By Mike Neilson, Section Leader, Healthcare Reprocessing, BS, RM(NRCM) CQPA(ASQ)
When you hear the term “reusable medical devices” you may think of surgical instruments like forceps or scissors. Reusable devices often have intimate patient contact, become grossly soiled during use and need to be reprocessed before their next use. Reusable device manufacturers are well aware that these types of devices require cleaning and disinfection or sterilization validations before they can be sold to hospitals or other patient care facilities.
However, device manufacturers may not realize that many non-patient contacting devices also require cleaning and disinfection validations. The FDA expects these validations be performed for any device surface in a patient care setting that may become contaminated with blood-borne pathogens or other potentially hazardous organic material. This would include adjustment knobs, handles, carts, cables, monitors, probes, and docking stations.
Cross-contamination is a growing concern in healthcare settings where patient infections continue to be prevalent. The FDA is requiring device manufacturers to consider the human factors that exist. If a non-patient contacting surface becomes contaminated, there is a real potential that unwanted materials could be transferred back to a patient via gloved hands or other means.
Worst-case scenarios should also be considered. A sheath may be used to keep a probe from becoming contaminated, however, what if the sheath were to break? Validations should simulate these types of worst-case scenarios in order to create cleaning and disinfection procedures that are appropriate for any adverse situation that may arise.
Testing for non-patient contacting devices can be tricky. These devices are often larger than a typical reusable device, creating difficulties with cleaning, extracting and testing. A monitor or probe docking station for example, cannot be simply submerged in fluid and extracted. Because these devices will often be processed at the point of use and not by the sterile processing department, manufacturers need to consider what cleaners or disinfectants will be readily available in the specific patient care setting where the devices will be used.
Nelson Labs has a lot of experience in performing these types of tests and can greatly assist medical device manufacturers to ensure their reusable non-patient contact devices are appropriately validated.
We have test soils that simulate many different types of clinical contamination. We also have experience in helping our clients create clinically relevant contamination scenarios. We are comfortable using adjusted testing techniques to adequately process devices that are large or are susceptible to liquid and cannot be submerged. We also have an array of validated quantitative methods for evaluating device cleanliness post-cleaning.
Because of the increased requirements and accountability from the FDA, Nelson Laboratories recommends that companies who manufacture these devices begin conducting validations if they have not already done so.