MHRA Updates

Medical Device Alert - Nimbo Paediatric Walkers (MDA/2011/103)

A Medical Device Alert has been added to this page concerning the usability of Nimbo paediatric walkers manufactured by Drive Medical Ltd. This was issued on 4th November 2011. For further information, see the MHRA website.

Medical Device Alert - Rollators Model Number WA007 (MDA/2011/105)

A Medical Device Alert has been added to this page concerning the usability of Rollators, model number WA007 manufactured by Drive Medical. This MDA was published on 4th November 2011. For further information, see the MHRA website.

AHP Representation on MHRA Committee for the Safety of Devices

Allied Health Professionals representation on Medicines and Healthcare products  Regulatory Agency(MHRA) Committee for the Safety of Devices

Ros Ham currently represents Allied Health Professionals of the Medicines and Healthcare Products Regulatory Agency (MHRA). The Health Professions Council currently regulates 14 health professions (i.e. Art therapists, Biomedical scientists, Chiropodists/Podiatrists, Clinical scientists, Dieticians, Occupational Therapists, Operating Dept practitioners, Orthoptists, Paramedics, Physiotherapists, Practitioner psychologists, Prosthetists & Orthotists, Radiographers, Speech and Language therapists). The HPC is a regulator and was set up to protect the public. The Council keeps a register of health professionals who meet HPC standards for their training, professional skills, behaviour and health (www.hpc-uk.org).

From July 2009 and for the first time, AHP’s have been represented on the Committee for the Safety of Devices of the MHRA. Links have now been made with each professional body to ensure that opinions and comments from the most appropriate groups are obtained in a timely fashion from professional experts in the field. This also ensures that any information from MHRA is sent out to the group speedily and healthcare professionals are kept informed of information that is essential to their clinical practice and their patients.

The following information may be of interest to all professionals and PMG members:

1. The MHRA website - www.mhra.gov.uk has many aspects which may of interest to the membership. This includes online services which include the DEVICES and ‘Devices in Practice’ section and an educational package (15 mins). This is available in hard copy from This e-mail address is being protected from spambots. You need JavaScript enabled to view it and as a PDF. This may be of interest as an AHP CPD activity for personal portfolios.
2. There is also a publication entitled ‘Devices in practice – Guidelines for Health and Social Care professionals’ and many other leaflets and booklets and safety warnings under the Publications section which again may be of interest as an AHP CPD activity for personal portfolios. MHRA will send out any leaflets that you may require for staff, in-service meetings or waiting areas. There is a Conference and Learning section on the website.
3. On line reporting of near misses and defects with any medical equipment is available for professionals and patient/public now on line.
4. The Safety information section covers not only warnings, alerts and recalls, field safety notices, drug alerts, safety warnings, general information and a search facility but also Information to health care professionals in specialities which include currently the following: Home Care staff, Radiology, Theatre practitioners, Pathology, Pharmacy, Opthalmology, Orthopaedics, Critical care, Anaesthetics and Cardiology. There is also a therapist targeted speciality site – which will be of particular interest to all PMG members.
5. There is often confusion with reporting following incidents in the workplace. Staff in the NHS often report only internally to their risk department teams but any incidents involving medical devices, should also be reported to the MHRA. To date AHP reporting is very, very poor (less than 50/annum). This is the route to report, NOT just directly to manufacturers or suppliers.
6. MHRA are also keen to establish links with AHP educational establishments.
7. You can recieve online alerts are possible directly to your email inbox. Please find the link below which points to the MHRA email alerting service sign up page which will be useful to members: https://subscriptions.mhra.gov.uk/service/multi_subscribe.html?code=UKMHRA&origin=http://www.mhra.gov.uk/index.htm.

Drug Safety Update: September 2011 (Volume 5, Issue 2)

Drug Safety Update is essential reading for all healthcare professionals, bringing you the very latest information and advice to support the safer use of medicines.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htm

Medical Device Alert: All slings manufactured by Nottingham Rehab Supplies (NRS) and/or Moving Solutions (MDA/2011/094)

This Medical Device Alert has been issued because the manufacturer issued a Field Safety Notice (FSN) but has not had sufficient confirmation from users that they have received and acted on this information. The issue concerns the user instructions.

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON126282

Medical Device Alert: All telescopic bed rails manufactured by Harvest Healthcare Ltd. (MDA/2011/091)

This Medical Device Alert has been issued because the manufacturer issued a Field Safety Notice (FSN) but has not had sufficient confirmation from users that they have received and acted on this information. The issue concerns the instructions for use.

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON126104

Medical Device Alert: Eleganza Standard and Deluxe beds manufactured by Linet prior to December 2005 (MDA/2011/092)

This Medical Device Alert has been issued because the manufacturer issued a Field Safety Notice (FSN) but has not had sufficient confirmation from users that they have received and acted on this information.

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON126110

Medical Device Alert: Sterile 2ml Luer lock hypodermic syringe manufactured by Codan Limited (MDA/2011/089)

This Medical Device Alert has been issued because the manufacturer issued a Field Safety Notice (FSN) but has not had sufficient confirmation from users that they have received and acted on this information. The issue is that some syringes have been found to have cracks in the barrel.

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON125984