Medical Device Cleaning Validation: Manufacturers, The FDA And End Users
Improper cleaning of a medical device can have serious consequences. Both hospitals and the original manufacturers of these instruments have to establish controls in order to prevent the issues arising from the presence of contaminants. The Food and Drug Administration (FDA) is responsible for establishing basic criteria but place the onus for developing a thorough program for medical device cleaning validation on the manufacturer.
What Is Expected of the Manufacturer?
When it concerns reusable medical devices, the FDA has certain expectations of the manufacturer. The company must:
- Must test the instrument
- Must validate any of the claims pertaining to reuse
- Must provide clear instructions on the label for any form of cleaning process e.g. cleaning, disinfection, sterilization
- Must make certain the cleanliness level claims are valid
- Must determine the compatibility of the material
Of particular importance is the ability of the manufacturer to provide validation of any and all claims pertaining to the ability of the various forms of cleaning to achieve the stated goals of contaminant removal.
For this to be possible, the manufacturing company has to validate the products through various testing. The company must also provide pertinent information on who has responsibility for performing the validation study as well as who approves it and the acceptance criteria. Suppliers of medical devices as well as end users must also know when they will need to perform a revalidation.
While we tend to consider cleaning as a general term, for those in the business of producing and using medical devices, cleaning, disinfection and sterilization are three distinct processes. Each of these methods requires validation. To ensure a high level of compliance and safety, medical device cleaning validation must act upon each independently.
Medical Professionals and Validation
In hospitals, the need for cleanliness is imperative. From the initial cleaning, to the actual cleaning, disinfection and sterilization, those involved must take care to ensure the procedure follows certain exacting steps. While cleaning removes soil, disinfecting and sterilization are employed to eliminate microorganisms e.g. bacteria. Through the manufacturer, the medical facility or laboratory will have a clear understanding of the protocol to follow. Those involved will know not only how and when to clean the instruments, but also how and when to validate the method of cleaning.
Medical Device Cleaning Validation
Many medical devices are reusable. To ensure they achieve the high levels of cleanliness required for reuse, the FDA has taxed the manufacturing concerns to carry out certain procedures. These include not only testing the instruments but also cleaning them. Of particular importance is the performance of a medical device cleaning validation. This sets parameters, establishes specific methods, lists the necessary instructions and supplies other vital information so those whose lives depend upon the sterile nature of these instruments will not find their trust mislaid.