FDA’s Medical Device Software Oversight Faces Increasing Scrutiny

By Mike Rozembajgier

The Food and Drug Administration’s (FDA) 510(k) review process continues to face scrutiny due to its failure in regulatory oversight of medical device software, which has caused hundreds of deaths in the past several years according to a recent Los Angeles Times article.

Under the FDA’s 510(k) process, approximately 70 percent of medical devices that have been recalled since 2005 were originally approved for sale. This number illustrates a primary source of concern for both manufacturers and patients. Certain groups, including critics of the FDA and concerned patients, believe that the high percentage of recalls signals an indisputable need to reevaluate the current 510(k) process in order to prevent malfunctions that could lead to patient complications or death. Medical device software manufacturers, however, believe these reforms will impede their progress in the race to improve and evolve medical technology.

While claims by manufacturers on the potential impediment of innovation may bear some truth, those pushing for reform maintain the belief that device and software safety take priority over technological innovation. As debates continue on whether the review process needs to be reformed, manufacturers should be prepared for any potential lapses in the FDA’s oversight in order to effectively mitigate any future product recalls.

According to The Los Angeles Times, these medical software issues are now the third-leading cause for recalls of medical devices.  As this figure grows, so does the level of concern regarding patient safety and best practice models. The article notes that “the medical devices industry has been criticized for not adopting standard practices for developing and screening software before products go to market.” Without a system or standard practice to safeguard the industry, reform proponents argue, fatalities and risks of malfunction threaten to persist.

The Institute of Medicine recently critiqued the current 510(k) process and recommended that the agency “develop procedures to ensure safety and effectiveness of device software.” These procedures could prevent a wide range of software problems, both big and small. In spite of the increased attention and public pressure, the FDA asserts that “even within the accelerated process, it requires manufacturers to demonstrate that the products are safe and effective before marketing them and that they follow good manufacturing practices.”

Bakul Patel, FDA policy advisor explains that FDA officials recognize the validity of the issues that the Institute of Medicine Report raises. “We want to do the right thing…we understand that technology is growing,” said Patel, adding that the agency is currently awaiting feedback from its public meeting regarding the report on September 15.

While patients should remain aware of any pending issues regarding medical device software as well as the ongoing policy debates between proponents of reform and industry experts, responsibility chiefly rests with medical device software manufacturers. It is up to those companies to ensure that their products meet the highest safety standards. In the event that questions remain as to a particular products vulnerability to faulty defects, it is imperative that manufacturers are prepared with a comprehensive recall management plan.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.