1. The cleared SS1’s circulation pump was a [redacted] pump. In 1999, the pump was changed to [redacted] pump. According to internal Steris documents, the original circulation pump failed for low flow performance and seal leakage that resulted in decreased SS1 reliability and consumer complaints. The change to [redacted] pump altered the flow rate, the now characteristics, and the flow through the lumen of the device. These changes significantly impact the function and delivery of the sterilant to and through an instrument.
2. The cleared SS1’s high pressure pump was an [redacted] pressure pump with a flow rate of [redacted]. In 1992, you developed a new model SS1, Model 90. This new model had a [redacted] high pressure pump with a flow rate of [redacted]. In 1995, as a result of consumer complaints of the Model 89 series high pressure pump leaking, your firm began installing pressure switches in the pumps to monitor the function of the high pressure pump. In 1998, your firm developed an “HP Pump Enhancement Kit,” and in 1999, began replacing the [redacted] high pressure pumps in the Model 89A1 and 90B1 series with the new [redacted] high pressure pumps. The changes to the high pressure pump altered the flow rate and flow characteristics in the SSI and through the lumen of the device. Therefore, these pump changes significantly impact the function and delivery of the sterilant to and through the device being processed.
3. In December 1996, your finn made changes to the original software used in the device as cleared in 1989, in response to reports that customers were receiving high pressure pump alarms due to low facility water pressure. In response, you changed the software program to limit the operation of the high pressure pump to the sterilant exposure phase and the final drain. Because of this software change, the high pressure pump no longer runs during the final rinse phase. This action may affect removal of chemical residues from the processed devices and may pose a risk to the patient.
4. On August 19, 2002, your firm sent correspondence to all of your customers stating that it had changed the connector design on the Quick Connect Kits from individual components to one unit, in which all of the components are tethered together. The design change was initiated following microbiological testing failures related to the older, individual-component connectors. Additionally, new connectors were developed to facilitate the adaptation of the flow unit to the instrument to be processed. These changes to the connectors have a significant effect on the sterile fluid pathway and delivery of the sterilant.
5. The cleared SSI’s chamber volume was [redacted] After 510(k) clearance, your firm increased the chamber volume to [redacted] and then to [redacted] Along with this large increase in the chamber volume, the Sterilant 20 formulation was altered, with the intent of maintaining the final peracetic acid (PAA) concentration given the larger chamber volume. This large increase in chamber volume, which apparently also prompted a change in sterilant formulation, could significantly affect the ability of the system to sterilize by altering how sterilant is delivered and the concentration of ingredients in the sterilant.
6. Following the clearance of the 510(k), your firm added five additional [redacted] ingredients [redacted] and [redacted] to the formulation of the Sterilant 20. This change to the sterilant formulation could significantly affect safety or effectiveness of the device, specifically, the effectiveness of the active ingredient and its ability to sterilize, and by altering the stability of the sterilant.