Dive Brief:
- Renovo received a warning letter in October for supplying reprocessed medical devices without seeking 510(k) clearance from the Food and Drug Administration.
- The letter, which the FDA published Tuesday, accuses Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances. Renovo failed to evaluate how cleaning and re-sterilization of the additional models could affect performance and reliability.
- FDA inspectors also identified problems with Renovo’s approach to air particulate sampling that prompted warnings about the failure to establish control procedures.
Dive Insight:
Renovo cleans medical devices that have been used in procedures such as the ablation of soft tissue for reuse. Renovo has multiple 510(k) clearances that permit the company to supply reprocessed versions of devices such as Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars.
The problem, according to the FDA, is that Renovo has reprocessed models that are outside of the scope of its 510(k) clearances. Discussing the clearance for Arthrocare Ablation Wands, the FDA accused Renovo of reprocessing devices that have “smaller diameter shafts, smaller diameters lumens, and smaller tip elements” than the models included in the 510(k).
“They present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in [the 510(k)],” the FDA wrote. “Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability.”
The warning letter discusses five 510(k) clearances. In each case, the FDA said Renovo added models that were not included in the clearance without evaluating how the different designs could affect the performance of reprocessed devices.
FDA officials also highlighted breaches of current good manufacturing practice requirements. Inspectors found Renovo had not yet set acceptable levels for air particulate in a room where it reprocessed devices. The agency also accused Renovo of failing to assess if a potential issue with an air compressor system affected its product.
Renovo sent a response to the air particulate testing issues in June 2023, weeks after the FDA identified the problems on its inspection of the facility. The FDA said the response “appears to be adequate” and used the warning letter to tell Renovo that it will need to perform a follow-up inspection to assess the corrections.