FDA 483 - Reading Hospital - December 16, 2015

An FDA inspection conducted at The Reading Hospital and Medical Center from December 8 to December 16, 2015, revealed several significant deficiencies in the facility's medical device adverse event reporting practices. The inspection, documented in an FDA Form 483, indicated non-compliance with regulatory requirements for medical device user facilities. Major issues included the hospital's failure to submit timely reports for a device-related patient death and a serious patient injury to both the FDA and, in one case, the device manufacturer, violating the ten-working-day reporting mandate. Additionally, the facility's written Medical Device Reporting (MDR) procedure lacked a standardized review process for determining event reportability and failed to specify documentation requirements for information assessed during reportability determinations. Finally, MDR event files were not consistently established and maintained for all reported adverse events. To address these findings, the hospital is expected to revise its procedures, improve staff training, and implement more robust systems for accurate and timely reporting and meticulous recordkeeping, ensuring full adherence to federal regulations governing medical device user facilities.