A BBI

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 pati-ent 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 H. Timmons, CEO of Joint Commission International.

Two new distributors for DOBI

DOBI Medical International (Mahwah, New Jersey) reported another step in its continued expansion into international markets with the signing of new distributor agreements in Brazil and the Netherlands. Advanced Imaging (Sao Paulo, Brazil) and Tromp Medical Engineering (Castricum, the Netherlands) each will conduct a clinical trial using the company's ComfortScan system to aid in obtaining local approvals specific to their respective regions.

The ComfortScan system is a light-based, non-invasive and gentle dynamic optical imaging device designed to assist physicians in the diagnosis and management of breast cancer.

With the addition of these two distributors, the DOBI Medical's global distribution network now has nine distributors representing 13 countries, including Canada, Costa Rica, Columbia, the Czech Republic, Greece, India, Liechtenstein, Nicaragua, Panama, Russia and Switzerland.

The company said it expects to sign additional distribution agreements in 2005 as it continues to expand its international network.

DOBI said that according to the European Network of Cancer Registries, breast cancer is the most common cancer in females in Europe. While the incidence of breast cancer is rising among women in many European countries, the Netherlands currently has the highest incidence of breast cancer in Europe. The incidence of breast cancer also is now more common in South America, with Brazil having the highest number of breast cancer cases in that region, as reported by the International Agency for Research on Cancer.

"Advanced Imaging and Tromp Medical Engineering . . . have excellent reputations as leading medical suppliers within their respective countries," said Denis O'Connor, senior vice president of marketing, sales and service at DOBI. "After successful completion of the clinical trials, we expect the ComfortScan system to be available for commercial sale in Brazil and the Netherlands. These newest agreements further strengthen our global distribution network and reflect the growing medical need for the ComfortScan technology throughout the world."

Pentax order boosts Optiscan

Japanese imaging giant Pentax has placed a first-year order worth more than A$5 million with Optiscan Imaging (Melbourne, Australia) for miniaturized microscope components that will be used to produce a new type of medical instrument called a flexible endo-microscope. Optiscan and Pentax have collaborated over the past three years on the development of the new device, which combines Pentax's miniaturized camera endoscope technology and Optiscan's miniaturized microscope technology.

Pentax, which expects to have the new instruments available for sale to physicians during the first half of this year, will market and sell the flexible endo-microscopes into an annual global market for flexible endoscopes estimated at about $900 million. Optiscan said the number of flexible endo-microscope systems Pentax will purchase from it in the first year of market release for the new product exceeds its initial estimate of 40 to 80 such units.

Matthew Barnett, CEO of Optiscan, said, "We are thrilled with the size of this order, as it is greater than our upper-end forecast of 80 units. It shows that Pentax is committed to this technology and is a measure of their confidence for its success in the market."

Optiscan will supply Pentax with miniaturized microscope scanner inserts and laser confocal control box sub-systems. Under its collaboration with Pentax, Optiscan supplies those core components for Pentax to assemble into finished flexible endo-microscope systems. Revenue generated for Optiscan from deliveries against this order will occur mostly in the 2005-2006 fiscal year.

The Pentax-Optiscan flexible endo-microscope procedure was featured as the cover story in the September 2004 issue of the peer-reviewed journal, Gastroenterology, after clinical trials established what Optiscan described as "excellent medical utility" in diagnosing very early-stage colon cancers.

The device was granted clearance in October by the FDA for the U.S. market and CE mark clearance for Europe, as well as being approved for sale in other world markets.

Market introduction is anticipated in time for the important Digestive Diseases Week Congress (DDW), scheduled to be held in Chicago in May.

"This is a defining moment for Optiscan," said Barnett. "Our engineers have successfully miniaturized our powerful microscopes to create an endo-microscope, doctors have established the value of the endo-microscopes through clinical trials, the necessary regulatory clearances have been achieved and now significant revenues are starting with imminent worldwide market release."

Optiscan said it is in discussion with a number of international companies for further licensing of its miniaturized confocal microscope technology in other fields, including rigid endoscopy.

Media firm has eye on China

Two veteran global healthcare marketers with extensive knowledge of the Chinese market have launched JYT Health (Palo Alto, California), a new media company that matches global medical device and pharmaceutical marketers with opportunities in that country. JYT stands for Jia Yi Tong, which in Chinese means "Good medicine everywhere."

Lena Chow, founder of Lena Chow Advertising, a top-50 U.S. healthcare agency, is chairman and CEO, and Dr. Feiyan Shen, a physician by training and former managing director of Euro RSCG Life, China, the country's leading healthcare agency, is president.

JYT Health's China operations are based in Shanghai.

Referring to China as a "unique and complicated market undergoing significant healthcare reform," Chow said major trends in that country include the privatization of the health system, expanded insurance coverage and growing consumer expectations for healthcare information and services.

"Our mission," she said, "is to be a driving force in helping to achieve the goals of improving healthcare and increasing accountability in the new and evolving healthcare system."

Chow said JYT Health would collaborate with government and professional associations to create media products that bring best practices in professional development and patient education to China's healthcare system.

The company offers global pharmaceutical and medical device companies sponsorship and advertising opportunities, branded and unbranded custom programs built around JYT's proprietary platforms, and strategic relationships and collaborations.

In May, JYT will launch the Chinese Medical Doctors Association's (CMDA) Leadership Summit 2005 in Beijing. It said the event would bring together a group of Chinese and U.S. healthcare leaders, "to facilitate dialogue and future collaboration."

The by-invitation meeting will feature representatives from China's top hospitals, government officials and CMDA's leadership. CMDA was inaugurated in 2002 to organize and give the 1.3 million physicians in China a voice in defining the future of healthcare in that country.

JYT Health is working with the Chinese Licensed Pharmacists Association to hold an event similar to the CMDA leadership summit at that group's annual conference in September.

It also is partnering with the Shanghai Health Education Institute to implement novel patient education programs, examples of which are a series of community bulletin boards to reach consumers in high-traffic locations such as bicycle parking areas, as well as a healthcare hotline guidebook for consumers.

Egyptian approval for Avitar products

Avitar (Canton, Massachusetts), developer of the world's first on-site oral test for drugs of abuse, said that the government of Egypt has approved its OralScreen oral fluid-based drug testing products for sale.

"Acceptance by the government of Egypt, a country with a population of over 75 million, demonstrates the tremendous worldwide market potential for saliva-based drug testing products," said Pete Phildius, Avitar's CEO. "We're confident that our position as the performance leader in oral-based testing solutions continues to differentiate Avitar from our competitors and play a very important role in our future growth."

The Egyptian Ministry of Health and the Ministry of Trade have approved the sale of Avitar products, including OralScreen disposable tests for illicit drugs, and the company's OSR handheld electronic reader.

Avitar's business partner in Egypt is Egyptian International Co. for Environmental Protection (EICEP), a distribution firm with international reach. EICEP has signed an agreement with a reseller in the Middle East with more than 30 sales locations across Egypt and 13 additional offices in additional Arab countries.

DiaSys signs up Chilean distributor

Global diagnostics products firm DiaSys (Waterbury, Connecticut) has entered into an agreement with Galenica, the largest diagnostics distributor in Chile, to distribute its products throughout that country.

"We continue to rapidly enter new markets through leading diagnostics distributors," said Jose Puig, DiaSys sales manager for Latin America. "Galenica has a strong track record in the medical community in Chile, and we believe that this agreement will help us reach many of the largest potential customers for our innovative medical tests."

Founded in 1985, Galenica has 20 technical support personnel located in two offices in Chile supporting its 12-person sales force. Galenica exclusively represents companies such as Beckman Coulter (Fullerton, California) and Bio-Rad (San Diego). Its annual revenue is approximately $8 million

Previously, DiaSys entered into distribution agreements with Tecnodiagnostica, the largest distributor of clinical diagnostic products in Costa Rica; Repreclin, a large clinical diagnostics distributor based in Venezuela; and Grupo Mex Lab, a leading Mexican distributor of diagnostics products.

Taiwan is newest market for MSI

Medical Services International (MSI; Edmonton, Alberta) said it has expanded into Taiwan. The company reported reaching a distribution agreement for its VScan HIV test kit with a large pharmaceutical company headquartered in that country.

MSI said its receipt of regulatory approval in China, India and Vietnam and its accumulation of "significant test data" from Southeast Asia "was instrumental in negotiating a deal that is very favorable to the company."

In order to maintain its distributorship, the un-named pharmaceutical company must purchase a minimum of 1 million HIV test kits in the first year of the contract. Each subsequent year of the three-year contract, the distributor must purchase in excess of 1.5 million HIV test kits per year.

The HIV test kits for this contract will be supplied from MSI's Shanghai facility. The company said it expects to begin shipping to Taiwan within the next 45 days.

Medical Services International said there also has been "significant interest" in Taiwan for both its Tuberculosis test kit and Dengue Fever test kits, and that negotiations are ongoing related to those kits.

The VScan rapid test kit is a single-use, disposable and easy-to-use test for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, Dengue fever, West Nile virus and syphilis.