Medical Device Link.

US MARKET

Transformation agenda

The domestic United States (US) medical device market consists of almost 15000 manufacturers with nearly 100000 medical products in the market place. Responsibility for ensuring the safety and effectiveness of these products lies with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). Although a major focus of the CDRH is to review and approve new devices entering the market, it is also tasked with monitoring the safety of all commercialised medical devices and taking remedial action where necessary to protect the public health. During the past year FDA has been criticised for what some lawmakers perceived as a failure to aggressively monitor medical device safety.

On 18 January 2006, FDA released a report titled “Ensuring the Safety of Marketed Medical Devices,” which describes CDRH’s Medical Device Postmarket Safety Programme and summarises the challenges it faces in implementing this programme.1 The report outlines CDRH’s basic goals for the programme and lists a series of steps it is considering to strengthen its postmarket effectiveness.

The existing system

The current CDRH postmarket programme consists of three parts: problem identification, problem assessment and public health response. CDRH uses a number of tools to identify, quantify and qualify public health hazards related to medical devices, including Medical Device Reporting, MedSun reports, FDA inspections, recall notifications, Bioresearch Monitoring investigations, user comments and complaints, international vigilance reports, medical device modification reports and the results ofmanufacturers’ postmarket study reports.

After the CDRH identifies a potential hazard, it analyses and evaluates the potential risk. It attempts to identify the nature, magnitude and public health significance of the problem and makes appropriate recommendations to protect public health. Depending on the level and urgency of the risk, CDRH will use a communication or an enforcement approach. Communication is directed to the appropriate audience (public, industry and/or health-care professionals) using a variety of media, including urgent alerts, multimedia outreach, technical publications, presentations and workshops. For higher risk situations, the agency will employ enforcement actions that could include administrative and judicial actions. Administrative actions include warning letters, device and import detentions, recalls, penalties and restraints. Judicial actions can include injunctions, seizure and prosecution.

Difficulties with monitoring

CDRH has identified several factors that increase the difficulty of monitoring and assessing the safety of existing medical devices. The quantity and quality of adverse event reports appears to be of particular concern, and off-label use and the shift from clinical use of devices to home use by nonprofessionals also make effective postmarket monitoring an especially challenging undertaking.

FDA’s goals

While recognising the many challenges involved, CDRH has stated that it is committed to achieving its basic goals for its postmarket programme,which are to access accurate and timely data about adverse events; analyse and assess this information quickly; and alert device users to potential risk.

This transformation will focus on a number of important areas, including

• the development of an electronic reporting system for adverse medical events
• improvement of medical device identification, including standardised and globally accepted names
• ways to improve device information in patient records
• improved internal collaboration on postmarket safety issues
• greater collaboration with professional organisations and the device industry related to improved device safety.

A Postmarket Transformation Leadership team of senior-level CDRH management and experienced outside consultants will help guide this effort. The team’s first step is to review CDRH’s Medical Device Postmarket Safety Programme report and make recommendations on ways to address areas that need improvement. The team is expected to make its recommendations within approximately four months (thus, by June 2006).²