Lawford Kidd's Blog

European Health and Consumer Policy Commissioner John Dalli has called on Member States for immediate action to be taken at national level to ensure full and stringent implementation of the current legislation on medical devices.

Following the discovery of the use of non medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company in France, the priority now is for the Member States and the Commission to act together to tighten controls, provide a better guarantee of the safety of medical devices and to restore patient confidence in the law that protects them.

Commissioner Dalli has written to Member States asking for their co-operation within the existing legal framework to tighten controls, in order to provide a better guarantee of the safety of medical technology, especially high risk devices. The actions proposed include the following:

• Verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence.
• Ensure that all notified bodies in the context of the conformity assessment make full use of their powers given to them under the current legislation which including the powers to conduct unannounced inspections.
• Reinforce market surveillance by national authorities, in particular spot checks in respect of certain types of devices.
• Improve the functioning of the vigilance system for medical devices for example by giving systematic access for notified bodies to reports of adverse events; encouraging healthcare professionals and empowering patients to report adverse events; enhanced coordination in analysing reported incidents in order to pool expertise and speed up necessary corrective actions.
• Support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers.

Railcare Ltd has been fined £133,000 (reduced from £200,000 on account of their guilty plea) at Glasgow Sheriff Court for a breach of Section 2 of the Health and Safety at Work etc Act 1974, following the death of one of their employees in December 2008. John Smith, a 53-year old employee of the company, died as a result of head injuries sustained whilst working at an axle lathe that had an unguarded chuck.

The company pled guilty to:

• failing to carry out a suitable and sufficient risk assessment of the risks to employees when cleaning axles on a lathe;
• failing to implement a safe system of work in that the chuck of the lathe was unguarded when employees were working close to it; and
• failing to provide adequate information, instruction, training and supervision on the use of the lathe.

Following the case, Elaine Taylor, Head of the COPFS Health and Safety Division, said:

“This case yet again demonstrates the crucial importance of employers carrying out suitable and sufficient assessment of risks to their employees in the course of their daily work, taking the steps necessary to identify such risks, and thereafter ensuring that safe systems of work are in place and dangerous machinery parts are properly guarded. Railcare failed in each of these respects in relation to the axle lathe.”

"As a result, Mr Smith lost his life in an entirely avoidable incident.”

Provisional figures released by the Department for Transport confirm that 1,690 motorcyclists were killed or seriously injured in July to September 2011.

This means 18 motorcyclists were killed or seriously injured every day between July to September 2011 - an increase of 2% compared to the same period in 2010 when 1,652 were killed or seriously injured.

While all casualties among car users have reduced by 7%, the figures for motorcyclists have remained stagnant. Around 5,630 motorcyclists were injured between July to September 2011, compared to 5,666 in the same period of the previous year (a 0.64% decrease).

The Institute of Advanced Motoring director of policy and research, Neil Greig, said: “The increase in motorcycling casualties is worrying especially while casualties among car drivers continue to fall. The government needs to ensure that education campaigns targeting motorcycling continue and funding is made available for local initiatives. The police and councils must continue to work together to improve high risk routes, encourage post test training and target bad riding behaviour through innovative enforcement techniques.”

The Government has announced an overhaul of victims’ services that will see up to £50 million generated from offenders to help create a speedier, more supportive system for victims of serious crime.

Under the new proposals set out by the Justice Secretary, Kenneth Clarke, criminals will be forced to fund victims' support services and those with unspent convictions could be banned from claiming compensation.

The proposals have now been put out to public consultation, which will run until 22nd April 2012. The proposed reforms include:

• Ending payments for minor injuries such as sprained ankles, cuts and grazes and speeding up payments for serious injuries;
• Greater funding for victims' support services, better targeted at those most in need;
• Stopping criminal injuries compensation payments to people with unspent convictions - totalling at least £75million over the past decade;
• Banning criminal injuries compensation payments to people who have been resident in the UK for less than 6 months (except for UK and EU/EEA nationals);
• A new statutory Victims' Code including the right for victims to make a personal statement and to request a meeting with their offender;
• A simpler route of complaint and redress for victims.

Justice Secretary, Kenneth Clarke, said:

'Victims in this country must be able to rely on a justice system which punishes offenders properly and ensures that victims who suffer serious consequences are properly helped and supported.

'Cash compensation should be better focused on blameless victims of the most serious crimes and more support for victims should be funded by offenders rather than taxpayers.”

Lanarkshire Health Board has been fined £24,000 at Hamilton Sheriff Court for a breach of Section 3 of the Health and Safety at Work etc Act 1974, which led to the serious illness of a hospital patient.

Over the course of November 2008, the 64-year old female patient at Hartwoodhill Hospital became gravely unwell.

She was admitted to Wishaw General Hospital, where it was discovered that she was suffering from pneumonia and severe sepsis and was diagnosed as having Legionnaires’ Disease. She was treated with intravenous antibiotics, but required to undergo a tracheotomy on 1st December 2008. She returned to Hartwoodhill Hospital on 23rd December.

An investigation by the Health and Safety Executive (HSE) identified that legionella bacteria was present in three sources in the water system at the hospital. Two of those sources, including the shower used by the patient on a daily basis, matched the strain of legionella bacteria that had caused her illness.

The HSE investigation also established that a suitable and sufficient assessment of the risks from the potential presence of legionella bacteria to persons using the facilities had not been carried out, nor was there a safe scheme in place to manage and control the risks of exposure to that form of bacteria in the water system at Hartwoodhill Hospital.

Following the case, Elaine Taylor, Head of the COPFS Health and Safety Division, said: “Legionnaires’ disease is a very dangerous illness and those who fail to manage their systems adequately and expose persons to risk of contracting it, whether private companies or bodies such as Health Boards, can expect to be prosecuted.”