Medical Device Daily Contributing Writer
And MDDs

Medical devices using chemicals known as phthalates must be clearly labeled under a revised European Directive passed by the European Parliament that came into effect in April.

The European directive stopped short of banning products using di(2-ethylhexyl) phthalate (DEHP), a compound used to soften vinyl plastic found in medical devices such as IV bags and tubing. Instead the labeling requirement is meant to aid hospitals that are seeking to either phase out or eliminate products containing DEHP.

A significant number of research reports indicates that DEHP can leach out of plastic bags and tubing into the human body. Multiple studies have reported a link between DEHP and altered development of the male reproductive system.

The healthcare procurement journal Healthcare Equipment and Supplies (HES; Sidcup, UK) reports that the European Union argued against a total ban, saying the result would be a ban on too many medical devices considered indispensable for the protection of health.

HES quotes European Commission vice president G nter Verheugen as saying that the new regulation "allows for enhanced patient protection and supports medical progress and innovation. It will improve the functioning of the internal market and strengthen the competitiveness of the European industry."

The boost to European competitiveness is expected to come through the development of alternative products.

A spokesman for the Health and Environment Alliance (Brussels, Belgium) told European Hospital Magazine that while the group was disappointed the Parliament did not ban DEHP outright; "The new law is a progress for those hospitals that have already been trying to avoid plastic softener but are having a hard time doing so because of a lack of information."

Karolina Ruzickova, safer materials coordinator for Health Care Without Harm Europe (HCWHE), said, "Alternatives are readily available. A number of European hospitals are already using PVC-free devices for neonates and hemodialysis patients."

In a statement, HCWHE lauded several examples, saying "the Vienna and Styrian hospital associations, accounting for more than one-third of hospital beds in Austria, are phasing out medical devices containing DEHP and PVC. A majority of neonatal departments in Sweden and Denmark use products without DEHP-softened PVC."

DMS reports robust growth in scanners

Diagnostic Medical Systems (DMS; Montpellier, France), a manufacturer of medical scanning equipment, reported that it is back in the black and in a recent statement announced that it is ahead of its plan to realize the 20% growth in revenues for 2007.

Caught in a cash squeeze in early 2006, the company was unable to meet production schedules for contracted equipment.

A stock offering in September 2006 raised 18.3 million ($10.3 million) against pledges to reduce fixed costs and increase sales.

In April, DMS reported first-quarter sales of 16.2 million ($8.6 million), an increase of 63%, boosted by contracts in Japan and Europe.

DMS's cash problems were linked to the development in 2005 of a sophisticated new product, Paladio, a digital sensor composed of a cooled high-resolution charge-coupled device (CCD) camera with a high reading frequency and a chain of high-performance and automatic images processing which allows immediate visualization of the image and facilitates the interpretation.

DMS at the time reported that while sales were not the cause of its cash problems it was nonetheless forced to cut back international commercial activities to meet its obligations to suppliers and banks.

Current sales activity boosting the company's financial performance are linked to traditional products. The company confirmed in April that it had won a European contract for 14.8 million ($6.7 million) for remote-controlled radiology tables, sales that will be invoiced in the second and third quarters. DMS said it is in discussions with the same customer for a second contract valued at 1800,000 ($1.1 million).

Reports of sales in Asia in late March sent the company's stock price soaring on the Euronext exchange. DMS announced sales in Japan of 10 UBIS 500 units, an ultrasound bone densitometer and said it targets a 10% share of the estimated 1,000 sold in Japan annually. A contract for osteodensometers in South Korea, valued at 11 million ($1.39 million), is expected to be invoiced before the end of this year.

Looking forward, DMS said a new osteodensometer unit, called Stratos, will come onto the market by the end of 2007, adding that in 2008, it will launch a new remote-controlled radiology table called Trixell.

It also said that it will create a new division this June dedicated to women's health, called S lenyos, focused on digital mammography.

For 2006 DMS reported a loss of 1600,000 ($834,000) against sales of 125.7 million ($35.7 million), a significant improvement from a 2005 loss of 18.3 million ($11.5 million).

In its report to stockholders in March, DMS said personnel expenses have been reduced by 2% and it has cut fixed charges by 15%.

Visudyne indication to be deleted

QLT (Vancouver, British Columbia) said it has been informed that the Committee for Medicinal Products for Human Use (CHMP) will recommend to the European Commission that the indication of the use of Visudyne in the treatment of occult subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) be deleted.

The European Commission is expected to endorse the CHMP recommendation in a final decision that should be issued within about two months. QLT said such a decision is not expected to affect the approved use of Visudyne in the predominately classic or pathologic myopia indications.

CHMP said the opinion was based on its review of data from the Visudyne in Occult (VIO) trial that, as reported in September 2005, did not achieve the significance level required of its primary end points.

The VIO study was undertaken in part at the request of CHMP to confirm the results of an earlier trial, Visudyne In Photodynamic Therapy, that demonstrated evidence of efficacy in the occult patient population.