft has been out probably qualifies as an extended period. However the FDA did tell Congress, and the public, that the guidance would be released by the end of this fiscal year. Outsiders cannot tell if the appropriate FDA people are hard at work on this item, or if they are distracted in part by other issues. The FDA’s claimed devotion to transparency does not include being able to see how such things are progressing.Read More
The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity. This guidance targets individual medical devices rather than the network they may be resident on, and it also includes non-networked devices. The FDA notes that both networking capability and portable media increase vulnerability. The latter issue might be called intermittent or remote connectivity.
Guidance documents tell interested people what the FDA’s current thinking is relevant to its regulatory authority, in this case the review of 510(k), PMA and related submissions. A draft guidance is in effect what the FDA is thinking about thinking. Drafts go through a comment period (90 days in this case) after which the FDA contemplates the comments and, after an unspecified time, either issues a guidance document, issues a revised draft, withdraws the draft, or just lets it sit there. Since guidance documents are not requirements, there is standard language that you can use an alternate approach if you can justify it. An open question for me is whether even a draft sufficiently establishes an FDA expectation that should be followed in the interest of a smooth submission review.There are many draft guidances currently under comment or post-comment review, including the long awaited guidance on medical apps discussed here.Read More
As noted before, from time to time I answer questions and exchange ideas with folks from hospitals, companies and with students. It’s a karma thing with me – if I can help out with reasonable effort in situations where there’s no immediate consulting opportunity (although there may in the future), and it’s interesting, then I do what I can.
The following is the most recent exchange from a conversation I’ve been having with a product manager at a HIT software vendor about MDDS. They develop and sell an information system, part of which consumes medical device data. Not every customer already has an MDDS, and those that don’t look to their company to provide one as part of a “complete solution.”
From my research, it seems that having FDA clearance for MDDS seems to assure that the product will work out of the box and it’s tested for safety and effectiveness and seems to be a better choice to have than an MDDS (reliability, safety for patients).Read More
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