Medical Devices

Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home – December 9, 2009

MedSun Education Webcast Transcript:
Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home

December 9, 2009
1:00 p.m. - 2:00 p.m. ET

Coordinator: Welcome and thank you for standing by. All lines will be in a listen only mode for the duration of today’s conference. This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the conference over to your host for today, Ms. Eve Zimmerman. You may begin.

Slide 1 (picture of wheelchair)

Eve Zimmerman: Good afternoon, everyone. My name is Eve Zimmerman, and I am a Project Nurse with Social and Scientific Systems, Incorporated, the FDA contractor for the MedSun project. I’m happy to welcome you to the one-hour MedSun sponsored Webcast, Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home.

Slide 2

Today’s program will include an overview of the FDA, MedSun, and HomeNet, a look at the trends impacting home health care, and the risks unique to the home environment. We will also explore the role of the FDA and home medical device safety and the FDA’s definitions of the medical device and adverse events.

Next, we will review the types of medical device issues you should look for and report; and give you examples of medical device adverse events that can occur in the home. We will also discuss the role of the home health care provider in understanding, recognizing, and reporting medical device adverse events. Lastly, we will answer a few questions that were submitted by you, the audience, at the time of registration.

Slide 3 List shown on slide:

At the end of this session you will be able to:

  • Describe four common types of medical device problems
  • Explain why reporting problems with medical devices is important
  • Explain how the home environment impacts the use of medical devices
  • Describe the role of the home healthcare professional in promoting patient safety with medical devices

Slide 4

If you have any questions or difficulty accessing the slides, please call MedSun at 800-859-9821.

Slide 5

One nursing continuing education contact hour is available to MedSun site participants for this program. Certificates of participation with this credit will be available after the Webcast by going to the registration website and completing a brief evaluation. A link to the registration site can be found in your confirmation e-mail.

Slide 6

Our speakers today in the order they will be presenting are Diana Rivi, a public health analyst in the Office of Surveillance and Biometrics (OSB) in the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). Diana has a Masters in Public Health and is the HomeNet Project Director. She coordinates production of the MedSun public newsletter and has experience in the analysis and trending of MedSun medical device adverse reports.

Our second speaker is Mary Weick-Brady, the Associate Director for Home Care and International Initiatives in OSB within CDRH at the FDA. Mary holds a Master of Science in Nursing and is the Home Health Care Committee Chair at FDA. She is currently at work on global harmonization efforts for post-market regulations of medical devices and is assisting with the development of international standards for home care electronic equipment. And with that I give you, Diana Rivi.

Slide 7

Diana Rivi: Thank you so much, Eve. I would like to start by giving you some background information about FDA, CDRH, MedSun, and HomeNet, and to let you know how they are related.

The FDA is a large federal agency that has certain responsibilities for protecting public health. We have listed the different centers and offices within the FDA to highlight the breadth of the agency’s oversight.
List shown on slide:

Organization of FDA

  • FDA is comprised of several Offices and Centers
  • Office of the Commissioner (OC)
  • Office of Regulatory Affairs (ORA)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Veterinary Medicine (CVM)
  • National Center for Toxicological Research (NCTR)

Slide 8

Within the FDA there are three Centers that oversee the safety of medical products. The MedSun project functions within two of the FDA Centers: the Center for Devices and Radiological Health, known as CDRH, and the Center for Biologics Evaluation and Research, known as CBER.

Slide 9

CDRH is the center within FDA that is responsible for approving the use of medical devices and overseeing the manufacturing, performance, and safety of these devices.

Slide 10

The Medical Product Safety Network, known as MedSun, is a medical device related adverse event reporting network within CDRH that is made up of 350 health care facilities around the United States. Since you are participating in this webcast today, it is likely that the health care facility you’re associated with participants in MedSun.

Slide 11

HomeNet is a specialty subnetwork within MedSun focused on the collection and sharing of information about potential and actual adverse events associated with medical devices used in the home. Additionally, HomeNet works to identify barriers to reporting problems with medical devices in the home environment.

Working through MedSun and subnetworks like HomeNet is one of the ways that CDRH learns about problems and potential problems with medical devices. Often times, we rely on our subnetwork members to participate in special studies or surveys so that we have the opportunity to speak with you one-on-one to learn about your experiences with medical products.

MedSun uses an internet-based reporting system that is designed to be an easy and secure way to report adverse events. FDA/CDRH also learns about device related issues when they’re reported by the manufacturer or by consumers. This information is captured in the MAUDE database, which stands for Manufacturer and User Facility Device Experience.

FDA nurse analysts and biomedical engineers work with this data to spot device trends. Our hope is that by providing educational programs, such as this, we can increase reporting about medical device problems to the FDA and therefore enhance patient safety outcomes.

Slide 12

Let’s look at some trends affecting home health care. As medical care continues to shift from the hospital to outpatient and home settings, the delivery of this care is shifting from clinicians to family caregivers to patients themselves. At the same time, the number and complexity of medical devices used in the home environment continues to grow.

Advances in technology have supported these trends. Medical devices have become smaller and more portable. Patients have also changed in recent years. Because patients and their family caregivers have easy access to health information, they’re becoming more knowledgeable about care options. Patients are more empowered, invested, and active in the decisions related to their care.

Slide 13

Eve Zimmerman:Thank you, Diana. We will now turn the program over to Mary Weick-Brady. She will provide you with some background facts and figures about home health care and explain further the FDA’s role in home medical device safety. Mary?

Slide 14

Mary Weick-Brady: Thank you, Eve. I would like to start by stating how FDA currently defines a home use medical device. First, it is intended for users outside a clinical environment, which could be a home, school, office or a car, for example. Second, it is managed partly or wholly by the user, which puts a lot of responsibility on that person.

It requires adequate labeling for safe use, which includes good instructions for use and maintenance of the device, and fourth, it may require training by a health care professional so that it can be used by the end user in a safe and effective way.

Slide 15 (picture of home health professional talking to a patient; picture of patient in a wheelchair)

Home care is a burgeoning field. There are around 6,000 hospitals in the US and 20,000 home care facilities. In addition, there are 15,000 distributors of medical equipment. There are at any given time over 7-1/2 million people in home care. And this is at an annual cost of over $50 billion.

Of these people in home care, 75% receive skilled nursing, which usually includes some self or caregiver care along with it. The majority of the patients are over 65 with multiple health issues. Caregivers are another group to consider, and as you can see, 44 million people have a caregiving role and 66% of these are women.

It is estimated that, in 20 years, there will be close to 72 million people over the age of 65 in the US. It is also important to note that 20% of U.S. adults report having at least one type of disability. What we shouldn’t forget, though, that beyond the elderly, there are other populations who are also recipients of home care such as newborns, people with chronic conditions, and people with temporary home care needs.

Slide 16 (picture of blood pressure monitor)

The message I want to get across here is that home care for the most part is a very cost effective way to treat patients. This slide gives you some examples of some pretty big cost savings for patients on ventilators, oxygen, chemotherapy, and IV antibiotics.

Even though the cost savings isn’t that much for congestive heart failure, I would also want to factor in the quality of life for these patients and then the decreased need for hospitalization and emergency room visits that go with home care.

List shown on slide:

Cost of Inpatient Care (per Patient Month) Compared to Home Care

ConditionsHospital CostHome Care CostSavings
Ventilator dependent patients$21,570$7,050$14,250
Oxygen dependent children$12,090$5,250$6,840
Chemotherapy for children$68,870$55,950$13,920
Congestive heart failure in adults$1,758$1,605$153
IV antibiotic therapy$12,510$4,650$7,860

Slide 17
There are a lot of risks unique to the home environment when you introduce medical technology. I’ve divided these up into environmental issues and use issues, all of which are found in a home environment and not in a hospital environment.

Children. Depending on the age, they can injure themselves with accessories such as needles, use devices as play toys, and try to operate the devices themselves by changing settings along the way. Electromagnetic interference is big in the home. There are televisions, microwaves, Wiis, telephone lines, and other electronic technology that can wreak havoc with medical devices.

When you’re looking at location, if a patient is in a rural setting, for example, it may be more difficult for them to access supplies and seek help if a device malfunctions than if they were in an urban setting. So you have to keep that in mind.

The environmental part of noise. There’s a lot of outside noise in homes. There are vacuums, TVs, electronic games, telephones, people arguing, and the like can all interfere with the ability to hear whether or not your device is operating correctly or whether an alarm has sounded.

Pets and vermin. I’ve seen squirrels and other rodents chewing on tubing, roaches in the equipment, and pets sitting next to a patient doing open wound care or dialysis. The issue of power outages is very common in the Midwest and other areas. Many devices do not have backup plans for power outages because they weren’t intended to be used outside of a clinical environment.

Public health emergencies. I read somewhere that after Hurricane Katrina hit New Orleans and other areas, close to 50% of people in the shelters had some type of medical equipment with them. So we have to keep this in mind. In the area of safety, what you don’t want here is to advertise that you are on intravenous morphine, for example. There are a lot of people who’ll not think twice about going into someone’s home and taking their medication and equipment.

Another safety issue would be long tubing that’s throughout the house that can pose a danger for tripping or choking. And then you also have neighborhood safety for the caregiver or provider who would be coming to visit you in the home.

In the area of sanitation, homes should never be considered to have a sterile environment. Many times there is open garbage, dirty dishes, dirty towels in the bathroom, and unclean surface areas. Setting up medical equipment in these environments can be very difficult. The ability to properly dispose of waste can also be a huge issue.

In the environmental area of space, this always needs to be taken into consideration, especially for large equipment or equipment that is potentially cumbersome to have around. Hospital beds take up a lot of room, and if you live in a tiny walk-up, it’s not going to be an option.

Temperature and humidity. This includes storage of devices and their accessories as well. Excessive heat or humidity can cause a device to fail or to malfunction, and this always needs to be taken into consideration. Condensation from a cold to hot environment has been observed in the past as well.

The area of water. Having potable water must be checked out before bringing a device home - if not for the device, then for cleaning the device or its components. Well water versus city water is also a consideration to be taken into account for the safe operation for some devices like home hemodialysis.

And then in the area of use, we should look at the compatibility of the device with the person’s lifestyle. Ask yourself, “Will the patient find the treatment with the equipment to be conducive to their lifestyle?” In the area of instructions for use, if you have durable medical equipment, there is a good chance the labeling will not be with the device in the home.

If there are some biomeds listening right now and you are making sure that instructions for use are going into the patient’s home, then I’m very proud of you, and I would consider you to be the exception to the rule. Nurses spend a lot of time writing up instructions for the patient.

In the area of interface and ease of use, these devices need to be as foolproof or as close as possible to being foolproof. Off-label use. There are many times I’ve seen Foley catheters put to use well beyond what their basic labeling calls for.

Ruggedness of the device. People are traveling or going to school or work and they’re playing outside with their device, and the device has to be compatible with the environment in which it’s being used. Selling prescription devices on the internet. This is becoming a bigger and bigger problem, and people are buying prescription devices over the internet without having the prescription necessary or without having the proper components or accessories available with that device.

And then you also have to take into consideration the user or the caregiver, their educational level, their emotional stability, and their physical capabilities. And Diana will be talking about this a little bit later.

Slide 18 (picture of wheelchair; picture of physiological monitor)

Even if the device is designed for the home or for a specific type of patient as seen here, it must be something that they will use. It has to be useful. People must want to use the device, or it will be ignored. It has to be usable. It must have a minimal number of steps to operate. It should be easy to get back to a main screen, if there is one.

It needs to be iterative. It should be something that can be repeated easily if needed. The device must be intentional. The steps must be deliberate steps to operate the device. That is, the user must understand with each interaction with the device that they’re causing it to do something.

The device must be intuitive. It must be something that when done intentionally, it is easy to operate, kind of like an iPod or a telephone or a Wii. The device must be integratable. You must be able to make the device and treatment fit into a person’s every day life or they will skip steps, not use the device, or not take care of themselves.

It must be informative. So when the device provides information it must be meaningful data to the user or they will ignore that data or put the device away. And it must also address the risks that I just talked about that are unique to the home environment. The device must be able to go into a home without it disrupting the current environment or end up being a risky item to have in the home.

Slide 19 (picture shows cartoon of individual multitasking: talking on cell phone with brief case in hand while running)

New applications are being made of old technologies not originally developed for health purposes. There are aging-in-place technologies that involve new interfaces or interaction paradigms, and new core technologies and scientific capabilities are being developed.

It is important to know that none of these new technologies listed here are really operating in and of themselves. They are designed to operate within a system of systems to talk with each other, to operate with each other, and to share the information they are gathering with each other. There will soon be other technologies that come along, and even though they may be used outside the home as well, many of these had an ambulatory patient or a home use in mind when they were developing the technology.

List shown on slide:

  • Examples of Emerging Technologies for the Home
  • Health informatics
  • Nanotechnology
  • Smart homes and interoperable technology
  • Telehealth
  • Wireless technology

Slide 20 (picture / cartoon of man next to home made mechanical device)

The purpose of the FDA is to establish reasonable assurance of the safety and effectiveness of medical devices, and this will include these new technologies and should include home use. We need to continue having our labs research human factors design, EMI [electromagnetic interference], imaging software, interoperability studies and other areas including nanotechnology.

We must continue to collaborate with other government agencies to assure we are talking with a united voice. We must develop guidance and further regulation as needed. By doing this, we can standardize how home use labeling should look, and we can use existing international standards for home use to help us accomplish this.

We must address the growing industry of selling prescription devices on the internet. Devices are getting into the wrong hands. And even if they did get into the right hands, they most likely will not have labeling, which means they won’t have the manufacturer’s information, how to operate the device correctly, warnings and precautions, maintenance nor compatible accessories listed.

Through premarket review, we can monitor the claims and the labeling for the emerging technology. We even have postmarket tools to continue to monitor these devices once they are in broader use. This can be done through post-approval studies or postmarket studies, depending on the type of device. We also have the mandatory reporting database that Diana talked about earlier to give us signals if a device is failing more than it should.

Slide 21 (picture of blood pressure monitoring device; picture of glucose monitoring device; picture of patient in bed receiving intravenous therapy)

Eve Zimmerman: Thank you, Mary. I will now turn it over to Diana Rivi.

Diana Rivi: Thank you, Mary and Eve. This slide lists types of medical devices and some general categories that you may be familiar with or see on a daily basis. Some devices you may not realize are considered medical devices such as laboratory solutions or computer software. This list is not all inclusive, but gives you some idea of the spectrum of devices.

Devices can be anything from a Q-tip and tongue depressor to a walker or a wheelchair to a sophisticated scanner or high tech heart-lung machine. It’s important to note here that regardless of how simple the device may be, it can still be problematic and contribute to an adverse event for a patient, family caregiver, or health care provider.

List shown on slide:

Types of Medical Devices and Examples of Home Health Care Devices

  • Capital equipment
    • Medical beds, bedrails, scales, wheelchairs, walkers, IV poles, infusion pumps, enteral feeding pumps, lifts, shower chairs, blood pressure equipment, home hemodialysis, negative pressure wound therapy
  • Instruments
    • Glucose meters, pulse oximeters, insulin pumps
  • Monitoring systems
    • Cardiac, telemetry, patient call systems
  • Reagents
    • Fecal occult blood test
  • Disposables & accessories
    • Ventilator breathing circuits, filters
    • Oxygen therapy related devices
    • Needles, syringes, IV catheters, IV tubing, foley catheters, feeding tubes, gloves
  • Implantables
    • Defibrillators, hip/knee implants, drug-eluting stents
  • Computerized medical systems
    • Hardware
    • Software versions

Slide 22

Before we go further, let’s define an adverse event. It’s an event whereby a medical device has or may have caused or contributed to a death or serious injury. An adverse event may result from device failure, device malfunction, improper or inadequate device design, manufacturing problems, labeling problems, training issues, or use error.

Slide 23

This next slide is a quote from Dr. Lucian Leape from Harvard that reads, “Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of a single individual.” This quote addresses the complexity of the medical error and the challenges of determining what happened, who’s involved, and why. The kinds of adverse events we’re discussing with devices falls under the general category of medical error.

As you can see from the risks that Mary previously identified and discussed, specifically the environmental and use risk examples, devices used in the home environment are associated with yet another layer of complexity.

Slide 24

This slide is a modified version of the Swiss Cheese Model developed by James Reason, a well-known safety expert. It depicts a trajectory of harm, shown here as the black arrow, that moves through a hole or breakdowns in systems where the cumulative effects of failures result in harm to a patient. Also, it can be described as a domino effect that continues because no intervention occurs.

It’s important to note here that in isolation each hole or failure in and of itself may be okay, but as a process of successive failures, the result can be serious harm or even death to a patient. Let’s look at the model in the context of a problem involving an infusion pump in the home setting.

We begin with an older infusion pump that does not have any labeling or instruction for use, and has not been properly maintained. In this example, an initial free flow event occurs when being used by the patient. No harm to the patient occurs. The problem is not shared with the home care provider or with the home health agency or hospital-based biomedical engineering department.

The device is not removed from the home and eventually a free flow event occurs again, but this time the result is catastrophic and the patient receives a drug overdose. You can apply this model to many potential for harm type events that can easily slip through the holes in the home setting.

Slide 25

Medical devices interface with the environment, people, and with accessories and disposables. When an adverse event occurs, it’s important to consider the impact these factors might have had on the event.

In this example, the device is a ventilator. If a problem were to occur with the ventilator, one must consider the environment such as the power source, the lighting, temperature, and interference with other devices, and the people involved, the patient, the family caregiver, the home health nurse, the device operator, as well as any accessories and disposables involved such as filters, valves, ports, and tubing. One or many of these could impact the adverse event, and they warrant further investigation to determine the root cause of the problem.

Slide 26 (picture of patient in a bed receiving IV therapy; picture of a walker)

Before we get into specific examples, this slide shows the top medical devices reported into MAUDE between June 2008 and August 2009. There are a total number of 1,059 events where the event location states home. Infusion therapy, respiratory therapy and durable medical equipment consistently appear in the top reported medical device adverse events that occur in the home setting.

List shown on slide:

Top Reported Adverse Device Events in MAUDE June 2008 – August 2009

Total number of events equals 1,059 where location states “home”

  • Insulin infusion pumps
  • Implantable cardioverter defibrillator
  • Automatic implantable cardioverter defibrillator with cardiac resynchronization
  • Ventricular (assist) bypass
  • Mechanical walker
  • Implantable pacemaker pulse generator
  • Piston syringe
  • Intravascular administration set
  • Continuous ventilator (facility use)

Slide 27

In the next slides, we’re going to look at the different types of medical device problems and potential problems that you should be aware of. This is a list of broad categories or ways to classify possible causes of adverse events. We’ll cover these in more detail by providing you with examples in the next several slides from actual MedSun reports.

List shown in slide:

What Types of Medical Device Issues Should I Look for?

  • Defects
  • Software problems
  • Failure to work as intended/malfunction
  • Instructions/labeling/packaging issues
  • Interactions with other devices, or other electronic equipment in the home
  • Use errors
  • Human factors issues
  • Combinations of the above

Slide 28 (picture of a nurse putting IV pumps on an IV pole)

Here are some examples of home device product defects that have been reported to MedSun. One report I want to draw your attention to deals with collapsing crutches. Even though crutches may not be what you typically think of when you think of home use devices, it is one that has the potential to cause harm, especially as was the case in this event.

In this case, the home medical equipment technician was adjusting the patient to their new set of crutches. When the patient began to bear weight on the crutches, the pin that locks the sliding bar in place slipped, and the crutch collapsed. What is interesting about this event is that the reporter included a tidbit about the patient’s weight not being a factor. So here the crutches were indeed appropriate for the patient’s weight, and this is simply an issue of a defective locking pin.

List shown in slide:

Examples of Problems (continued)

  • Defects
  • IV pump bracket found with large crack and sharp edges
  • Ventilator started smoking
  • Gloves found discolored and with holes
  • Crutches collapse

Slide 29 (picture of a physiology monitor)

This slide provides some examples of medical computer software problems. I want to talk about the first bullet. In this case, a vital signs monitor did not transmit patient vitals to the central station. The patient’s family discovered that no vital signs transmissions had occurred since the monitor was placed in the home. After follow up with the manufacturer, the home care agency was informed that there is a software error that occurs in the central station causing a patient’s vital signs to fail to transmit and that there is no cue that provides notification of this transmission failure.

This event reminds us that telemedicine is a new technology, as Mary discussed. And while it can be useful to provide homebound patients with a better quality of life, we need to be sure that their vital signs are being transmitted without error.

List shown on slide:

Examples of Problems (continued)

  • Software problems
  • Vital signs monitor did not transmit information to central station
  • Software glitches with new software installation
  • Virus infects device operating software
  • Daylight savings software considerations

Slide 30 (picture of an IV fluid bag; picture of a walker)

Here are some examples that define what we mean by failure to work as intended or malfunction. Another interesting report describes a patient fall as a result of a patient lift malfunction. In this event, the patient was being transferred from the bed to shower using a lift with a sling. What is interesting about this report is the details the reporter provides in the event.

In this case, staff found the gray connector clip on the sling had snapped in half and caused the patient to fall. Also important is that the reporter notes that the sling had had multiple washings, most likely with the clip attached. The multiple washings may have contributed to the clip’s poor integrity.

List shown on slide:

Examples of Problems (continued)

  • Failure to work as intended/ malfunction
    • IV pumps not infusing as programmed
    • Safety mechanism on IV catheters/syringes failing
    • Medical bed would not maintain position
    • Shower chair collapse
    • Walker leg malfunction
    • Broken connector clip on patient lift

Slide 31 (picture of mail package labels)

We’ve received many reports discussing issues with a device’s instructions, labeling, and outer packaging. It is confusing, missing, hard to understand, or hard to read, for example. I want to draw your attention to one report that describes unclear glove packaging. In this case the product package states sterile latex, powder-free gloves.

Many times staff has misinterpreted the packaging to mean latex-free instead of latex powder-free. The reporter indicates that this product does have a symbol on the package for latex, but the staff seem to overlook this and focus on the powder-free latex label instead. This unclear package labeling can have huge implications if a patient is in fact allergic to latex. It’s important that products be clearly labeled and also easily understood by staff and by patients.

I also want to draw your attention to a report that describes incorrect tubing size for home hemodialysis. In this report when the tubing was opened, it was noticed that the tubing size on the outer packaging was not the same size as the tubing found in the package. In this event, the size is incorrect.

List shown on slide:

Examples of Problems (continued)

  • Instructions/labeling/packaging issues
    • Instructions for use (includes graphics/icons/charts)
      • Unclear
      • Misleading
      • Incomplete
      • Difficult to see, i.e. too small, colors
      • Absent
      • Complex, i.e. written for healthcare provider and not for patient or family caregiver
      • Packaging
      • Damaged package
      • Missing components
      • Sterility issues
      • Device size is incorrect

Slide 32 (picture of a person in a wheelchair using a laptop computer; picture of a cellular phone)

We have received reports that discuss device-device interactions, allegedly, with cell phone interference. Two MedSun reports describe issues with ventilators, one report where the screen suddenly went blank, another report describing erratic inspiratory times.

In each case, staff attribute the root cause with the close proximity of a cell phone. In one of the reports the manufacturer even recommends to keep cell phones 20 feet from a device. Other potential device-device interactions that have been reported are with hybrid vehicles and pacemakers, as well as with gaming systems and pacemakers. We are currently investigating these issues.

List shown on slide:

Examples of Problems (continued)

Interactions with other devices

  • Electrical instrument deactivates pacemaker
  • Cell phone use interferes with monitoring equipment

Slide 33 (picture of IV pumps)

The phrase ‘user error’ or ‘human error’ asserts that any issue caused when using a device is the fault of the user. It suggests that the user does not understand how to make the device work properly. Many believe this concept puts blame in the wrong place - on the user - instead of on the poor design of the device and its failure to take into account the human, which is what we mean by use error.

In other words, use error is likely to occur when a device is not intuitive to the user or may not be designed in a way that makes it easy to use. I want to share a report with you, one that provides a good description of use error disguised as user error. At first glance this event seems to be equipment failure, but of course there’s an interesting twist to the story.

In any case, an unsecure hook caused a sling to come off a mechanical lift device. Yes, another one. But this time the patient had a hip fracture as a result of the fall. At first the reporting facility wrote it off as human error, but when the same event occurred within a week’s time, staff called the manufacturer and learned about a sling retrofit hanger upgrade kit. After the kit was installed, the problem was solved and the sling no longer came off the lift.

Originally, it was assumed that this event occurred because of user or human error by not securing the sling correctly, until it was repeated and later learned that there was a reason - besides the user - that was causing this to occur.

Here is yet another example of use error. A patient seated in a power wheelchair sneezed and the power wheelchair shot forward. The patient rammed into a TV set and broke the glass door on the bottom of the TV stand. The physical therapist noted the close proximity of the joystick and the speed button and how easy it was for the patient to increase the speed.

It’s important to note here that although you may think of these examples as user error, they may be the result of a poorly designed device so it’s important to report that to us. We can use these reports to encourage the manufacturer to make a design change that better caters to the user. And this brings us to the topic of human factors.

Slide 34

Human factors is the science of how humans interact with technology. When evaluating the role of human factors in medical device problems in the home setting, one must consider these things. Mary previously addressed these human factors elements but I’d really like to focus on user considerations which drives home the importance of appropriate training for a variety of user audiences.

Slide 35

User considerations are an important piece of the human factors puzzle and greatly impact how a medical device is used in the home. The user group in the home care setting includes an array of individuals such as nurses, therapists, allied health professionals, lay caregivers, and the patient. The number of potential users in addition to their varied ability level, limitations, and familiarity adds to the complexity of assuring the proper use of a medical device in the home setting.

Examples of caregiver and patient limitations that can affect the use of a device include health, strength, vision, coordination, and mental capabilities. Additionally, user expectation is an important consideration. We’ve had reports about infusion pumps that are made by the same manufacturer and look similar but operate differently, so misprogramming of a medication occurred.

Patient and family caregiver training and education is also a concern that can lead to medical device problems, which I will go into more detail in the next slide.

Slide 36 (picture / cartoon with a book next to a person)

Training must be provided and needs to be appropriately tailored to lay caregivers and patients as well as clinicians who regularly see home care patients.

Because most home caregivers do not have a clinical background, devices should be usable with little to no training ideally. Of course this is all good in theory. So when we think about training patients and their caregivers about how to use their medical device in their homes, I really want to reiterate the importance of considering things like the user’s educational level. Devices cannot be complex or intricate. Their labeling must be at an eighth grade level and preferably a sixth grade level.

The user’s emotional stability should be considered. Family caregivers are going to be extremely concerned about caring for a loved one and their emotional state is going to be precarious. Their ability to learn and digest what is being taught is also very compromised.

And of course the user’s physical capabilities. Most of the people who need home care have some sort of physical impairment or a physical condition that goes along with their diagnosis. These impairments must be considered when a patient is going home with a medical device.

The easier it is to learn how to use a device, the better the patient safety outcome. Training becomes an issue FDA would like to hear about when it is not appropriate to the audience, it is unclear, misleading, incomplete, or it is simply not provided and most likely should be.

Having appropriate training that includes instruction on device operation in addition to device maintenance, troubleshooting, how to obtain device replacement parts, like batteries, is also important to note.

Slide 37

Home health care professionals also encounter multiple brands and versions of a particular device, depending in part on the patient’s insurance coverage, durable medical equipment provider, and discharging hospital. Add this to all the other risks that enter the home environment and it’s the perfect storm, which is why we, FDA, are so interested in learning more about issues with devices used in the home setting.

Slide 38

I want to provide you with another example of a report that was submitted through MedSun about a liquid oxygen stationary home unit. This report is a good one because it incorporates tons of detail, which helps us with report analysis and with our follow up with the manufacturer, and thus is likely to initiate some sort of design improvement.

In this event, the patient’s caregiver was unable to determine the actual amount of oxygen in the tank because of a defective contents indictor. This problem had been occurring since the manufacturer changed from plastic fitting to brass fittings on the indicator.

As a result of these recurrent issues, the reporting facility performed leak testing in both brand new, out of the box, contents indicators and those already in use, ranging from two-days to five-months old. All were found to have small cracks at the brass inlets on the contents indicators, allowing small amounts of oxygen to escape and continuously made the contents indicators read empty even when the units had known amounts of liquid oxygen still inside the container.

MedSun follow up with the manufacturer led the firm to implement a corrective action to address the oversized threads on the brass hose barb, which caused the cracks and, thus, was associated with the leaking and the inability to obtain accurate liquid level gauge readings on the stationary home unit.

Slide 39

This next report was selected from the MAUDE database as it was submitted by a manufacturer. Because this event discusses serious injury to a patient, the manufacturer is required by regulation to report it to FDA. We chose to share this report with you because it occurred in the home setting and because it is an issue of concern.

In this event, a home care patient had been receiving negative pressure wound therapy on two wounds on their inner and outer calf. When the nurse removed the dressing from the outer calf wound, the patient began to bleed. The nurse applied pressure to the wound but could not stop the bleeding. The patient was taken to the ER where their vessel required two sutures to stop the bleeding.

Similar events had been submitted to FDA and as a result led FDA to examine the issue further. While FDA is still investigating, we did release a Preliminary Public Health Notification to health care providers and to patients, which provides recommendations to reduce the risk for bleeding and infection when using negative pressure wound therapy systems, as seen in this reported example.

It is reports like these that we receive from manufacturers and care providers like yourselves, that help FDA identify problems with medical devices and, are therefore, in the position to take action toward fixing the underlying issue.

Link provided in slide for preliminary public health notification about negative pressure wound therapy systems: ucm190658.htm

Slide 40

You play a huge role in patient safety, especially with patients who use medical products in the home setting. It is important to be able to recognize and report device problems or even potential device problems.

Slide 41

Potential device problems are those issues that you catch before any harm occurs to the patient or to the provider. All the times you had to think outside the box and develop a workaround is a reportable event that FDA would like to know about.

Slide 42

Your reports have huge impact. It is important for you to report medical device problems for all of the reasons cited on this slide.

List shown in slide:

Why Reporting Medical Device Problems Is Important In Your Home Care Agency

  • Prevent future problems and protect your patients, families, staff
  • Achieve performance improvement goals
  • Assist Risk Management with claims or litigation
  • Provide information to manufacturers and/or U.S. Food and Drug Administration
  • Impact the public health for the nation’s patients, family caregivers and/or health care providers
  • Effect changes in policies and procedures

Slide 43 (picture of reading glasses on top of a piece of paper)

Please report when you think a device has, may have, or has the potential to contribute to death, serious injury, or minor injury to your patients and also to the caregiver.

Slide 44

It is important to include as much detail as you can when you report device issues to FDA.

For example - what happened and to whom? Where did the event happen? Describe any patient characteristics or comorbidities that may have been associated with the event, and include any follow up. Most importantly, please include as much information about the device as possible. For example, device manufacturer, brand, or ID numbers like lot or model number.

Slide 45

Every facility is different. And as we’ve learned from HomeNet, every home health agency operates differently as well. It is important that you know your organization’s reporting system, policies and procedures, so that the appropriate people can submit your report to FDA.

Slide 46

Again, you have a very important role. You are the one who see patients in the home. We rely on you to talk to your patients about their device, and when necessary report events with as much detail as possible.

I also want to take this opportunity to make a plug for a special pilot initiative that we are rolling out based on feedback we have received from our HomeNet sites. Many have expressed the need for patient and caregiver education about recognizing when a device issue occurs and how to report it. So we have developed a form or a handout to encourage reporting issues that may occur with medical devices used in the home setting.

The handout has two formats -one that can be electronically completed by the provider, and also as a paper version for the patient to keep in their home. They can use it to jot down any issues they see, and can share it with their provider, who can then use this information to formally submit a report through MedSun. We hope that home health providers like you will share this form with their patients as a tool to increase reporting device problems in the home setting.

If you are interested in participating, please contact us at MedSun. The phone number is 800-859-9821. This phone number and the MedSun email address will appear on the final slide of this presentation.

Slide 47

FDA is very interested to hear about issues with medical devices used in the home setting. We hope that this offering provided you with some valuable information about the importance of reporting issues and also provided you with some examples of the type of issues that we would love to hear about.

The home environment is so different from the hospital environment. Care is moving into the home and we all need to be ready for it. Being proactive about device issues as well as issues surrounding their safe and effective use in the home is a huge deal, and we really look forward to working with you in this growing arena.

Slide 48

Eve Zimmerman: Thank you, Diana. Now, we will proceed to the question and answer portion of the presentation. As previously mentioned, these questions were submitted by audience members at the time of registration.

Slide 49

Our first question is, “What is the best type of IV pump for home use?” Mary, can you address this?

Mary Weick-Brady: Yes, thanks, Eve. As we discussed earlier, FDA is responsible for regulating companies that manufacturer, repackage, re-label, and import medical devices sold in the United States. This is accomplished through scientific review of premarket data submitted by a medical device manufacturer to establish a device’s safety and efficacy, and then once on the market, we monitor medical device adverse event reports to detect and correct device-related problems in a timely manner.

It is important to note because the FDA’s scope of work is to regulate the medical device industry, the FDA cannot and does not recommend specific medical devices for use. This conflicts with our purpose of getting safe and effective medical devices out on the market, and monitoring them while on the market.

Additionally, the FDA does not regulate the practice of medicine. So we encourage you to review the instructions for use for a device you plan to use in the home before deciding on the one best for a particular patient population.

Slide 50

Eve Zimmerman: Thank you, Mary. Our next question is from a home health care nurse who asks the following, “A patient recently asked me about whether it was okay to buy a wheelchair on the internet. What should I tell them about purchasing medical devices on the internet?” Mary, would you like to address this?

Mary Weick-Brady: Sure. Sure. While buying online has certain advantages, it can produce pitfalls for some consumers. And I kind of talked about this a little bit earlier. As we are all aware, buying online offers privacy, convenience, and potential cost savings. While the internet offers many quality medical devices from legitimate sites, it also offers medical devices that in some instances don’t work and some that may even be harmful to the person purchasing it.

Some websites sell medical devices for unapproved uses or they sell medical devices that have not been cleared or approved by FDA. Some may come with instructions for use and a list of compatible accessories and others may not. Other websites sell prescription medical devices without asking for a prescription.

Some foreign websites sell medical devices to customers in the United States where the medical devices have not been cleared or approved for sale. The FDA has monitored internet sales of health products for several years and has sent warnings about illegal practices to more than 50 companies. Even though its resources are limited, the FDA is increasing its monitoring of internet sales and is working with the Federal Trade Commission (FTC) to stop illegal advertising.

The FTC works with both state and federal consumer protection and public health agencies. It can take legal actions against internet advertisers of health products that run false or misleading advertisements.

Slide 51

For more information about what to be aware of when buying a medical device online, go to this FDA related site, and you’ll be able to see that. But go on that site and we tell you a little bit more about purchasing devices on the internet.

Link provided for more FDA-related consumer information about buying a medical device online: BuyingMedicalDevicesandDiagnosticTestsOnline/default.htm

Slide 52

Eve Zimmerman: Thank you, Mary. And the last question, “I care for a patient who lives in a rural area and is being discharged from the hospital on home hemodialysis. She will be two hours from the nearest dialysis clinic. What medical device associated risks should I consider?” Mary?

Mary Weick-Brady: Okay. This is a good example, as there are many factors one must consider. In this case, it is important that you check on the power sources in the patient’s home. You need to make sure that the power capacity of the house can support the electrical needs of the hemodialysis system because you don’t want the house shorting out each time the machine is turned on.

You need to make sure that the hemodialysis system can be plugged in, so make sure that the plug prongs and sockets match. Also in the event of a power outage, especially given the distance from the closest dialysis clinic, it is important that the user knows what to do, who to contact, and have backup power available.

In addition to power issues, it is imperative that you check to see if there’s enough space in the house to handle the size and accessories needed for the hemodialysis machine. You need to check on the water source and find out if the patient uses well or tap water, as this will make a difference in the type of filtration system they end up using.

Find out if they have potential distractions like children or pets in the house that could lead to interruptions in treatment or the time of treatment. Check the house for cleanliness and ability to store supplies safely. And lastly, make sure that the patient is a good candidate for home hemodialysis. Are they motivated? Are they capable? Do they have a care partner who can help them out? Have they been trained to use the device and know what to do in emergencies? These are all things one must consider.

Slide 53

FDA developed a checklist with important questions to ask when considering home health care medical devices, and the next slide provides you with a link to this brochure, which you may download and print to use in your facility.

Link provided for the FDA Checklist for Home Healthcare Medical Devices: ucm070217.htm

Slide 54

Eve Zimmerman: Thank you, Mary.

This will conclude our program today. On behalf of the FDA, I’d like thank you for attending. Again, let me remind you that certificates of participation with one nursing continuing education contact hour are now available to staff from participating MedSun sites.

You may go to the registration website listed on your confirmation email, complete a short evaluation and print a copy of the electronic certificates.

Additionally, if you know of others at your MedSun organization who would like to receive a replay of this presentation and the associated nursing continuing education contact hour, call us at the number above. Thank you.

MedSun information provided in slide:


Slide 55
Information provided in slide:
For information about limitations on the use of the Microsoft ® images contained in this presentation, go to

For information about limitations on the use of other images contained in this presentation, contact MedSun at


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