Medical Device Dailys

A large-scale independent study of home care in England for patients with chronic health conditions shows recommended care is actually received in 62% of cases.

The study, part of the English Longitudinal Study of Aging (ELSA), showed huge variations by health condition, with 19,082 opportunities for care to be delivered but where actual care was only given in 11,911 of those opportunities.

Saying the report describes a "large gap" in at-home care, the report's lead investigator, Nicholas Steel, senior lecturer in primary care at the University of East Anglia School of Medicine (Norwich), said the reported shortfalls have "serious implications."

Taking coronary heart disease as an example, the report shows that if 90% of at-home patients with coronary heart disease received recommended drug therapy, including beta-blockers, 3,067 coronary events would be prevented annually in England.

The study used questionnaires and face-to-face interviews with 8,688 participants aged 50 or more, of whom 4,417 reported diagnoses of one or more of 13 conditions.

Quality for geriatric conditions was relatively poor in this study and no geriatric conditions were included in the general practice contract. It is possible that inclusion of geriatric conditions in future pay-for-performance programs would improve quality.

Medical conditions where general practitioners receive extra compensation under their contracts with the National Health Service showed better results that the average, with 75% of such cases receiving appropriate interventions.

Only 58% of people with conditions not covered by the contract received effective treatment.

Receipt of care was also substantially higher for screening and preventative care at 80% than for treatment and follow-up care at 64% or diagnostic care at 60%.

"Worryingly," said the report's authors, "conditions associated with disability and frailty had the largest shortfalls in terms of the care that people were not receiving but should have been."

"Many opportunities are being missed for healthcare to improve the quality and length of life," note the authors.

The report estimates there are 60,000 avoidable deaths annually in England, "the highest rate among comparable countries."

A comprehensive study on quality in the U.S. found adults received only 55% of recommended care in 1998-2000, the report adds.

"A study from the Netherlands found that guideline recommendations were only followed 67% of the time, again with large variation," the ELSA report authors note.

"These similarities suggest that compromised quality of care is a property of health systems internationally and that system level changes may be required," the report concludes.

Alquest aids Biotest BLA review

Alquest (Minneapolis), a contract research organization (CRO) specialized in medical and diagnostic devices, reported helping its client, Biotest Medical Diagnostics (Dreieich, Germany), earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the FDA.

The mid-August approvals covered BLA submissions for 26 monoclonal antibody-based blood grouping reagents; two anti-human globulin products; 13 reagent red blood cell products; and supplements to three previously licensed reagents.

Alquest assisted the German manufacturer with project management and BLA submissions and supplements, and in developing CMC (Chemistry Manufacturing and Controls) systems and procedures.

The CRO also performed statistical analysis of the clinical data for the final clinical report to support the license applications. In addition to preparing the BLAs, Alquest functioned as Biotest's U.S. regulatory contact to support communications, interactions and responses with the FDA.

"We are pleased to be able to support the commercialization of Biotest's exciting automated systems and blood grouping reagents," said Alquest President Ann Quinlan-Smith. "Our team worked diligently with Biotest staff over a period of two years to earn these approvals. We are proud of their professionalism and effort."

As a result, Biotest can now operate as a full-service provider in the area of immunohematology as one of only three companies to do so in the U.S. The system developed by Biotest for automated blood group typing in blood banks and hospitals, Tango optimo, including the associated test substances, was granted FDA approval in 2005.

Czech/Slovak distributor for Misonix

Misonix (Farmingdale, New York) has entered into a new two-year, exclusive distribution agreement with privately-held North Med, based near Prague, Czech Republic, for the distribution of the SonaStar Ultrasonic Surgical Aspirator, the BoneScalpel Ultrasonic Bone Cutter, and the SonicOne Ultrasonic Wound Debrider.

The agreement provides North Med with the rights to sell the Misonix products in the Czech Republic and the Slovak Republic, and includes minimum purchase requirements. North Med distributes medical devices and capital equipment in both countries, with special emphasis on neurosurgery, spine surgery, oncologic surgery and orthopedic surgery.

The SonaStar is used by neuro and general surgeons for quick and efficient removal of both hard and soft tumors while sparing most vessels. OsteoSculpt bone-sculpting technology can be employed with the SonaStar to safely remove osseous structures, thus providing access to the surgical site.

The BoneScalpel is a tissue-specific osteotomy device capable of making precise cuts through bone and hard tissue while largely preserving soft-tissue structures.

The SonicOne is an ultrasonic wound care system that offers tissue-specific debridement and cleansing for effective removal of devitalized tissue and fibrin deposits while sparing viable cellular structures.

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