News
Jun 2009
Monthly News - Device & Service Regulations |
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When the FDA begins to implement a global unique device identifier (UDI) system, Class III devicemakers will be the guinea pigs as regulators “work out the kinks,” an agency official says. Because Class III contains the least number of devices and implementing UDI for that class would be relatively cheap, the FDA will slowly test the system on these devicemakers.
Source: FDA Device News EBulletin 24 Jun 09
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Devicemakers creating combination products should expect international regulatory agencies to use appropriate elements of more than one model when determining the necessary evidence, evaluation and quality requirements for the products. Guidance documents developed for such products should be flexible to allow for their use in countries with either well-established regulatory systems or less-established systems, Larry Kelly, head of the Office of Blood and Tissues at Australia’s Therapeutic Goods Administration, said.
Source: FDA Device News EBulletin 24 Jun 09
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UK hospitals will have to introduce self-resheathing needles under European Union health and safety legislation on reducing needlestick injuries.
A landmark agreement on the safer use of needles to prevent injury among hospital staff was set to be announced on 9 June at the European Public Services Unions annual congress in Brussels, Belgium.
The agreement has been made between the European Public Services Unions – which represents the majority of health trade unions across the EU including Unison, the RCN and the RCM – and Hospeem which represents hospitals and healthcare employers across Europe, including the NHS Confederation.
It is expected to become EU health and safety legislation before the end of the year. As a result, hospitals across the EU will soon be legally obliged to take action to prevent needlestick injuries to their staff.
This will mean all hospitals in member states will have to carry out risk assessments on needlestick injuries and introduce safer equipment, including needleless IV connectors, self-resheathing needles and blunted surgical needles.
Unison repeated calls for safer needles to be made compulsory in the NHS last February, following the death of Juliet Young, a nurse who contracted HIV from a needlestick injury while working at the Maudsley Mental Health Hospital in London.
According to the RCN’s Needlestick Injury in 2008 survey, nearly one-half of the 4,700 respondents had been stuck by a needle or sharp at some point in their career and 10% had sustained an injury in the past year.
However, 28% of nurses said they had never received advice from their employer about what to do after being injured and only 15% of respondents said they were offered prophylactic treatment after having been stuck or cut.
Another report, publi shed by the Health Protection Agency just after the RCN survey results, suggested doctors and dentists were reporting more needlestick and sharps injuries than nurses for the first time.
The HPA’s report – Eye of the Needle – showed that during 2006 and 2007 doctors and dentists reported 46% of work-related exposures to bloodborne viruses via needlestick and sharps injuries, compared to 44% among nurses.
Overall there were 914 incidents of healthcare workers being put at risk over the two year period. Three healthcare workers were reported as having acquired hepatitis C infection as a result of their injury.
Source:http://www.nursingtimes.net/5002435.article
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The EU’s Restriction of Hazardous Substances (RoHS) directive will impose unnecessary regulatory burdens on devicemakers, according to several groups, including Eucomed and the European Diagnostic Manufacturers Association. Under a new proposal, RoHS, which restricts the use of certain hazardous substances in electrical and electronic equipment, would include medical devices.
Source: FDA Device News EBulletin 23 Jun 09
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The European Commission has issued a much needed interpretative document concerning the implementation of the revised Medical Device Directives which is vital reading for the entire Medtech industry as it prepares to meet impending new EU requirements.
The aim of the document is to provide a guide for the uniform implementation of Directive 2007/47/EC throughout the 27 countries in the European Economic Area on a matter where there is currently great uncertainty.
The document is available on the Commission website at:
http://ec.europa.eu/enterprise/medical_devices/guide-stds-directives/transitionalperiod_2007-47-EC_guidance_final.pdf
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The UK has maintained its leading position as centre for life sciences innovation and delivery says the UKTI Inward Investment Report 08/09 - Life Sciences.
A rush of deals among the world’s largest pharmaceutical companies is set to inject a new wave of opportunity into the life sciences sector. Pfizer’s US$68 billion takeover of Wyeth kicked off the consolidation in January 2009, followed by Roche’s US$45.7 billion bid for Genentech and Merck’s US$41.1 billion move on Schering-Plough.
Alongside this global consolidation in the sector, the UK’s reputation for creativity and delivery held true. The country’s success in life sciences – with UK companies accounting for 45 per cent of new biotechnology drugs in late-stage clinical trials in Europe – is driven by its rich pool of talent and skills. Its world-class scien tific institutions, impressive research base and track record in product development continue to attract and retain healthcare innovators.
The healthcare and medical technology sector also remained buoyant, helped by the UK Government’s continuing commitment to increase investment in the NHS. The NHS acts as a highly effective incubator of life sciences achievement, boosted by its close relationship with UK centres of academic excellence and its focus on the progress of translational medicine.
In the healthcare and medical technology sector, UKTI received an upsurge in inquiries about telehealth, telemedicine, medicines for children, translational medicine and dentistry. In addition, UKTI is progressing enquiries across a broad range of disease areas and treatments including neurosciences, oncology, infectious diseases, vaccines, monoclonal antibodies and tissue engineering.
Regulatory developments
The UK Government agreed a new Pharmaceutical Price Regulation Scheme (PPRS) with the industry in February which will provide a stable and supportive environment for pharmaceutical companies for the next five years.
Importantly, the new agreement introduces a more flexible pricing regime, allowing companies to raise or lower list prices following evidence about a drug’s efficacy, or if a product proves useful for different treatments. Furthermore, the National Institute for Health and Clinical Excellence (NICE) will now assess the drug at this new price for clinical and cost-effectiveness.
The agreement also sets out a more systemic approach to Patient Access Schemes. These schemes can improve the cost-effectiveness of drugs, so giving patients access to medicines that would otherwise be considered too expensive.
In July last year Lord Darzi published “High Quality Care for All”, the final report of his Next Stage Review of the NHS. The report centre s around increased patient choice, partnership between key players and quality care. It sets out an environment within which innovation can flourish, ensuring that effective medicines and medical technologies are adopted, and creating new partnerships between the NHS, universities and industry to develop pioneering new treatments.
The newly formed Office for Life Sciences will be the driving force in healthcare innovation in the coming year. Led by Lord Drayson, Minister for Science and Innovation, the Office comprises officials from the Department for Business, Innovation and Skills, the Department of Health and HM Treasury.
Its focus over the next six months will be to take swift action to improve the operating environment for the pharmaceutical, medical biotech and medical devices sectors. Its work will contribute to Government initiatives to establish a “new industrial activism”, to improve the UK’s business environment for leading industries.
One of the key objectives of the Office will be how best to market and communicate the UK’s strengths in life sciences to the world. UKTI will play a lead role in this work, drawing together business, academia and government to ensure that the UK message is coherent and compelling to overseas purchasers and investors.
To review the report in full: http://www.ukinvest.gov.uk/investmentreport/4046343/en-GB.html
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