publication date: Dec. 16, 2016
FDA Finds Lapses in Reporting of Patient Harm, Deaths Resulting from Medical Devices in Hospitals Nationwide
By Matthew Bin Han Ong
Rep. Mike Fitzpatrick (R-Pa.), a staunch advocate for mandating individual reporting of adverse events by physicians
After a broad survey of reporting standards at hospitals across the U.S., an FDA investigation recently concluded that the vast majority of the 17 institutions inspected did not file timely reports of injuries and deaths caused by medical devices.
The inspections earlier this year were triggered by public scrutiny of power morcellation, a surgical procedure known to spread undetected uterine cancer via the device’s spinning blades, as well as by reports of infections associated with contaminated duodenoscopes, flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine.
“While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, we did not see corresponding adverse event reports in our adverse event (MAUDE) database,” Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, acknowledged in a blog post.
These findings notwithstanding, FDA imposed no penalties against hospitals that failed to comply with the reporting requirements. A conversation with FDA officials appears here.
The agency’s report was published weeks before President Barack Obama signed the 21st Century Cures Act, a comprehensive health care reform and research funding measure that some critics lambasted for not including a medical device safety bill designed to address systemic lapses in reporting of adverse events (The Cancer Letter, Dec. 2).
The full FDA report, with links to the agency’s observations at individual hospitals, can be downloaded here.
In a three-year investigative series, “How Medical Devices Do Harm,” The Cancer Letter focused on failure on the part of hospitals and device manufacturers to report patient death and injury resulting from power morcellators.
The most prominent of these stories revolved around two women who were harmed by power morcellators: Erica Kaitz, the late wife of a Boston attorney, and Amy Reed, at the time an anesthesiologist at Beth Israel Deaconess Medical Center, who underwent power morcellation at Harvard-affiliated Brigham & Women’s Hospital on Oct. 17, 2013 (The Cancer Letter, July 4, 2014).
After Reed and her husband, Hooman Noorchashm, realized that the device contributed to the upstaging of her unsuspected leiomyosarcoma, the couple learned that they were not the first to be affected (The Cancer Letter, Nov. 21, 2014).
Kaitz, who underwent the same procedure at the same hospital over a year before Reed, died on Dec. 7, 2013, from metastatic disease. As Kaitz was dying, Reed was recovering from her first round of treatments.
Reed learned that she could have avoided power morcellation—alas, gynecologists at Brigham, who knew of the risks, didn’t inform her or report Kaitz’s case to FDA (The Cancer Letter, Dec. 18, 2015).
In the years since, over 300 patients and families have come forward claiming harm. FDA said it did not receive any reports of adverse events involving power morcellators before December 2013 (The Cancer Letter, Nov. 20, 2015).
Brigham: We Thought the Cases Weren’t Reportable
During the 2016 inspection, FDA found that Brigham & Women’s Hospital did not—upon becoming aware of patient injury or death—submit adverse outcome reports to FDA or to device manufacturers within the 10 working days, as required by federal law.
The agency’s observations during its inspection of Brigham can be downloaded here.
A Brigham spokeswoman said to The Wall Street Journal and The Boston Globe that the hospital contacted the FDA by phone in March 2014 about Kaitz and Reed. However, hospital officials did not believe the events were reportable because the cases did not meet the criteria for mandatory reporting, the spokeswoman said.
“The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences,’’ the spokeswoman said in an e-mail.
In April 2014, FDA issued a safety advisory against power morcellators, finding that 1 in 350 women with symptomatic fibroids are at risk of having an undetected cancer upstaged by morcellation. Two years later, the agency allowed containment bags to be used with power morcellators to prevent spillage of tissue: the bags were developed by Advanced Surgical Concepts Ltd. of Bray, Ireland, and introduced Nov. 15 by Olympus America Inc. (The Cancer Letter, April 8).
Brigham is defending against medical malpractice lawsuits filed by Richard Kaitz and Reed’s husband Noorchashm, formerly a surgeon at Brigham and Thomas Jefferson University Hospital. Earlier this year, Brigham chose not to contest the plaintiffs’ offers of proof at a Massachusetts tribunal (The Cancer Letter, May 13).
Other hospitals linked to patient harm resulting from power morcellators—Rochester General Hospital and the University of Rochester Medical Center—were found to lack written medical device reporting procedures and did not meet documentation and recordkeeping requirements, according to the FDA report.
The inspection also found lapses at hospitals including Massachusetts General, UMass Memorial, New York Presbyterian Hospital, and UCLA Ronald Reagan Medical Center, which “failed to provide all information concerning individual adverse event reports that is reasonably known to them, including information found in documents in possession of the user facility,” the agency wrote in the report.
In 1990, Congress mandated adverse event reporting by hospitals, also known as user facilities, to complement similar reporting by manufacturers. In 1997, Congress also required that FDA establish a reporting program that could limit hospital reporting to a subset of representative user facilities.
The agency subsequently set up a network of 300 hospitals, called MedSun, or the Medical Product Safety Network. Even with MedSun, all hospitals were required to continue reporting until FDA implements, by regulation, a program limiting user facility reporting to a subset of facilities.
“Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren wrote in the blog post. “We want to work with all hospitals to address these issues.”
The report comes over a month after the House Committee on Energy on Commerce launched a review of the FDA Office of Criminal Investigations over “management concerns,” insufficient performance measures, and morale issues.
The House probe follows a Reuters report detailing how OCI managers forced FDA agents to pursue cases involving mislabeled foreign-imported injectable drugs at the expense of cases with more potential to protect the public health.
In related news, the Government Accountability Office is expected to complete its report on the controversy over power morcellation in January 2017.
FDA: No Action Against Hospitals Necessary
FDA officials determined that no “additional action with regard to these hospitals is necessary,” despite acknowledging that there is widespread noncompliance with federal reporting requirements.
“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,” the agency said to The Cancer Letter. “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.”
Device-related deaths and serious injuries that occur in hospitals and other device user facilities may involve complex circumstances, agency officials said.
“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,” officials said. “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.”
FDA’s answers to questions from The Cancer Letter appears here.
Taking no action would constitute a “dereliction of duty” on the part of FDA, said Noorchashm, who launched an aggressive campaign against power morcellation after Reed underwent the procedure in late 2013.
“If a federal agency finds a corporation in non-compliance with federal laws within their jurisdiction, especially when unsuspecting citizens have died or been severely harmed, I am not sure it is legal for the agency to not take any steps towards prosecution, at the very least,” Noorchashm said to The Cancer Letter. “In the case of the power morcellator, there was clearly corporate negligence—at best professional lethargy—at work.
“For FDA to just write a useless letter comes nowhere near the magnitude of pain this bad professional behavior has imposed on the many women and families affected. In the end, I think either the FDA or the Office of the Inspector General will act in accordance with their responsibility to publicly prosecute the culprit organizations—if for nothing else, to demonstrate that this type of legal non-compliance is not acceptable in the United States.”
In December 2015, agency officials said they were not aware of criminal prosecutions that have resulted from a failure to report adverse events (The Cancer Letter, Dec. 18, 2015). Moving forward, FDA officials say they plan to improve compliance through awareness and education programs.
“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,” FDA officials said. “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.”
On Dec. 5, the agency held a public workshop to solicit input and advice on improving hospital-based surveillance systems, including the incorporation of unique device identifiers into electronic health records to aid generation of evidence.
“In order to effectively address these issues, we will work with the hospital community on what role they should play in assuring the safe use of medical devices,” Shuren wrote in the blog post. “This work will include how they can effectively participate in the National Evaluation System for health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers.”
NEST, developed under a cooperative agreement between FDA and the Brookings Institution, is designed to link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims (The Cancer Letter, Dec. 18, 2015).
“Although FDA has recognized that requiring all hospitals and other user facilities to report may provide limited added value and could entail unnecessary costs that take away from patient care, we have not yet established the program limiting reporting to a subset of user facilities,” Shuren wrote. “In the past, we have not enforced universal reporting requirements for hospitals and other user facilities.
“We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path, especially in light of developments in the creation and evaluation of electronic health information.”
Continuing a Legacy
In 2015, two years after Reed and Noorchashm launched their campaign against power morcellation, their House member, representing Bucks County, Pa., publicly joined their cause, writing letters to hospitals and federal agencies.
Rep. Mike Fitzpatrick (R-Pa.) proved to be an effective ally. Having served in the House for a total of seven years over the last decade, Fitzpatrick rallied his colleagues on Capitol Hill, demanded answers, pushed for investigations, and lobbied heavily for more stringent reporting requirements.
Even Vice President Joe Biden’s Cancer Moonshot was considered fair game: in a letter, Fitzpatrick asked Biden to advocate for medical device safety in his moonshot efforts (The Cancer Letter, April 15).
In June, Fitzpatrick and Rep. Louise Slaughter (D-N.Y.) introduced two bills designed to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices (The Cancer Letter, June 10).
One of the bills, the Medical Device Guardians Act, would require individual practitioners to report adverse outcomes, in addition to current statutes requiring institutions—hospitals and manufacturers—to report.
In a Capitol Hill interview with The Cancer Letter earlier this year, Fitzpatrick said he was working to include his bill’s individual mandate in the 21st Century Cures Act.
“This would codify a simple provision that’s already in the Code of Ethics of the American Medical Association,” Fitzpatrick said. “So it’s already a responsibility of all physicians. I think it should be codified in federal law.”
A video of the interview is posted here.
Fitzpatrick’s efforts to amend the Cures Act were unsuccessful, and he ended up voting against the bill in disappointment (The Cancer Letter, Dec. 2).
“It was a badly missed opportunity for some very prominent congressional representatives and senators to provide an effective and relatively cost-neutral measure to bring some measure of security to medical device space,” Reed and Noorchashm said in a joint statement to The Cancer Letter. “They missed this chance or floridly ignored it.”
Sources familiar with FDA drug and device regulation pushed back against the idea of an individual reporting mandate, saying that it is an ineffective method of tracking events as well as an inefficient use of the agency’s resources to sift through the potential thousand-fold increase in adverse outcome reports (The Cancer Letter, Dec. 18, 2015).
“There are some that definitely think the federal government shouldn’t mandate reporting, and I would say, in the first instance, that if the reports were flowing into the FDA without that mandate, we would understand that,” Fitzpatrick said to The Cancer Letter. “In the case of the power morcellator, there were zero reports to the FDA until Amy Reed stepped up and provided the first report as a patient. So something was wrong with the reporting.
“And then the second point is, if the mandate leads to safer devices, better therapies, more cures, patient safety, and something positive in the health care profession, we shouldn’t just back down because it’s another mandate. If it’s a mandate that saves lives, it’s a good mandate.”
Fitzpatrick, who underwent surgery for cancer in October, is leaving Congress to comply with his pledge to serve no more than three consecutive terms. His younger brother, Brian, an attorney and a former FBI supervisory special agent in California, ran for his seat and won the election Nov. 8.
Brian will continue his brother’s efforts on medical device review reform as well as increased safety standards. On the campaign trail, he pledged to “reform the FDA incident and compliant process so that patients are empowered to report faulty technology or treatments which have caused unintended harm—from Essure [a female permanent sterilization device] to power morcellators.”
Reed and Noorchashm said they would continue to work closely with Brian Fitzpatrick on bringing the Guardians Act into law, even as Reed is recuperating from major abdominal cancer surgery. She has been scheduled for treatment of other metastatic lesions throughout her body in 2017.
“We are anxious to understand what the GAO report has to say about the power morcellator disaster,” Reed and Noorchashm said. “Certainly, we believe that this report ought to reinforce the need for defining physicians as legally mandated reporters of safety concerns with medical devices, because the power morcellator disaster was, in fact, a result of a failure to report a deadly complication on the part of many professionals who knew of the problem quite well—some for well over 20 years.
“We are also pressing ahead with all possible immunotherapy, adjunctive therapy and chemotherapy options to cure the leiomyosarcoma that has affected our family.”