A Medical Device Daily

The UK government is undertaking a review into patient safety in a move intended to help protect patients from poor medical practice and misconduct.

The review, which is part of the Department of Health's response to the Shipman Inquiry into patient safety, is being led by England's chief medical officer, Sir Liam Donaldson.

Donaldson is charged with making his report on the Department of Health's patient protection measures later this year in order to minimize any delay in the introduction of measures to improve patient safety and ensure that physicians are fit to practice.

The review will identify measures to:

  • Strengthen procedures for assuring the safety of patients in situations where a doctor's performance or conduct poses a risk to patient safety or the effective functioning of services.
  • Ensure the operation of an effective system of revalidation.
  • Modify the role, structure and functions of the General Medical Council (GMC).

Health Secretary John Reid said the review will draw on the findings of the Shipman Inquiry and other relevant inquiries into instances of poor clinical performance.

“We will not settle for a quick and weak response to [the Shipman] inquiry“ led by Janet Smith, said Reid. “We take what [she] has said very seriously.“

Reid added: “It is clear that a review into patient protection is needed, immediately followed by strong patient protection measures informed by the review's findings. We want to put an end to the idea that the GMC is a representative body for doctors. It is not. Its primary role must be to protect patients.“

Citing Donaldson's review task, Reid said, “Only by having a robust system for testing doctors' fitness to practice can we increase patient confidence and promote good medical practice.“

An advisory group will support the chief medical officer throughout the review. The group's members include experts from organizations representing consumer, healthcare quality and professional interests.

French office for Joint Commission International

Joint Commission International (JCI) reported the opening of an international branch office in Ferney-Voltaire, France.

JCI is the international affiliate of the Joint Commission on Accreditation of Healthcare Organizations (Oakbrook Terrace, Illinois), the largest accrediting body for healthcare organizations in the U.S.

Paul vanOstenberg, DDS, formerly executive director of international accreditation for JCI, will serve as managing director of the new office. His focus will be on developing relationships with European healthcare organizations and helping European Union national health agencies, hospitals, laboratories, home care agencies and medical transport organizations in their efforts to reduce risk and improve health outcomes, while permitting the flow of patients and healthcare funds across borders.

Joint Commission International said the new office, which is located near Geneva, Switzerland, will permit it to better support the needs of European clients and improve coordination of JCI quality and patient safety initiatives with other international agencies such as the World Health Organization (Geneva) and the International Hospital Federation (Ferney Voltaire, France).

JCI said it already has provided services to 10 countries in Europe and has ongoing projects in more than 60 countries around the world. Its services are aimed at helping international healthcare organizations, public health agencies, health ministries and others evaluate, improve and demonstrate the quality of patient care and enhance patient safety.

“Our commitment to safe, high-quality healthcare has always been worldwide and the new office will help us participate more closely as a trusted partner in further advancing that mission within the European community,“ said Karen Timmons, CEO of Joint Commission International.

European trial of VentrAssist expands

Ventracor (Sydney, Australia) said it has received final approval to begin recruiting patients in the UK as part of the CE Mark trial it already has under way.

The CE Mark trial is aimed at gathering data to support an application for permission to apply the CE mark to the VentrAssist left ventricular assist system (LVAS) so it can be sold in Europe.

Ventracor CEO Colin Sutton, PhD, said a recent notice of formal approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) followed approval from the Papworth Hospital (Cambridge, UK) ethics committee.

“This means medical investigators at Papworth Hospital in Cambridge will now begin the process of trial site initiation and hospital staff training in preparation for recruitment,“ Sutton said.

Cardiac surgical staff from Papworth Hospital were trained in use of the VentrAssist at The Alfred Hospital in Melbourne late last year.

Papworth Hospital recently celebrated the 10th anniversary of its LVAS program. The hospital established the UK's first transplant program and performed the UK's first successful heart transplant in 1979, followed by Europe's first heart-lung transplant in 1984.

Ventracor said it has relocated two experienced clinical staff to the UK to support Papworth Hospital and other European transplant centers taking part in the trial.

The company's VentrAssist LVAS is being developed for heart failure patients. Ventracor's goal is to commercialize the system “in record time“ and capture “a significant share“ of the global LVAS market, which analysts expect to be valued at between $7.5 billion and $12 billion a year.

No Comments