A Medical Device Daily
The UK government has published a White Paper outlining what were described as “landmark proposals” on how to regulate health professionals and ensure patient safety. Once adopted, the plan will require all health professionals to prove their fitness to practice every five years
There also are plans for a radical overhaul of the processes for death certification.
Based on consultation on the chief medical officer’s review of medical regulation and the accompanying review of other professions, the main proposals in “Trust, Assurance and Safety, The Regulation of Health Professionals in the 21st Century” include:
- Professional regulators independent of the government and led by an equal partnership of independently appointed professionals and members of the public;
- All health professionals required to demonstrate periodically that they are fit to practice by revalidating their professional registration;
- A move from the criminal standard of proof to the civil standard in fitness-to-practice cases;
- A stronger role for the medical Royal Colleges.
- Introduction of a system of regional GMC Affiliates providing support to local employers to address concerns about doctors and independently quality assure local revalidation.
The document includes proposals that “will ensure patient, public and professional confidence in the health professionals’ watchdogs, improving patient safety and ensuring the fair treatment of health professionals,” the government said.
The government also is publishing its response to the Fifth Report of the Shipman Inquiry, setting out a plan of action to help healthcare organizations identify healthcare professionals whose performance or conduct might put patients at risk, and to take the necessary action to protect patients.
A complementary publication, “Learning from Tragedy, Keeping Patients Safe,” gives an overview of the action the government is taking in response to the six reports of the Shipman Inquiry.
The government said the two publications make the protection of patients and the public the “first priority of all who are concerned with healthcare.” Together, “they set out proposals which will sustain and enhance the high regard in which the public hold health professionals and ensure that good regulation does not get in the way of good patient care.”
A national advisory group will oversee implementation of the White Paper and Shipman response.
The main proposals from the safeguarding effort are:
- Better support for patients who want to register concerns;
- Information from different sources brought together so that a full picture about professionals is considered and robust action is taken;
- More rigorous checks on references and qualifications when health professionals are recruited;
- Comprehensive guidance on preventing transgressions of professional boundaries and sexual behavior with patients.
- Adoption by primary care organizations of best practice in investigating and acting on concerns.
Health Minister Patricia Hewitt reported her intention to consult on proposals for an overhaul of the processes for death certification, a key recommendation of the Shipman Inquiry to ensure a unified system of death certification that provides much more effective scrutiny and stronger safeguards for the public, she said.
Hewitt said, “These changes are radical and significant and offer the opportunity for a long-term settlement. They enable us to put an end to the disagreements of the past and to focus clearly on patient safety and public and professional confidence.”
European patent granted to SpectraScience
SpectraScience (San Diego) reported receiving the decision to grant it European Patent number 0910284 for its Optical Biopsy Forceps design.
The company developed the Optical Biopsy Forceps for use with its WavSTAT Optical Biopsy System in diagnosing tissue to be normal, pre-cancerous or cancerous, within one second.
The system is FDA-approved for use in detecting cancer in the colon.
The forceps feature a small optical fiber located coaxially in its center to diagnose pre-cancers. In the same procedure, treatment can begin by removal of the tissue with the forcep jaws. The optical probe can be then used around the margin of the tissue to ensure that all diseased tissue has been removed.
A new application for detecting pre-cancers in the throat, also called Barrett’s esophagus, is being tested in a clinical trial. Cancer of the esophagus is more than 90% fatal and is growing five times faster than all other cancers, the company said.
UK sales unit opened by SpineVision
SpineVision (Paris/San Francisco) said it has established a direct sales subsidiary in Chester, UK, near London.
The operation is being led by Raymond Thomasen, previously VP Europe for Wright Medical Technology for three years. Prior to Wright Medical, he held various posts during eight years with Stryker in the Middle East, Africa and the UK, and also has worked for C.R. Bard, 3M and Smith & Nephew.
Julian Mackenzie, SpineVision CEO, said, “We expect Ray to ramp-up quickly and hire at least 10 direct sales representatives or agents in the near term to begin calling on neurosurgeons and spine surgeons throughout England, Ireland, Scotland and Wales.”
He added that Thomasen’s group “will be looking for opportunities related to distributing other companies’ products, if they are complementary.”
SpineVision sells its motion preservation and fusion products directly in France, Italy Belgium and the U.S., and utilizes distributors in 10 other countries, including Egypt, Finland, Greece, Ireland, Israel, Luxembourg, Portugal, South Africa, Spain and Turkey. It said it expects to add additional market coverage this year in Australia, Brazil, Chile, Mexico and Singapore, and in Japan in 2008.
COSTAR results to be presented at EuroPCR
Conor Medsystems (Menlo Park, California) said it plans to present the results for its COSTAR II U.S. pivotal clinical trial at the EuroPCR meeting in Barcelona in May.
“The last patient was followed-up in February, and we expect the independent clinical research organization to commence the data analysis in March, providing sufficient time for presentation at the upcoming EuroPCR meeting,” said Michael Boennighausen, Conor Medsystems general manager.
COSTAR II is a randomized, single-blind, non-inferiority study comparing Conor’s CoStar cobalt chromium paclitaxel-eluting stent with the Taxus Express2 drug-eluting stent made by Boston Scientific (Natick, Massachusetts) in the treatment of de novo lesions in patients with single- or multi-vessel coronary artery disease.
The study includes 1,700 patients from more than 70 clinical sites.