Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices

Table 4 A timeline of significant events associated with the STERIS System 1 and System 1E

Year	Events
1988	The Food and Drug Administration (FDA) grants the STERIS System 1 (“SS1”) and its accompanying Steris 20 sterilant a 510(k) clearance (reference No. K875280)[19]
1992-1998	Several articles questioning the safety and effectiveness of the SS1 are published[21,29,33,38-40]
1996	The FDA grants a 510(k) clearance for a biological indicator (BI) to be used exclusively with the SS1[25]
1999	A hospital in New York City (NY) links patient injury to the SS1[34,35]
1999	The CDC writes a report that links the SS1 to patient injury[34]
February 2000	The safety and effectiveness of the SS1 is questioned in the newspaper Investors Business Daily[25]
October 2000	Another article questioning the safety of the SS1 is published[36]
April 2001	The FDA raises doubts about the “sterility” of the SS1’s filtered rinse water and, therefore, about the SS1’s effectiveness[32]
2002-2004	Two articles questioning the labeling claims, effectiveness and safety of devices (like the SS1) labeled to achieve liquid chemical sterilization are published[23,31,36,37]
2003, 2004	A hospital in Pittsburgh (PA) links patient injuries to the SS1’s rinse water and “defective” water filters[21,90,91]
2003	An ex-employee of STERIS asserts that the SS1 “poses a public health risk”[21,90]
Circa 2004	The federal government investigates whether the SS1 may have been “adulterated”[21,90,91]
December, 2004	The safety and effectiveness of the SS1 is questioned in the newspaper The Wall Street Journal[21]
April, 2008	The safety of the SS1, namely, the validity of its labeling claim that the SS1’s filtered rinse water is “sterile,” is again questioned[22]
May, 2008	On May 15, 2008, the FDA issues a warning letter concluding that the SS1 is adulterated and misbranded pursuant to the Food, Drug and Cosmetic (FD&C) Act[43]. The FDA states in this letter that changes made to the SS1 by its manufacturer could significantly affect the device’s safety and effectiveness
January, 2009	Steris “discontinues” marketing of the SS1 and its Steris 20 sterilant[44]
January, 2009	Steris submits a 510(k) application to the FDA requesting to market this censured and “updated” model of the SS1 known as the STERIS System 1E[44]
July-August, 2009	An article about the SS1 concludes that reusable medical instruments including rigid endoscopes whose labeling lists the (censured) SS1 as a reprocessing method may themselves be misbranded[16]
December 3, 2009	The FDA notifies healthcare facilities that the SS1 has been without a legal approval or clearance (as required for its marketing and sale) since 1988. Facilities are provided a period of 3-6 mo to transition to a legally marketed alternative[41,42,45]
January 5, 2010	While acknowledging that the SS1 is an “unapproved” device that “violates US federal law,” a Canadian health agency writes that it has “no objection” to this device’s continued sale and use[58]
February 2, 2010	The FDA extends for 18 mo (through August 2, 2011) the time period for healthcare providers to stop using the unapproved SS1 and transition to a legally marketed alternative[46]
February 22, 2010	The FDA writes a letter stating that reusable medical instruments including rigid endoscopes listing in their labeling the (censured) SS1 as a reprocessing method are themselves be misbranded[15,48]
April 5, 2010	The FDA grants the “updated” SS1, known as the STERIS System 1E, or SS1E, a 510(k) clearance. Unlike the SS1’s clearance in 1988, however, the SS1E is cleared without a BI or a “sterile water” claim[20]
April 6, 2010	The FDA clarifies the SS1E’s 510(k) clearance, stating that this device’s filtered rinse water “is not sterile” and, therefore, its “final processed devices (or instruments) are not sterile”[51]
April 9, 2010	The FDA again writes about the SS1E’s clearance, adding that “because the rinse water is not sterile, devices processed using liquid chemical sterilization cannot be assured to be sterile”[50]
April-July, 2010	On April 20, 2010, the FDA obtains a Consent Decree of Permanent Injunction, requiring its manufacturer to stop selling the unapproved SS1[52]. Pursuant to this Injunction, each healthcare provider continuing to use the SS1 (and to receive service, parts, consumables, accessories, including purchase and use of the Steris 20 sterilant) are required to complete and return to the SS1’s manufacturer a signed Certificate of Medical Necessity (CN) by July 2, 2010[53,54]
March, 2011	The FDA extends the use of the unapproved SS1 for 6 more months, until February 2, 2012[55]
December, 2011	The FDA again extends the use of the unapproved SS1 (and both the sale and use of its Steris 20 sterilant) for 6 more months, until August 2, 2012[47]. This time, however, the FDA requires healthcare providers continuing to use the SS1 (and to receive service, parts, consumables, accessories, including purchase and use of the Steris 20 sterilant) to sign, complete, and comply with a Certificate of Transition, which is to be returned to the SS1’s manufacturer by February 2, 2012[47]
February 2, 2012	Healthcare providers who have not completed and returned to its manufacturer a signed Certificate of Transition by February 2, 2012, will be prohibited from using the unapproved SS1 and from purchasing its accompanying Steris 20 sterilant[47,52-54]
March 30, 2012	The FDA grants a 510(k) clearance for a spore test strip (i.e., a BI) to be used exclusively with the SS1E
August 2, 2012	According to the FDA, healthcare providers (who had returned a signed Certificate of Transition to the SS1’s manufacturer by February 2, 2012) can no longer use the unapproved SS1 after August 2, 2012[47]