PATIENT SAFETY IN HEMODIALYSIS –�HUMAN FACTORS AND TECHNOLOGY ASPECTS

Dr. Michael Etter

Nov. 6^th 2021 | Hanoi (via Webinar)

© Copyright

FOR INTERNAL USE ONLY

© Copyright

FOR INTERNAL USE ONLY

DISCLAIMER

Page 3

• DR. MICHAEL ETTER IS A FULL-TIME EMPLOYEE OF FRESENIUS MEDICAL CARE ASIA PACIFIC LTD
• PICTURES OF MEDICAL DEVICES OR PHARMACEUTICALS ARE FOR ILLUSTRATION PURPOSES ONLY AND DO NOT REFLECT ANY RECOMMENDATION OR PREFERENCE OF THE PRESENTER
• PLEASE CHECK THE AVAILABILITY AND REGULATORY STATUS OF MEDICAL DEVICES AND PHARMACEUTICALS MENTIONED IN THIS PRESENTATION SINCE THIS MAY DIFFER BETWEEN COUNTRIES

​

​

​

​

Two examples: technical failure or human error?

Fire after short circuit on electrical board due to water ingress as a result of incorrect cleaning and disinfection procedure.

Blood leak due to disintegration of tubing connection near pump segment as a result of a manufacturing issue.

Hippocrates said "first, do no harm“

Education of Nephrologists and hemodialysis nurses is well established in many countries.

​

Regulatory authorities like FDA, NMPA or BSI ensure “safety and effectiveness” of medical devices before they can be used by clinicians.

So why are the still accidents/incidents in hemodialysis causing harm to patients?

​

🡺 Everything in life has risk!

​

• Residual risk
• Risk from error

​

• Technical failure
• Human (user) error

​

KNOWLEDGE TRANSFER �– MANUFACTURER – CUSTOMER – END USER

It is a challenge to ensure that all staff who operate medical devices are trained and trained competently.

​

There is a responsibility to ensure that the customer has also received this information sharing and handles the device according to the operators manual / instruction for use (IFU) with all staff operating the respective devices.

�In addition, the clinical application training provided by the manufacturer and following a standard and documented approach including is probably the most essential part of the knowledge transfer.

Footnote

Page 6

11/4/2021

- IMPACT OF TRAINING ON ADVERSE EVENTS / MEDICAL INCIDENTS

FOR INTERNAL USE ONLY - Footnote

Page 7

11/4/2021

Falls at home have remained the top incident category for 2 consecutive years. Patient education on exercise and falls prevention was initiated in September 2020 and the AP falls prevention awareness campaign and OHS safety audits will continue to be a focus to assist countries to improve in this area.

It has been well documented that staff education can have immediate and long-term positive effects on knowledge, skills and attitudes in preventing adverse events , and modestly influence the reporting behavior of staff.

​

Journal of Biosciences and Medicines > Vol.8 No.6, June 2020

Effect of Medication Safety Education Program on Intensive Care Nurses’ Knowledge regarding Medication ErrorsImad Abukhader*, Khadija Abukhader, Faculty of Nursing, Arab American University, Jenin, Palestine.

​

​

Nursing Standard > 35, 1, 31-34. (2019)

Improving the uptake of medical device training to promote patient safety.

Shields R, Latter K Division of Cancer and Associated Specialties, Nottingham University Hospitals NHS Trust, Nottingham, England

​

​

BMC Health Services Research volume 11, Article number: 335 (2011) Effects on incident reporting after educating residents in patient safety: a controlled study

José D Jansma, Cordula Wagner, Reinier W ten Kate & Arnold B Bijnen

​

Don’t forget patient education!

DIALYSIS MONITOR ALARM MANAGEMENT & SAFETY FEATURES

E.G INTERACTIVE PPT TO ASSIST THE END USER WITH QUICK TROUBLE-SHOOTING GUIDANCE

Page 8

Hydraulic Alarms

​

​

Blood Alarm

​

TMP

Air Bubbles

​

Temperature Alarm

​

Access Alarms

Venous

Arterial

Alarms

Types

Processing

Conductivity Alarm

​

Flow Alarm

​

Warnings

Cyclic PHT

​

Blood leak detector detects dimness

​

Dialysis water deficiency

Battery Backup

Blood Leak Alarm

​

​

Air in system

Heparin pump end position reached

​

Example: Fresenius Medical Care 4008S

VENOUS NEEDLE DISLODGMENT – A CASE WHERE TECHNOLOGY CAN HELP

• The HD device sets limits around the pressure value

​

• Alarms (audible and visual) are activated, Blood pumps stops and a message appears on the monitor

​

• The venous pressure limits are set asymmetrically – this allows a quicker device response if the pressure falls below the limit

​

• Build in technology (e.g. venous access monitor (VAM)) will allow a quicker respond to pressure drop (15 mmHg drop vs 30 mmHg)

​

• Add-on devices like external wetness detector(e.g. VenAcc) that can be used to increase the ability to early detection VND

Footnote

Page 9

11/4/2021

CASE STUDY: VND WITH 1.5 LITERS OF BLOOD LOSS

DATA DOWNLOAD FROM A INCIDENT WHERE IT WAS CLAIMED THE DEVICE DID NOT ALARM

Footnote

Page 10

11/4/2021

12 mins after commencement 1^st access alarm

19 secs later reset and an immediate alarm again

Same access alarm 13 mins later

14 secs later reset and an immediate alarm again

30 mins blood pump stop and 41 secs later restarted

2.5 hrs later access alarm (venous)

33 secs later reset and an immediate alarm again

6.5 mins later access alarm (arterial)

Footnote

Page 11

11/4/2021

CASE STUDY: VND WITH 1.5 LITER OF BLOOD LOSS

VENOUS PRESSURE TOO LOW – TECHNOLOGY GIVES A HINT, BUT THE OPERATOR HAS TO TAKE ACTION!

12

Key take away message

​

- The HD machine is a monitor

​

- The messages are to inform the operator and to ensure and machine functions within acceptable parameters

​

- Ensure you do NOT take for granted the alarms, they are the safety mechanisms and are there to protect the patient

​

- It is YOUR responsibility to ensure you have read the IFU and are confident and competent with the machine operation

“USER ERROR” VERSUS “TECHNICAL DEFECT”

• Most errors are the result of human error due to poor systems, programs, education, environmental issues, or situations. These are managed by correcting the cause, looking at the process, and fixing the deviation—not the human.�
• Extracorporeal medical devices are rarely a major cause of morbidity, human factors at the machine interface and suboptimal communication among caregivers are common sources of error.

​

• Major causes of potentially reversible adverse outcomes include medication errors, infections, hyperkalemia, access-related errors, and patient falls. �
• Root cause analysis of adverse events and "near misses" can illuminate care processes and show system changes to improve safety.

​

• Patient observations and their participation in error reduction increase the effectiveness of patient safety efforts.

MEDICAL DEVICE LIFE CYCLE MANAGEMENT

• All mechanical devices are subject to “wear and tear”

​

• Regular maintenance is an essential requirement for safe and effective use of a hemodialysis machine

​

• Qualified and prompt technical service an be life saving

​

• Any attempt to temper with a hemodialysis machine by non-certified people will invalidate the manufacturers warranty and put staff and patients at risk

​

• look at “total cost of ownership”

Parts replaced during technical service for wear and tear

​

​

​

​

​

Dialysis machine with “bypassed” dialysis fluid filter

EVERYTHING OKAY! �…. OR NOT?

Footnote

Page 15

11/4/2021

NOTED ISSUES OF POOR PRACTICE AND HIGH RISK TO PATIENT

MACHINE SAFETY PARAMETERS ARE BYPASSED

1. The venous line is not through the venous occlusion clamp
2. Therefore there is no protection if there is an air bubble as it can’t clamp the line and prevent the air bubble going to the patient
3. Not through the line clamp means the optical detector can’t detect blood – so the device is in Preparation mode
4. Therefore there will never be an audible alarm as the device does not know a patient is on the machine
5. Because it is in preparation mode all the alarm limits are at either end of the scale, so no arterial or venous pressure limits
6. No lower venous pressure limit means no detection of venous needle dislodgment
7. Finally, the dialysate flow is off – which means NO dialysis

​

In addition

• No arterial pressure monitoring
• Universal ill-fitting blood lines
• Incorrect size heparin syringe (blood back flow)

​

Footnote

Page 16

11/4/2021

WHAT TO TAKE HOME?

In hemodialysis ….

​

• Most errors are the result of human error; technical errors are less common. Human errors are also preventable!

​

• The manufacturer takes care of technical risk reduction, but the user needs to manage process and operational risk management.

​

• Training and education are your best ways of error reduction and risk management.

​

• If there is a (suspected) technical issue, it is essential to report. We can only get better if we know where we are weak!

​

• Safe and effective function of a dialysis machine requires a quality product and regular maintenance. �
• Always consider “total cost of ownership”, not just cost of a single item. This will benefit your patients and your hospital administrator.

cảm ơn bạn