Tighter medical device regulation could not have prevented the PIP breast implant scandal, according to a UK regulatory lawyer.

Regulatory processes cannot defeat a deliberate violation of the law, such as the French company PIP’s use of industrial rather than medical grade silicone, Dev Kumar of law firm Bristows commented.

Meanwhile, a Commons Health Select Committee has challenged the NHS decision to provide only PIP implant removals but not replacements, on the grounds that it forces patients to undergo an avoidable follow-up operation.

The PIP implant scandal has rocked the European medical device industry and led to calls for tighter regulatory controls and better surveillance.

This coincides with changes to the European regulatory framework for medical devices arising from other scandals, including the high failure rate of metal-on-metal hip implants.

“The House of Commons’ Health Select Committee’s report on the PIP breast implants has once again brought the medical device regulatory system to the forefront of everyone’s attention,” said Dev Kumar.

“The report, which also mentions the safety concerns of metal-on-metal hip implants, suggests that the CE mark requirements and regulatory framework are strengthened.

“The timing of the PIP case and Select Committee report are all the more relevant as they have surfaced at a time when the European Commission is drawing up proposals to revise the regulatory system for medical devices. Currently, these include plans to improve and strengthen the regulatory framework through the introduction of measures for more pre-market testing and post-marketing surveillance.

“However, the PIP case concerns a company that intentionally chose to use an industrial, as opposed to a medical grade, silicone filler. No regulatory system, however robust, can guarantee against a further incident of this nature occurring if there is deliberate intent to circumvent the law.”

The question of how the NHS should assist patients who received PIP implants from private clinics remains contentious. Current NHS policy is that such patients can have the implants removed, but not replaced, on the NHS if the clinic will not help.

However, a Commons Health Select Committee argued that to save patients from being operated on twice, the NHS should remove and replace the implants but impose a charge of about £1,500 for the latter procedure.

The DH responded by saying that requiring patients to pay for an NHS treatment would set a dangerous precedent.

The new UK life science strategy and NHS innovation review, launched by the Government this month, has been praised by the UK medical technologies sector for its promotion of innovative research and the rapid uptake of high-value technologies.

The NHS Chief Executive’s review Innovation, Health and Wealth: accelerating adoption and diffusion in the NHS outlines a number of measures the NHS will take to work in partnership with industry in order to implement effective new medical technologies throughout the NHS.

The document draws in attention, in particular, to the potential of telehealth systems to improve the management of long-term conditions, reducing hospital admissions and GP visits and so reducing the overall cost of care while improving patient outcomes, as demonstrated by the recent Whole Systems Demonstrator project.

Other areas of medical technology highlighted by the innovation document include the use of fluid monitoring in acute care and the use of assistive technologies, including wheelchairs, to improve the access of disabled people to working and other everyday environments.

Peter Ellingworth, Chief Executive of the Association of British Healthcare Industries (ABHI), the leading UK medtech trade association, said: “I welcome the Government’s focus on the life science industry. As highlighted by the Prime Minister our sector is part of ‘the virtuous circle of health, wealth and well-being’ – a real growth area for the Government as well as having the potential to make a difference to patients through the innovation we bring.

“Measures such as reform to the tariff system, enforcement of NICE guidance and the development of a procurement strategy, if done properly, could make a real difference to the medical technology sector.

“ABHI will work with the Government to make sure that the measures outlined in the Innovation Review are translated into firm actions. The measures could make a real difference to the SMEs in our sector and it is crucial that we are able to take advantage of them and continue to grow.”

Doris-Ann Williams MBE, Chief Executive of the British in Vitro Diagnostics Association (BIVDA) and a member of the Innovation Review’s External Advisory Group, commented that the Government’s announcements “represent a crucial opportunity for the life sciences sector” – and that the life science strategy and the innovation review in combination “will reinforce a genuine partnership between industry, the NHS and government.”

“To accelerate the use of innovative technologies to benefit patients and the NHS, tangible and realistic proposals were needed,” she added. “The NICE Implementation Collaborative, an innovation scorecard and a commitment to examine reimbursement mechanisms for diagnostics will all help the IVD industry to do what it needs to do to turn the vision into reality.”

Tony Davis, Chair of health technology business support organisation Medilink UK, noted that the new life science strategy “sets the stage for telehealth and telecare technologies to be made available to every person with a long-term condition or in need of care in the UK, helping them manage their health while maintaining their independence.”

“Medilink UK has been working with industry, other trade associations and the Department of Health to accelerate the roll-out of telehealth and telecare services in the NHS and social care, which will enhance the lives of three million people over the next five years,” he concluded.

Industry association Eucomed has proposed a new unified regulatory framework for medical devices across Europe.

The association’s position paper outlines six steps that will ensure patients have rapid access to innovative medical technologies that are value-based and safe.

Consistency, transparency and an integrated approach are the key themes identified by Eucomed as being in the shared interest of industry, healthcare providers and patients.

Eucomed’s position paper ‘A new EU regulatory framework for medical devices’ calls for enhanced member state engagement together with unified and science-based co-ordination of the regulatory system.

While prioritising delivery of high-quality healthcare, patient safety and rapid access to value-based medical technologies, the proposals also aim to encourage R&D and reduce the administrative burden on SMEs.

The association calls for a legal framework to provide a unified regulatory approach to the evaluation and certification of medical devices, with consistent and comprehensive implementation across all EU member states.

Existing bodies such as the European Commission, Competent Authorities and Notified Bodies can be used efficiently to provide a ‘smarter’ legal framework for medical devices, Eucomed says.

The six steps outlined are:

1. Only the best Notified Bodies – better control and monitoring of NBs are needed, including mandatory requirements for designation.

2. A single approach to vigilance and market surveillance – with a centralised reporting and surveillance system based on an EU portal.

3. Stronger harmonised standards – with greater engagement of international experts and earlier involvement of member states.

4. Consistent implementation of guidelines – to make medical device guidance more efficient and consistent across the EU, the current procedure must be revised (e.g. by commitment of member states to uniform implementation) and the European Commission’s current Medical Devices Expert Group (MDEG), which develops guidance, must be upgraded to a formal Advisory Committee.

5. Improved transparency – for better access to information for patients, consumers, healthcare professionals and manufacturers as well as regulatory and legislative bodies, it is critically important to establish a single EU database with information relating to such areas as market surveillance, vigilance and what products are available.

6. An integrated approach – better co-ordination and management, which could be supported by the Commission’s DG SANCO and Joint Research Centre (JRC). The JRC could play a crucial role in such areas as auditing Notified Bodies, co-ordinating vigilance, providing foresight intelligence on health issues, and giving scientific and policy advice to legislators.

John Brennan, Eucomed’s Director of Regulatory and Technical Affairs, commented: “By improving the regulatory framework for medical devices through the six solutions outlined in our position paper, we believe Europe will become stronger in many areas. We suggest many improvements that aid better management of the system by authorities and the Commission.

“In achieving this we think that the JRC is the natural partner for DG SANCO, member states and industry to shape and drive a smart EU medical technology legislative framework, as it is independent and experienced in the broad range of technologies that reflect the medical device industry.”

A cardiac pacing system designed for safe use during magnetic resonance imaging (MRI) scans has been implanted in UK patients for the first time.

The Accent MRI pacemaker and Tendril MRI lead from St Jude Medical were implanted at London’s Heart Hospital by Dr Edward Rowland.

The new pacemaker and lead (pictured), which received CE Mark approval in April 2011, enable the patient to undergo full-body, high-resolution MRI scans.

Approximately 46,000 UK patients receive pacemakers each year, and up to 75% of those are likely to benefit from MRI scans at some time in order to check for diseases that cannot be as effectively diagnosed with other imaging modalities.

The Accent MRI pacemaker system features an MRI Activator device that allows the pacemaker to be programmed to the appropriate MRI mode for use during the scan by a single button press, using parameters pre-set by the patient’s doctor.

Dr Rowland commented: “Undertaking MRI scans in patients with pacemakers has previously been impossible or fraught with technical difficulties. I feel I can now advise patients that a magnetic scan can be performed without compromising the safety of the pacemaker.”

"The Accent MRI conditional pacemaker has many advantages over what is currently available,” said Paul Turner, St. Jude Medical’s VP for the UK, Ireland and Canada. “It is a state-of-the-art pacemaker that offers full body scanning capability without restrictions, which is especially important to patients who may need an MRI scan in the chest and abdominal area.”

Based in Minnesota, USA, St. Jude Medical develops medical devices to treat cardiac and neurological disorders and chronic pain.

Michael Huggins, former North America President of bone implant specialist Synthes, has received a nine-month sentence for his role in an unauthorised clinical trial of bone cement that caused three human deaths.

Three other former Synthes executives, convicted of involvement in the same criminal activity, are awaiting sentence.

The US Justice Department had prosecuted the four executives in a drive to hold individuals to account for corporate crimes.

The executives had senior roles in Synthes’ Norian unit, which manufactured osteobiological implants. Norian was purchased by US company Kensey Nash earlier this year for $22 million.

Between 2002 and 2004, the Justice Department said, Norian carried out unauthorised clinical trials of Synthes’ Norian XR bone cement in surgeries to treat vertebral compression fractures (VCF), despite a warning against such use on the product label.

Initial studies had shown that the bone cement reacted chemically with human blood in vitro, producing clots – and that when used in a pig, the cement caused blood clots in the lungs.

Synthes continued to test the product on humans until it had caused three deaths, and even then the company misled the FDA, the Justice Department said.

In April 2011, Johnson & Johnson purchased Synthes for approximately $21.3 billion to merge it with its own troubled DePuy orthopaedic device business.

Intensive control of type 1 diabetes to maintain near-normal blood glucose levels halves the long-term risk of kidney disease, according to a US trial funded by the National Institutes of Health (NIH).

The landmark Diabetes Control and Complications Trial (DCCT) followed patients for more than 20 years following a 10-year trial period.

The results provide definitive evidence of the long-term benefits of intensive monitoring and medication adjustment soon after diagnosis to optimise the value of insulin therapy.

This finding adds significantly to the body of evidence supporting an intensive control strategy, despite the financial and logistical challenges it presents, and endorsing the use of new technologies for monitoring and insulin injection that help to address those challenges.

The DCCT was conducted from 1983 to 1993 in 1,441 people with type 1 diabetes, an average of six years after diagnosis. Half of them used conventional blood glucose control (based on daily testing) in the trial and half used a more intensive approach.

After an average of 22 years follow-up, 24 in the intensive group developed significantly reduced kidney function compared to 46 in the conventional group. Intensive control also reduced eye and nerve damage.

Griffin P. Rodgers, Director of the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, which oversaw the DCCT, commented that it showed “the value of long-term studies”.

“The full benefit of treatment may not be seen for decades, especially for complications of diabetes, such as kidney disease, which can progress slowly but have devastating consequences,” he said.

Diabetes is a leading cause of kidney failure – in the US, it accounts for 38% of patients on dialysis or living with a kidney transplant.

The British Standards Institution (BSI) is strengthening its presence in the German medical devices market by rebranding EUROCAT, the German medical devices Notified Body and Test House owned by the BSI Group, as BSI Healthcare Germany.

The rebranding of EUROCAT is expected to attract new business by offering a global market access capability to companies in the German, Austrian and Swiss medical devices markets.

BSI’s increasing investment in Germany shows the country’s growing importance within the European medtech market.

The new organisation will retain German Notified Body status and continue to use the EUROCAT approval number CE 0535.

Since its acquisition by BSI in 2009, EUROCAT has gained the capacity to approve high-risk in vitro diagnostics, raising its profile in the medtech market.

EUROCAT founder Werner Kexel said: “Without doubt the German medical devices market will benefit from the values associated with the BSI brand. BSI holds a significant market position across the globe based on world expertise, capability and quality of service.

“This, coupled with the ongoing investment which has been evident since the acquisition, will allow Germany to offer a testing services business with a truly global footprint, which we hope will attract new business from larger industry players.”

“In a difficult economic climate medical device manufacturers are under increasing pressure to become more efficient and increase the speed of their products to market,” commented Gary Slack, Director of BSI Healthcare.

“In response BSI is striving to help manufacturers gain market confidence by enhancing its capability and presence in the German market and by improving links with government competent authorities in Germany.

“Bringing EUROCAT under the BSI brand is evidence of BSI’s continued commitment to recognising Germany as a critical market for medical device certification,” he concluded.

A new point-of-care ultrasound system could help to guide clinicians during acute care procedures such as regional anaesthesia, pain medication delivery and examination of critically ill patients.

The Sparq system (pictured) from Philips Healthcare, launched at this year’s MEDICA congress, is a mobile device designed to provide immediate, user-friendly ultrasound imaging in the operating room or at the patient bedside.

Key features of Sparq include:

• It is the first ultrasound system with a touchscreen for control, which assists infection control as well as providing a simple interface.

• It can be set to Simplicity Mode, a one-touch solution that presents only the functions needed most often.

• Its AutoSCAN feature adjusts the image while scanning, reducing the need for manual adjustment.

• Its Needle Visualisation feature provides rapid and accurate needle guidance.

Sparq offers a wide range of specific clinical applications for emergency medicine, critical care, regional anaesthesia and pain medication for specific regions of the body.

Further service capabilities can be added to the system, such as online clinical or technical support and proactive patient monitoring.

“The simplicity of its design and the intuitiveness of its user interface make Sparq a pleasure to use,” said Barry Nichols, Consultant in Anaesthesia and Pain Management at Musgrove Park Hospital, Taunton.

“Sparq’s ergonomically efficient controls and high-resolution screen really benefit our clinicians’ day-to-day workflows. A compact and highly mobile device, it is also perfect to use in the operating theatre environment.”

Conrad Smits, Philips Healthcare’s General Manager, Ultrasound, commented: “A great deal of effort went into Sparq’s features and design to meet the specific needs of our point-of-care customers. Our goal is for Sparq to simplify the use of ultrasound for clinicians.”

Based in the Netherlands, Philips Healthcare is a market-leading supplier of solutions for cardiac care, acute care and home healthcare.

Telehealth Solutions has launched a new managed telehealth service in the UK that has the potential to transform the treatment of serious long-term conditions.

The new service combines a customised home monitoring system and a specialist nurse triage service for patients with chronic obstructive pulmonary disease (COPD), diabetes or chronic heart failure.

As well as improving patient care through more regular monitoring and timely intervention, managed telehealth is expected to reduce hospital admissions and administrative workload for clinicians.

COPD affects 900,000 COPD people in the UK, with hospital admissions for these patients costing the NHS an estimated £35 million per year.

The ‘end-to-end’ managed telehealth service directly involves patients in their own treatment, while enabling clinicians to personalise the collection of data for each patient, detecting warning signs and making early interventions.

The Telehealth Solutions home monitoring system incorporates a range of vital sign collection devices: weight scales, peak flow meter, thermometer, pulse oximeter, blood pressure meter, ECG, blood glucose meter and INR tester.

John Dyson, Chief Executive of Telehealth Solutions, said: “The Telehealth Solutions ‘end-to-end’ service is a tailored, comprehensive patient care model, ensuring full collaboration and dialogue between patient and healthcare professional from the outset.

“It is a significant step forward for patients with these long-term conditions as they can now take more control over their treatment plan and actively participate in consultations.”

The DH will shortly publish the outcome of the NHS Whole Systems Demonstrator programme, which has trialled telehealth systems with 6,000 patients over three sites in England.

Based in Watford, Telehealth Solutions has achieved success with its GP practice-based Surgery Pod for monitoring patients with long-term conditions.

Philips Healthcare UK has donated two Intellivue MP5 monitors and associated kit to the surgical charity Medical Missions for Children (MMFC).

The monitors will be used in 15–20 missions per year around the world, assisting the surgical repair of children with burn images, cleft lips and palates, malformed ears and head or neck tumours.

The equipment package made its first mission to Quito, Ecuador, where over 75 operations were completed.

Together with the monitors, Philips supplied various add-ons including Mainstream and Sidestream technology.

“Our volunteer surgical teams travel to regions with some of the least developed healthcare systems in the world and we have to be able to rely on the equipment we carry with us, said Liz Desmarais, Executive Director of MMFC.

“The MP5 monitors are lightweight, robust and simple to set up – exactly what we need on the road. These monitors will be our constant companion over the next few years.”

The monitors will next be taken to China and then the Philippines, and will support thousands of patients over the next few years.

Cathal Boyle (far left in photo), Philips’ clinical applications specialist in patient monitoring, assisted with the use of the monitors in Quito. His skills as a trauma nurse enabled the MMFC surgical team (pictured) to run an additional operating table.

Dr John Pook, a UK consultant anaesthetist and volunteer anaesthetist with Medical Missions for Children, contacted Philips to request assistance. He commented:

“I'd like to thank Philips sincerely for their generosity, and for sending Cathal Boyle to join our Quito team,” Dr Pook commented. “He was exceptional – not just in commissioning and teaching us how to use the monitors, but in using his enormous clinical experience became an essential member of the operating team.”