January 26, 2021 – A manufacturer began removing a bronchoscope model from use, worldwide, in response to some regulatory and safety questions, according to a letter it issued to users last summer, though this action may not yet have been completed in the U.S.
Reports submitted to the FDA weeks ago, in November and December, suggest the device is still in use. None of these regulatory reports links the bronchoscope to a patient harm or infection, however, and this device’s use appears consistent with the terms of this recall action.
Two years earlier, the manufacturer had recalled this same bronchoscope, but apparently because of a different quality issue.
One of the recent reports filed in December describes a cultured bronchoscope twice testing positive for bacteria after cleaning and disinfection,* also known as reprocessing. This regulatory report states that the cause of this device’s contamination, identified at a U.S. facility, had not yet been determined.
Three months earlier in September, the manufacturer had informed healthcare professionals, by way of a letter dated August 31, 2020, that it had begun to remove this device — the BF-Q180 bronchoscope. The FDA’s database listed the notice of this removal action the next month on September 25th. This action, like this model’s earlier recall in 2018, was classified as Class II device recall.
According to this notice, the manufacturer began removing this device from use in part because it “does not have a 510(k) clearance.” Federal regulations require manufacturers of bronchoscopes and many other types of medical devices to submit a 510(k) notification to the FDA prior to marketing the device in the U.S.
When a device is “cleared” through this process, the FDA issues the manufacturer an order — or, 510(k) clearance — in the form of a letter stating that the Agency has concluded the device to be “substantially equivalent” to (or “as safe and effective as”) a legally marketed device called the “predicate.”
The September 25th notice additionally states that the BF-Q180 bronchoscope model is being recalled by the manufacturer because the device “is associated with a higher rate of patient infections than other comparable” bronchoscopes the company also markets. According to the manufacturer’s accompanying August 31st letter, however, this risk is “low (0.01%).”
This removal action affects 5,813 BF-Q180 bronchoscopes distributed worldwide including 2,648 devices distributed throughout the U.S., this September 25th notice reports. Bronchoscopes are used to examine a patient’s throat, larynx, trachea, and lower airways. Approximately 500,000 procedures are performed each year in the U.S. using a bronchoscope.
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A “transition” period, “past changes”
During this transition time, facilities may continue to use the BF-Q180 bronchoscope clinically, the August letter states, “until suitable alternatives are sufficiently available.” However, the recall requires that the user “prepare and inspect” the bronchoscope “before each procedure, as described in its Operations Manual.”
The manufacturer also recommends that, during this transition time, users continue to adhere to the BF-Q180 device’s “Instructions for Use related to reprocessing,” and cautions that any endoscope “showing any irregularity should not be used but rather returned to (the manufacturer) for service.”
Addressing this device’s regulatory status, the manufacturer’s August 25th letter states that the BF-Q180 bronchoscope had apparently undergone some “past changes” for which the company has concluded “a better approach would have been to submit a 510(k). “
The letter clarifies that “since this product is now being recalled we do not plan to submit a new 510(k).” The FDA originally cleared this bronchoscope model in 2006.
While not every change to a legally marketed device necessitates the submission of a new 510(k) submission, the FDA generally requires manufacturers to submit a new premarket notification whenever a legally marketed device (that is subject to the 510[k] requirements) undergoes a change or modification that could significantly affect its safety or effectiveness.
The BF-Q180’s recall in 2018
Two years before beginning last summer to remove the BF-Q180 bronchoscope model from use, the manufacturer had recalled this device along with almost two dozen other bronchoscope models, the FDA’s device recall database indicates.
The FDA’s database listed the notices of these device recalls on September 29, 2018. Explained in these notices, one for each affected model, the bronchoscopes were recalled because of a potential quality matter.
These recalls in 2018, however, did not require that the BF-Q180 and other affected bronchoscope models necessarily be removed from use. Instead, the recall notices advised that the devices could remain in clinical use provided certain safety criteria were satisfied as detailed in the recalls’ instructions.
The bronchoscopes were recalled, the notices explained, because the attachment of other companies’ accessories to the bronchoscope’s instrument channel (or biopsy) port “may have resulted in more applied force than expected and lead to loosening of the instrument channel port.”
Use of an endoscope with a loosened port could possibly hinder effective cleaning and disinfection, the manufacturer acknowledges. The types of accessories in question that a clinician might attach to a bronchoscope’s instrument channel port are not identified in the recall notices, but presumably would include endotherapy devices.
In 2019, Mehta and Muscarella authored an article in Chest that discussed, in part, the 2018 recalls of these bronchoscope models including the BF-Q180 device. Their article provides recommendations to prevent bronchoscopes from transmitting multidrug-resistant bacteria and related organisms.
Additional recommendations intended to improve the safety of bronchoscopes based on these 2018 and 2020 recalls are provided below. (Evidence suggesting that the reasons for the BF-Q180’s recall in 2018 could be related to this past summer’s action to remove this same model from use was not identified, and an association between the two should not be assumed.)
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The BF-Q180’s 2018 recall instructions
Addressing the potential for the instrument channel port of the BF-Q180 device and the other recalled bronchoscope models to loosen under the described circumstance, the 2018 recall notices directed customers to inspect the ports of these models, prior to the device’s use, in accordance with the recall instructions and provided diagrams.
These instructions advised that the device be removed from use and returned to the manufacturer for repair if this port could be manually rotated or turned (in a counter-clockwise direction) or the rubber part around this port was visually found to be “lifted from the molding parts.”
Otherwise, if this port did not rotate or turn and this “rubber part is in a normal condition,” the bronchoscope “can be used in a patient procedure,” the 2018 recall instructions explained. An on-line safety notice letter, dated contemporaneously in October 2018, includes color diagrams that may help users better understand these recall instructions.
In another on-line notice posted around the same time discussing these recalls, users were notified that the manufacturer had identified the potential for the instrument channel (or biopsy) port to loosen while investigating a complaint involving, not a BF-Q180 device, but the BF-1T180 bronchoscope, which was also one of the models recalled in 2018.
Several thousand devices in the U.S. and Canada were subject to these recalls in 2018. Of these, 5,845 were BF-Q180 bronchoscopes in the U.S. and in Canada. Almost as many (5,810) BF-1T180 bronchoscope models were also recalled in these two countries. (These almost two dozen bronchoscope models were also recalled the same year in other countries, too.)
Reports in 2003 about a bronchoscope’s loose “biopsy-port cap”
For background, a study published in the New England Journal of Medicine (NEJM) in 2003 reported the possible infection of patients at a medical facility in Tennessee “as a result of the inadequate disinfection of bronchoscopes because of a manufacturing defect.”
The investigators found that the biopsy-port caps of two bronchoscopes (one cap for each bronchoscope) “were not securely fastened and were easily removable, contrary to manufacturing specifications. The port caps were loose enough to be unscrewed with two fingers but not so loose that the problem was apparent to the bronchoscopy staff.”
Swab specimens from the biopsy port and cap of the two bronchoscopes were positive for Pseudomonas aeruginosa and Serratia marcescens bacteria, the study reported. “The PFGE patterns of P. aeruginosa isolates from the bronchoscopes, patients, and two environmental samples were indistinguishable,” the investigators also found.
Another study published in the same issue of NEJM reported an outbreak of P. aeruginosa infections at a medical facility in Maryland that were “apparently caused by a loose biopsy-port cap in the bronchoscopes,” which may have “sheltered organisms and thus rendered disinfection procedures ineffective.“
This second study concluded, among other findings, that instrument safety and surveillance methods for bronchoscopy “must be improved, and better recall procedures are needed for medical devices.”
These two studies in NEJM are discussed only for historical perspective. (Evidence suggesting that the causes of these two outbreaks reported in 2003 could be directly or indirectly related to the recalls of the bronchoscope models in 2018 or to the action initiated last summer to remove the BF-Q180 model from use was not identified, and an association between the two should not be assumed.)
Recent infections linked to the recalled BF-Q180 bronchoscope
To provide additional insights into the manufacturer’s action this past August to begin removing the BF-Q180 bronchoscope from use, a brief review of the FDA’s database listing potential patient harms associated with medical devices was performed.
In addition to the regulatory reports filed in November and December discussing the BF-Q180 bronchoscope, a year earlier the FDA received a report, dated in August 27, 2019, linking use of the BF-Q180 bronchoscope at a medical facility outside of the U.S. to nine (9) and two (2) possible patient infections of Serratia marcescens and Enterobacter cloacae, respectively.* Whether either organism was “CRE” or another type of multidrug-resistant bacteria is not noted in this regulatory report.
No reprocessing lapses were identified in this report, and no bacteria were recovered when the implicated bronchoscope was sampled. CRE, or carbapenem-resistant Enterobacteriaceae, are a type of multidrug-resistant bacteria whose infections can be associated with a mortality rate of as high as 50%. Carbapenems are “last resort” antibiotics used to treat serious hospital infections.
FDA received other regulatory reports, too, linking the BF-Q180 bronchoscope to possible infections. Nevertheless, no recent cases were identified during this review linking patient infections to a BF-Q180 bronchoscope with a loosened instrument channel port.
However, almost 6 weeks before the device was recalled along with the BF-Q180 and the other affected models because of the potential for the instrument channel port to loosen under the described circumstance, the FDA received a report on August 14, 2018, linking a contaminated BF-1T180 bronchoscope to bacteria found in several patient cultures. The report states that the device “had a loose cap on (the) biopsy port.” No lapses in the device’s high-level disinfection were identified in the report.
One year later, the FDA received another report about a loose biopsy port on a BF-1T180 device that “was reportedly taken apart and foreign residue was present.” The report, dated October 25, 2019, states that no patients were injured, but that this facility in the U.S. “reported the (bronchoscope) was linked to two cases of possible contamination.”
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The following recommendations are provided to improve the safety of bronchoscopes. They are based primarily on the 2018 and 2020 recalls of the BF-Q180 bronchoscope model.
1. Check the facility’s inventory to determine whether any BF-Q180 bronchoscopes are in clinical use.
A. If so, review and follow the instructions discussing this model’s removal (e.g., the instructions in the manufacturer’s August 31, 2020, letter) to ensure compliance and safety.
— These recall instructions may be supplemented with those provided in the recall notice listed in the FDA’s database on September 25, 2020).
B. According to the manufacturer’s August 31st (2020) letter, this recalled model may continue to be used provided “you prepare and inspect your endoscope before each procedure, as described in its Operations Manual. Any endoscope showing any irregularity should not be used but rather returned to Olympus for service.”
C. Contact the manufacturer to discuss both returning the BF-Q180 device and replacement options as instructed in the manufacturer’s August 31st letter.
2. Similarly, check the facility’s inventory to determine whether any of the other bronchoscope models recalled two years earlier, in 2018, are in clinical use. (A listing of the each of these models recalled that year is provided by clicking this text.)
A. If so, review and follow the instructions discussing the recalls of these other models (i.e., the manufacturer’s instructions provided in the recall notices posted on-line on September 29, 2018, one for each of these other recalled models) to ensure compliance and safety.
— For example, perform the inspection procedures described in these recall notices (e.g., confirm that the bronchoscope’s instrument channel port is not loose and the “rubber part is in a normal condition”).
— If the device fails these safety procedures per the recall’s instructions and provided diagrams, do not use the endoscope and return it to the manufacturer for repair, as the recall’s terms specify.
3. Confirm that each of the facility’s endoscope models is associated with a legal FDA clearance and/or the FDA otherwise deems the device’s use legal. (A determination may be facilitated by clicking this text and inserting the data into the provided fields.)
A. Contact the manufacturer, if necessary, for more information.
4. Consider performing a risk assessment to evaluate the clinical merits of adopting and applying to bronchoscopes (when deemed feasible and warranted — for example, in an outbreak setting) one or more of the four “supplemental measures” the FDA published in August 2015 to improve the effectiveness of duodenoscope reprocessing.
A. These measures are: (1) microbiological culturing; (2) low-temperature sterilization (e.g., ethylene oxide sterilization); (3) use of a liquid chemical sterilant processing system; and (4) repeat high-level disinfection.
— This 1st listed practice would involve sampling the bronchoscope after reprocessing (e.g., sampling its working channel and instrument channel port) to detect bacterial contamination, especially of “high concern” organisms, such as CRE and related multidrug-resistant organisms.
— Remove the bronchoscope from use for assessment if the device remains persistently contaminated with bacteria after reprocessing performed in accordance with the manufacturer’s instructions, or if the device “shows visible signs of damage.”
— Muscarella (2019) reviewed 23 outbreaks of multidrug-resistant organisms linked to a duodenoscope. Included in his review is a discussion of the mitigations, including ethylene oxide sterilization, facilities in the U.S. and overseas adopted to terminate the outbreaks.
5. Review the recommendations Mehta and Muscarella (2019) published to reduce the risk of infections and improve the safety of bronchoscopes. 6. Review the recommendations the FDA provided in its September 2015 safety communication entitled, “Infections Associated with Reprocessed Flexible Bronchoscopes.”
B. Consider other preventive measures, too, as warranted (e.g., using a borescope to examine the bronchoscope’s working channel for contamination or for irregularities that could pose an infection risk — for example, tears, scratches, perforations and other damage; or the presence of residual soils, biofilms or blood).
Note: This list of recommendations intended to reduce the risk of infection during bronchoscopy is incomplete. Please review the manufacturer’s device labeling and instructions for additional safety guidance.
* Footnote: (1) “Linking” (or “associating”) an endoscope or another type of reusable device to (or with) an infection or an outbreak does not confirm the device necessarily transmitted and caused the infection. More data would be required to conclude more definitively a causal relationship between the device and the infection. (2) Regulatory reports submitted to the FDA routinely describe important clinical cases and experiences, but the findings and conclusions of these reports generally have not been peer-reviewed and may be incomplete, or, at least in part, inaccurate.
Article by: Lawrence F Muscarella, PhD. Copyright (2021). LFM Healthcare Solutions, LLC. All rights reserved. Dr. Muscarella is the president of LFM Healthcare Solutions, LLC, an independent quality improvement company. Click here for a discussion of his quality improvement healthcare services. E: Larry@LFM-HCS.com. Twitter: @MuskiePhD