Physiotherapy and occupational therapy

The site will be regularly updated with content of most relevance to you, so please book mark the site and return often, or sign up for email alerts to let you know when new content has been added.

Many medical devices used during therapy come under the general term 'Assistive Technology' (AT). The MHRA has a specific unit which investigates all AT related incidents and which also provides advice and guidance on safety/quality issues. If you require advice and cannot find any relevant guidance on this web page please email bav@mhra.gsi.gov.uk

Latest news:
Medical Device Alert: Various models of Anaesthetic CareStations manufactured by GE Healthcare (MDA/2010/058) - added 9 August 2010 
Medical Device Alert: Alvema ITO pushchair for disabled children manufactured by Eurovema AB and supplied in the UK by Rainbow Mobility Ltd (MDA/2010/057) - added 3 August 2010

Medical Device Alerts 
Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care.

Each MDA is designated either for Immediate action or Action. MDAs may also be used to provide updated information. Below are an example of some MDA's we have published that are of particular relevance to physiotherapists and occupational therapists . MDAs are removed from the list after between three and six months. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website

Medical Device Alert: Various models of Anaesthetic CareStations manufactured by GE Healthcare (MDA/2010/058) - added 9 August 2010 
Medical Device Alert: Alvema ITO pushchair for disabled children manufactured by Eurovema AB and supplied in the UK by Rainbow Mobility Ltd (MDA/2010/057) - added 3 August 2010
Medical Device Alert: Appollo bath hoists manufactured by Reva Industries Ltd (MDA/2010/051) - added 2 July 2010
Medical Device Alert: Liftmaster 160 and 190 electrical hoist manufactured by Patterson Medical Ltd (MDA/2010/049) - added 2 July 2010
Medical Device Alert: Hoists and standing aids manufactured by BHM Medical Inc (MDA/2010/022)
Medical Device Alert: All types of Oxford slings and standing harnesses, for use with hoists and stand aids, manufactured by Joerns Healthcare Ltd (MDA/2010/019)
Medical Device Alert: All metal-on-metal (MoM) hip replacements (MDA/2010/033)
Medical Device Alert: Mobile hoists - Arjo Minstrel standard type and EPC type manufactured by Medibo Medical NV (MDA/2010/029)
Medical Device Alert: Endotracheal (ET) tubes, adult and paediatric sizes manufactured by Unomedical (MDA/2010/027)
Medical Device Alert: Hoists and standing aids manufactured by BHM Medical Inc (MDA/2010/022)
Medical Device Alert: All types of Oxford slings and standing harnesses, for use with hoists and stand aids, manufactured by Joerns Healthcare Ltd (MDA/2010/019)
Medical Device Alert: All models of mobile hoists, ceiling hoists and bathing lifts manufactured by Joerns Healthcare Ltd (MDA/2010/018)
Medical Device Alert: Arjo Passive Clip sling and Arjo Passive Clip Flite slings manufactured by Medibo (MDA/2010/013)
Medical Device Alert: Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet) (MDA/2010/011)
Medical Device Alert: C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) (MDA/2010/010)
Medical Device Alert: T-piece connector incorporated into various breathing systems manufactured by Intersurgical Ltd (MDA/2010/009)
Medical Device Alert: Action 3 and Action 4 manual wheelchairs manufactured by Invacare (MDA/2010/004)
Medical Device Alert: Medical devices in general and non-medical products (MDA/2010/001)

Reporting of adverse incidents or adverse drug reactions
Any actual, suspected, potential or avoided adverse event should be reported. Further examples of cases which should be reported are available in the sections below. If in doubt, please report. You can help us by reporting adverse incidents. These reports enable us to identify medical devices and medicines that are of concern and allow us to take appropriate action.

The UK's Yellow Card Scheme collects information from healthcare professionals and patients on suspected adverse drug reactions. This vital information helps us safeguard public health. Please report if you know or suspect that use of a medical device has resulted, or could have resulted, in an adverse incident for a patient or user.

What should I report if I suspect a medicine is associated with an adverse reaction?
Please complete a Yellow Card to report suspected adverse reactions to prescription medicines, over-the-counter medicines, or herbal remedies. For further information, please see http://www.yellowcard.gov.uk/ (external link).

We are particularly interested in receiving Yellow Cards that report serious adverse reactions to established medicines, or that report any reaction to a medicine that is new to the market and carries a black triangle. So that we can assess the Yellow Card, please ensure that you report the suspect drug(s), suspect reaction(s), and basic patient details if known (age, sex, weight, patient's initials, and local identification number for your reference).

What is a medical device and what I should report?
Please see our section on reporting safety problems.

Guidance and publications
The following guidance documents/posters all relate to areas of practice that physiotherapists and occupational therapists may be involved in and so may be of help:

8 February 2010 | Reporting Adverse Incidents and Disseminating Medical Device Alerts - DB 2010(01)
4 December 2006 | DB 2006(06) Safe Use of Bed Rails
6 November 2006 | DB 2006(05) Managing Medical Devices
16 October 2006 | DB 2006(04) Single-use Medical Devices: Implications and Consequences of Reuse
30 January 2006 | Directives Bulletin 18 - The Medical Devices Regulations: Implications on Healthcare and other Related Establishments (63Kb)
31 October 2005 | DB 2005(03) Guidance on the Safe and Effective Use of Batteries and Chargers for Medical Devices
5 May 2004 | DB 2004(02) Guidance on the Stability of Wheelchairs
1 March 2003 | DB 2003(03) Guidance on the Safe Use of Wheelchairs and Vehicle-mounted Passenger Lifts
1 June 2001 | DB 2001(03) Guidance on the Safe Transportation of Wheelchairs

Guidance notes
Guidance Note No 16 | Guidance Notes for Manufacturers of Prosthetic and Orthotic Appliances
Guidance Note No 9 | Guidance Notes for Manufacturers of Custom made Devices
Guidance Note 8 | Guidance Notes for the Registration of Persons Responsible for Placing Devices on the Market (64Kb)

Booklets
Medicines & Medical Devices Regulations: What you need to know (46Kb)
5 August 2008 | Devices in Practice - a guide for health and social care professionals

One Liners
One Liners is a short news sheet aimed at all healthcare professionals and care staff, which highlights problems with the use of medical devices. It is often a light hearted review of user issues that have been brought to our attention and are generally reports of continuing user’s misuse of simple medical equipment.

We know that all medical devices can fail but an increasing number of incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of the One Liner is to detail briefly some of these problems in an attempt to make users more aware of what can go wrong - it is all too easy to take equipment for granted.

Many of the One Liner series are generic but we have produced a number of editions that focus on a specific device or a theme, or are of interest to primary care trusts or the care homes sector.

One Liners

One Liners issue 75 | March 2010: Beds
One Liners issue 59 | June 2008: Walking aids
One Liners issue 47 | February 2007: Assistive technology
One Liners issue 52 | October 2007: Hoists and slings

Posters and leaflets
Poster on mattress decontamination
Symbols used on medical devices
Devices Orthopaedic poster 2009
Oxygen cylinders and their regulators - top tips leaflet
Poster on electrical cables 'Shocking Trips'
Reporting faulty medical equipment - poster
Safe use of bed rails - poster
Single-use medical devices - leaflet
Tips on domiciliary ventilators
Reporting adverse incidents for assistive technology (688Kb)
Checklist for patients discharged from hospital with a medical device (174Kb)

Interactive education modules
Every year many patients and staff are injured needlessly by medical devices that are either badly maintained or used incorrectly. These injuries are often due to user error or poor systems of work, not the device function or design. In these education packages we have tried to give a generic overview of some of the devices that have been reported to us as problematic.

To this end we have produced a series of certificated educational packages that are simple to use, informative and should take no more than thirty minutes to work through. All our educational packages have been developed by MHRA staff, some in conjunction with and endorsement by royal colleges and other professional bodies.

The packages are aimed at different levels of healthcare staff and can be either simply reviewed or undertaken with the aim of achieving a certificate at the completion of the training. They provide some valuable dos and don’ts when using and operating medical devices.

Devices in practice
Anaesthetic machines
Electrosurgery
The operating table

Your input counts
We would be grateful for your comments on the content and usefulness of this page. Please send your feedback to webusability@mhra.gsi.gov.uk