DTA to Comment on New FDA Guidance
At the June FDA Reprocessing Reusable Medical Devices Conference, FDA staff presented new draft guidance that affects most DTA members.
Several important take-away points for the dental device industry were raised at the conference, including:
1. The impact of the new draft reprocessing guidance.
Dental devices were not specifically referenced at the conference, except with reference to government reports mentioning dental office staff failure to properly process dental devices and boxlocks. Also, CDC advised that there had been an investigation related to complaints that multi-use syringes used in a dental office had visible contamination, possibly from previous patients. Exterior disinfection may be cited by FDA in future reviews. In addition, presentations were offered on the dilemma facing central supply staff in large institutions that have to clean and sterilize thousands of different devices. They encounter poor quality IFUs, sterilization recommendations that do not match the models of sterilizers they are using, difficulty in following cleaning IFUs, and in some cases, manufacturers and websites that are not providing adequate help regarding proper sterilization of equipment..
2. Problems associated with inadequate validation of reprocessing procedures and instructions.
DTA members need to be aware that a major change is taking place in how FDA thinks reprocessing instructions, cleaning, and sterilization need to be handled. This renewed focus will inevitably be felt in the 510(k), IDE, and PMA areas. Reprocessing and associated labeling (IFUs) need to be included in a company’s design control process. Careful attention and effort needs to be focused on validating IFUs. Once the guidance takes its final format, FDA will expect that manufacturers include user feedback in their design inputs. Without feedback from customers/users, it is not possible to validate the cleaning and sterilization procedures contained in your IFU.
3. How the U.S. and the E.U. look at sterilization methodology.
Mention was made several times of the European focus on vacuum sterilization. In the U.S., gravity displacement is generally the preferred method. DTA members who plan to market their products in the E.U. should be aware of this difference and validate their sterilization IFUs accordingly.
New draft guidance may allow lawyers to invalidate a company’s labeling and reprocessing instructions. Thorough and complete validation of cleaning and sterilization procedures, as well as the device’s IFUs, may offer some protection. While much attention was paid to cleaning, disinfection and sterilization, little specific mention was made of infections caused by reprocessed devices. However, accumulated biological debris inside a device could infect a patient. It seems reasonable to expect FDA to start paying more attention to validation concerns during inspections even before it issues the final guidance. Any complaints of infection found in your complaint files could result in further scrutiny by an FDA investigator.
If you haven’t reviewed the guidance document (insert direct link here), please take a moment to do so. A DTA committee will prepare and submit comments before the draft is finalized. To add your opinion, please contact Fred Freedman at the DTA.
We will be reporting additional details about this vital subject in future issues of DTA Update and on DTA’s website.