ECRI Institute is discontinuing the Computerized Problem Reporting System (CPRS) at the end of 2007.

We will continue to receive healthcare facilities’ voluntary (3500) and mandatory (3500A) MedWatch reports for 2007 and mail them to the appropriate recipients as instructed by the CPRS user. During the first week of January 2008, we will also complete each facility’s annual report of mandatory MedWatch reports submitted during 2007. However, we will no longer manage healthcare facilities’ MedWatch reports for 2008 and thereafter.

Our reasons for discontinuing the system are twofold. We saw the need for significant improvements in the software supporting the CPRS system; however, the utilization of CPRS has declined as healthcare facilities have found alternative means to manage their medical device reporting in accordance with the Safe Medical Devices Act (SMDA). Currently, we have only a few users of the CPRS system.

We recognize the inconvenience that the system’s discontinuation presents to CPRS users, and we have provided some questions and answers about medical device reporting to help you find the necessary material to remain compliant with the medical device reporting requirements of the SMDA. Additionally, we will be sending CPRS users a transition kit with sample forms and instructions for maintaining a reporting program.

Please note that this change does not affect ECRI Institute’s Problem Reporting Network (PRN), a voluntary and confidential reporting program through which healthcare providers, patients, and manufacturers may confidentially report medical-device-related incidents and deficiencies to us. As we have for the past 40 years, we will gather and investigate reports of incidents involving medical devices (including capital equipment, reusable and disposable instruments, and reagents) to help improve patient care and inform purchase decisions.

Please feel free to call either of us if you have any questions about the discontinuation of CPRS or about medical device reporting in general. Again, we apologize for the inconvenience this decision has created for your medical device reporting program.

Sincerely,

Dan Alt Senior Project Engineer Manager, Problem Reporting Network Health Devices Group Phone (610) 825-6000, ext. 5445 E-mail: dalt@ecri.org	Cynthia Wallace Director, Risk Management Publications Phone: (610) 825-6000, ext. 5161 Email: cwallace@ecri.org