Medical Safety Flashcards
Where should accidents be reported to?
MHRA = Medicine & Healthcare Products Regulatory Agency
What equipment causes the most accidents? (most to least)
- 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%)
What equipment causes the least accidents?
- imaging/n vitro diagnosis (5%)
- drainage/suction (4%)
- beds/mattresses, disinfection/sterilization/monitors (2%)
What are the most common types of errors?
- device delivered faults (32%)
- no established link to the deice (32%)
What are the least common types of errors?
- user error (15%)
- device developing faults after delivery (21%)
Who’s fault is it if the device delivers faults?
- manufacturer
Who’s fault is it if the device develops faults after delivery?
- fault of manufacturer if under warranty
- if out of warranty, hospital as need to look after
How much error is not related to the device?
Nearly 50%
HUMAN ERROR
What does monitoring device mean?
- maintaining quality assurance
- continuing to update standards of equipment + give training
What is the study that looked at types of errors/equipment?
Jacobson & Murray 2007
HTM8 Standard
Hospital Technical Memorandum 8
- design + construction standard
- by Dpt of Health + Social Security
Health & Safety at Work Act
- all aspects of the workplace
- puts responsibility on employers and employees
- for employees/visitors/patients/students/contractors
ESCHILE
Electrical Safety Code for Hospital Lab Equipment
- Dpt of Health + Combined bodies
- lab equipment
MDA Supplement 1
- checks + tests newly delivered medical devices
- correct voltage/current
- testing under routine conditions
MDA 2
Management of in vitro diagnostic medical devices
BS-EN (3rd)
- general requirements for basic safety + essential performance
- inadequate equipment can cause hazards
- need risk management process
- risks are acceptable if prepared for them
Penalty against HSWA?
£20, 000 to unlimited fine
6 months to 2 years imprisonment
European Medical Devices Directive 1994
Infusion devices, defibrillators, implanted devices, x-ray
Essential for legal requirements over its lifetimes
Manufacturer needs to meet requirements & ensure its fit for purpose
What manufacturer labels are there?
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)
What is the chain of safety?
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
What are the steps of the chain of safety?
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
What are the 7 hazards of medical devices?
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
Which equipment are most susceptible to infection transfer?
Multi-use
e.g. thermometer
Whose fault are mechanical hazards?
Clinical engineers
Manufacturers
What equipment causes the most hazards?
BEDS!
How to avoid misuse hazards?
Easily with training
What increases risk of fire explosion?
Short circuits
Why are electrical hazards so common?
- patients are deliberately connected
- patient immobile/cannot detect pain
- staff intentionally use devices that could never be considered electrically safe
How to prevent biohazards?
Hygiene
Dispose + label bio-waste
Training
Record incidents
How strong is x-ray vs. CT exposure?
X-ray = 10mrem CT = 1500mrem
How to prevent radiobiological hazards?
Minimize exposure time
Maintain distance from source
Place shielding
(Up to care providers)
Chemical Hazard Prevention
COSHH policy
Protection
Training
First Aid
Standards to prevent Hazards
- 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
