• March 13, 2019
• CMZ Law
• no comments

Tragically, many serious infections and deaths have been spread in hospital settings because of tainted medical scopes. This shocking finding, recently reported by members of Congress, federal officials and health-policy experts, has prompted intense dissatisfaction with the FDA’s surveillance system for such devices, a system which is clearly inadequate, relying too heavily on manufacturer’s reportage of problems with their own products.

 Being aware of the serious problem is the easy part; remedying the federal warning system to warn doctors and patients of the risk of scopes, implants and surgical tools is much more challenging, involving as it does overcoming partisan Congressional divides and involving increased government funding. Many foresee years before a more effective system can be put into place.

Patient advocates and federal auditors are not the only ones with doubts about the FDA’s commitment and ability to reform the system, since there has been criticism of agency oversight of medical devices since the 1990s. As recently as January 13th of this year, Sen. Patty Murray (D-Wash.) presented evidence of an antibiotic-resistant strain of bacteria, originating from defective duodenoscopes (used for gastrointestinal examinations and procedures) that had spread throughout the country. In addition, Senators investigating the problem cited 19 superbug outbreaks that had sickened nearly 200 patients for 2012 to 2015. Amidst concern that these outbreaks were occurring, no substantive action was taken, and 68 more patients developed serious infection.

Sen. Murray has proposed a new system for tracking medical devices that would make use of insurance claims to supplement injury forms. Such a system would be similar to the method now used to monitor prescription drugs which works in a much more timely fashion. Robert M. Califf, President Obama’s nominee for FDA commissioner, has endorsed this data-driven approach.

One aspect of the new proposal, putting bar codes on every instrument, is already underway, being phased in over the next few years. Unless such bar codes are included on insurance claim forms, however, they are unlikely to be of much help. The hope is that tracking device IDs will work as car ID numbers do, enabling patients across the country to be notified promptly in regard to a defect device so that they could be checked for signs of possible infection immediately at the nearest hospital.

If you have suffered an infection or injury as a result of a defective medical device, you should contact personal injury attorneys with specific knowledge of the law surrounding defective medical devices so that you can be appropriately compensated for your pain, suffering, and/or resulting disability.