MEDISISS Response to FDA Article
In July, 2009, the US Food and Drug Administration (FDA) issued a warning on its web site, reporting the presence of residual tissue on some Arthroscopic Shavers despite the fact the manufacturers’ cleaning instructions were allegedly adhered to by the healthcare facilities in question. The following is MEDISISS’ response to the FDA’s report; we shared this response with our customers within a week of the warning’s issuance.
July 17, 2009
Dear Valued Customer,
Recently an article surfaced on the FDA’s website entitled "Ongoing Safety Review of Arthroscopic Shavers" which reports that residual tissue has been found on some Arthroscopic Shavers.
First and foremost, MEDISISS shares the FDA’s concerns relative to such findings. It is important to note, however, that this article refers to the cleaning protocols surrounding the use of reusable Arthroscopic Shavers as opposed to Single Use Arthroscopic Shavers which are reprocessed by FDA-registered medical device reprocessing companies such as MEDISISS.
Nonetheless, we took the FDA’s report very seriously and immediately conducted research with regard to the Arthroscopic Shavers we provide our customers. After an extensive search of all records we did not find any reference to residual tissue problems relative to our shavers or any others that are produced by FDA-registered reprocessors.
Please note that original manufacturers of reusable devices are required to provide cleaning instructions with their devices. In an effort to avoid problems such as those referenced by the FDA, this warning is aimed towards facilities that use and then internally clean reusable shaver blades. Reusable devices must be cleaned and sterilized in strict accordance with the OEM’s specifically described instructions and internal protocols must be established and monitored to ensure proper sterilization.
Reprocessors, such as MEDISISS, are held to incredibly stringent standards relative to the decontamination, cleaning and sterilization of Single Use Devices. As it relates to decontamination and cleaning , MEDISISS performs a series of soaks and mechanical flushes with enzymatic and disinfectant solutions. These steps are performed at the initial cleaning and decontamination stages of our process and then again near the end of the refurbishing process. Devices are then rinsed using proprietary rinsing and drying agents and individually inspected under microscope at least twice before the products are packaged, labeled, sterilized and shipped.
With regard to sterilizing devices, MEDISISS has validated a sterilization cycle that is adequate to ensure a Sterility Assurance Level, SAL, of 10-6. In fact, MEDISISS employs the standard "overkill method" of sterilization wherein devices are exposed to ETO for twice the length of time needed to reach 10-6 SAL. In addition, MEDISISS must ensure that the level of EO residuals is safe prior to returning any device to a customer and that the sterilization process has not adversely affected the product materials.
As a final thought, contained within the GOA’s 8-year study which focused on the use of Reprocessed Single Use Devices, it was reported that Single Use devices do not present an elevated health risk. In addition, this study also noted that "none of the representative ... hospitals who participated in the FDA focus groups reported being aware of any infections related to the use of reprocessed SUDs."
I hope this information proves helpful; in the event that you have questions or would like additional data, please feel free to call me. My contact information is provided below. Thank you.
Ken Diebner
Vice President, Sales & Marketing
ph: 541-923-3310
kdiebner@medisiss.com
www.medisiss.com
Redmond, OR 97756
866-866-7477
To read FDA Article, click here.