FDA reprimands two device firms for multiple violations

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently warned two foreign medical device companies – a manufacturer of microcatheters and a laparoscopic instrument maker – for issues including failing to follow through on corrective actions plans, not seeking necessary approval for a new device use and a lax materials testing program.
 
The targets of the warning letters, which were posted to FDA’s website on 7 February, include Costa Rican firm MicroVention, which makes microcatheters, and German firm Getsch+Hiller Medizintechnik GmbH, a maker of Class II monopolar laparoscopic instruments. Both companies export products to the US market.
 
The warning letter to MicroVention followed a four-day inspection in late-May 2022; one of the problems was the company’s failure to verify that its washing procedure “sufficiently removes foreign material from the manufacturing process,” rendering the devices adulterated.
 
For example, the validation process and corrective actions “fail to address the residual sterilant levels after the changed catheter wash procedure and device sterilization.” FDA referenced the international standard ISO 10993-7, which states that ‘a valid method of extraction and measurement shall be used to determine the amount of EO [ethylene oxide] and, where necessary, ECH [ethylene chlorohydrin] delivered to the patient.”
 
In other areas, FDA said the firm’s corrective and preventive actions (CAPA) plan is lacking in that it fails to identify rejects as nonconforming product and “misses all nonconforming product during the manufacturing process as a quality data input to the CAPA system.” Such a problem “greatly” diminishes the firm’s ability to detect recurring quality issues.
 
Firm needs to seek approval for reprocessing
 
FDA also issued a warning letter to Getsch+Hiller Medizintechnik for multiple violations, including failing to establish and maintain procedures for accepting incoming product. During a three-day inspection in mid-July, the investigator “identified multiple raw materials that according to staff had not gone through your firm’s incoming acceptance process,” yet these materials were located next to approved raw materials.
 
The firm also failed to obtain approval for its monopolar laparoscopic instruments for use with reusable tip inserts. While the company offers its monopolar single use laparoscopic instruments in two designs, a 2-part system and a 4-part system, it also manufactures reusable tips with reprocessing instructions that state the tips can withstand 50 reprocessing cycles. This goes “significantly beyond the clearance in K171523 and provide[s] evidence that device components that were cleared for single use are now intended for multiple use following reprocessing.”
 
FDA said that such a change from single use tips to reusable tips represents a change or modification of the device “that could significantly affect the safety or effectiveness of the device, for which your firm lacks clearance or approval.”
 
The firm also failed to establish and maintain a design history file for products.
 
Both firms have 15 days to respond.
 
MicroVention
 
Getsch+Hiller