• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Building Relationships Between Biomedical Engineering and Clinical Staff to Improve Medical Device Safety and Event Reporting


NWX-HHS-FDA-CDRH

Moderator: Margaret Francis
July 25, 2013

Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen-only mode until the question and answer portion.

At that time if you would like to ask a question you may do so over the phone by pressing Star then 1. To withdraw your request you may then press Star 2.

Today's conference is being recorded. If you have any objections you may disconnect at this time.

I would now like to turn the call over to Ms. Tina Powell.

Tina Powell: Thank you very much. My name is Tina Powell and I am the Manager for the Educational Programs presented by the FDA MedSun program.

MedSun stands for Medical Product Safety Network. And I want to thank everyone on the call today from MedSun hospitals across the nation for making time for this important Webinar.

We're very excited to have three presenters from Brigham and Women's Hospital part of the Partners Healthcare System in Boston. Brigham and Women's is a Harvard teaching hospital.

Here in MedSun we consider this a very important topic that we're dealing with today on the importance of collaboration between biomedical engineering and clinical staff to work together for patient safety and for reporting.

At MedSun we tend to get higher numbers of reports that are richer in detail when we're working with hospitals that have very good collaboration between biomedical engineering, risk management, and clinical staff.

In those hospitals biomedical engineers have come to know the work of the clinical staff and really understand how they use medical devices in a way that's helpful to their work in investigating problems with medical devices.

And the clinical staffs are more willing to provide information when they know that the information that they give is going to be useful in an investigation of what happened with a particular medical product.

We have talked with Mary White who is a Risk Manager and MedSun representative from Brigham and Women's and she's not able to join us because she's home with her new baby today.

But I want to say a few words from her statement about the importance of this collaboration. She said that the risk management department -- and she thinks she can safely speak for her clinical colleagues as well -- can't imagine going backwards to a time when they didn't have the role of the bedside technologist working closely with biomedical engineering in place.

"The liaison helps our hospital ensure that we fully understand the equipment problems we encounter, identify workable solutions that make sense from both an engineering perspective and a clinical perspective, and determine when a satisfactory clinical solution can't be devised.

The liaison also helps us ensure when we're reporting adverse effects causing harm or with potential to cause harm that helps us report those quickly to FDA through MedSun.

In short risk management finds this role tremendously helpful, essential and investigative based in biomedical engineering, a United Nations ambassador of sorts who can speak all kinds of the required languages helping us improve safety of the care that we provide which automatically improves life for our clinicians every day.

And as far as the various simulation laboratories that Brigham and Women's has, the anesthesia simulations laboratory, the nursing simulations laboratory, and STRATUS based in the emergency department, those have become an integral part of physician training programs for years at Brigham and Women's."

They have developed a simulation laboratory for nursing, which Carol Luppi will describe during this presentation.

And STRATUS, the multiple disciplinary simulations lab based in the emergency department where clinical teams practice and hone their skills to prepare them before they work on a patient.

So you'll hear more about these during the presentation itself. At this point I want to just thank the presenters very much for their work preparing today and turn the program over to Elyse Beck who is a Biomedical Engineer on our staff.

Elyse received her degree in biomedical engineering from the University of Michigan -- who I know is on the call today -- and Elyse joined the FDA staff in November 2012 as a MedSun analyst and will be moderating this seminar today. Thank you Elyse.

Elyse Beck: Thank you Tina. Welcome to the MedSun Webinar. Today we're going to be discussing building relationships between biomedical engineering and clinical staff and how these relationships can improve medical device safety and event reporting.

Next slide please. As Tina said I'm  Elyse Beck. And I am a member of the MedSun staff here at FDA. The presenters joining me today are Michael Dumais, Michael Fraai and Carol Luppi.

Michael Dumais has been a MedSun reporter for Brigham and Women's Hospital for several years and works with the biomedical engineering department, risk management, and clinical staff throughout the hospital.

He's also the author of the article titled "A Nurses Role in the Biomedical Engineering Department" published in Biomedical Instrumentation and Technology in July 2005.

Michael Fraai is a native of Curacao and received his undergraduate degree from Tulane University and a graduate degree from Hartford Graduate Center / RPI.

He is the Director of Biomedical Engineering and Brigham and Women's and focuses on strategic and innovative use of technology to match the current clinical practice model in the hospital.

He's also responsible for an inventory of over 24,000 medical devices covering Brigham and Women's Hospitals distributed campus.

Carol Luppi was a member of Brigham and Women's Hospital Labor and Delivery unit for 23 years as a staff nurse, critical care obstetric nurse, and clinical educator before becoming the Nurse Educator for Technology in 2004.

Carol has collaborated with biomedical engineering on numerous projects during her time in this role. Since 2005 Carol has also partnered with biomedical engineering in the planning, creation, and implementation of the Nursing Simulation Program.

Next slide please. This slide gives a brief description of the content that will be covered in today's presentation. You may refer to it at any time after the presentation if you like.

Next slide please. At the end of this presentation you should also be familiar with the roles of the clinicians in the Biomedical Engineering Department, and the role simulation plays in education, and the investigation process at Brigham and Women's Hospital.

Next slide please. This is your standard disclosure statement. None of the presenters have any relevant financial relationships to disclose today. And now I will turn things over to Michael Fraai. Next slide please.

Michael Fraai: Okay. Thank you. So to start off we would like to give a brief introduction about what we do at the Brigham and Women's Hospital and some of the activities that happens at the Brigham and Women's Hospital which we are very proud of.

We are a 793 bed quaternary care hospital, which is a highly specialized hospital providing the most complex and sophisticated care available by hospitals.

We have an extensive scope of healthcare which includes some of the phase transplants that has been performed here as first in the nation and that we have received quite a lot of press for.

To give you a level of activity that we have here with employees, we have 18,000 employees on staff, of which 5000 of those employees are in the nursing department.

From the biomedical engineering staff perspective we have eight Clinician engineers, and 22 Biomedical Equipment Technicians who are the folks who actually have the frontline interaction with nursing.

We also have a center of our nursing excellence at Brigham. They provide orientation for about 350 to 400 new nurses each year.

Each one of those orientation sessions consists of a four day core nursing course session, which is every two weeks.

Next slide. So as you have seen and heard in the introductions earlier on today there's an increased reliance on patient care technology in the hospitals.

Some of those technologies being introduced are also high risk type of technologies. And those are actually used now more as the care is evolving for evidence based care and the evolving clinical practice.

And that's not only at the Brigham and Women's Hospital, it's also on most of the hospitals for the folks that are on the line with us.

Patient care technology introduction and its use is no longer solely a technical or a purchasing decision.

If in the past there was a clinical or a technical pool to buy a technology because it was cool or it was the best price available in the market we've bought the technology that's no longer the case.

Right now it should be a multidisciplinary approach with clinicians and biomedical engineering staff involved, playing critical roles in how those decisions are made.

From another perspective the technology can also be overwhelming to caregivers, which is something that we don't want to do.

A lot of the conversations that my other two team members will present today will actually provide different ways of trying to mitigate those making it overwhelming for our caregivers.

When getting these technologies introduced or purchased we need to also take into account the clinical aspect or the clinical story that needs to be factored in. From the point that technology is being introduced, the training component of it that Carol Luppi will expand on later, with use of simulation, the incident investigations that Mike Dumais will expand on greatly later as well, and how we do  MedSun reports.

And the reporting component of it is not just reporting for reporting purposes it's also reporting to really press on the manufacturers to make sure that we provide safer and more efficient patient care to take care of our critically ill patients.

Now when you want to do all of this it sounds nice but why do we actually do that? And why is that you need the collaboration?

So we hope that through the talk today it was shine light on why do we need collaboration between these two professions and why it's so essential.

Now this didn't start yesterday at Brigham, this started quite a while ago with Jeff Cooper -- who some people on the line may know -- that actually had a vision to actually have this and have clinicians embedded in our biomedical engineering organization.

So I will pass on to Mike Dumais now who will continue and expand on the topics. Next slide.

Michael Dumais: So this is Michael Dumais. Good afternoon to everyone. In our department we actually have several clinicians actually embedded in our department.

The first one is Dr. Amy Miller who's a board certified Electrophysiologist. And part of her role here, and before she became a physician and Electrophysiologist her first career was actually as a biomedical engineer.

You also have myself. I am a registered nurse and I'm the Nursing Bedside Technology Specialist. And basically I'm a full time employee of the department. And you'll hear a little bit further the things that I do.

We also have an operating room physician, Dr. Jim Phillips. He's a board certified Anesthesiologist as well as a Certified Clinical Engineer. Again his first career was clinical engineering.

Part of our department also includes a robust collaboration with the nursing department most particularly the nursing education folks.

We've observed over the years that many times there are difficulties that are associated with medical devices that come from not exactly understanding the technology. So we work very closely with them to make sure that all nurses are properly trained.

We're also very closely aligned with Risk Management Department and for things like investigating sentinel and non-sentinel events as well as with decisions as to whether report up to MedSun or other local regulatory bodies.

Next slide please. Probably the biggest role that we have here for the clinicians in the department is acting as a liaison between our two departments.

And our biggest customer actually happens to be the nursing department. We act as the bridge between the clinical folks and the technical groups.

This also helps with understanding the clinical perspective in project specification, solution development, and accident investigations.

We also have that liaison with the greater nursing department, risk management, and just as importantly with our vendors. Next slide please.

Carol Luppi: Good afternoon at least to those of you on the east of the Mississippi it's afternoon. This is Carol Luppi.

And as Elyse mentioned I am the Nurse Educator for Technology here at the Center for Nursing Excellence at Brigham and Women's Hospital. I'd like to thank you all so much for inviting me to be part of this Webinar today.

As Michael Fraai mentioned the current partnership between our nursing department and the biomedical engineering department didn't crop up yesterday.

It actually evolved from the intentional creation of a liaison committee between these two departments about ten years ago.

Each director saw the potential for improved patient and staff safety when both departments worked together regarding the use of the high risk technology that's ubiquitous throughout our hospital.

Each department recognized a need for clear communication, pedagogically sound adult education methods, involvement of each disciplines end users, and interdepartmental collaboration, and this is to reach both staff and patient safety goals.

Our initial interdepartmental project was a hospital wide rollout of a new brand of defibrillators, both an airport grade defibrillator for the public areas of our hospital and a more complex multifunction defibrillator for the inpatient units.

Representatives from both our departments met with the vendor and we created an implementation plan.

It included the multidisciplinary training sessions, self-paced learning modules, and daily communication regarding the completion of all training.

This model has subsequently been successfully used for various other technology implementations here at Brigham and Women's.

The two departments further strengthened our partnership during the smart infusion technology software and hardware upgrades.

All our hardware and software upgrades require locating every pump in the institution and then transporting the pump to a central location where biomedical engineers can perform their upgrades.

Prior to the installation of our wireless network every smart pump drug library upgrade would also require locating each pump in the institution and manually uploading the new library.

These projects entailed removing pumps from patients while they were in use. So a complex partnership between the clinical nurses and the biomedical engineers is essential for these upgrades.

Clearly communicating the timeline of the project to the unit based nursing leaders was one component of our strategy.

The nursing leaders were engaged to take part in the upgrade. They ensured accurate communication of the plan to their staff; they facilitated staff cooperation with the process.

Our nursing Float Pool staff work closely with our biomedical engineers and our unit based nurses to acquire the hardware, remove it from patient use, and replace the pump with upgraded hardware.

This model has also been successfully used for several hardware and software upgrades, and also with product recalls.

Next slide please. In 2006 the Nursing Department and the Biomedical Engineering Department entered into a groundbreaking partnership to create a Nursing Simulation Center at the Center for Nursing Excellence.

This center would not be possible about the vision and the support of my colleague and Biomedical Engineering Director Michael Fraai.

Michael saw that simulation based education was essential. It was emerging as a prominent pedagogical approach in both our nursing schools and more recently even in hospital based professional development programs.

Next slide please. Michael recognized that simulation based education incorporates sound pedagogical principles related to adult education including experiential learning, transformational learning, and a rather unique method of reflective collaborative learning found in the debriefing sessions following a simulation scenario.

A multi-disciplinary planning team was formed here, and we've created a nursing simulation program at Brigham Women's Hospital.

As a result of that team being formed, one of my educator colleagues and I applied for and received a grant to investigate how to incorporate human patient simulation into Brigham and Women's Hospital nursing education and how to create a nursing simulation program.

We travelled to Oregon Health Sciences University Simulation Center and consulted with internationally renowned nursing and physician experts.

We were extremely fortunate to also have similarly internationally renowned experts right in our backyard at the Center for Medical Simulation at Harvard University.

Next slide please. Due to all these efforts our participants now are more engaged in clinically based contextual education.

Our response based student roles have allowed us to combine focus practices of Brigham and Women's Hospital nursing in a standardized evidence based curricula.

Simulation is very helpful in sharpening nurses critical thinking skills that are needed to work in our increasingly complex clinical environment with all the high risk technology.

Our first simulation room was designed for newly hired nurses during their central orientation that Michael mentioned.

And it incorporated the use of high risk technologies into a simulated patient care scenario. This experiential learning in the center reinforced their classroom instruction in the use of high risk technology.

We teach them about smart fusion pumps, physiological monitors and different defibrillators for example.

The collaborative group discussion's during the debriefing period that follows a scenario has been identified by our participants as the most important aspect of their learning process.

The participants have also identified multiple other factors that were perceived to be essential for their learning during simulation based education.

Simulation based education provides a safe and nurturing judgment free learning environment. There's a supportive relationship between the peers and the faculty, there's realistic simulation scenarios, and there's that unique experiential reflective learning components that help our participants learn and understand how to use technology.

Since the inception, over 450 nurses have participated in this Simulation Based Orientation Program, we call it SBOP here.

We've expanded our simulation based education and use of the simulation center to provide courses for many of departments in the hospital including our Interventional Radiology Department, our Center for Diagnostic and Interventional Cardiology and our Mother-Baby units.

We've also have simulation components and education for critical care interns and our novice newly licensed nurses.

We've also used our simulation center audiovisual equipment and collaborated with our educators to create multiple best practice videos that illustrate the safe use of high risk technology such as telemetry units, defibrillators and CVH machines.

Next slide please. These are pictures of our Nursing Simulation Center. The technology in the room is authentic, it's functional, and it mirrors the technology in our clinical areas.

Our center includes two adult beds that you can see here. We have one adult high fidelity human patient simulator. We also use various other low fidelity manikins and actors in many of our programs.

Next slide please. Both our adult beds are equipped with physiologic monitors. And a functional patient care tower that includes live electrical outlets, and functioning air, and oxygen and wall function connectors.

Next slide please. Brigham and Women's Hospitals doesn't provide pediatric care however we do have a very large neonatal intensive care unit and three wellbore - newborn nurseries.

This picture shows our infant high fidelity manikin. We're hoping to acquire a newborn high fidelity manikin that would provide more realistic scenarios for our neonatal nursing participants.

Next slide please. This slide illustrates our functioning Clinical Information Center, or CIC, and our desktop computer technology. It affords our staff the ability to interface with these authentic technologies.

We have multiple telemetry units they can connect to our CIC for a variety of patient scenarios and technology troubleshooting opportunities.

Next slide please. There is a one way mirror between the simulation lab and the control room. Sometimes our participants like to see what's going on the other side of the mirror.

Next slide please. And this is what's going on. We're able to control our human patient simulator and are audiovisual equipment from this area.

We have four cameras and two microphones installed in the ceiling of the lab. There's one very high resolution camera that was installed specifically for the evaluation of the high risk technology and user interface.

This camera has the ability to zoom in with minute detail to analyze all the human factors that could potentially influence the use of high risk technology.

This feature is extremely useful in the evaluation of high risk technology when you're thinking about purchases, or for the root cause analysis of potential or actual patient safety issues.

It should be stressed that debriefing following adverse patient outcomes does not require this type of high fidelity human patient simulation and complex audiovisual technology.

As I mentioned earlier the collaborative group discussions during the debriefing period that follows the simulation scenario have been identified as the most important aspect of our participants learning process.

Simulation faculty are trained in specific debriefing techniques to provide the necessary degree of psychological safety for staff members so they can engage in a general analysis of an adverse event and also more importantly to self-reflect on their individual actions during the event.

Faculty members are encouraged to maintain a judgment free attitude regarding the mindset of the staff members and to approach them in the debriefing discussion with genuine curiosity and respect for their professional practice.

Questions are asked in an inquisitive and not a punitive manner. This approach facilitates the analysis of the staff member's frame of reference.

We need to know where the staff member is coming from. What are they thinking? What are their assumptions and beliefs regarding the situation and their resultant actions?

Faculty training could be generalized to any debriefing process. That being said it's also very useful to be able to re-create the clinical events surrounding an adverse patient outcome in our Nursing Simulation Center.

Next slide please. We're able to re-create all aspects of the clinical environment in our Nursing Simulation Center. The slide shows our virtual patient care area.

Our nursing and biomedical engineering departments have partnered with our information services colleagues to create this computerized virtual patient care unit for authentic learning and recreation of various software applications that are used in conjunction with our high risk equipment.

We can enter orders on all of these patients; we can approve medications in our pharmacy IS systems. We can simulate administering medications to stimulated patients using our Electronic Medication Administration Records.

And we can also access a simulated outpatient medical record to tie in all the technology and computer programs.

This virtual environment allows our participants to interface with our authentic software without violation of any HIPAA regulations, all these patients are virtual.

This illustrates a very important positive aspect of simulation based education. Participants are able to practice with high risk technologies in an authentic setting without any type of harm to patients, whether it's physical harm, psychological harm, or even the violation of their privacy.

Next slide please. The unique collaboration between the biomedical engineering and the nursing departments and Brigham and Women's Hospital has created a culture of safety that facilitates the safe use of high risk technology.

Our strategies of clear and timely communication, pedagogically sound education programs, multidisciplinary end user workgroups, and open investigation of any adverse patient care event have been very successful in creating this environment that is safer for both our staff and our patient. Next slide please.

Michael Dumais: Hi. This is Mike Dumais again. I'm just going to pick up where Carol left off. When we talked about some of the roles for our clinicians in the department, one of them again is education - and when I speak of education in our department I'm talking about clinical training for the technical staff.

We really try and give our engineers and our technicians as much clinical training so that they'll have an increased understanding of what devices do and the clinical applications for the device.

Also it provides for greater understanding of clinical practice in planning future installations. And especially helpful is greater insights for troubleshooting, especially when you get that 2:00 AM phone call from the department and they're looking for assistance.

Next slide please. Evaluation is a another major role that we have as far as not only including ongoing evaluation of current medical devices but for brand new technologies that are coming on the market; also evaluations for new devices.

We'll also always take our potential new devices and we bring them over to the Nursing Simulation Center and we put them through their paces.

And we look to make sure it's user friendly using those cameras Carol was just talking about. We can really focus in closely and see how they interact with the devices.

As far as - we also get from an evaluation perspective we get input from our Nursing Clinical Informatics Committee a couple times of the year.

I'll go over there and they're in there during their meetings and just ask them for their input, like for when we get new monitors and such.

A couple times a year we sit down with our major vendors and we let them know what we're looking for. And that's a way for them to have input from the staff nurse level.

Next slide please. Investigations, here at our hospital we're proud of the fact that we conduct all of our own sentinel and non-sentinel events. They're performed in house.

We occasionally will have a third party come in, that's usually ECRI, if we have an especially tricky investigation with a device that we don't have much experience with.

And we pretty much avoid vendor involvement in our investigations whenever possible. We've discovered over the years that nobody cares about our investigations as much as we do.

And we found that sometimes it can take a long time to get vendors to evaluate logs and things like that, so we try and do everything in house.

Next slide. Another major role is as a regulatory liaison. More specifically that's with the Department of Public Health on those occasions when we have a sentinel event that needs to be reported. And the FDA at the national level and that's via the MedSun project.

Next slide please. Communication is a big part of the job I do here especially when it comes to large scale notifications for recalls and communications regarding alerts and upgrades.

You know, we've noticed over the years that sometimes a vendor will go ahead and issue an alert, but they won't have a specific fix for it yet, but they'll have a workaround.

And so making sure we communicate that out is really important from a patient safety perspective. And so that's one of the jobs that I do as well.

Next slide please. As far as our sentinel event process and reporting goes I'm just going to go through what we do here at Brigham.

We've found that over probably the last ten years it's become fairly successful when we've created a great collaboration with the MedSun staff.

Here at our hospital it always begins with a safety report. This is an example of one. You'll notice it has a lot of information. It's a very rich report. And if the clinician takes the time to fill it out properly it gives us a lot to work with.

Before we had the safety reporting system sometimes we would get literally an email with like with the one sentence, you know, a one sentence alert as to what happened. And then we'd have to start from scratch.

At our hospital all staff can author safety reports. And it's actually encouraged by our hospital leadership.

And as I mentioned it provides us a lot of detail. And including the precise device with its control numbers and such which helps us track down the piece of equipment through our radiance tracking system.

Next slide please. Once I've received the safety report it goes to myself and to our two directors. We then assign it to the specific teams. And we have four teams here: they're the OR, Med/Surg, Heme-Onc, and ICU.

We found that it's best to do the investigation at the team level where they already have an established relationship with the unit and a very clear understanding of the specific technologies.

You know, it would be tough assigning an ICU nurse or ICU engineer to investigate an OR device and vice versa. So that's why we keep it at the team level as much as possible.

Next slide. Before I actually assigned the incident out I actually do a MedSun review, especially prior to - if we have any occurrences that haven't happened here in the past or anything new and usual.

The reason for that is not only is MedSun a reporting agency but it's a place where you can go and they have a really rich database where let's say there was an incident report with a smart infusion pump.

You can enter a keyword in the brand name and you can find out every incident nationwide that happened with it.

And it kind of gives us an idea of the problems that are already being seen or have been seen in the past and can help us figure out the right questions. Sometimes that's the hardest part of it is just figuring out what questions you have to ask.

Next slide. Evidence collection is the next section. We encourage our engineers to have a timely clinical review with the nurse or physician involved asking the usual who, what, where, when and why questions so we can get a good clinical story.

Next slide. Next they go through a technical review. And that includes documenting the physical condition of the device as well as functional testing.

So on things like say we have a smart infusion pump issue where the nurse thought it infused too quickly.

We'll actually go ahead and program the pump according to what the last imported settings were and try and reproduce those results.

Next slide. Something that we discovered probably about ten years ago was that you can on many devices we could actually pull the data logs. And over the past probably ten years we've made that as part of our investigations wherever possible.

They can be kind of tricky to learn how to interrogate but once you've got a system down and once you understand how the logs work you can get great information from them.

You know, the one thing that we like about it is that data logs aren't afraid that they're going to lose their job because of what might've happened.

They're not nervous that their colleagues are going to see if maybe a mistake was made.

And so it's really probably the most objective source of data that we have. And so, because we typically can get the start time of the incident from a safety report, we're able to go in and use these logs to help us paint a picture in addition to the clinical story of what happened.

Next slide please. Something that we always do too as well is we like to archive our investigations and we've been doing so for a long time.

So we encourage our engineers to take lots of pictures. There have been occasions where video was helpful as well as text documentation.

With the advent of the iPhone, it's gotten easier to do all of these things. Most people have the technology right in their back pocket. So it's much easier than it used to be.

Also we know that our partners at MedSun love to get this kind of information. If we decide that we ultimately need to report this out, having pictures that document exactly what happened, especially video, on at least one occasion we submitted videos.

And it really kind of paints - it doesn't paint a picture it actually shows a picture. It's a great way to document.

So next slide please. So once we've got those four major things, we've got the clinical stories, physical condition, functional testing, and log data interpretation we come up with our final conclusion of what we think happened and then it's sent to risk management for consideration as to whether or not we need to submit a MedSun report.

Generally the decision is a collaborative one with risk management and we follow their lead on that.

Next slide. As far as what we do to report, well we fill out the report as per our routine, entering as much data as possible.

Because I do a lot of the MedSun searches when we have a new or unusual event I've noticed that sometimes reporters will just give a one sentence description of what happened and there's not that much detail.

So we like to add as much detail as we can so that we can help the next person down the road with their - with, help them to understand their investigation.

If we have supporting documentation with either video or audio in the report usually in the description I'll indicate that we have supporting documentation.

And typically the analyst will contact us afterwards and give us a way to get them that supporting documentation.

We've gotten the feedback from MedSun that they really do like that a lot and it really helps them with their investigation.

Next slide please. The last thing is feedback to clinical staff. Now the one thing I think the one thing that we've done well here -- and maybe it's because there are clinicians here -- is we stay away from the use of "use error" whenever we can't find out what the problem was.

So we'll only give feedback based on facts. We will never place a label of use error unless we can provide evidence of use error.

And we've just discovered that, you know, sometimes the presence of a fully functional device does not equal use error.

Just because it passes its functional test doesn't mean it was a use error problem. And not knowing what happens - what happened from - not being able to find the results of it doesn't mean its use error either.

And because of that I think that we've been able to establish a good relationship with our staff nurses. They're not - they seem to be more prone letting us investigate, and without fear of our saying oh it was a user error.

Next slide please. Here we have our summary. And it's going to be Mike.

Michael Fraai: Okay thank you Mike Dumais and Carol Luppi for excellent presentation today.

So in summary hopefully you've seen the benefits of a collaborative effort between biomedical engineering and nursing and what type of results you are able to get from those and the last and most importantly the lessons that you learn in the process of that collaborative effort.

We hope you've seen that we have enhanced technology training programs that have contributed to overall patient safety.

Mike Dumais also spent a lot of time and energy on the incident investigation and how you report to MedSun to increase patient safety with technology use not only in our hospitals but nationwide and what we hope to achieve with those.

Carol Luppi spent a lot of time on simulation use to augment training programs and how we use the lab to validate new technologies or software upgrades before they get into the institution.

And also to re-create scenarios of situations where we do incident investigations which will contribute to overall patient safety.

Finally we hope that the enhanced results of incident investigation for MedSun reporting through this collaborative effort within biomedical engineering and nursing only helps with increased patient safety in our hospital and also benefiting other hospital - other institutions. And most importantly it allows us to share the lessons learned through this process we will open up now for questions if we - next slide.

Elyse Beck: Before we answer questions I just wanted to thank the presenters one more time for putting together this presentation and being on this call today.

And I would like to ask the operator to open the lines up for questions while we answer ones that were submitted beforehand.

Our first question submitted earlier was "Can you as presenters provide some specific examples of how the interdepartmental relations can be initiated in a facility where biomed and risk management seem to operate in separate areas altogether? And is there a template that you can share for a biomed and risk management meeting?"

Michael Fraai: Okay. This is the other Mike, Michael. Yes we can. I think our recommendation would be to try to identify a joint project or effort to work on that will serve as a catalyst to start this process of collaboration.

To use patient safety or enhanced safety processes as a common goal in the process. So rather than being and working in silos let's try to work collaboratively together with common goals as an outcome and how each profession can contribute to and enhance outcome.

So rather than each biomedical does it on its own, nursing does it on its own, really look at if the two professions work together that the joint outcome is bigger than the individual outcomes. And really work on these professions, each profession's strength.

I think the part of it is that it doesn't happen overnight. You have to be persistent in the effort. And I think both professions, there are people like Carol Luppi and Mike Dumais in every institution.

You know, there are people who are willing to share and work together and work jointly and collaboratively together. So this doesn't only have to happen at the Brigham.

As far as the question about a template, we don't have a template. It's not something that is very prescriptive, you know, try to approach it from a collaborative effort right rather than a prescription. Did I answer the question?

Elyse Beck: Yes, thank you. Okay our next question coming in was "What recommendations do you have for facilities that have a standing meeting between biomed and risk who want to have a more rich more productive conversation about device issues?

Michael Fraai: So this is the other Mike again. So again take a device concern and do a deep dive about it and how it affects biomedical engineering, the institutional risk, care practices, and what could be done to prevent that?

I think Carol mentioned earlier about how you ask inquisitive questions without being punitive, without pointing the finger, which I think is very important to this process. It's you really have to be open - really asking open ended questions.

Mike Dumais also talked about that we  try not to point fingers. We don't use "use error" because we really try to understand what happened so we can learn.

So use those methods to really start the process. Be methodical in your process. Be systematic and really have a methodical collaborative approach rather than a punitive approach.

Elyse Beck: Great, thank you. Our next question is "Do biomedical engineers participate in patient safety rounds at your facility and do you recommend that members of the biomedical team be included in patient safety committees?"

Michael Fraai: I'll try to answer that question. So, on the first one do we participate in patient safety rounds? We used to at Brigham.

I would recommend that because it allows engineers to provide answers, or solutions, or hear firsthand about the concerns.

And it also really fosters the collaborative effort between the engineers, the technical staff, and the clinical staff that you have on board.

So patient care technology device safety doesn't only include the device, it includes the environment, the culture and the area that it was used.

Biomedical engineers typically can contribute during these rounds with substantive information about a device, the use, and really help in the discussions that typically tend to happen during those types of rounds.

So from that perspective I would say yes, you could do it. It depends somewhat on the culture of your institution as well where you are in this process but generally it's a good idea.

Michael Dumais: And I'd like to add one thing to that. The one thing that's part of their daily routine is that our engineers do rounds in their areas to check on their equipment and such.

So - and part of that is safety so just so that you don't get the idea that that's not happening it really does happen here but it's more like on a daily basis. And that's it.

Elyse Beck: Okay, thank you. The last question submitted beforehand, and then I will begin taking live questions, was "What specifically would be your ideal way to engage front line staff?

And how can facilities help the bedside nurse and the biomedical engineers understand each other's roles better in medical device and patient safety?"

Michael Frey:  So I'll try and I think my nursing colleagues that I would - we can probably augment my question. So really from a technical perspective really try to be a resource to the clinical staff to the nursing staff.

Understand the clinical world that they live in, the practice model, and what we can help as technical folks to making the process of taking care of patients a little bit easier.

Make it known that biomedical engineering the profession is not here to make the life miserable the clinical life miserable or harder but rather to provide a tools, or enablers, to provide safer and more efficient care.

There are several things you could do to achieve that. And again I think earlier I mentioned that it doesn't happen from today tomorrow it's something that you have to be persistent, you have to be methodical about it.

Be visible to the nursing staff. Follow up with them when they - are questions and really provide an answer. Just don't say I'll get back to you and never show your face again.

Be visible. Be proactive. Do regular meetings before there are I would say the situation gets tense so that you already have built the relationships with the clinical profession and really helping and solving problems.

When we were doing - at the Brigham folks who are in the Eastern side of the country probably know that we actually did a built a new hospital the Shapiro building.

And of course when you do any project you do it as always outstanding items that come to light, and when you do a brand new hospital even more.

Amazingly I thought they were going to have probably a book with 30 pages worth of concerns, and it wasn't really that much.

But what we ended up doing was we actually developed a list of concerns, and we systematically worked with one item at a time.

So we had regular status meeting with nursing. We identified of the list of concerns the highest priority items. And we worked with them systematically.

And the things that was going to take the longer time because we needed some software upgrade from the vendor we continually provided feedback.

So what that helped was it helped with really we were seen as we were providing a solution helping to provide a solution and it continued to foster that collaborative effort we had already at Brigham. So hopefully that answers the questions.

Michael Dumais: And I actually have an input to that as well. Just to expand a little bit being present on the unit is a big deal.

If you - I found that if you want to know if there are any issues out there going out and asking them is usually a first good step.

Also make sure that they understand that you're on their side. You want to help them. And that makes them more likely to want to collaborate with you.

And ultimately I think Mike touched on it a little bit but to emphasize make sure that they understand that you're there to help solve problems, to help solve clinical engineering problems.

And I think if you do those things it goes a long way to gaining the trust of the nurses and building that collaboration.

Carol Luppi: Hi. This is Carol again. And I also want to add here that if the culture of safety that both Mike Dumais and Mike Fraai have talked about it needs to be supported from your nursing leadership.

The resources have to be identified. We're very lucky here that we have a committee structure that is supported by the department where nurses are taken out of their clinical role and brought together in a collaborative group to discuss issues.

And they're involved from every aspect of technology acquisition, to technology implementation, and follow up.

We have this rich resource to go to on a monthly basis to meet with these clinical practice committees.

We have a clinical informatics meeting that Michael Dumais spoke to about in a few moments ago.

Having access to these nurses outside of the clinical area when they have time and energy to be creative with you to solve issues is essential.

But I also agree with Michael Dumais that meeting the nurse in the clinical area is very, very important. Whenever we have a major product rollout or upgrade our Clinical Informatics Director Clinical, the Innovation Director, and I make rounds daily to see the staff and say okay how's it going?

How's the new software doing? Any issues that we need to follow up with? Are there any - were there any hardware problems being very meticulous with your follow up with the staff.

When they ask you a question, when they present a problem, getting back to them builds - is a - build strong relationships between the two departments.

Elyse Beck: Great. Thank you. Okay our first live question submitted was "Does your investigation process extent to implants and disposable devices as well?"

Michael Dumais: Yes. It would be hard not to. For instance, if we have say an IV pump that's involved with an incident, sometimes if a check valve on a disposable wasn't manufactured correctly and that could end up being the source. So we try and get all the disposables that we can.

As far as implants go I can't say that I've actually had the opportunity to investigate anything from an implant perspective. So I really can't speak to that.

Carol Luppi: And I do want to add a little bit here that when you're investigating with regarding disposable devices, nurses need to be well educated and supported in saving all disposable equipment that's being investigated.

We constantly have to reinforce to our end users that the biomedical engineers need the device and the disposable to accurately investigate any incident with a patient.

I have posters that we, you know, that we regularly send out to staff and remind them because it's not intuitive to the end user that they have to save every single piece and all the disposable parts as well to fully investigate an incident.

Elyse Beck: Okay thank you. Operator do we have any live questions over the phone?

Coordinator: We do not at this time.

Elyse Beck: Okay. I have one more question that was submitted in the Live Meeting and it's the clinicians are wondering if you have an RFID system on your equipment?

Michael Fraai: This is Michael. Yes we do. And it helps greatly.

Michael Dumais: Before we used to have to track down the 1200 IV pumps if we were going to update a drug library. And while we still have to track them down having them printed out on a map showing exact locations is enormously helpful.

It's also helpful with incident investigations because whenever they fill out their safety reports they have to put the control number of the device on the report.

And if we had that we'd just go into our RFID system and we can pinpoint where it is and retrieve it. So it's enormously helpful when - in the investigation end of it as well.

Carol Luppi: Yes optimally our staff have we removed any device from use, but where they put it sometimes is not as obvious to the biomedical engineering staff as the nursing staff would think that it would be.

They're putting it in their nurse manager's office. Sequestering it in a safe place to them is not the same safe place that perhaps a biomedical engineer would look for it.

Elyse Beck: Great. Thank you.

Tina Powell: We had a question come in about do you measure return on investment?

Do you have any comments about that from the various activities that you've talked about today? Do you have any measures that relate to the return on investment for the type of collaborative activities that you have?

Michael Fraai: This is Michael. I think that's a valid question but it also a very hard question right because it's like you can normalize, for example, safety until something bad happens.

So we chose to actually take the approach that we are going to invest into this because it's not just the collaboration that comes out of it but also there are other derivatives that comes out of it.

We do better incident reports. We do better training programs. And when you do better training programs, the calls to your biomedical department also come down.

It's a safer environment when you do better questioning -- inquisitive type of questions that Carol talked about earlier. You are able to get the answers easier and we can facilitate our process.

So we haven't done an ROI process but we believe that the qualitative results outweigh the hard numbers that we would get out of this process. Did that answer the question?

Elyse Beck: Yes, thank you. I have one more question and this will be the last question submitted during the Live Meeting. And then I will forward any further questions to you after this.

"Does Brigham and Women's Hospital's biomed department provide parallel support to users of the other realm of medical devices, products such as catheters, drains, staplers and IV sets for example?"

Michael Dumais: No not really. We don't, we typically wouldn't be involved with any of those things. The only thing that you mention on that list was I think IV sets.

And we don't directly support those; that comes from our material management department. But if they're involved in an incident, then we would, of course, evaluate that as part of the whole investigation but those other items no, we do not support.

Michael Fraai: So this is the other Mike. I think, in the process they may ask engineers to participate because they need technical input into the process.

We tend to do that but it's not all the time, because it typically involves biomaterials and knowledge that we may not have a lot of depth in onboard.

Elyse Beck: Great, thank you. And I'm now going to turn it back over to Tina Powell for closing remarks.

Tina Powell: Well I want to thank our speakers Mike Fraai, and Michael Dumais, and Carol Luppi so much for your presentations today, and all the work that went into this.

Clearly you have such a commitment to patient safety and to sharing what you have learned at your hospital with the other hospitals around the country. It's very impressive to hear about that.

I want to underline something that Mike Fraai said for biomedical engineers: be a resource. Understand the clinical world practice model and what can help in the process of taking care of ill patients.

Make it known that the biomedical engineering profession is not to make the nurses life harder but to provide the tools for safe and more efficient patient care.

I just really want to thank all of you for being our presenters today, Elyse Beck for all of her work in preparing and moderating this session today, and Margaret Francis with helping with preparations and implementing the Webinar today.

Everyone will be receiving an evaluation form by email, just with three quick questions that help us in planning additional Webinars in the future. We're very interested in your comments and suggestions for additional topics.

We will have two more Webinars later this year. And you'll be hearing about them in the future MedSun News and in emails. So look for those and please plan to spread the word and participate. Thanks to everyone.

Carol Luppi: Thank you.

Michael Fraai: Thank you.

Coordinator: This concludes today's conference call. You may disconnect at this time.

END