, according to a new study presented at the American Society for Reproductive Medicine’s 2023 meeting.
ETCs are medical devices used routinely in assisted reproduction. The findings highlight the need for increased vigilance in tracking and reporting adverse events associated with these devices, according to the investigators.
“With hundreds of thousands of embryo transfers being performed per year, surveillance of the safety, performance, and quality of embryo transfer catheter devices is critical and should not be taken for granted,” said Anita Madison, MD, MPH, from the division of reproductive endocrinology and infertility at Johns Hopkins School of Medicine, Baltimore, who led the study. “There are a variety of transfer catheters with different indications, with little data on the superiority and safety of the brands compared to one another.”
Although the number of reported adverse events associated with ETCs is relatively small, the problems can significantly affect patient care, the researchers said.
Dr. Madison and her colleagues used the Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events associated with ETC devices. The MAUDE database is a voluntary reporting system that holds hundreds of thousands of medical device reports of suspected device-associated deaths, injuries, and malfunctions reported to the FDA annually.
For each adverse event in the database linked to an ECT, the researchers collected information related to the brand of the device, the nature of the event, and the nature of the reporter. The researchers omitted the device and manufacturer names from the presentation of the study findings, delineating them only as “Brand 1,” “Brand 2,” “Brand 3,” “Brand 4,” or “Other.”
Problems with devices included contamination, packaging problems, malfunction, mechanical flaws, and material separation. Patient-level adverse events included retaining of foreign body, trauma, malfunction, or failed embryo transfer.
Between 2014 and 2023, Dr. Madison and her colleagues identified 101 adverse events associated with ECTs in the database. About 25% of these occurred in 2018, with 27 cases reported. Contamination was the most prevalent problem, found in 68 reports; oil was the most common contaminant.
The distribution of types of adverse events varied, depending on ETC brand. A breakdown of occurrences revealed high numbers for Brand 2, with 52 adverse events. Although Brand 3 accounted for only 16 adverse events, the majority of these were related to device separation.
“That finding stood out,” Dr. Madison said.
Nearly 1 in 4 (22%) of all reported incidents led to overt patient harm. Retention of a foreign body was the prime type of injury, occurring in 12 cases. Malfunction and injury were found in four cases each, with two failed embryo transfers reported, Dr. Madison said.
Because the majority of these adverse event reports were submitted by manufacturers (87%) and were rarely submitted by end users (for example, physicians, lab staff), the researchers said their findings likely underestimate such problems.
“I’m surprised the [number of reported adverse events] is as low as it is,” said Kimball Pomeroy, PhD, scientific director at the World Egg and Sperm Bank, Scottsdale, Ariz., who was not part of the study team. “Laboratories are required to report failed devices; they have to have a plan for that.”
Dr. Valerie L. Baker
“It just comes down to underreporting,” added Valerie L. Baker, MD, director in the Division of Reproductive Endocrinology and Infertility at Johns Hopkins Medicine, Lutherville, Md., who was not affiliated with the study.
“In two of these reports, they failed to transfer the embryo; they actually lost the embryo,” Dr. Pomeroy added. “That’s drastic for those patients; it’s a serious problem that needs to be addressed.”
Citing these findings, the authors underscored the need for heightened surveillance of ETC devices and recommend further studies to assess the sensitivity of these procedures for attempting pregnancy. They urge physicians and lab staff involved in these procedures to exercise continued vigilance and to improve the reporting of problems with ETC devices.
Dr. Madison, Dr. Baker, and Dr. Pomeroy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.