Research firm Kalorama Information has issued a report that addresses medical device security for infusion pumps, among other facets of the market. The World Market for Infusion Pumps (Large Volume Pumps, Ambulatory Pumps, Insulin Pumps, Enteral Feeding Pumps, Others) contains market sizes and forecasts for several areas of the infusion pump market.
Since 2009, the FDA has noted a marked uptick in the number of infusion pump recalls and their severity, with 21 companies affected by recalls for infusion pumps and related equipment between 2003 and 2013. Several recalls were attributed to faulty device design, leading the FDA to establish the Infusion Pump Improvement Initiative in 2010 and increase its role in the evaluation of infusion devices, including software development. A July 31 FDA warning also indicated that the manufacturer Hospira’s Symbiq drug infusion pump could be accessed and controlled by hackers through a hospital’s wireless network.
“Competitive balance in the infusion pump market may be shifted by increased regulatory and purchaser attention to device IT vulnerabilities,” said Kalorama analyst Emil Salazar. However, he noted, “significant adverse effects on the market as a whole are not anticipated as results of the recent FDA warning. The infusion pump market has maintained its trajectory of steady growth through several tumultuous years of recalls.”