News: November 29, 2007
Manufacturers May Need Updated Software as FDA Goes Electronic.
In the current regulatory environment, product lifecycle management software is becoming an increasingly necessary tool for companies to stay on top of the Food and Drug Administration’s (“FDA” or “the agency”) quality system and adverse event reporting requirements. With the Center for Devices and Radiological Health (“CDRH”) becoming an increasingly electronic entity, expectations are on the rise for immediate access to consumer complaints or corrective and preventative action (“CAPA”) systems during FDA inspections. In addition, the agency increasingly expects manufacturers to be able to submit adverse event reports in a quick and easily accessible electronic format. A new software package called Teamcenter 2007 for Medical Devices, which was developed by Siemens’ PLM Software unit and Tata Consultancy, is touted as the first fully integrated product lifecycle management solution for medical devices. The software models every component and assembly step for a specific device and manages these systems as separate logical entities allowing companies to more quickly and precisely carry out the requirements of a CAPA or respond to a consumer complaint. The software may also help companies to pull together information from different geographical locations and manufacturing sites quickly and effectively. Other manufacturers of similar product lifecycle and quality system management software systems include Pilgrim Software, Omnify Software, Camstar Systems, and PTC Corp. Additional information is available at www.thegraysheet.com (paid subscription service).
New FDA Website Highlights Device Safety Problems.
On November 14, 2007, FDA launched a new public website displaying information about device safety issues observed by hospitals in the MedSun adverse event reporting network. The website, which can be found at www.fda.gov/cdrh/medsun, is a monthly online newsletter for health professionals that is dedicated to medical devices. The MedSun network consists of 350 participating hospitals that agree to cooperate fully with FDA adverse event reporting laws. These hospitals provide accurate, detailed, and thorough information regarding the injuries and deaths associated with medical devices. In return, the agency provides participating hospitals with feedback in the form of safety tips and suggested preventative measures. The information gleaned from this network has resulted in ten product recalls in the last year. Each month, FDA plans to select approximately 20 reports to highlight on the web site, providing safety tips and news articles about problem devices. The names of the problematic devices and their manufacturers will also be listed. Interested parties can register online for e-mail updates associated with the site. Additional information is available at www.fda.gov/cdrh/medsun and www.thegraysheet.com (paid subscription service).
CMS Proposes to Maintain the Status Quo for Renal Stenting Coverage.
In its November 20, 2007, proposed coverage policy, the Centers for Medicare and Medicaid Services (“CMS”) suggested that the current renal stenting coverage policy be maintained. This decision came as a shock to many industry insiders who expected the agency to further restrict coverage, due to week data on the effectiveness of the intervention. CMS encouraged enrollment in randomized studies to help resolve the uncertainty about the benefits of stenting over other treatment options, but did not make such enrollment a prerequisite for coverage. Nevertheless, CMS realizes that there is little incentive for investigators to conduct rigorous trials for renal intervention under the current policy and investigators blame slow enrollment rates in part on the coverage policy. Additional information is available at www.thegraysheet.com (paid subscription service).
EU Regulations Result in Barriers to Device Innovation.
According to Eucomed, a member association that represents the interests of European medical technology and device manufacturers, inconsistent compliance with European Union (“EU”) rules and added costs from funding and reimbursement have hampered the timely introduction of new medical technologies in the European marketplace. The association believes that these hurdles result in additional cost with little or no increased patient safety benefit—serving only to deplete company resources that could be devoted to research and increasing the time it takes to bring a device to market. Eucomed recently urged the European Commission to implement the Medical Device Directives and bring member states in compliance with current regulations regarding late payments. Additional information is available at www.fdanews.com.