Alan Lynch Head of Wheeled Mobility and Seating Centre Blackpool Chairman of International (ISO), European (CEN), British (BSI) Standards Groups for Wheelchairs.

Slides:



Advertisements
Similar presentations
Why are children restraint devices necessary in cars? Statistics have proved the increased number of children, less than 12, who are involved in traffic.
Advertisements

A CASE HISTORY OF A FATALITY IN A POWERED WHEELCHAIR Alan Lynch
Helmets – Standards, Certification and Regulations Ian Brodie, MSc. Project Manager September 19, 2006 Smart Risk Learning Series.
Australian Guidance Document Number xx Cathy Thomas Professional Representation OT Australia WA.
HSSE Policy Z Contractor HSSE Induction V2. HSSE Policy Z Contractor HSSE Induction V2.
Child safety with respect to vehicle protection and booster seats - a proposal for a CRF for children > 4yo 1 Informal document GRSP (55 th GRSP,
Wheelchair and Passenger Restraints Your Logo Here A straightforward presentation to be viewed at your leisure, but not to be ignored. Working with equipment.
Federal Role & Safety Standards Standardized Child Passenger Safety Training Program Winter 2004.
Correct Use of Seatbelts and Child Car Seats Presented by:
Transportation Safety for Wheelchair Occupants Linda van Roosmalen, PhD Douglas Hobson, PhD Department of Rehabilitation Science and Technology University.
District 1220 Assembly 2006 Health and Safety HEALTH AND SAFETY For Rotary District 1220 and its Member Clubs.
47th GRSP Session Status report of Informal Group on CRS Pierre CASTAING Chairman Informal Document No. GRSP (47th session, May 2010, agenda.
ECE Regulation N°129 55th session of GRSP May 2013
Options for Regulation and the Impact of Regulation on the Marketplace 29 November 2005 Alan Kent
Our GOAL …… SAFER WHEN THEY LEAVE Child Passenger Safety Susan Burchfield, Trauma Injury Prevention Coordinator Child Passenger Safety Technician.
ECE Regulation N°129 17/12/201354th Session GRSP December th session of GRSP December 2013 Informal document GRSP (54 th GRSP,
Federal Motor Vehicle Safety Standards. Applicability Each standard of this part applies to all motor vehicles or items of motor vehicle equipment manufactured.
MHRA Guidelines. Understanding how to improve practice/safety.
SHE Code 4: Safety and Safe Use of Work Equipment
Lec#14.  Disable person needs equipment with the degree of impairment and desired degree of independence in area of personal care, mobility, leisure,
7th February PQG Supplier Auditor Certification and Training scheme Introduction to the scheme & implications of the changes David Mogg PQG Chairman.
Creese Andrew Chief Executive Officer, Unwin Safety Systems
Health and Safety Awareness Low Risk Areas Lawrence Dickson Training and Audit Co-ordinator Health and Safety Department.
1 Frontal Accident Research Data in Japan Frontal Accident Research Data in Japan JASIC 29 January 2014.
Boosters. 2 Basic Types Belt Positioning Belt Positioning Backless Backless High back High back Shield (no longer on the market, lbs.) Shield (no.
GRSP December 2004 The Safety of Wheelchair Occupants in Road Transport Vehicles Donald Macdonald Head of Engineering and Research Mobility & Inclusion.
Wheelchair Crashworthiness
Motor vehicle safety Child safety
Life Saving Rules Motiva Enterprises.
EEVC WG20 European Enhanced Vehicle-safety Committee 12 th December, 2006 Slide 1 EEVC WG20 and WG12 Rear Impact Test Procedure Development Programme Presented.
46th GRSP Session Status report of Informal Group on CRS Pierre CASTAING Chairman Informal Document No. GRSP (46th session, December 2009,
NEW PHOSTOXIN LABELING
Practical Implications of Electrical Product Safety Regulation in Ontario International Consumer Product Health and Safety Organization Sixth International.
Introduction to Revision of GTR 7
Side-facing wheelchair after a frontal impact test
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Firefighter Emergency Escape Systems New York State Department of Labor Public Employee Safety and Health (PESH)
Safety in existing lifts and effects
Rick Statham HAS Dip, CMIOSH (Joint Managing Director) Safety & Access Ltd SG4:10 Preventing Falls in Scaffolding Revised Industry Guidance.
SCOTTISH BORDERS SAFETY FORUM WORKING SAFELY WITH WORK EQUIPMENT Compiled by Donald A Mackay Mainetti UK Ltd.
The Repairing Standard ELECTRICAL INSTALLATIONS AND APPLIANCES.
Safety Management Systems Session Four Safety Promotion APTA Webinar June 9, 2016.
National Research Institute for Labour Protection 1 Personal protective equipment for the prevention of occupational accidents and diseases specific to.
Wheelchair Seated Passenger Transport The State of the Art Part 2 PMG NTE 2009.
Menauitpuitptransport#MENAUITPmenauitpuitptransport#MENAUITP CHALLENGES OF STUDENTS WITH SPECIAL NEED ALEX ROBINSON 1.
SG4:10 Preventing Falls in Scaffolding Revised Industry Guidance
Safety in Product Design, Manufacture and Use.
Transmitted by the expert from CLEPA Informal document GRSP-57-25
Transportation of Class 7 materials: Compliance & Regulatory issues
Review of GRSP e Proposal for amendments to R44 11/05/17
Maintaining Safety Standards
The Provision and Use of Work Equipment Regulations 1998
45th GRSP Session Status report of Informal Group on CRS
Unclear defined items in Regulation No.129
National Standardized CPS Certification Training April 2007 – R1010
Risk Management Simplified
FACT SHEET Recreational Vehicles (RV’s) and Child Occupants
Introduction of Booster Cushions in R129
Introduction of Booster Cushions in R129
Forklift Workplace Safety Guide – Read Now!
Introduction to Revision of GTR 7
Registration Policy and Practice First Aid Forward
Wheelchairs Updated 9/17/2018
Standardized Child Passenger Safety Training Program Winter 2004
Sleeper coaches Martin Hellung-Larsen
National Standardized Child Passenger Safety Training Program May 2004
lesson 9.5 CONTROLLING FORCE OF IMPACT
Resources Updated 4/15/2019.
National Standardized Child Passenger Safety Training Program May 2004
Real World Side Impacts Involving Rear Pediatric Occupants
Presentation transcript:

Alan Lynch Head of Wheeled Mobility and Seating Centre Blackpool Chairman of International (ISO), European (CEN), British (BSI) Standards Groups for Wheelchairs and Seating 30 JUNE 2003 GSRG (Ad-hoc) Group Informal document No. 9 (85 th GRSG, October 2003 agenda item 3.)

On 1 April 2003 MDA joined with MCA (Medicines Controls Agency) to become the MHRA (Medicines and Healthcare products Regulatory Agency) MHRA is an Executive Agency of the Department of Health

The MHRA (Devices) is the primary source of expertise within the UK Department of Health for matters relating to the safety, quality and performance of all medical devices. Also on behalf of the UK Secretary of State for Health MHRA (Devices) is the UK Competent Authority for the European Medical Devices Directive (CE marking).

Major areas of MHRA (Devices) workload:- Adverse Incident Investigations Advice & Guidance European Affairs Standards Activity Product Evaluation

There are over 1,000,000 wheelchair users in the UK and thousands of vehicle journeys are completed every day with few reported problems. However, a small number of injuries and fatalities have been reported.

MHRA has attempted to raise awareness and understanding for all concerned by producing two guidance documents on the Safe Transportation of Wheelchairs. Guidance on the Safe Transportation of Wheelchairs MDA DB 2001(03) June 2001 Guidance on the Safe Use of Wheelchairs and Vehicle-mounted Passenger Lifts MDA DB 2003(03) March 2003 The documents are available as a download from MHRA website and in paper form from MHRA.

The UK Medical Device Regulations 2002 SI No 618 The Disability Discrimination Act 1995 European Union Directives on Vehicle Construction Manual Handling Regulations International Standards All have implications for wheelchair users, carers, prescribers, transport providers, vehicle and equipment manufacturers/suppliers.

In general the safety of wheelchair users in vehicles should compare with other vehicle users. When a wheelchair user is travelling in a vehicle where other seated passengers have an occupant restraint and/or headrest then an occupant restraint and/or headrest should be provided for the wheelchair user.

As part of their CE marking process manufacturers of wheelchairs must: 1. Undertake a risk analysis. 2. Ensure that the device meets all the requirements of the relevant directives. 3. Make a declaration of conformity.

RISKS/HAZARDS EXAMPLES (Wheelchairs) Start with a description of the intended user Then identify ALL intended usage Risks/hazards both from and to :- User, environment, construction materials, transport, maintenance/repairs, electrical safety, fire retardency, biocompatibility, hygiene, any other potential hazards

MINIMISE OR REMOVE RISKS Consider:- Specification/design of equipment Instructions/Warnings Labelling Training

In some cases standards can be used by manufacturers to show how they have reduced risks and met some of the essential requirements of the Medical Device Regulations.

For transportation elements of their risk management, many wheelchair and seating manufacturers look towards the available issued (or draft) standards. Standards (or draft standards) are available for the dynamic impact testing of, - wheelchairs - wheelchair tie down and occupant restraint systems (WTORS) - seating units

ISO 7176 Part 19 (issued) - Wheeled Mobility Devices for Use in Motor Vehicles ISO Parts 1 to 5 Wheelchair Tie-down and Occupant Restraint Systems (WTORS) (issued)Part 1General Requirements (issued)Part 2Four Point Strap Type Tie-downs (draft)Part 3Docking Tie-down Systems (draft)Part 4Clamping Tie-down Systems (draft)Part 5 WTORS for Specific Wheelchairs ISO Part 4 (draft) Wheelchair Seating for Use in Motor Vehicles

ALL THESE STANDARDS INCLUDE A forward facing impact simulation at 20g. A lap and diagonal belt restraint for the wheelchair occupant with an above shoulder ‘B’ pillar mounting or guide. A tie-down system for the wheelchair. Pass/fail criteria and design/labelling for the equipment itself. NOTE: Only ISO Part 5 specifically includes children at this time.

The standards concentrate on equipment pass/fail, dummy movement and the possibility of contact with the vehicle structure or other vehicle passengers. They do not at present include any form of injury level measurement for a wheelchair user. The wheelchair could pass whilst the dummy occupant had been subject to high impact loading as confirmed by some of the TRL and other test results in this subject.

Occupant restraints provided by the WTORS manufacturer shall: have both pelvic and upper torso belts designed to apply forces to the occupant’s skeletal regions function independently of the wheelchair, such that the restraint belts anchor to either the vehicle or wheelchair tiedown components so that occupant- restraint loads are not transmitted through the wheelchair have belt restraints that can be adjusted in length without the use of tools

Range of required angles for pelvic belts and locations of pelvic belt anchor points

If occupant restraints include structural components for the attachment of upper anchorages or guides for upper torso belts, locations for the upper anchor points shall be provided that are: adjustable in height so they can be positioned at or above the shoulder level of the intended user(s), or that are located at least 1 100mm above the wheelchair ground plane

Clear zones for wheelchair seated occupants

Example of warning label illustrating improper positioning of occupant restraint belts

Illustration of proper belt fit

The vast majority of wheelchairs and WTORS now being sold in the UK have been tested against these standards. Older wheelchairs have not been tested, but reports received so far do not reveal any major problem trends in the field when used with appropriate WTORS.

Lack of a “Test Certificate” for a wheelchair based on one of these standards does not mean it is totally unsafe in all situations. Conversely A Test Certificate does not mean it is totally safe for the wheelchair user in all situations.

The wheelchair manufacturer should give information on: suitability for use in vehicles transport any limitations if suitable should give information on how to transport it safely Also the WTORS manufacturer should give information on: compatibility how to use safely any limitations in use

FUTURE - The standards are still evolving. - The inclusion of children into these standards will start soon (only Part 5 includes children at the moment). - Rear facing in a frontal impact and forward facing in a rear impact are also under consideration. (Incorporating information obtained so far from provisional ISO Working Group tests plus the TRL research work.) - Rear facing will probably be covered by a WTORS standard.

Adverse incidents concerning wheelchair users should be reported to MHRA. Incidents can be reported on-line or by completing paper copies of adverse incident forms obtained from our web page at: All adverse incident reports are registered on the MHRA (Devices) database for investigation or trending.

Instructions for downloading safety warnings or guidance from go to Devices go to publications/safety warnings choose Device Bulletins to download further copies of the Device Bulletins choose Safety Notices to download earlier Safety Warnings choose Device Alerts for Safety Warnings after December 2002)

Old MDA Web page New MHRA Web page Wheeled Mobility and Seating Centre Tel no: Fax No: