10/13/2011
By Alpa Patel, Department Scientist, Hospital Reprocessing, BS, RM(NRCM)
As technology advances, so does the complexity of the medical devices. The industry of reusable medical devices is facing increased scrutiny to previously accepted validation methods. Cleaning, disinfection and sterilization methods are being analyzed in greater detail by the FDA. The FDA is recommending increased testing procedures that more closely simulate actual and clinical use.
The FDA would like to see validations performed in worst case scenarios. These scenarios include:
- using clinically relevant soils
- performing more runs of the validation
- performing an exhaustive extraction to obtain an extraction efficiency
- end of use life testing
All these points are explained in a greater detail in the FDA draft guidance document that was published in May of this year.
Manufacturers will need to use test soils that simulate actual use and are clinically relevant. TIR30 has a list of test soils that are commonly used for cleaning validations. Additionally, the FDA is requesting worst case dwell times (i.e. 4 hrs, 8hrs, or 24hrs, when the test soil is dried onto the devices) tested in the validation testing (dwell time indicates time between patient use and the actual cleaning procedure).
Through recent FDA responses we have determined that the FDA would like manufacturers to perform testing on three test validation runs for cleaning validations preferably on the same devices to show reproducibility. This is a change from previous practices and is catching many manufacturers by surprise. Some manufacturers have been required to redo testing to provide the three run data.
The FDA also requires cleaning validations analyzed through a series of assays such as protein, hemoglobin, carbohydrate, endotoxin, and Total Organic Carbon (TOC). The FDA is focusing more on the above cleaning markers than on bioload reduction Bioload reduction alone does not indicate the efficacy of the cleaning process. The FDA would like to see the manufacturers validate their device using the detergent’s dose and time specified on the detergent labeling.
Nelson Labs has been a leader in reusable device testing and recommends that reusable medical device manufacturers conduct the expanded validation requests per these new requirements. All of these recent FDA requirements are part of the consultation provided by Nelson Labs. Manufacturers should also strongly consider using the new FDA guidance when determining their validation plan. Failure to test according to the new guidance document may result in increased risk and delays in product launches.
Nelson Labs will be attending the FDA Summit October 11-12 where these issues will be discussed in greater depth. Nelson Labs have been involved with the manufacturer’s and the FDA to address the changes to the validations and will continue to be involved in the future changes.