A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

The first surgical instrumentation system designed for minimally invasive 3D correction of complex spinal deformities has been launched worldwide.

The VIPER 3D MIS Correction Set from DePuy Spine, a Johnson & Johnson company, consists of devices and instruments for a range of correction processes.

The system’s focus on minimally invasive surgery (MIS) promises to reduce infection rates and hospital stay times compared with open surgery.

3D spinal corrections are used to treat complex medical conditions such as adult degenerative scoliosis (ADS) by aligning an abnormally curved spine. At present, most of these procedures require open surgery.

The new set includes devices for 360-degree correction; sagittal alignment and derotation; and orientation at individual levels. It can be fitted with any combination of bone screws in an MIS or open setting, enabling surgeons to customise the technique according to patient needs.

Praveen Mummaneni, MD, one of DePuy Spine’s design consultants, said: “The VIPER 3D Set makes performing complex corrections through small incisions less challenging and should help surgeons offer the minimally invasive option to more patients.”

“DePuy Spine continues to work to develop minimally invasive surgical devices and instruments that are intuitive and versatile to better help surgeons adopt the technique for appropriate spinal pathologies,” commented Namal Nawana, Worldwide President of DePuy Spine.

The VIPER 3D Set has received the 2011 Edison Best New Product Award for innovation in the medical and scientific category. It has also won a J&J award, the Johnson Medal, for innovation, patient impact and perseverance in ensuring the success of a product.

A former medical salesman has been jailed for up to 12 months for stealing $1.8 million worth of surgical devices.

Joseph Raymond, 39, from Orchard Park, USA, stole a collection of implants and other devices over the course of five years, whilst working for Synthes USA Sales.

Mr Raymond pleaded guilty to grand larceny and tax crimes and told the judge he takes “full responsibility” for his actions, which also included underpaying taxes and cheating his lawyer.

Bank cheques for $60,000 to an attorney of his former employer and $3,040 to a representative of the Department of Taxation and Finance, compensating them for his crimes, were recovered as evidence.

Erie County Judge Michael Pietruszka told Mr Raymond that he planned to sentence him to seven years imprisonment before learning that he had made full repayment.

It was heard that Mr Raymond voluntarily surrendered $1.7 million in surgical devices when first confronted by investigators. The equipment, which was originally destined for Buffalo’s Mercy Hospital, had been stored in Mr Raymond’s garage for safekeeping.

Defence Attorney Rodney Personius added that the $60,000 worth of medical technology that Mr Raymond had tried to sell consisted of “obsolete items” that Synthes had replaced with updated products.