Personal Injury Blog

Medical Device Report to Recommend Additional Regulations

August 6th, 2011
Future Medical Device reports to offer more extensive safety recommendations.

Future Medical Device reports to offer more safety recommendations.

A scientific group is expected to soon release a report that is likely to recommend additional regulations on the medical device industry.  The medical device industry is launching a preemptive strike, arguing that the medical device report is biased even before it comes out.

The Institute of Medicine is expected to release its report into the medical device industry later this week.  The medical device report is likely to suggest that the medical device industry be put through stronger approval processes before the devices are approved.  This could include stronger approval processes for a variety of devices, including cardiac devices and hip implants.

The report comes at an opportune time.  The medical device industry has been plagued by one scandal after another, all involving defective devices.  Last year, the Food And Drug Administration forced Johnson & Johnson’s subsidiary DePuy Orthopedics to recall two of its hip implants that had been linked to serious injuries and illnesses.  The implants had been found to cause serious complications, and patients have suffered pain, blood poisoning from metal ions leaking from the implants, swelling, restricted movement and mobility and a number of other complications.

The DePuy recall is just one in a series of defective medical device-related scandals in the industry.  Thousands of medical devices have been recalled over the past few years after they caused severe injuries to patients.  In a backdrop like this, it’s very important that the federal administration review its policies about the approval of medical devices.  The Institute of Medicine report could provide essential guidelines for this to come about.  The report by the Institute of Medicine has been commissioned by the Food and Drug Administration.

However, the medical device industry is a powerful one, and it has already galvanized efforts against the report.  Efforts are on now to discredit the Institute of Medicine report even before it is released.  According to the Institute of Medicine, this is the first time it is coming across an instance in which one of its report is being attacked even before it has been published.

In recent weeks, the medical device industry’s campaign against the report has been intensifying.  According to manufacturers of medical devices, any additional regulation on the industry would severely hamper growth and effect economy.  It would take away jobs, slow down innovation in the industry, and even harm patients.  Medical device manufacturers have been calling on the Food And Drug Administration to ignore the recommendations of the report.

One of the biggest concerns that California product liability attorneys have always had is the Food And Drug Administration’s special fast-track approval process.  The 510 (k) process is used to approve devices that manufacturers believe are similar to other devices that have already been approved.  However, the 510 (k) process has been widely misused by the medical device industry.

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