Medical Safety

Question 1

Where should accidents be reported to?

Answer 1

MHRA = Medicine & Healthcare Products Regulatory Agency

Question 2

What equipment causes the most accidents? (most to least)

Answer 2

• surgical equipment + consumables (23%)
• implants (23%)
• infusion/transfusion/dialysis (16%)
• life support/incubators/monitors (10%)
• syringes/needles (10%)
• imaging/n vitro diagnosis (5%)
• drainage/suction (4%)
• beds/mattresses, disinfection/sterilization/monitors (2%)

Question 3

What equipment causes the least accidents?

Answer 3

• imaging/n vitro diagnosis (5%)
• drainage/suction (4%)
• beds/mattresses, disinfection/sterilization/monitors (2%)

Question 4

What are the most common types of errors?

Answer 4

• device delivered faults (32%)

- no established link to the deice (32%)

Question 5

What are the least common types of errors?

Answer 5

• user error (15%)

- device developing faults after delivery (21%)

Question 6

Who’s fault is it if the device delivers faults?

Answer 6

• manufacturer

Question 7

Who’s fault is it if the device develops faults after delivery?

Answer 7

• fault of manufacturer if under warranty

- if out of warranty, hospital as need to look after

Question 8

How much error is not related to the device?

Answer 8

Nearly 50%

HUMAN ERROR

Question 9

What does monitoring device mean?

Answer 9

• maintaining quality assurance

- continuing to update standards of equipment + give training

Question 10

What is the study that looked at types of errors/equipment?

Answer 10

Jacobson & Murray 2007

Question 11

HTM8 Standard

Answer 11

Hospital Technical Memorandum 8

• design + construction standard
• by Dpt of Health + Social Security

Question 12

Health & Safety at Work Act

Answer 12

• all aspects of the workplace
• puts responsibility on employers and employees
• for employees/visitors/patients/students/contractors

Question 13

ESCHILE

Answer 13

Electrical Safety Code for Hospital Lab Equipment

• Dpt of Health + Combined bodies
• lab equipment

Question 14

MDA Supplement 1

Answer 14

• checks + tests newly delivered medical devices
• correct voltage/current
• testing under routine conditions

Question 15

MDA 2

Answer 15

Management of in vitro diagnostic medical devices

Question 16

BS-EN (3rd)

Answer 16

• general requirements for basic safety + essential performance
• inadequate equipment can cause hazards
• need risk management process
• risks are acceptable if prepared for them

Question 17

Penalty against HSWA?

Answer 17

£20, 000 to unlimited fine

6 months to 2 years imprisonment

Question 18

European Medical Devices Directive 1994

Answer 18

Infusion devices, defibrillators, implanted devices, x-ray
Essential for legal requirements over its lifetimes
Manufacturer needs to meet requirements & ensure its fit for purpose

Question 19

What manufacturer labels are there?

Answer 19

CE = will comply with requirements over its lifetime ONLY IF it is used following manufacturer’s guidelines
Limited Stability
Use By (sandtimer)
Single Use Only (2 in a circle with a cross)

Question 20

What is the chain of safety?

Answer 20

Transfer of responsibility from manufacturers to users

• how risks are removed in this process
• manufacturer needs to meet device requirements
• care providers need to buy suitable device
• liability transfers to user if not used in approved manner, services and maintained
• clinical engineers responsibility is to service and maintain device according to manufacturers requirement

Question 21

What are the steps of the chain of safety?

Answer 21

1) Manufacturer approves design
2) Manufacturers follow requirement specification
3) Care providers carry out initial inspection to see if device is functioning correctly
4) Care providers give users training
5) Care providers get clinical engineers to maintain and service device
6) Daily checking being carried out

Question 22

What are the 7 hazards of medical devices?

Answer 22

1) Mechanical (loose wheels/tripping)
2) Absence of function (care provider, manufacturer)
3) Excessive/insufficient output (users, manufacturer, clinical engineer)
4) Infection (up to care providers and users)
5) Misuse (care providers and users)
6) Risk of fire explosion
7) Risk of exposure to electrical currents (users)

+

8) Biohazards = organisms/by-products of organisms
9) Radiobiological = x-rays, CT
10) Chemical

Question 23

Which equipment are most susceptible to infection transfer?

Answer 23

Multi-use

e.g. thermometer

Question 24

Whose fault are mechanical hazards?

Answer 24

Clinical engineers

Manufacturers

Question 25

What equipment causes the most hazards?

Answer 25

BEDS!

Question 26

How to avoid misuse hazards?

Answer 26

Easily with training

Question 27

What increases risk of fire explosion?

Answer 27

Short circuits

Question 28

Why are electrical hazards so common?

Answer 28

• patients are deliberately connected
• patient immobile/cannot detect pain
• staff intentionally use devices that could never be considered electrically safe

Question 29

How to prevent biohazards?

Answer 29

Hygiene
Dispose + label bio-waste
Training
Record incidents

Question 30

How strong is x-ray vs. CT exposure?

Answer 30

X-ray = 10mrem
CT = 1500mrem

Question 31

How to prevent radiobiological hazards?

Answer 31

Minimize exposure time
Maintain distance from source
Place shielding

(Up to care providers)

Question 32

Chemical Hazard Prevention

Answer 32

COSHH policy
Protection
Training
First Aid

Question 33

Standards to prevent Hazards

Answer 33

• NIST (non interchangeable screw threads with different diameters/thread directions)
• PIN INDEX SAFETY SYSTEM
• Colors for different sources
• Pressure regulation in case risk of explosion