My internetworks

Report of the Post-Market Transformation Leadership Team Nov 09 2006 US Food & Drug Administration Washington DC

After a thorough review of its post-market processes, FDA CDRH recently published 2 documents--"Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Post-Market Safety Framework" and "Ensuring the Safety of Marketed Medical Devices--Synopsis & Recommendations."

These reports recommended improvements in the following 4 areas: intra-Center communication, post-market data systems, risk communication efforts, and enforcement strategies.

The reports also recommended that a senior team of leaders evaluate the report's recommendations and propose an implementation strategy. The Post-market Transformation Leadership Team (PTLT) was formed in response.

The PTLT met several times in Jan-Sept 2006 and identified issues that needed to be addressed. The Team also developed a list of prioritized recommendations for action to be taken by CDRH, in order to address these issues and achieve post-market transformation.

ISSUES

The issues the PTLT identified included inadequacies in CDRH's internal communication network, shortcomings with the current system for receipt, processing and analysis of reports from the Medical Device Reporting system (MDR), under-utilization of data and expertise outside of the Center, to better evaluate post-market issues, the inadequacy of the Center's current computer systems to efficiently track, search, and analyze data, confusion in the industry as to how and when to report adverse events, lack of a comprehensive risk communication system for external stakeholders, need for increased coordination between CDRH and ORA especially given the shrinking resources available for field activities, and an inadequately coordinated system for using postmarket data to inform premarket decisions, and assist in enforcement and compliance actions.

RECOMMENDATIONS

The PTLT made several recommendations to address these issues. These recommendations elaborated the four areas designated for improvement in the previous post-market reports and are outlined below.

CREATE A CULTURE OF COLLABORATION

The Center should add cross-cutting product-related groups over the current functionally-based organization to foster information sharing, collaboration and, ultimately, more effective public health promotion and protection. This cross-cutting matrix should be permanent, so that collaboration occurs not just in crisis situations, but also as a part of routine, day-to-day operations.

In addition, Center managers should encourage cross-organizational collaboration through training and recruitment. Employee recognition should be based on successful collaboration, and communication with outside experts on post-market issues should be formalized and expanded.

DEVELOP WORLD CLASS DATA SYSTEMS

Data input, mining, analysis, and tracking systems should be strengthened, improved, or created as needed for post-market issues. Unique device identifiers, electronic registration and listing, electronic medical device reporting (eMDR), and alternative summary reporting strategies would streamline the process of acquiring data.

The MAUDE database, which houses the Center's MDR data, should be updated. MedSun, the Center's user facility reporting network, should play a larger role in the early identification of postmarket issues. CDRH staff should be cross-trained to evaluate adverse event reports, and outside experts should be asked to assist in the review process. Finally, a pilot project should be initiated to prospectively quantify the risks associated with different medical devices.

ENHANCE RISK/BENEFIT COMMUNICATION EFFORTS

CDRH should be a trusted, publicly identifiable source for safety information about medical devices and radiation-emitting products. To that end, an analysis of the communication needs of CDRH stakeholders should be performed, and a process for the development and dissemination of risk-benefit information should be done in collaboration with clinical practitioners and professional communities.

COLLABORATE ON ENFORCEMENT STRATEGIES & OUTCOMES

Both the quantity and the quality of Center /ORA interactions should be transformed through increased collaboration among CDRH, the Office of Regulatory Affairs, and the Office of Chief Counsel.

Post-market data and information should be considered when prioritizing inspections, and part of the inspection preparation process should include a review of recent post-market data.

These data should also be integrated into other CDRH programs. CDRH should develop ways to leverage the audit results obtained by accredited third-party auditing bodies. Enforcement data systems should be updated, and employees trained to use them. All available enforcement tools should be used, including civil money penalties.

IMMEDIATE PRIORITY ACTIONS

Immediate priority actions were identified by the PTLT. They are to:

* Create a matrix system of collaborative product groups to complement the largely functional organization of the Center

* Develop metrics and methods for tracking the handling of post-market issues

* Pursue the development of unique identifiers (UDI) for medical devices

* Propose mandatory electronic MDR reporting

* Revise and update the MAUDE system, and expand the premarket data-warehousing project to include post-market needs

* Increase the quality and quantity of Center/ ORA/OCC interactions

* Develop and implement a risk-communication strategy

* Design a pilot project to test the usefulness of quantitative decision-making methods for medical device regulation across the total product life cycle

* Enhance utility of MedSun programs

The PTLT acknowledged that much work is required to realize each of these recommendations, and the Team proposed next steps for beginning the process.

INTRODUCTION

The FDA Center for Devices & Radiological Health (CDRH) is committed to achieving a seamless approach to the regulation of medical devices. In such an environment, the Center's premarket evaluation activities would be integrated with continued post-market vigilance and enforcement, and appropriate and timely information would be fed back to all of its stakeholders.

This regulatory approach, which encompasses the entire life cycle of a medical device, is described in the Center's "total product life cycle" (TPLC) model - a model that guides CRDH as it works to fulfill its public health mission to protect and promote public health.

Most observers tend to break the life cycle of medical devices into premarket and post-market phases, based on the legislative framework for device regulation. While this approach has been very useful to date, it does not reflect CDRH's vision of TPLC in which premarket activities and post-market activities are integrated into a smoothly functioning and efficient whole.

Recently, CDRH published 2 documents on the post-market safety of medical devices. One describes CDRH's post-market goals and the approaches the organization uses to monitor and address adverse events and risks associated with the use of devices that are currently on the market (see "Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Post-market Safety Framework").

The 2nd document provides a number of recommendations for improving the post-market program (see "Ensuring the Safety of Marketed Medical Devices--Synopsis & Recommendations").

Both of these documents are available on the CDRH website:

http://www.fda.gov/cdrh/post-market/mdpi.html One of the recommendations in the Synopsis and Recommendations is that a senior-level team, comprised of Center management and experienced outside consultants, be established to evaluate the recommendations in the report and propose an implementation strategy. This recommendation led to the formation of the CDRH Postmarket Transformation Leadership Team (PTLT).

CHARGE TO THE CDRH POST-MARKET TRANSFORMATION LEADERSHIP TEAM

The PTLT was given the following charge in Jan 2006, by the Director of CDRH:

A comprehensive TPLC approach to post-market safety is necessary to identify and address problems with marketed products, integrate the information learned into Center activities, and feed back the lessons learned to the public, manufacturers, and health professionals. The Post-market Transformation Leadership Team will evaluate the recommendations in the CDRH document, "Ensuring the Safety of Marketed Medical Devices--Synopsis & Recommendations," collect additional data as necessary, supplement the recommendations if needed, and propose a prioritized implementation plan for a transformed post-market process to the Center Director.

The name of the group was deliberately chosen to underscore the expectation that the recommendations that resulted were to be targeted toward nothing less than a transformation of the Center's post-market program.

The PTLT used a series of meetings to focus on the structural, programmatic and procedural changes that would be necessary to transform the post-market program. Presentations were made by each Center Office on what works and what does not work in that Office's handling of postmarket issues.

Important insights into the impact of organizational change were presented by the Office of In-Vitro Diagnostic Device Evaluation and Safety (OIVD) and the Office of Science and Engineering Laboratories (OSEL). Meetings and phone discussions were also held with selected CDRH staff.

In addition, the PTLT heard from the chair of one of the Center's most visible cross-cutting teams, the Defibrillator Working Group, and from the outside consultant who recently completed an analysis of internal communication in CDRH. During the same time period that the PTLT was meeting, a series of meetings to discuss post-market issues was held with an industry working group.

The insights obtained in these meetings were used to review the four recommendations made for improving the post-market program in "Ensuring the Safety of Marketed Medical Devices - Synopsis & Recommendations" and to …

My internetworks

Sunday, March 4, 2012

NEW MEMBER JOINS SCHOOL BOARD TONIGHT.(CAPITAL REGION)

Pakistan vs. Australia Scoreboard

Wright hits first homer of spring, has three RBIs

Camp spotlight

CUTLER WATCH

Strengthening FDA's post-market program for medical devices.(Company overview)

Saturday, March 3, 2012

TELEMATICS PUT INTERNET ON THE REAL HIGHWAY.(LIFE & LEISURE)

Advertising revenue for CMP Media's (Manhasset, NY) GovernmentVAR increased 96% in 2003, going from 48.5 ad pages in 2002 to 95 pages in 2003, while editorial increased 31% during the year and total folio was up 70%.(Brief Article)