FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary

In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn’t have proper reporting and documentation procedures in place.

For some hospitals with significant violations of federal medical device reporting regulations, FDA officials said the agency received a response that was not adequate to address those violations.

“These hospitals indicated their willingness to work with us and address the violations, and at this time, we do not believe any additional action with regard to these hospitals is necessary,” the agency said in response to questions from The Cancer Letter. “Hospitals also expressed willingness to work with us on more efficient and effective ways to collect the information we need.”

FDA responded in writing to questions from Matthew Ong, a reporter with The Cancer Letter.

FDA: We cannot comment or confirm any criminal investigation into morcellators. In a separate action, the FDA’s Office of Regulatory Affairs inspected 17 hospitals to assess their level of compliance with FDA’s medical device reporting (MDR) regulation requirements, which mandate, among other things, that hospitals and other device user facilities submit a report to FDA and, if known, to the device manufacturer when the user facility becomes aware of information reasonably suggesting that a device has or may have caused or contributed to the death of a patient.

The agency inspected these 17 hospitals after learning that they may have had patient adverse events related to the possible spread of uterine cancer from use of power morcellators or infections associated with duodenoscopes and determining that corresponding medical device reports did not appear to have been made by the hospitals. Six of the 17 hospitals are MedSun program partners, which means the FDA entered an agreement with these facilities to report adverse events related to medical devices.

The FDA issued a Form FDA 483 to 15 U.S. hospitals to notify them of objectionable conditions relating to medical device reporting requirements observed at their facilities. The FDA plans to post redacted versions of the Form FDA 483s in the ORA FOIA Electronic Reading Room.

For some hospitals with significant violations of the MDR regulation, FDA received a response that we determined was not adequate to address those violations, and we engaged with these facilities to facilitate an effective path to voluntary compliance.

Here’s a link to webpage, which has individual links to each of the Form FDA 483 reports issued to the 15 hospitals:

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/HealthCareProviders/UCM526194.pdf

What is FDA’s response to observations gained from the inspections? Were the hospitals reviewed found to be non-compliant with the agency’s reporting requirements?

FDA: The observations noted during the inspections varied by facility but included observations that written medical device reporting (MDR) procedures had not been developed, maintained, and implemented. The chart posted on the FDA’s website provides more details on these observations.

Observations noted during the inspections also included failure to report to the FDA and/or the manufacturer within ten working days after becoming aware of information reasonably suggesting that a reportable event, such as when a device may have caused or contributed to the death of a patient of the facility, occurred.

It is important to note that Form FDA 483 lists observations made by the FDA representative(s) during the inspection of a facility. They do not represent a final agency determination regarding the facility’s compliance.

What is FDA’s rationale for not taking action against these hospitals? Also, is this in keeping with the agency’s history of not criminally prosecuting for failure to report adverse events?

FDA: For some hospitals with significant violations of the medical device reporting (MDR) regulation, FDA received a response that we determined was not adequate to address those violations, and we engaged with these facilities to facilitate an effective path to voluntary compliance.

These hospitals indicated their willingness to work with us and address the violations, and at this time, we do not believe any additional action with regard to these hospitals is necessary. Hospitals also expressed willingness to work with us on more efficient and effective ways to collect the information we need.

The FDA recognizes that device-related deaths and serious injuries that occur in hospitals and other device user facilities may involve nuanced and medically complex circumstances. For example, it may not be immediately apparent to health care providers that a patient’s exposure to a device may have caused or contributed to that patient’s death. Sometimes a patient death could occur at the hospital, months or even years after a patient’s treatment at the facility using the device at issue.

Nevertheless, the FDA considers hospital reporting of device-related patient deaths and serious injuries to be critical to improving the safety of medical devices and improving patient care overall. We are seeking ways to improve this reporting system by increasing awareness of current medical device reporting requirements and challenges hospitals may face when trying to comply with those requirements.

We plan to partner with hospitals to educate them on the agency’s medical device reporting requirements in order to improve their reporting of device-related adverse events.

During the inspection process, did FDA find no evidence of harm caused by power morcellators—or other medical devices—to patients?

FDA: No. We have not changed our thinking on uterine power morcellators. The FDA continues to stand behind the November 2014 warning against the use of power morcellators for the vast majority of women undergoing removal of the uterus (hysterectomy) or fibroids (myomectomy) and continues to believe that the warning is appropriate.

The FDA has required a boxed warning for these devices and also for cleared containment bags to make it clear to patients and healthcare providers that the use of the containment bag has not been clinically demonstrated to reduce the risk of cancer spread during procedures that use power morcellators to remove tissue from the uterus.

How many staff members—or number of current FTEs—are in the division of FDA that reviews medical device adverse events reports? What is FDA’s budget for that department?

FDA: Medical device adverse event reports are reviewed by the Division of Postmarket Surveillance (DPS) in the Office of Surveillance and Biometrics. There are about 40 staff members in that division, though not all of them review medical device reports.

Here’s a link to the website for more information on that division: http://www.fda.gov/medicaldevices/safety/cdrhpostmarketsurveillance/default.htm

Is there a backlog on the number of medical device reports that have not been reviewed, and how long does FDA take to go through the reports?

FDA: FDA receives medical device reports on a continuous basis, and there is no backlog. Data from these reports are entered as quickly as possible into the FDA’s database and are available for review by MDR analysts. Each report is reviewed, redacted, and posted on Public MAUDE.

FDA applies a risk-based approach to reviewing MDR reports, consistently reviewing 90 percent of death reports with five days; and 90 percent of Code Blue reports within 72 hours. Code blue MDRs are defined as high priority MDR reports based on criteria including but not limited to: pediatric deaths, multiple deaths and serious injuries, device explosions, and electrocution.

FDA reviews these reports as one of many data sources to identify signals and trends to inform ‎and support decision making for both premarket and post-market activities.