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U.S. Department of Health and Human Services

Medical Devices

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Medical Telemetry and Wireless Connectivity - FDA Perspective

Nancy Pressly
Issues Management Staff
Office of Surveillance and Biometrics
Center for Devices and Radiological Health

 


Transcript

Slides

 Historic Involvement

  • 1998
    • DTV Broadcast disrupts hospital telemetry
    • Issued Public Health Notification
    • Began working with FCC
  • 2000
    • FCC implemented the Wireless Medical Telemetry Service (WMTS)
    • Issued updated Public Health Notification

Historic Involvement (cont.)

  • 2005
    • Issued Public Health Notification warning about changes in the 460-470MHz band
  • Present
    • Continuing collaboration with FCC
    • Drafting guidance on Use of Wireless Communications in Medical Devices

Wireless Services for Possible Use with Medical Devices

  • WMTS
    • 608-614 MHz, 1395-1400 MHz, 1429-1432 MHz
  • MICS (Medical Implant Communication Service)
    • 402-405 MHz
  • ISM
    • 13.56 MHz, 27.12 MHz, 915 MHz, 2450 MHz
  • IEEE 802.11
    • ISM Frequencies
  • Bluetooth
    • ISM Frequencies

Concerns Specific to Wireless

  • RF wireless coexistence
    • Ability of one wireless system to perform its task in a given shared environment
  • Quality of Service
    • Reliability of data transmission, including transmission rate and error rate
  • Integrity of data transmitted
  • Security

Addressing RF Wireless

  • Priorities
    • Device function, use of wireless and data transmitted
    • Consequences of not getting data across wireless link correctly, timely, and securely
  • Present standards do not adequately address wireless medical device concerns
    • EMC standards IEC 60601-1-2 and IEC 61326-1 exclude testing in-band for RF wireless
  • Addressing RF wireless medical devices
    • EMC
    • Wireless Coexistence
    • Wireless data integrity and quality of service
    • Wireless data security

Report problems to FDA!!!

We need to hear about the problems to be able to work toward fixing them

 


Nancy Pressly
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
FDA
nancy.pressly@fda.hhs.gov


 Transcript for "Medical Telemetry and Wireless Connectivity - FDA Perspective"

We will go on now to FDA’s representative and that is Nancy Pressly. She’s currently a member of the Issues Management staff in the Office of Surveillance and Biometrics within the Center for Devices and Radiological Health. And the Office of Surveillance and Biometrics is also where MedSun is located.

Ms Pressly is currently a member of the CDRH Electromagnetic Compatibility Working Group. She also leads the team that developed three FDA public health notifications related to medical telemetry and the WMTS. Ms Pressly is also involved in other projects concerning electromagnetic compatibility, pacemakers and defibrillators, and various other specific device issues.

She holds a BS Engineering Degree in Biomedical Engineering from Catholic University. And she will be talking about FDA’s involvement in medical telemetry system.

Nancy Pressly: Thank you Terrie.

I’m just going to give a bit of a background and overview of FDA’s involvement. I think you’ve gotten the technical aspects of this very nicely from Rich and Rick already.

So going on to Slide 2 of mine.

FDA really began their main involvement in medical telemetry back in 1998 when DTV started interfering with hospitals in Texas. That’s when it really became an issue for us and we took notice of it. We issued a public health notification warning hospitals that this could happen and that’s really the start of our workings with FCC.

We began working with the FCC and worked with them and the industry and the hospitals and the organizations representing the hospitals to get the wireless medical telemetry service in place.

And as we’ve heard from Rick, WMTS isn’t perfect but it is probably better than what we had previously.

Also in 2000, when FCC did go out with their wireless medical telemetry service, we issued a new public health notification trying to make hospitals aware of this.

Moving on to the next slide.

In 2005, we also issued another public health notification warning about the changes that were taking place in the PLMR band, the 460 to 470 megahertz band that you have heard the other speakers speak about. And we really do want to urge people to get out of that band. We don’t think it’s a safe place to be. The problems that are likely to be seen in that band are probably transient and they’re going to be unpredictable because these are mobile radios. It’s very difficult to know when interference might happen, when one of these mobile radios might come in the vicinity of your hospital, when it might leave, and then tracking down the source is going to be very difficult.

So for those reasons, we really don’t think it’s a safe band to be in and we strongly encourage people to get out of there.

Presently, we are continuing our collaboration with FCC. We meet periodically with them, roughly quarterly we meet with them to discuss what’s going on in the medical device area that both FCC and FDA are involved in. We’re working closely with them.

We at the FDA are working on drafting a guidance on wireless communications in medical devices. This a guidance that’s mainly geared toward manufacturers of wireless medical devices but may have some information that would be appropriate to the hospitals as well. And it certainly outlines some of the areas that we’re concerned about.

Moving on to the next slide. I’ve laid out some of the wireless services and wireless bands that are available. There are really three bands that are mainly in use now as we’ve discussed, the WMTS band. We haven’t heard much about MICS band, that’s medical implant communications service and that’s a band that’s used mainly for implants to communicate wirelessly with their programmers, but that is another band that’s set aside for medical use. And then the ISM band.

Within those bands, there are several different protocols for communication. The IEEE 802.11 and the Bluetooth protocols and those are typically seen in the ISM frequencies. But as was mentioned before, there really are no protocol standards for the WMTS band. So that’s one of the things that people need to be cautious about and be aware of.

Moving on to the next slide.

FDA does have some concerns that are specific to wireless communication. We are very concerned about the RF wireless coexistence. And as was alluded earlier by one of the other speakers, the ability of one wireless system to work is probably not so much in question. It’s what happens when it to has to coexist with all the other wireless systems that are in your hospital.

What happens when you get systems together that are using different communication protocols? What’s going to happen? Who’s going to take priority? What’s going to happen to the quality of service for that medical device? What’s the reliability of the data transmission, including the transmission rate and the error rate, particularly when these devices are being used in the real world scenario where there are competing transmissions out there?

We want to ensure that the integrity of the data stays constant and the security of the data.

And that’s one of the things that we need to impress upon the other people in the hospital using wireless systems for the non-patient care wireless transmission is that when you are using wireless transmissions for direct patient care, it’s different than just transmitting any old data or patient record or anything like that.

The problems with the transmission can really lead to problems that could impact directly on the well-being of that patient. And that’s a real concern for us and what’s going to happen in that area.

Moving on to the next slide on addressing RF wireless. The idea of priorities is important and this gets back to when there are more than one wireless system or even just one wireless system, what is the priority of the data that’s being transmitted?

It’s okay if there is a lag in data transmission or packets need to be resent if you’re just sending data that’s going into a medical record. If you’re sending patient critical information such as an arrhythmic event that’s being transmitted that would trigger an alarm and have to trigger intervention, there isn’t room for a delay in the transmission of that kind of data. It has to take priority over any other transmissions that are going on at that time.

Present standards that are out there really do not adequately address wireless medical device concerns. There are safe standards for medical devices but these standards exclude testing in the band transmission frequencies that aren’t wireless which means that the frequencies that we would be most concerned about, what the device is operating in, the testing that goes on, that’s called wireless standard is not performed there.

So there really are no standards that adequately address this in medical devices. That’s why some of the work there, like Rick is doing in IEEE and coming up with standards and guidelines, is very important and FDA is also actively participating in those groups.

You know when you’re looking at RF wireless medical devices and telemetry, you know, there are number of things that you need to consider. You need to consider EMC in general, the electromagnetic compatibility. Just because this is wireless doesn’t mean it’s not going to cause electromagnetic compatibility problems in general.

And then the whole issue of the coexistence, the data integrity, and the data security all have to be addressed. And this has to be addressed not just by the manufacturer, these are things that the hospitals need to consider once this has gone in place in the hospital. The manufacturers all have to do this before they can get a medical device approved but making sure that these remain as the manufacturer intended and some of the responsibility of the hospital once the system is put in place and is in use in your hospital.

Moving on to the next slide. One of the things that we think is most important is you need to report problems to the FDA.

You are all MedSun facilities, so we would hope that you would work through MedSun to report these issues even if they’re not mandatory reportable events - we still want to hear about them. As Rick mentioned, there are hospitals out there that we know are having problems but they’re not reporting to the FDA and they’re not reporting to the FCC.

Without those types of reports coming in it’s very hard for FDA to work to do something to get changes made.

Basically, we’re working on anecdotal, hearsay information without having actual reports. At this point when people ask us, “Well what kinds of problems are you seeing?” and when FCC asks us, “Well what are you seeing your database with problems related to telemetry and other wireless communications problems with medical devices?”

We go back and look in our database and there’s practically nothing there - yet we know that there are problems out there.

So it’s very important that we get hospitals to report these problems, even if they’re transient, even if you manage to fix them, it’s still good for us to know about it.

And that pretty much concludes my overview and my contact information is there on the last slide.

Thank you.