FDA warns bronchoscope manufacturer for complaint handling, validation issues
The manufacturer of a rigid bronchoscope system received a warning letter last month from the US Food and Drug Administration (FDA) for lack of adequate evaluation of complaints that components of the system separated during procedures, together with other deficiencies.Massachusetts-based Lymol Medical Corporation (Lymol) manufactures the Medical Elite X Class Rigid Bronchoscope System and the Lymol Medical Optical Telescope. The FDA warning letter of 7 April 2020 followed a February 2020 inspection at which an FDA investigator discovered a failure to validate manual cleaning, sterilization, and storage conditions for both devices.
The inspection found that a design change made during production that would prevent the telescope becoming stuck within the bronchoscope was approved and implemented without validation. The FDA found that this change wasn’t tested under actual conditions of use or simulated use conditions, so safety and effectiveness of the device could not be proven.
Lymol also failed to evaluate complaints to determine whether they required reporting to the FDA. The warning letter cited Lymol’s own procedures, which call for the company’s quality assurance staff to complete a Medical Device Reporting (MDR) decision tree in the event of a reported event or problem. Two separate complaints filed with the company reported separation of two components of the bronchoscope during operation. No MDR decision tree was completed in either case. In the second case, Lymol documented that no injury had occurred to the patient as the result of the uncoupling, although the box on the relevant form indicated that it was “unknown” or “not reported” whether injury had occurred.
Another two complaints from the same facility reported repeated problems with O-rings detaching from the barrel during the sterilization procedure. Two months elapsed between the first and the second complaints without investigation by Lymol, according to the warning letter.
Lymol also did not enter into a quality agreement with a critical supplier of components for the bronchoscope system. “Your firm failed to ensure that purchased or otherwise received product or services conform to specifications since there was no agreement between both parties on the methods of quality assurance that will be used to decide the acceptability of product or services (Bronchoscope components),” noted the warning letter.
Further, production processes were not developed, conducted, controlled or monitored to ensure the device conforms to specifications, according to the letter. Assembly was observed during which the employee did not measure torque as components were tightened, contrary to Lymol’s assembly procedure for the bronchoscope’s universal barrel.
Further, device history records did not include required batch records or labeling. Finally, in 2019, Lymol had stopped filling out assembly inspection reports for all but three components of the bronchoscope system, telling inspectors that “there had not been any issues with the parts,” according to the warning letter.
Lymol received a previous warning letter in January, 2019 for failing to comply with milestone dates for completion of postmarketing requirements for a sterile talc powder product. Its predecessor company, Bryan Corporation, in 2007 agreed to pay a $4.5 million fine in a criminal prosecution brought by the Massachusetts US Attorney’s office for conducting interstate commerce of a misbranded drug and an adulterated device, and for corruption in obstructing a federal investigation.