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Unlicensed Cosmetic Surgery Hospitalizes 6 in N.J.

New Jersey medical authorities are investigating the incidence of and issuing alerts on unlicensed cosmetic surgery providers after 6 women suffered...

Rotator Cuff Repair Restores Strength, Not Function

Rotator cuff surgery may restore a patient's normal shoulder strength, but mobility issues persist in the repaired joint, according to researchers a...

Do Patients Expect Too Much From Joint Replacement?

Even with a thorough pre-op education program, more than two-thirds of joint replacement patients don't share the expectations that their surgeons d...

Home > News > February, 2010
FDA Extends Timeline for SS1 Replacement by 18 Months
Facilities have until August 2011 to transition to alternative reprocessors.

The FDA is giving healthcare facilities 18 more months to discontinue use of the Steris System 1 tabletop liquid chemical reprocessor and transition to a legally marketed alternative device.

In an update notice, the agency says it extended the recommended time period for replacing the SS1 after healthcare providers and professional organizations warned that the original 3- to 6-month transition period would be difficult for facilities to attain and therefore could "adversely affect patient care."

Facilities that fail to meet the 18-month deadline won't be penalized, but the FDA urges you to transition to FDA-cleared alternative reprocessing devices as soon as possible. "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 warns.

Irene Tsikitas

Categories: Gastroenterology, Infection Control, Product Reports, News
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