Medical Devices

MedSun Reporting by Biomedical and Clinical Engineers: Sites' Safety Stories and Successes - July 24, 2012


2:00 pm - 2:05 pm
Welcome & Overview
Chuck McCullough, MSEE
MedSun program
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration (FDA)
2:05 pm - 2:35 pm
MedSun Reporting
2:35 pm – 2:55 pm
Hospital Experiences

Eastern Maine Medical Center

  • Robyn W. Frick, CCE
    Biomedical Engineer

Long Beach Memorial Medical Center
Miller Children’s Hospital

  • David Stiles, CBET
    Director, Department of Biomedical Engineering & Central Equipment Services
2:55 pm – 3:00 pm
Wrap up & Adjourn
Chuck McCullough, MSEE
MedSun program
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration (FDA)


Coordinator: Welcome and thank you for standing by. At this time all participants in today’s call are in a listen only mode. Today’s call is being recorded, if you have any objections you may disconnect at this time.

I would now like to turn the call over to Mr. Chuck McCullough, you may begin sir.

Chuck McCullough: All right, well thank you. I’d like to welcome everyone to this FDA MedSun webinar titled MedSun Reporting by Biomedical and Clinical Engineers - Safety Stories and Successes.

I’m Chuck McCullough, I was a hospital-based biomedical engineer for many years and formerly a reporter to the MedSun program. And I work here at FDA on the other side of the MedSun equation reviewing your reports and so forth.

We want to begin the webinar with an agenda and review of learning objective. Before we get into that I want to point out that if anyone is having trouble with viewing the webinar, please call the 800 number, 800-859-9821, the MedSun main number and someone waiting there will help you out.

As far as the learning objectives for this - we hope by the time you’re through with this session you’ll have a better understanding and awareness of what FDA’s MedSun program is. You’ll learn about the unique contribution of biomedical and clinical engineering staff to our understanding of device safety issues.

You’ll basically hear and increase your awareness of the sorts of things we’re looking for here at FDA from particularly the biomedical engineering reporters to the program.

And we’ll also hear at the end, what is perhaps the most fascinating part for us: two hospital’s experiences reporting particular issues MedSun from a uniquely biomedical engineer’s perspective and, how that lead to resolving some device problems for them.

Our two presenters today are Robyn Frick from Eastern Maine Medical Center and David Stiles from Long Beach Memorial Medical Center and Miller’s Children’s Hospital.

They’ve both been at MedSun for quite a while and we’ll hear more from them shortly. I want to start by discussing what prompted us to design this webinar. I do a lot of talking to biomedical engineers, who participate in MedSun, and in doing so came to realize that the reports we get from biomedical engineers in the program are often uniquely different in many ways.

They’re not so much adverse event related in some cases but they really reflect the technical understanding that you all have - those of you who are in this clinical engineering field.

So we’re going to talk about what is MedSun; what does it have to do with the Safe Medical Device Act, that’s the SMDA term which is often known by hospital people and maybe some of the other terms such as MedWatch.

It was described by a biomedical engineer I ran into once as “Well, MedSun, that’s just MedWatch on steroids…”. And I got a chuckle out of it at the time but in some ways it’s sort of is true, maybe you’ll gain an understanding of why we feel that way in many ways.

Is MedSun FDA sponsored or is it something else? Hospitals sometimes think this must be a paid program, a subscription service, something run by a third party.

But we’ll tell you it is actually an FDA - 100% FDA process and we’ll explain that in some more detail. We want to go over what we would like to have reported to us which is a big broad topic, and I’ll try and elaborate on that in some detail.

We want to talk about where reporting to MedSun fits into the hospital’s safety program because after all if MedSun reporting didn’t make sense for a hospital and there wasn’t a “what’s in it for me side of things”, you wouldn’t do it.

And most importantly, for this particular webinar where do biomedical and clinical engineers and technicians fit into MedSun? We think they have a very unique place there.

So first of all, MedSun, what is it? MedSun is a project of FDA’s Center for Devices and Radiological health. It’s been around since 2002, prior to that it was a pilot program with a very small number of hospitals.

It’s presently at a network of about 300 hospitals nation-wide - these are all sizes, all types, all facilities, pretty widely scattered across the country.

Hospitals in MedSun can meet their reporting requirements for mandatory reporting under the Safe Medical Device Act through participation in MedSun.

But it’s a whole lot more than that. Participating in MedSun is, to a large extent, about voluntary reporting. Creating this trust between the FDA and the facilities in MedSun creates a triangle of communication between hospitals, most of you on the call, the FDA and very importantly also the device manufacturers who are really the ones who create these devices, solve problems and make them better.

So an important message I always emphasize to really anybody I speak with in the MedSun hospitals is that through MedSun you really have FDA’s ear.

You have a pipeline directly to the FDA - we care about what you tell us. We value what you tell us and that’s really important. I’d point out that FDA CDRH, the Center for Devices and Radiological Health, this particular center regulates medical device manufacturers.

And as such, we need the perspective of the medical device users about safety concerns, issues, near misses, and things that keep you up at night as you use devices, maintain devices and otherwise come in contact with them.

This is the perspective that’s different than what we might get from manufacturers or even in hospitals who are reporting only on a mandatory basis.

Your hospital benefits when you report potential for harm issues, I’ll talk more later in the program about what we mean by potential for harm. But we use that phrase a lot. But your hospital, I think you’ll see, really benefits from raising this awareness of the device related potential for harm issues and concerns that you often bring to our attention.

On this slider there are two articles which appeared fairly recently: one in “24 by 7” magazine a couple of years ago and one in AAMI’s Tech World. These were aimed at the biomedical engineering community and both articles talk about the role that biomeds play in MedSun and are very much along the same line of what I’ll be talking about here today.

Next, I always like to start by pointing out the huge diversity of what we call medical devices. Really it’s this giant spectrum of things all the way from tongue depressors and most simple devices, cribs, IV poles and such, all the way up to CT scanners and the most complex cardiac devices.

It’s a huge - it runs the gamut of all sorts of devices and of course clinical lab. There is standalone software where basically software is the medical device.

And, there is software that’s contained inside the device - this is all of concern. But I point out on this slide too that as you look at this list, if you’re a biomedical engineer in the audience, there are some of these things you don’t handle, or that you’re not involved with every day.

Catheters, feeding tubes, gloves, perhaps these aren’t what your staff deals with. But we want to kind of float the idea that you have a lot of technical expertise that you can help the folks in Risk Management or elsewhere in the hospital with in understanding adverse events involving these things.

Your technical expertise can be of great help in doing the root cause analysis, and adding to the understanding of what a device failure may have been, even if it’s not a classic quote/unquote “biomedical device”.

Your expertise can be very valuable so we encourage that and we’ll talk some more about that later too. We have this little puzzle here to illustrate that really everybody is a player in this puzzle, putting together this story of what happened in an adverse event.

In understanding a device safety concern, all these departments that handle devices including biomedical engineering, patient care departments, the users, and also the medical device manufacturers who need to hear the things that you report as much as FDA does.

So what kinds of things should you report? This is kind of an overview of the list of things, I’m just going to hit the high spots but we start with problems you haven’t seen before, you know unexpected things.

–And… we would hope in many cases that the things that get reported are not - did not result in harm; did not result in adverse events.

They’re just surprising problems that you believe from the safety point of view you need to tell us at the FDA. For example, increases well known problems - sometimes there’s a baseline of issues that can occur with a certain medical device.

But if you see an increase in that, you know why is this happening, maybe you need to tell us about that. Issues with instructions and labeling of devices,- maybe the labeling and the instructions is not correct.

It’s misleading, it’s duplicative, it’s not as good as it could be and that’s a safety issue. Defects – this covers a lot of ground, a product that’s defective right out of the package or a product that turns out to be defective after you start using it.

Software problems, again we’ll talk some more about this, software problems that are more and more at the heart of device problems with high tech equipment.

Any time a device doesn’t do what the user thinks it should do whether it’s the user’s understanding of it or it’s an actual malfunction, and you know that this could represent a safety issue that is something we’d like you to tell us about.

Interactions with other devices, or human factors. We place a big emphasis these days on human factors concerns. We think device users and clinical engineers can have a lot to say about devices that are really from a human factor’s point of view, not optimal.

Unsafe designs - really any time, and again we’ll talk about this, you think in your technical framework that a device is not safe. Tell us that story. Problems with off label use, things are used off label, etc.

FDA doesn’t regulate the practice of medicine but we do want to know when things have happened when products are used off label.

In other problems that may result in harm, regardless of cause. So biomedical engineers and technicians, we feel, are in a unique role because you have your hands on so many devices across the hospital and you go in so many places, and know about so many different systems throughout a hospital.

And it’s rare that there’s any one other discipline that may be so present everywhere in a hospital touching so many medical devices. So we think that’s a unique perspective that we’re glad to have in our program.

Clinical engineers work very closely with users when they have problems with equipment. This is what you do, I think of myself as having done that for many years, and as such you learn what users think of this equipment, what problems they’re having.

And you form conclusions about maybe why that’s taking place. You’re often in communication with manufacturers about problems and solutions. I think again, the clinical engineer and biomedical engineer are a frequent point of contact for manufacturers, both the sales side and the service side.

And we like to hear in MedSun reports what they’re telling you, what sorts of repair solutions are they coming up with, whether it be recalls, upgrades, what they are doing….

We think that clinical and biomedical engineers can provide valuable insight about the design of the equipment they service. It’s a lot like some of us who may have tried to work on our cars from time to time, and you just shake your head and say “well who designed this?”.

It just can’t be serviced, it’s not right. And I think all of us who have worked on biomedical equipment often have some valuable perspective, and opinions. We’re fairly opinionated but what we think of the design of the equipment we service and a lot of that includes safety issues.

Other things you can share with FDA and we value that insight: Biomedical and clinical engineers often observe user error scenarios that can be related to poor human factors design.

“No problem found”, “Unable to duplicate” repair, or perhaps non-repair is a frequent issue in biomedical departments and so we’d ask that you think about situations in which that could be caused by the design of the equipment from a human factors point of view, or some other point of view that makes it – that makes this use error happen more often than it should.

So we’ll move on to talking a little bit about what should I report? The first two categories involve situations where a device may have caused or contributed to the death or serious injury of a patient - this is the mandatory medical device reporting for hospitals - the Safe Medical Device Act category of things.

I won’t go into the detailed definition of this serious injury category but most people are familiar with this and they follow this reporting.

But here in MedSun we like to emphasize the other side of this, it’s a much bigger thing we think, and probably much more positive for patient safety. Let’s hear about minor injuries, close calls, potential for harm events and then I’ll explain that little asterisk that’s there later.

The safety concerns, let’s hear about these things before they can result in death or injury of a patient. And in MedSun we focus on that a lot.

As frequently speak with biomedical and clinical engineers, this was a - this was brought up in a public forum some time ago: “Well, does MedSun want biomeds to report every repair they do?”

Malfunctions, repairs are what we do, but what should I report? This was actually posed in just such a way to us. Well the answer is no - we trust your judgment on what you think FDA needs to know to improve the safety of the medical devices you deal with.

Knowing from the earlier slide that you have FDA’s ear, this is the question you should ask yourself, and those are the sorts of things we’d like you to report.

I frequently look at the BiomedTalk and some other listservs that are out there and I see questions like this: “Has anyone else seen this problem?” And they’ll describe a problem and often people will chime in - other people have seen this problem.

“Someone should tell FDA about this…” and people will again describe a problem they’re seeing with a particular medical device or they’ll say the manufacturer is telling us they’re working on a fix.

And they elaborate on that, and as I read these, some of these hospitals who post are in MedSun, most of them are not. And I think gosh if we could just have these people share this information with us through MedWatch or MedSun - these are things we need to know!

And yes, we think someone should tell FDA about these things. So we’ll talk about what do we mean by “potential for harm”. One is events that are caught before anything harmful occurred and again this is kind of getting away from the adverse event paradigm, certainly adverse events are something that we’d like hospitals to report.

But events that happen - in this case an OR table dropping, the staff was there, and they were able to catch a patient and prevent any kind of injury.

This was not you might call an adverse event but we like reports that talk about why this happened because this very easily could have been an adverse event.

Important observations of a product problem with a device, again clinical and biomedical engineers are in a very good position to observe this. Problems that just keep happening and you say to yourself, “this should not be occurring at this frequency”, particularly if it’s a very new device.

Example of IV pump which frequently requires repair of a set door, might be something that you just see in great numbers, and you might want to tell us that story.

Problems which lead staff to develop ‘work-arounds’. An example is the end user frequently applying tape to secure an easily dislodged component or control.

We’ve seen situations in which end users had placed a piece of tape over a switch a switch and a sign which said “Do not put this switch in the down position”. I saw a report very recently where users had found it necessary to put a piece of tape over a connector in order not to accidentally plug a cable into the wrong place..

And this is a workaround in which someone is trying to promote safety by designing that workaround. But these are the things that we’d like users and clinical engineers to tell us about, because there’s a safety story there when you see these kinds of workarounds.

Out of the box problems that are identified before use on a patient. Now whether this is a clinician or a nurse who opens some sort of a single use device and observes that the catheter is cracked, broken, defective.

We had a case where a biomedical engineering department was doing incoming inspection of a large number of new infusion pumps. And a very large percentage of those were failing incoming performance inspection for a specific reason. And this was an example of their technical judgment - this engineer felt that this should not be the case.

And the assumption is that more might be failing when they’re on patients, so we heard about that, and it’s a good thing that we did.

Human factors issues - we’re really placing a lot of our focus, our internal and external education on talking about human factors issues with medical devices.

In one case there was a PCA pump with programming that was so complicated and unintuitive, that not only could users not safely program it or correctly program it, but the biomedical staff had a tough time with it also.

Even the company sales rep that was doing the in-service had a very difficult time correctly demonstrating how to program this. That’s clearly a human factor issue and that’s a story that we would love to have told to us, an example of that.

So the little asterisk up there by “potential for harm”: in all of these kinds of cases we want to emphasize - please explain what the potential safety implication is.

We sometimes get reports that say the CT scanner went down or you know the monitor went blank - and intuitively that’s not a good thing certainly.

But, particularly from our technical reporters or to help our clinical reporters explain some detail about what happened and why this is a potential safety implication.

This helps us to understand that and to work with the manufacturers. So I’ll go through some typical device safety concerns that we see and we encourage from clinical and biomedical engineers.

These are by no means all the kinds of things that you would tell us about. But a frequently seen problem relates to battery issues. Batteries are used in medical devices all across the spectrum.

So many things are battery powered these days, batteries of all kinds. Things to report - short life, ineffective charging, premature failure.

Again, use your technical judgment to say this is something I’d like to report because I don’t think this should be happening. Or this didn’t used to happen and suddenly I’m seeing this.

Interoperability issues - interoperability is kind of a big buzz word these days.

Many devices are designed to interoperate with other devices, some of them from the same company, some of them from other companies.

We would like to know more and have reported issues that come up involving the compatibility in a communication between devices that are connected together and that includes things on the hospital network. That’s the way many interoperable devices are supposed to work correctly.

Clinical device integration - somewhat related - this is a big topic right now. Many biomedical engineers and IT departments are working more closely than ever before to integrate classic medical devices with things like the electronic health record, other IT products whether it be PACS systems and cardiovascular data information systems.

But with a lot of this medical device integration going on, we want to keep a very close eye on issues, safety issues that may come out of that device integration when things don’t play with each other the way they should. So we encourage you to report those things.

Design issues - As I said before, clinical engineers being as technical as we are we tend to be fairly critical as we look at the design of the products that we work with every day.

We look at the problems that are reported to us and form opinions about designs that seem prone to failure, are mechanically unsound, or are difficult to use or maintain. These are things, this is a story that you can describe to us in a MedSun report, we would value that.

Software issues. As I said software can be a medical device in its own right.

More frequently software is contained within many medical devices, whether its IV pumps, ventilators, you name it, there is software down underneath the hood.

So when there are issues like lockups and reboots, error messages, the need to reload or upgrade software to solve a particular problem - that’s a report that we frequently encourage. We like lots of details about software versions and so forth when you do that.

Manufacturer fixes - As I mentioned in that slide about the listserv posts, manufacturers often work closely with the clinical engineers to install various fixes whether that be some sort of parts kits, upgrades.

They send a notification and say hey we’d like to come in and do a certain kind of an upgrade or modification, or field change order. We like it when our hospitals tell us about these things.

Again please emphasize what the safety implications of this might be, what kind of a problem is this meant to solve and whether you have experienced it as well.

Interference and RFI EMI issues are important to report. I think, in hospitals we’ve all moved beyond the hysteria over cell phones. But on the other hand we’re being very vigilant about whether there are still issues out there and under what conditions do they occur and it’s not just limited to cell phones. It’s radio frequency interference, and EMI with all kinds of medical devices, whatever they might be.

So that’s something we need to hear about, we need to collect safety stories about that and there you are on the front lines looking at those things.

Okay so details to report in a report - we’ll go through some of those. If there was an injury we like to know what happened to the persons affected. So sometimes - as I said we’ll get that report that says something malfunctioned but we don’t know what the injury may have been.

So in this case if the report says “loss of ventilation, patient was manually ventilated”, we know what happened and we know what kind of patient interactions had to happen to mitigate that.

And what specifically were the problems with the device involved? We think clinical engineers generally describe that, when they report to us, but I think sometimes you can help other reporters on the floors describe exactly what the malfunction was.

Ventilators, an error code 130 message to stop ventilating, that’s very specific. Most biomeds are used to getting equipment reported where a note just says “broken”.

And that’s not helpful if you’re a clinical engineer as you know. In the same way in your MedSun reports we want to - we like that detail, that really helps us analyze your reports.

What if any were the original medical procedures for which the device was used, we like to know this when we get a report about, particularly, an adverse event - what was going on? What were they trying to do here?

What was this procedure when this thing took place? What if any were the follow up medical procedures required so - and again I think sometimes when I was a reporter to MedSun I thought only of the technical side of the report, I could talk about the components.

But I may not have talked as much about the patient side and what kinds of interactions were needed and that all was part of making a complete MedSun report.

What are the names and manufacturers of the devices involved, what are other relevant manufacturer device identification numbers. So it’s really important that we get not only the manufacturer but we identify as much detail about what this specific device is.

So of course, as you know, that includes the serial, the model number, the lot number, catalog number, all kinds of other identifiers.

And a very important thing just happened, I’m sure everyone’s very excited about, smiling here, the FDA UDI [Unique Device Identification] rule was recently put out for public comment. This was a big milestone; people have been talking about the universal device identification number for some time.

But this - when it comes to fruition and it’s fully implemented, medical devices will have a number a lot like consumer products have a bar code number, or other identifier that specifically identifies that product.

When that day comes, it will be much easier to identify what medical device may have been involved in an incident so we’re excited about that.

We’re going to be actually asking hospitals to tell us a little bit more about what they know about UDI, what they don’t know about it and so forth. So look for some more forthcoming information from us about that.

And what did you do to solve the problem? We like to know, well, what sorts of steps had to happen when this problem took place?

And you know this is something I’m sure biomedical engineers preach to their customers, their clients, save the device, save the accessories, save the packaging.

And the same goes for our MedSun reports, it may not be only about the device in question, the ventilator with the error 130 message, it may also be about the accessories, the tubing, the packaging - other accessory devices.

So we like people to save all of those, we preach the same thing you all do and we’d like the identifiers provided in a report if we can get those.

So lets talk about some additional information that clinical and biomedical engineers can supply to us and actually, it’s sometimes news to their risk management and safety people in the hospital that some of this documentation exists in your departments.

Copies of the manufacturer and/or biomedical service reports. When we get a MedSun report where the reporter states that the manufacturer came in and performed extensive repairs, replaced parts, did various upgrades, a copy of that manufacturer service report is very valuable to us.

More and more of our reporters are sending these to us to supplement the reports so we welcome that. And your own in house service reports can work that same way.

It’s good when you make risk managers who are filing reports aware of the existence of those documents, because they may not know that you have an extensive file with those things.

Information on additional testing that was done to determine the cause of the problem - very often a clinical engineering department may try to duplicate a particular scenario or try to reproduce why it took place and understand it.

If you can tell us about that in the report, that helps a great deal. There’s a test section in the MedSun report where you can put that but if you tell us that story, that’s a good thing.

Everyone carries camera phones for the most part these days and we are getting more and more photos that illustrate the device in question, where the device broke, some other feature of the device, you know, a picture really is worth 1000 words to us in a MedSun report.

So, we welcome those to supplement what you’re telling us. I also wanted to mention that there is information in biomedical engineering departments contained in their computerized maintenance management software, the CMMS software that they use to schedule their maintenance and keep repair histories and records and so forth.

Often risk managers don’t realize what a vast store house of knowledge this is, it’s maintained in the clinical engineering department.

Also that you all have access to device identifiers, service history, age of equipment, all kinds of trends.

This is valuable information and we’d like to dive deep in there and sometimes there’s a reason to do so. We’re actually working with some cooperating MedSun sites now to explore how we can data mine this CMMS data that might be provided to us to identify potential device safety signals.

Maybe it doesn’t take a specific report, maybe there’s a signal that you know is just bubbling up and if we look in the CMMS maintenance data and compare it across hospitals we might - it might help us to identify safety signals. So we’ll be talking - if you have an interest in that please contact us here at MedSun.

You can call the 800 number and ask for me, I’m Chuck McCullough once again or just call and say you want to know about this.

Lastly - your technical expertise in explaining the nature of the problems and the safety implications, this is what you bring to the table for us at MedSun. We really value that.

So lastly let’s talk about some other ways you can help as a biomedical engineer. We encourage you to get to know and work with the risk management and safety staff who also report adverse events and concerns in MedSun.

In some cases our reporters directly interacting with the system are biomeds, in other cases the reports go through risk management. We’d like to encourage you to get know those folks and for them to get to know you.

Your risk management department can really use this engineering and technical knowledge to help them understand all sorts of adverse events, the problems with devices, as I said, that are not necessarily classic biomed devices.

But perhaps there’s a catheter which is snapping off at the hub or some sort of single use device that’s malfunctioning and a technical person looking at that could help explain it to us and could help the clinical staff understand what that malfunction is all about.

So we encourage you to get to know those folks and work together on things. Sharing your concerns back and forth - risk management needs to know about the concerns of biomeds have on the safety of these devices.

So why is reporting problems important in your own hospital?

To prevent future problems, to protect patient staff, families, visitors - the more you recognize and build a climate of looking at device safety problems in a proactive way, the more you prevent future problems and then protect patients.

That just kind of goes without saying. This whole thing contributes to hospital’s quality management goals, the hospital wants to improve their quality management, medical device reporting, safety awareness, this is all part of that equation.

Reporting to MedSun fosters the collaboration between manufacturers and the FDA and I should point out - and the hospital. You really get a dialogue going as a MedSun reporter with manufacturers - they pay attention to you, they begin to realize that you’re engaged.

And that you want to work on making medical devices safer. Outcomes for MedSun reporting can include recalls and corrective actions such as manufacturing label changes, public health notices, and all sorts of results can come out of your reporting.

And overall that’s the kind of thing that impacts the overall public health for all patients. So it kind of spins off, we have some great examples of one hospital reporting something that had an impact on hospitals all across the country.

So with that I would like to introduce our first speaker Robyn Frick, a biomedical engineer with Eastern Main Medical Center. Robyn is a member of AAMI, ACCE and the New England Society of Clinical Engineering.

He’s been to about 20 countries and spent a total of five years overseas doing medical equipment missions and training and Eastern Maine Medical Center has been part of MedSun since 2006 so we know Robyn well and we’re really glad that he agreed to be a presenter for us.

So turn it over to you. Robyn are you on the line?

Robyn Frick: How about now?

Chuck McCullough: Okay, you sure are.

Robyn Frick: Is that better? Okay again I work at Eastern Maine Medical Center; it’s a 411 community hospital or general hospital in northern and eastern Maine.

And we with MedSun our clinical engineering department has investigated you know many incidents but about five or six of them have led to manufacturer recalls so that’s pretty impressive for us with a 12 man biomed shop.

Anyway, Cancer Care of Maine is a 60,000 square foot, $41 million outpatient cancer hospital that’s a division across town that was built offering the state of the art radiation oncology, it opened in December of 2009.

And you can see the picture of this nice building and I got a new office in the building and of course it’s in the basement. Slide please. Just to give an idea of the modern world of radiation oncology we have this drawing of the setup of our linear accelerators. In the upper left quadrant is the Varian vaults.

We have three vaults and you can see there’s a lot of computers and equipment… the record and verify, imager, multi leaf collimator, and then you start seeing some other companies there in the center like BrainLab is a tumor location system.

And then moving across you have Mosaic servers which Mosaic is a trade name for Electa and then moving across more we have Cerner for our EMR and we have AGFA for the PACS and all these things really need to tie together.

And then if you look in the lower left we have Pinnacle which is a treatment planning software used by the dosimetrist to plan the doses of radiation, that’s made by Phillips.

And then finally you have some GE CT simulator and some other capture devices by GE called the GE Advantage work station and all these things had to work together and just give you an idea of what’s coming in the next slide here.

Can we have the next slide? So Varian you know had a lot of this - a lot of pieces and parts related to the Varian vaults - like the intercom and in this case the circuit breaker was purchased from Varian.

But of course it’s a different vendor and in this case it’s Gexpro and they had a breaker panel for each of the vaults. And in those breaker panels they have 12 volt, four amp hour batteries which are used to hold the breaker safety stop switches.

When you do testing of the batteries help hold the switches so the breaker doesn’t trip prematurely and for other reasons you need the batteries for this circuit.

Well, the battery charger was this or similar to this little you know two wire plug pictured here, a 12 volt adapter with nothing else going to the battery so of course the chargers just pump the batteries full of current with no regulation. We started having problems with the batteries and saw the batteries were bloated and they were overheating and breakers were tripping prematurely during the test.

And we had a lot of problems. So we went back to Varian and they initially said Gexpro supports the chargers and it’s not us. And this is a really super classic that “nobody else has ever seen that kind of problem”. They tap dance around the issue of what’s going on.

Next slide please. So what we did, we filed the report, a lot of help from my colleague here (Dennis Santares), a 30 year BMET who’s now a CBET, he worked with the details here and we reported it to MedSun.

And with help from MedSun, Varian began working with Gexpro to identify an acceptable solution. Gexpro came up with an upgrade kit and Varian let us know how to obtain it, we had to buy it, it wasn’t too expensive.

And our local electrician here, on staff electrician installed it and took care of it. Now with help from MedSun Varian takes this seriously on all requests for help even if it’s for their third party items that they sold us.

In fact there was example of two other things since this happened, with their equipment made by other companies and they were very supportive, very helpful, especially to us way up in the cold northeastern Maine. .

And it was fantastic to be able to have that attention. Because even if companies don’t know an immediate answer to your problem, at least you want their attention so they’ll listen to you.

And I think that was a huge thing for MedSun to help with in this particular case. So I think I’m pretty much done at that point.

Chuck McCullough: Okay, well thank you Robyn, appreciate that.

Robyn Frick: Sure.

Chuck McCullough: Up next we’ll hear from David Stiles, as I said he’s the director of biomedical engineering and central equipment services at Long Beach Memorial Medical Center and Miller’s Children’s Hospital in Long Beach California.

David’s biomedical career has extended past 32 years, he’s involved in AMI as an editorial board member for biomedical instrumentation and technology, the journal.

Most importantly he’s also been a MedSun participant since 2006 so we also know David very well here at MedSun, so David the floor is yours, go ahead.

David Stiles: Thank you very much Chuck and Robyn thank you for that nice example from back east. I’m talking to you from Long Beach California.

Long Beach Memorial Medical Center, we’re a 750 bed hospital. I’m the director of two departments, Biomedical Engineering and Central Equipment Services in which we distribute and manage all of the medical devices in house.

t Long Beach we do practice our ABCs which I wanted to share with the group and that’s Accountability, Best practices, Compassion and Synergy.

If we can have the next slide - Now on the next slide we’re going to discuss an issue and it’s a common issue and it may seem benign for a lot of reasons but it took us a little bit of time to really latch on to this event.

This event occurred in our 56 bed telemetry monitoring station under the watch of an EKG tech as he was looking at the monitors.

We have several monitors in this central station area that he can transfer between monitors and keyboards by the use of a KVM switch which is a keyboard video and mouse selector switch.

As he selected the KVM to move to the other monitor, all the monitors froze and he could not control the keyboard, the mouse or the touch screens.

He was unable to select a bed sectors, he couldn’t silence any alarms, he could not use his touch screen and most importantly he could not select his patient beds or patient data.

The ECG technician contacted biomedical engineering and we arrived to troubleshoot it and we duplicated the same issue and had to reboot the central station.

Once rebooted, the central station returned to normal. We started doing some more troubleshooting and as we found every time we recycled the KVM switch about once out of every ten times I would have this freeze up failure.

We then eliminated the switch and we started disconnecting the keyboard and the mouse right from the monitors and we found that the CPU and central froze.

So next slide please, and lo and behold it turned out that the problem that led to the lockup was due to the KVM switch overs by the monitoring technicians. Since these were older style KVM switches the switching time seemed diminished and they would cause a lag in switching from one set of keyboards to the next set.

We also noted that when the KVM was disconnected and reinserted it had that same issue with the CPUs, which was similar to problems that we had with our PS2 switches on our old Windows operating systems on many of our computers.

We ascertained that these have been the issues because these were not - these keyboards and mice systems were not USB connected.

We contacted the manufacturer of the central station and they were able to provide a power supply for the KVM switch which they explained would get rid of the “spurious” voltages which would allow these lockups.

At that time we did submit a MedSun report we are awaiting their follow-up.

Next slide please. We did a review of the MAUDE database and we found a couple of other instances where this issue was occurring on some of the other central stations around the country with this problem of disconnecting these keyboards.

Additional inspections noted additional equipment issues with loose connections, broken connectors and other failures.

And we started making corrective actions on the spot. Many of these disconnections go unnoticed until the device fails so we started getting more and more concerned.

And so we provided - we surveyed the medical center, we provided connection, (securement) and strain relief to a lot of our devices, especially on our mobile equipment.

And on all of our telemetry central stations we’re waiting news from the manufacturer on allowing us to insert USB rated mice and keyboards through our testing, as we found that these do not cause lock ups.

But of course we needed the manufacturers. We were adamant about us following FDA guidelines and when it went through 510K, they really realized that they couldn’t make any changes until they processed that as a 510K improvement.

Next slide please. And so why did we report to MedSun? I think this is so great about today’s issue that many reasons, there are many issues that we may think are benign or not effective but rather are listed as battery failures.

It’s not just the user’s unplugging the batteries; it’s the connections failing that supply charging power to the batteries.

So many equipment related adverse events did occur from weak or failed electrical connections, unexpected failures can and do occur from common component design.

And I just wanted to show on the right side of this slide I selected some good examples of good solid connection systems that frankly were used on a lot of the medical equipment many years ago.

And we’re seeing all of these fall out of favor on a lot of equipment but these are secured keyed connection systems that when we insert they don’t become disconnected.

They maintain strong electrical connections, the middle example is a good example of a strain release so when you do get a pull on a cord, you know the connection holds tight. And the same thing on the bottom one is that you could actually have several systems all on one loom and all on one system secured.

So we report to MedSun when we do find problems and we’re going to endeavor to do this more and more and we seek to have the manufacturers improve their design in the interest of patient safety.

And we do work with our manufacturers so when we do send in these small alerts and MedSun reports we do that in the interest of patient safety.

And I hope these examples kind of helped out, so I appreciate your time. Thank you.

Chuck McCullough: All right, well thanks David and Robyn, we appreciate your willingness to present these two scenarios. As I think about these and many others - these are so typical of everyday things that I think those of you in the clinical and biomedical engineering departments out there see every day.

Maybe you take that for granted because that’s what you do, but I think - I hope you realize that in your judgment, if you think FDA ought to hear about these things and we think quite often we would like to, I would encourage you to report these things to us.

Because you really do have our interest here and as I have said, patient safety has a lot of pieces. You heard from two experts today, but there are a lot of experts out there listening, I think.

MedSun can’t do it without you so we’re asking you to please report and we have - you have the means to call us on our 800 number.

We encourage you to call us up or email us and say “I’m seeing something and I wondered if you’d be interested in it”. So I would just say too that I’ve enjoyed meeting with a number of the biomedical engineers in the MedSun program, and intend to do more of that.

And especially through the project I described involving the data mining of biomedical CMMS software data, we’re anxious to work with some facilities about that.

It’s rare that I don’t go into a biomedical engineering department and hear lots of anecdotes and stories; people will pull me aside and say look at this, or let me show you that.

And you know, nine times out of ten I wish that issue were in a MedSun report and in the same way, as I read the biomedical listservs, I see things I also wish people would avail themselves of reporting to us..

So I hope this session has increased your awareness of the value of your participation as clinical engineers to our program and has been thought provoking and that will increase our dialogue even more from here.

So thank you to both our presenters and to all the listeners and appreciate your participation.

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