# Presentation: 435008

## Improving Patient Safety by Reporting Problems with Medical Devices

## Reporting Problems with Medical Devices

- At the end of this session you will be able to:
- Identify several types of medical devices
- Explain why reporting problems with medical devices is important
- Describe your  role in promoting patient safety with medical devices
- Describe the steps to take to report an adverse event or problem with a medical device in our hospital

## Types of Medical Devices and Examples

** ****Capital Equipment**
- cribs, bedrails, scales, wheelchairs, IV poles, infusion pumps, bathing tubs, blood pressure equipment,  MRI and CAT scanners, radiology equipment
** ****Instruments**
- lab equipment, surgical staplers, glucose meters, pulse oximeters
** ****Monitoring Systems**
- cardiac, telemetry, patient call
** ****Reagents**
- laboratory solutions

** ****Disposables &  ****  Accessories**
- ventilator breathing circuits, filters
- needles, syringes, trocars, IV catheters, IV tubing, foley catheters, feeding tubes, gloves
** ****Implantable**
- defibrillators, ventriculoperitoneal shunts
** ****Computerized****  Medical Systems**
- hardware
- software versions

## 
“Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of single individuals.”

Lucian L. Leape, M.D.
A leading patient safety expert
from Harvard University

- “Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of single individuals.”
*Lucian L. Leape, M.D.*
*A leading patient safety expert*
*from Harvard University*

## “Swiss Cheese” Model of System Failure that Can Lead to Injury 

**Device Maintenance**

**Device Problem Reporting**

**Culture of Low Expectations**

** ****Departmental Communication**

**FAILURE 1**
- Susceptible to maintenance-related breakdown; first free-flow event occurs

**FAILURE 2**
- Pump labeled “broken” without details
** **

**FAILURE 3**
- Recurring problem not pursued
** **

**FAILURE 4**
- Free-flow event
- not reported to staff

**2nd **
**FREE-FLOW:**
**PATIENT OVER-**
**MEDICATED**

## Think About the Device and its Environment

**Tracheal Tube**

**Environment**
**Electric Power, Heat, Humidity, **
**Light, Other Devices (EMI)**

**Heated Humidifier**

** ****Exhalation Filter**

**Medication Port & Filter**

**Pressure Valves**

**Accessories & Disposables**

## What Types of Medical Device Problems Should I Look for?

- Instructions/labeling/packaging
- Defects
- Software problems
- Failure to work as intended/malfunction
- Interactions with other devices
- Use errors
- Combinations of the above

## Examples of Problems

**Instructions/Labeling*****/*****Packaging**
- age/weight specific usage information not provided
- new cardiac catheterization kit changed to non-sterile outer package; staff unaware and thought entire package was sterile
- staff discovered contaminants in the buretrol packaging

## Examples of Problems (continued)

**Defects**
- IV pump bracket found with large crack and sharp edges
- infant heal warmer pack leaking
- gloves found discolored and with holes
- nurse opened two suction catheters and discovered a knot in one

## Examples of Problems (continued)

**Software problems**
- imaging workstation  downloaded patient A’s images into patient B’s folder
- CT scanner found to have a software glitch in new version
- virus infects device operating software

## Examples of Problems (continued)

**Failure to work as intended/ malfunction**
- open warmer bed improperly measuring patient temperature
- stapler fired but did not cut
- point-of-care glucose results differ from lab results

## Examples of Problems (continued)

**Interactions with ****other devices**
- burns with use of orthopedic shaver and grounding pad
- sandbag exploded inside MRI machine

## Examples of Problems (continued)

**Use Errors**
- infusion pumps by the same manufacturer look similar but operate differently
- otoscope and transilluminator look the same but have different light intensities
- incorrectly positioned radiant warmer temperature sensor causes overheating

## Why Reporting Medical Device Problems Is Important In Our Hospital

- Prevent future problems and protect our patients, staff, families, and visitors
- 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 and/or health care providers
- Effect changes in policies and procedures

## 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, staff member or visitor):
- Death
- Serious injury
- Minor injury
- Close calls or other potential for harm

## What Do We Mean by “Potential for Harm?”

**Events that are caught before anything harmful occurred**
- compatible connection between blood pressure cuff tubing and IV luer port
**Important observations of a chronic problem with a device**
- electrosurgical units used in an oxygen-rich environment
**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**
- ECMO membrane found to leak prior to being used on patient

## What Do I Report?

**If there was an injury, what happened to the persons affected?**
- second degree burn, respiratory arrest
**What, if any, were the problems with the device(s) involved?**
- circumcision clamp failed due to mismatched parts
**What, if any, were the original medical procedures for which the devices were used?**
**What, if any, were the follow-up medical procedures required because of the event? **
- repeat surgery, antibiotics administered
**What are the names of the manufacturers of the devices involved?**
**What are the relevant manufacturer device identification numbers?**
- serial, model, lot, catalog, and any other specific information
**What did you do to solve the problem?**

## How Do I Report?

**Our Reporting System Involves . . .**
*(Customized responses would be listed below)*
*Online reporting system via hospital intranet*
*Verbal or written reporting to supervisor*
*Written acknowledgment to the reporter including any follow up actions*
*Reward system for “best catches” that make patient care safer*

## When You See a Device That Presents a Problem You Should . . .

*(Customized responses would be listed below)*
*Attach an “out of service” tag and complete any questions to explain what happened*
*Inform your supervisor or biomedical engineering*
*Complete an incident report*
*Save the device and packaging and place in a clear plastic bag*

## Some Issues We’ve Addressed at Our Hospital

**What Was Reported . . .**
*(Customized responses to appear below)*
*ECMO pump malfunction** *
*backflow of secondary IV fluid*

**What We Did . . .**
*(Customized responses to appear below)*
*Found electromagnetic interference with nearby use of walkie-talkie; frequency changed; reported to MedSun*
*consulted manufacturer; height issue enforced with IV bags; reported to MedSun*

## Fostering a Climate of Patient Safety

*(Customized responses would be listed below)*
*Feedback and communication*
*Learning from errors*
*Compliance with policies and procedures*
*Teamwork*

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

*(Customized responses would be listed below)*
*Refer to the incident reporting section in our Policy and Procedures manual*
*Ask your supervisor, or*
*Call our reporting hotline at extension _____*

##  Your Role

- Identify actual and potential problems, adverse events, close calls with medical devices
- Report the problem or adverse event to your supervisor, according to policy and procedure
- Make sure your report includes details
- Remove the device and save the packaging

## In Summary . . .

- Our objectives were to:
- Identify several types of medical devices
- Explain why reporting problems with medical devices is important
- Describe your role in promoting patient safety with medical devices
- Describe the steps to take to report an adverse event or problem with a medical device in our hospital
***Have we met them?***

## And Remember . . .

- We can’t address issues we don’t know about.
- Please report.