Connectivity Standards Adoption Over Time

Connectivity Standards Adoption Over Time

I was listening today to the CE-IT Webinar on CE and HIT from the 2014 AAMI conference in Philadelphia. Much of the session reviewed what has happened over the last five years and it got me thinking about my experiences and what I’ve seen over the last ten years in medical device connectivity and remote monitoring. It’s been an interesting ride and yet I realize there are a few basic ideas that have resonated over the years. These basic ideas are:

  1. Specifying those requirements that are unique to my situation are where I have the most control in acquisition;
  2. There are other players in the market who may change the landscape of what is available to me; and,
  3. The government may require something which can constrain my options.
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Guidelines for Using Wi-Fi for Medical Devices

Guidelines for Using Wi-Fi for Medical Devices

On a recent LinkedIn group discussion, the following question was posed by Taimoore (Tim) Rajah of the NIH:

We are encountering many hospital which are still based on wired LAN technology for medical device connectivity. Many have mentioned their gripes and major concerns about using Wi-Fi technology for patient monitoring and drug delivery monitoring in the OR as well as ICU departments.

Many hospitals are still using WMTS telemetry in their more critical patient monitoring areas. This is very expensive and maintenance for such a system is costly.

Can you tell us what are the major criteria to ensure a reliable safe and secure Wi-Fi network for medical devices?

If a hospital decides to use Wi-Fi technology, what are the proper guidelines to which they must adhere, to ensure that their current and future Wi-Fi network will be stable, reliable, safe and secure? What are the important features they should consider seriously before embarking on using this type of technology?

Great questions. Here we go with some answers:

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Wireless Sensor Design Challenges: Gateways

Wireless Sensor Design Challenges: Gateways

Wireless sensors are intended to operate via short range wireless communications. That’s why they’re called “body area” networks. Due to power consumption constraints, wireless sensor radios typically don’t operate as 802.11 a/b/g/n radios used in enterprise networks. The reference designs from the manufacturers of radios intended for wireless sensors often indicate a range of a few meters and show wireless sensors communicating with a gateway device that aggregates sensor data and then communicates with the enterprise network where the sensor software applications reside.

When asked if they’d prefer their wireless sensors with a patient worn gateway (typically about the size of a deck of cards or smaller) or just the wireless sensors by themselves, most users – patients and caregivers – overwhelmingly chose the sensors-only option. They just got rid of those nasty sensor cables, why would they want some extra box they have to keep track of?

Asking requirements gathering questions on feature trade-offs that aren’t supported by the technology is often times a frustrating experience. It is, however, important to identify all market requirements, even the ones you may not be able to meet with current technology. Let’s look at how we might solve this conundrum.

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FDA Issues Final Guidance on Wireless Medical Devices

FDA Issues Final Guidance on Wireless Medical Devices

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.

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FDA Offers (draft) Guidance on Cyber Security

FDA Offers (draft) Guidance on Cyber Security

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.

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Wi-Fi Capacity and New Devices

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 other devices.   Cellular resistant building structures, which are increasing, also can create a desire to shift to Wi-Fi.

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