The FDA changes a deadline, says hospitals have 18 months to replace SS1
Hospital Safety Insider, February 3, 2010
Want to receive articles like this one in your inbox? Subscribe to Hospital Safety Insider!
After further consideration, the Food and Drug Administration (FDA) has extended the deadline to 18 months for hospitals to transition away from using the Steris System 1 (SS1) processor.
Previously, FDA officials said the transition could be made within three to six months. But after hearing from hospitals and others in the industry, the “FDA now understands that a three-to-six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care,” the agency said.
Using the FDA’s original December 2009 announcement of the six-month time frame, this week’s extension would bring the deadline to August 2011.
The SS1 is a popular sterilizing device used by thousands of hospitals and clinics in the United States. The FDA said Steris Corp. of Mentor, OH, modified the SS1 processor and the agency hasn’t approved the modifications yet.
Steris has been critical of the FDA’s stance, saying there has been no documented case of infection caused by the SS1 when the equipment is used properly.
The FDA does not expect to enforce the 18-month timeline for hospitals that don’t stop using the SS1. “But these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims,” the agency said.
Want to receive articles like this one in your inbox? Subscribe to Hospital Safety Insider!
Related Products
Most Popular
- Articles
-
- CMS seeks comment on quality measures
- Practice the six rights of medication administration
- Don't forget the three checks in medication administration
- Note similarities and differences between HCPCS, CPT® codes
- Nursing responsibilities for managing pain
- CMS creates web portal for questions about 1135 waivers, PHE
- Q&A: Primary, principal, and secondary diagnoses
- OB services: Coding inside and outside of the package
- ICD-10-CM coma, stroke codes require more specific documentation
- The consequences of an incomplete medical record
- E-mailed
-
- Coronavirus vaccination: 4 best practices for communicating with patients
- Q&A: Pressure ulcer POA code confusion resolved
- Neurological checks for head injuries
- Keyes Q&A: Generator lighting, fire dampers, eyewash stations, ISLM fire drills
- Including 46600 in E/M leveling systems
- How to get reimbursed for restorative nursing
- Fetal non-stress tests represent important part of maternal and fetal health
- Coding, billing, and documentation tips for teaching physicians, interns, residents, and students
- Coding tip: Know how to correctly code each procedure an otolaryngologist can perform on turbinates
- Coding Clinic reiterates guidelines for provider documentation
- Searched