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BECT™: Module TM2 – Medical Equipment Risk and Patient Safety

Mr.Eric Woo Kit Seong The 1st Thailand Healthcare Facility Management Excellence Seminar 2015 1

©2015 ECRI INSTITUTE

MEDICAL DEVICESRISK & PATIENT SAFETY

Eric Woo, Regional Director Asia Pacific

October 2015

Outline of Content

Definition

Risk from Medical Equipment

Managing Risk and Patient Safety

Case Study: Patient-Supplied Medical

Equipment



definition

What is Risk?

“ Combination of the probability of occurrence of harm and the severity of that harm.”

ANSI/AAMI/ISO 14971:2000

“ the chance of something happening that will have an impact upon objectives. It is measured in terms of consequences and likelihood.”

AS/NZS 4360:1999



Source: Sydney Herald, modified by Bernd Rohrmann

Risk from medical equipment?

RISK



Risk from Medical Equipment

Medical equipment does not cause harm unless a

sequence of events occurs to create a

hazardous situation

A hazardous situation occurs when people, property, or environment are exposed to a hazard

Typical Device Risk Levels

Three risk levels

(Guidelines from ECRI Institute; Refer to hand-out)

High-risk devices

Medium-risk devices

Low-risk devices

Source: Health Devices Journal



High-risk devices

Failure or misuse is reasonably likely to result in serious injury to patients or staff o Life-support devices

o Key resuscitation devices

Any device that has been associated with

serious injury in the past

High-risk devicesExamples:

Anesthesia Units and Vaporizers

Anesthesia Ventilators

Argon-Enhanced Coagulation Units

Aspirators (Emergency and Tracheal)

Autotransfusion Units

Defibrillators (including Automated External Defibrillators)

Electrosurgical (Surgical Diathermy) Units

Fetal Monitors

Heart-Lung Bypass Units

Hemodialysis Units

Humidifiers (Heated)

Hypo/Hyperthermia Units

Infant Incubators (including Transport), etc…



Medium-risk devices

Includes devices whose misuse, failure, or absence (e.g., out of service and no replacement available) would have significant impact on patient care, but would not likely cause immediate serious injury.

A failure of this type of device could affect or delay therapy

Patient outcome is unlikely to be significantly affected

Medium-risk devices

Examples

cardiac output units,

clinical laboratory equipment, and

ultrasound imaging systems

Blood Bank

Refrigerators

Blood Gas/pH Analyzers

Circumcision Clamps

Cryosurgical Units

Electrocardiographs

Electroconvulsive Therapy Units

Electroencephalographs

Endoscopes, etc…



Low-risk devices

This category includes devices whose failure or misuse is unlikely to

have serious consequences.

Examples:

Examination lights

Alternating-Pressure Pads

Aspirators (Low Volume)

Breast Pumps

Cast Cutters

Circulating-Fluid Pumps

Diathermy Units (Physical Therapy)

Electric Beds

Electric Wheelchairs, etc…

Managing Risk and patient safety



Identifying Risk Internal Sources

Incident reports

Case reviews and reports

Patient complaints

Informal discussion with other staff

Others

External Sources

International databases

Accreditation surveys

Insurance reports



1. Alarm Hazards - Inadequate Configuration Practices and Policies

Risk Factors■ Nuisance alarms

■ Alarm overload & fatigue

■ Competing alarms

■ Defeated/misconfigured alarms

Prevention■ Assessment of patient care

areas

■ Defined protocols and user permissions

■ Standardization and training



2. Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT Systems Risk Factors

■ Device/system incompatibilities

■ Missing or delayed data delivery

■ User error

Prevention■ Assess clinical workflow

■ Test, test, and retest

■ Comprehensive training and support

■ Facilitate problem reporting

3. Mix-Up of IV Lines Leading to Misadministration of Drugs and Solutions

Risk Factors

■ Device to device compatibilities

■ Common Luer fittings makes this an easy and deadly mistakes

■ Many lines on one patient

Prevention

■ Remove the most dangerous compatible connectors

NIBP monitors with Luer connectors

■ Monitor the new standards

■ Follow the Tracer approach

■ Label your lines



4. Inadequate Reprocessing of Endoscopes and Surgical Instruments

Risk Factors■ Intricacy of instruments

■ Time allotment for reprocessing

■ Lack of standardization

■ Coordination between OR and reprocessing staff

Prevention■ Careful equipment

selection

■ Develop reprocessing protocols

■ Train staff

■ Monitor staff compliance

5. Ventilator Disconnections Not Caught because of Mis-set or Missed Alarms

Risk Factors■ Very sick or vulnerable patients

■ Confusing and hectic environment

■ Poor or unclear policies for setting or monitoring for alarms

Prevention■ Establish strong alarm setting

policies

■ Routinely confirm that all alarms are set correctly

■ Routinely verify integrity of ventilator circuit connections

■ Consider ancillary alarm systems



6. Patient-Handling Device Use Errors and Device Failures

Risk Factors■ Improper use of patient lifts

(various designs)■ Issues associated with mobile

patient lifts. ■ Use issues associated with transfer

boards

Prevention■ Train caregivers to recognize

scenarios that might require the use of patient-handling equipment

■ Facilitate the proper use of patient-handling equipment for patient-handling activities that pose a risk of injury to patients or staff

■ Establish responsibility for the timely inspection, preventive maintenance, and repair

7. “Dose Creep”: Unnoticed Variations in Diagnostic Radiation Exposures

Risk Factors■ Exposing patient to radiation levels that were

too high or too low

■ Expose patient to additional radiation

■ Tendency to nudge the dose higher to get better-quality images

Prevention■ Train caregivers to recognize scenarios that

might require the use of patient-handling equipment

■ Facilitate the proper use of patient-handling equipment for patient-handling activities that pose a risk of injury to patients or staff

■ Establish responsibility for the timely inspection, preventive maintenance, and repair



8. Robotic Surgery Complications Due to Insufficient Training

Risk Factors■ Lack of training

Initial training

Continued training

■ Ongoing competency

Prevention■ Hospital developed policy

■ Training

■ Sustained proficiency

■ Evaluating equipment “interoperability”



9. Cybersecurity: Insufficient Protections for Medical Devices and Systems

Risk Factors■ Ever-increasing number of networked medical

devices■ Delays in the availability of OS patches ■ Continued need to use devices that operate only on

very old hardware or software, ■ Inconsistent support from medical device industry■ Inconsistent support from IT industry

Prevention■ Proactively assess medical device cybersecurity

risks■ Keep up with latest updates and patches for OSs

and anti-malware software■ Limit network access to medical devices through the

use of a firewall or virtual LAN■ Audit log-in access to all medical devices ■ Set up a process for monitoring and reporting

cybersecurity threats and events.

10. Overwhelmed Recall and Safety-Alert Management Programs

Risk Factors■ Implants are often stocked on consignment (and,

therefore, may not appear in purchase history data until after implantation)

■ Software updates■ Integrated device systems■ Loaner or other equipment not owned by the hospital■ Home care devices that are managed by the hospital

Prevention■ Executive sponsorship. Mandate from the top of the

organization will facilitate collaboration among alerts management staff and clinical experts who use, maintain, or manage technologies, reducing the likelihood of missed alerts

■ Designation of alerts management as a critical patient safety activity

■ In addition to the distribution of alerts, includes confirmation that an alert has been received by a responsible party and documentation of the remediation efforts



Understanding the Contributing Factors

How can the risks be minimized?

?


!Human Factors




Human factors

Work practices

Inadequate training

Lack of awareness

How Hazards Develop


Process factors

Process complexity

Planning, implementation

Maintenance, ongoing management

How Hazards Develop




Technology factors

Equipment faults, failures

Equipment design limitations

Technology complexity

How Hazards Develop

General Recommendations

1. Monitor for ongoing risks, take appropriate steps to reduce risk, and document actions taken



General Recommendations

2. Have a Technology Procurement Safety Checklist

What if an Incident Occurs?

Medication Error



Frequency or number of reports.

Can you depend on the central line kit/guide wire vendor?

What has been learned from others to prevent it?

What elements of a RCA are needed to truly get at the root causes?

How do you measure success for your corrective actions?

Retained Guide Wires

Discovering the Unexpected

Medication errors involving incorrect patient weights

40% from the ED. Many don’t have scales capable of weighing immobilized or unconscious patients without removing them from a gurney or stretcher.

The not-so unusual…

Patients scheduled for gall bladder removal only to find that the gall bladder was already removed. Failure to obtain a proper history (patients had dementia), and all the patients were diagnosed with ultrasound (a non-specific test) with no further confirmation.

Wrong surgical

Many cases involved inappropriate withholding of treatment, failure to rescue. (http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2008/Dec5(4)/Pages/111.aspx)

Discovering the Unexpected



Reporting & Prevention

► If a device is involved in an event, it should be isolated, without changing any control settings, so that an analysis can be performed

► It should not simply be sent to biomedical engineering for repair

► Disposable devices are no exception and must be saved for later analysis


Ensure that device-related events are reported through the proper channels




Patient Safety

It is everybody’s duty

Freedom from accidental injury

Freedom from unnecessary risk



WHAT to do when medical device accidents happen?

44

Protect patient

Protect equipment / environment

Notify clinician

Sequester equipment (including disposables)

Internal reporting

Third party involvement

Immediate Action Plan

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