Results of a recent study conducted by the Institute of Medicine question the reliability and effectiveness of the Food and Drug Administration's (FDA) process for testing Class II medical devices prior to making them available to the public. The Institute concluded that the FDA would be better off starting from scratch to develop a new approval process rather than modifying the process currently in use.
What is a Class II Medical Device?
All medical devices are classified as I, II or III according to FDA regulations. The class to which a device belongs determines the testing that must be completed before the device is approved for use. A Class I device receives the least regulatory scrutiny from the FDA while a Class III device receives the greatest. Most Class III devices must receive FDA approval before being released to the market.
About 43 percent of all medical devices are categorized as Class II. A Class II device is considered to present a moderate risk to patients. Chicago defective medical device attorneys have assisted patients who've been harmed by recalled product.
The Institute of Medicine study follows years of recalls of medical devices that were subject to 510(k) testing, including hip replacements, external heart defibrillators and pumps used in hospitals. The recent recall of hip replacement devices made by DePuy Orthopaedics is only one example of a number of medical device recalls in recent years.
What is the Current Testing/Approval Process for a Class II Device?
Section 510(k) of the Federal Food, Drug and Cosmetic Act details the premarket notification process that most Class II medical devices must clear. The Class II process focuses on 'substantial equivalence,' meaning that if the new device has enough similarities to another product already in the market, clearance of the new device is streamlined to get it to market faster.
But, the Institute of Medicine's study results reveal that the FDA's current testing procedure is insufficient to adequately protect patients who use Class II medical devices. The study claims that the FDA's 510(k) testing process inadequately protects patients because it insufficiently tests products before they hit the market.
The report tried to answer the question of whether or not the FDA's 510(k) program protects patients and public health, and, if it does not, what can be done to fix the problem. The Institute found that since 510(k) is based on legislative action rather than medical evidence, it should be scrapped and the FDA should work with medical professionals to develop a new set of standards and procedures to evaluate medical devices.
Currently, the 510(k) testing program has no standard against which devices are judged. Instead, devices are approved as long as they pose no greater threat to the public or patients than previously-approved devices. The Institute of Medicine believes this system is insufficient and recommends the FDA formulate a new system for these devices similar to the testing it performs for so-called "high risk" medical devices.
A Longer Road to Market for Class II Medical Devices?
The study has been applauded by patient rights groups but highly criticized by industry groups. Proponents of the study believe the report gives concrete evidence that reforms to medical device testing procedures are necessary, but industry groups believe that the study and the proposals it makes to reform the system will not benefit the public. Even before the report was published, the medical device industry ran a campaign to discredit the research in the report and encourage the FDA to dismiss its claims.
The FDA itself believes that there are flaws in its 510(k) system, but that there is no need to completely start over to develop a new set of standards.
If you or a loved one has been injured as a result of a faulty medical device, please contact an experienced personal injury attorney.
