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U.S. Department of Health and Human Services

Medical Devices

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Improving Patient Safety by Reporting Problems with Medical Devices – Home Version

Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home


 Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 1

 

Welcome participants.

 

STATE:

For the next 10 minutes we’ll be talking about improving patient safety in the home. As you may know, our home health agency is involved in a project called MedSun, which is a device-reporting project with the FDA. MedSun involves many other home health agencies that are working with FDA to ensure patient safety by reporting adverse events involving medical devices.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 2

 

STATE:

Our goal for the session is to

  1. increase awareness of incidents that potentially involve a medical device or technology and
  2. encourage our staff to report it quickly.

 

READ OBJECTIVES ON SLIDE:

 

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

  • Identify several types of medical devices
  • Identify several types of medical devices used in the home
  • Explain why reporting problems with medical devices in the home environment is important
  • Describe your role in promoting patient safety with medical devices used in the home
  • Describe the steps to take to report an adverse event or problem with a medical device used in the home

 

CLARIFY AND CONFIRM AS NEEDED

 


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 3

 

STATE:

Let’s look at some trends currently 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 and patients themselves.

 

At the same time, the number and complexity of medical devices used in the home health environment continues to grow.

 

Advances in technology have supported these trends. Medical devices have become smaller and more portable. 

 

Patients themselves have also changed in recent years. Because patients (and their family caregivers) have easy access to health information, they are becoming more knowledgeable about care options. Patients are more empowered, invested, and active in the decisions related to their care.

 


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 4

 

EXPLAIN:
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 ½ 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 caregiver 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 US adults report having at least one type of disability.

 

Of course there are other groups that receive home care besides the elderly. These include newborns, people with chronic conditions, and people with temporary home care needs.

 


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 5

 

EXPLAIN:

There are a lot of risks unique to the home environment when you introduce medical technology into the mix. These are divided into environmental issues and use issues. Here are some environment examples:

 

Children: Depending on the age, they can injure themselves with accessories such as needles, use devices as play toys, and try to operate the device themselves changing settings along the way.

 

Electromagnetic interference (EMI) is big in the home. Televisions, microwaves, Wiis, telephone lines, and other electronic technology can wreak havoc with medical devices.

 

Location: If a patient is in a rural setting, 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.

 

Noise: There is a lot of outside noise in homes – 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: Rodents may chew on tubing, roaches can get into equipment, and pets may be in close proximity to open wound care or dialysis.

 

Power outages are very common in the Midwest. Many times there is no back up plan for power outages.

 

Public emergencies: After Hurricane Katrina hit New Orleans and other areas, close to 50% of people in shelters had some type of medical equipment with them.

 

Safety: Patients on intravenous morphine can be at risk for medication theft. Another safety issue would be long tubing throughout the house increasing the risk of falls in the home. Neighborhood safety for the caregiver or home health staff is another issue and increases the risk of device theft.

 

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 difficult. The ability to properly dispose of waste can also be an issue.

 

Space: This always needs to be taken into consideration especially for large equipment or equipment that is potentially cumbersome to have around. A hospital bed takes up a lot of room and if you live in a tiny walk up, it may not be an option.

 

Whether in use or storage, devices and their accessories can be affected by temperature and humidity. Excessive heat or humidity can cause a device to fail or to malfunction. Condensation can occur when moving a device from a cold to hot environment. This too can affect a device.

 

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 of some devices.

 

In the area of use, we should look at the device’s compatibility with lifestyle. Will the patient find treatment with the equipment to be conducive to their lifestyle?

 

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. Nurses spend a lot of time writing instructions for the patient.

 

Interface and ease of use: These devices need to be foolproof or as close as possible.

 

Off-label use: Using a device for treatment other than what it is intended or longer than recommended can lead to problems.

 

Durability of the device: Patients may be traveling, going to work or school, or playing outside with their device attached. Devices that are going into these environments need to be made durable enough to handle it.

 

Selling prescribed devices on the Internet: This is not a good thing as the devices may or may not be prescribed for the person who is purchasing them. This is a market that is growing daily.

 

User’s educational level: Devices should not be complex or intricate. They must be geared to users with an 8th grade, and preferably a 6th grade, education.

 

User’s emotional stability: Family caregivers are going to be extremely concerned about caring for a loved one and their emotional state may be precarious. Their ability to learn and digest what is being taught could be compromised.

 

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 (e.g., Parkinson’s). These impairments must be considered when a patient is going home with a medical device.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 6

 

EXPLAIN:

This slide lists types of medical devices in 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 wheelchair to a sophisticated scanner or hi-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 healthcare provider.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 7

 

STATE

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.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 8

STATE:
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 break-downs 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 for 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 staff, 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 problems that can easily slip through the holes in the home setting.

 


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 9

 

EXPLAIN:
We know of the interface between devices and patients, but it’s important to consider the device in its many interfaces as well.

 

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, lighting, temperature, and interference with other devices;
The people involved: the patient, family caregiver, home health nurse, device-operator; as well as any
Accessories and disposables
involved, such as filters, valves, ports, and tubing, etc.

 

One or several of these could impact the adverse event and may warrant further investigation to determine the cause of the problem.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 10

 

What Types of Medical Device Problems Should I Look for?

 

STATE:
This is a list of broad categories or ways to classify possible causes of adverse events. Some of what is listed here may remind you of problems you’ve had or times you have questioned a device as the reason for a problem.

 

Let’s briefly run through the list here and we’ll cover more detail with examples in the next several slides from actual MedSun reports.

 

NOTE TO INSTRUCTOR: Read the list and move to next slides.

  • 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

 


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 11

 

NOTE TO INSTRUCTOR: Briefly describe the examples on each slide. It’s important to maintain a steady pace as you move through these next few slides to keep within the time frame. Spend approximately 1 minute per slide.

 

STATE:

Some examples of Defects include:

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

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 12

 

STATE:

This slide provides some examples of medical computer software problems.

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

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 13 

STATE: Here are some examples that define what we mean by failure to work as intended or 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

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 14

 

STATE: 

This slide depicts Instructions/Labeling/Packaging issues.

 

Instructions for use (includes graphics/icons/charts) may be:

  • 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 issues include:

  • Damaged package
  • Missing components
  • Sterility issues
  • Device size is incorrect

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 15

 

STATE:

Interactions with other devices include:

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

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 16

STATE:

 

In looking at Use Errors, 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
  • Electric-powered wheelchair joystick is too close to speed button

 

STATE:
It’s important to note here that although you may think of these examples solely as “use error” they may be the result of a poorly designed device so it’s important to report it.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 17

STATE: 

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 the factors listed here. I previously addressed some of these elements. I would really like to focus on user considerations, in order to emphasize the importance of appropriate training for a variety of user audiences.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 18

 

STATE: 

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 homecare 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 levels, limitations, and familiarity add to the complexity of assuring the proper use of medical devices used 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.

 

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 slides.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 19

 

STATE:

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 ideally be usable with little to no training. When we think about training patients and their caregivers about how to use their medical device in their home, I really want to reiterate the importance of considering things like:

  • The user’s educational level
  • The user’s emotional stability; and
  • The user’s physical capabilities.

The easier it is to learn how to use a device, the better the patient safety outcome.

Training becomes an issue when it is not appropriate to the audience, or it is unclear; misleading; incomplete; or it is simply not provided.

 

Having appropriate training that includes instruction on device operation, device maintenance, troubleshooting, and how to obtain device replacement parts, i.e. batteries, is important.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 20

 

STATE: 

Home health care professionals often 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 is the perfect storm, which is why the FDA are so interested in learning more about issues with devices used in the home setting.


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 21

 

STATE: 

So let’s talk specifically about, “Why Reporting Medical Device Problems is Important in Our Home Care Agency.”

It will, most importantly,

  • 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

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 22

 

STATE:

So you may ask, “When do I report?”

 

When you think a device has or may have caused or contributed to any of the following outcomes
(for a patient, caregiver, staff member):

  • Death
  • Serious injury
  • Minor injury
  • Close calls or other potential for harm

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 23

 

STATE: 

Next, let’s look closely at, “What Do We Mean by “Potential for Harm?”

 

Events that are caught before anything harmful occurred such as a

  • packaging defect leading to the product not being sterile


Important observations of a chronic problem with a device

  • cannot hear device alarmS
  •  device not easy to use


Problems which lead staff to develop “work-a-rounds”

  • taping devices together, or substituting parts because of problems with a certain part


“Out-of-the-box” problems that are identified before use on a patient

  • cracked tubing noted during setup

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 24

 

STATE: 

We’ve looked at when to report, let’s focus now on what to report. This information is so valuable because it’s focused on getting complete information initially from the staff person who may have been directly involved.

 

NOTE TO INSTRUCTOR: Read ‘What Do I Report?’ slide


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 25

STATE: 

And lastly, How Do I [you] Report?

Our Reporting System Involves. . .

 


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 26

 

STATE: 

When You See a Device That Presents a Problem You Should …


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 27

 

STATE: 

We’ve listed Some Issues We’ve Addressed here at Our Home Care Agency with device problems and the actions we took to solve them. We hope this will reinforce with everyone the importance of reporting what you’ve seen so we can intervene and prevent any harm to patients, staff, and caregivers in the home.

 

READ SLIDE

What Was Reported and What We Did


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 28

 

STATE: 

Here’s what we need to do as an organization to
“Foster a Climate of Patient Safety.”

 

STATE:
We need to:

  • Provide feedback and communication about adverse events and close calls
  • Learn from our errors
  • Comply with our policies and procedures
  • And promote and exhibit teamwork

Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 29

 

STATE: 

If You’re Not Sure What or How to Report…


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 30

 

STATE: 

And, Your Role is to. . .

NOTE TO INSTRUCTOR: Read Slide


Speaker Notes - HOME VERSION

 

DISPLAY SLIDE # 31

 

STATE: 

In Summary . . .

 

NOTE TO INSTRUCTOR: Read Slide


Speaker Notes - HOME VERSION

DISPLAY SLIDE # 32

And Remember. . . .

 

We can’t address issues we don’t know about. 

 

Please communicate with your patients.

Please report.