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February 1, 2010
FDA and NIOSH raise concerns
If your hospital uses Steris System 1® (SS1) processors, it might be a good idea to flag them as a recurring agenda item for your safety committee meetings—at least for the time being.
The FDA criticized the SS1 in a safety notice published December 3, 2009. In brief, the FDA encouraged hospitals to seek alternatives to the SS1 within six months, citing alleged infection control and safety risks resulting from modifications to the SS1 that the agency hasn’t approved yet.
With an estimated 30,000 pieces of medical equipment run through SS1 processors daily, any curb in use could be far-reaching.
You may want to bookmark Web pages for FDA medical device safety communications (http://tinyurl.com/ydn66nq) and Steris (www.steris.com/ss1) so you can monitor updates.
Hospitals using the SS1 should be figuring out what their next sterilizer will be and how quickly they can switch over, said Steven Silverman, assistant director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
“The responsible action for healthcare facilities with SS1s in inventory to take … is to transition to alternative devices, if available, and if not, to begin the process of transitioning,” Silverman told Briefings on Hospital during a media conference call December 4, 2009.
For its part, Steris Corp. in Mentor, OH, said it disagrees with the FDA’s warning and is in continued dialogue with the regulator.
“There has not been a documented case of infection directly caused by [an SS1] when proper guidelines and instructions are followed by certified health professionals,” Rosemary Niewolak, SS1 product manager, said in a statement issued December 4.
Joint Commission standards to review
There is no way a hospital can single-handedly resolve the FDA’s concerns about the SS1, the agency said.
The FDA will not take enforcement action against a hospital just because it chooses to continue using the SS1, but the agency could take action if a facility fails to file mandatory reports should the SS1 malfunction and cause injury.
Additionally, Joint Commission compliance comes to mind concerning the following EC standards:
EC.02.01.01, element of performance (EP) 11, which requires hospitals to respond to product notices and recalls
EC.02.04.01, EP 3, which mandates that facilities identify medical device testing and maintenance frequencies based on manufacturers’ recommendations, risk levels, and current hospital experience
EC.02.04.03, EP 4, which requires sites to properly maintain all sterilizers
Regardless of what brand or model sterilizer your facility uses, improving its operating procedures begins with checking your practices against an industry standard from the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), said Rose Seavey, president and CEO of Seavey Healthcare Consulting in Arvada, CO.
The standard is called ANSI/AAMI ST58:2005, Chemical sterilization and high-level disinfection in healthcare facilities.
“[ANSI and AAMI] basically say that any kind of chemicals or high-level disinfection requires knowledge and competency of trained and qualified personnel, and they should also be supervised by competent and qualified personnel,” Seavey said. That includes understanding manufacturers’ guidelines for both the sterilizer and the equipment being sterilized.
FDA and Steris butt heads
Seavey said that most hospital operating rooms, gastrointestinal laboratories, and ambulatory surgery centers she visits use the SS1. The processor was the only product of its kind in the industry for many years, but in recent memory, several alternatives have come on the market, including one from Steris itself.
Based on FDA adverse event reports and its inspections of the Steris plant, “the agency has not determined whether [the SS1] is safe or effective for its labeled claims, including claims that it sterilizes medical devices,” according to the agency. Using the SS1 could put patients in danger of contracting infections from equipment run through the sterilizers, it added.
It was the second FDA warning letter concerning the SS1 since May 2008, when regulators wrote to Steris about changes to the unit that raised questions about its effectiveness in sterilizing items.
In January 2009, Steris issued a notice to customers outlining its response, which included transitioning customers to replacements.
However, the FDA said in its most recent warning that the manufacturer “apparently has been reassuring customers that there is no need for a change in their clinical practice” and is also creating new accessories for the SS1, in conflict with commitments made to the FDA.
The FDA made several points for safety officers to consider regarding the SS1:
The types of malfunctions reported to the FDA could lead to staff member injuries
Alleged malfunctions could result in patient infections that would be difficult to attribute to the sterilizer
Injuries and infections among patients and workers attributed to the SS1 must be reported to the FDA; not reporting them could lead to enforcement action
NIOSH reviews potential acid exposures
The FDA’s pronouncements on the SS1 came on the heels of a report from the National Institute for Occupational Safety and Health (NIOSH) about other SS1 risks.
The report, Evaluation of Worker Exposures to Peracetic Acid-Based Sterilant During Endoscope Reprocessing, details how workers using the SS1 could be exposed to peracetic and acetic acids in a variety of ways, from broken seals in the devices to accidentally spilling acid refill containers when moving them from storage to the sterilizer.
Employee reports of skin and eye irritation from fumes at Kaleida Health-Buffalo (NY) General Hospital prompted a request for a NIOSH inspection in 2006. From interviewing staff members and managers, NIOSH found that inadequate ventilation and training led employees to forgo wearing personal protective equipment (PPE) while using an SS1, which could have led to chemical burns and the other symptoms.
“It was warm—there was very little fresh air brought into the room,” said David Sylvain, MS, CIH, a NIOSH investigator who coauthored the report. “There are times when these processors malfunction. It is at those times when there can be a release [of acidic fumes] into the air.”
Risky areas to beware of
An allegedly vulnerable piece of the SS1, the report said, is the inflatable processor lid seal. Leaks most frequently occur when this seal bursts, when the processor is opened suddenly, or defective endoscopes are used in the processor. There is also potential for employee injury with rough or improper handling and disposal of the sterilant cups, which contain concentrated peracetic acid.
NIOSH reviewed the FDA’s adverse event reports for the SS1 and offers more pointers for hospital safety leaders based on those reports and its own Buffalo inspection:
Require the use of appropriate PPE to prevent body contact with concentrated peracetic acid used in the SS1, as well as other cleaning chemicals and contaminated equipment
Confirm that minimum PPE worn while handling sealed SS1 cups includes tight-fitting, splash-resistant goggles, acid-resistant sleeves and aprons, and gloves made of butyl rubber or neoprene rubber
Provide OSHA hazard communication training for employees working in the sterilizer room
Train employees on how to deal with spills, leaks, and malfunctions
Inspect processors periodically for worn parts
Notify Steris of leaks and equipment problems
Increase ventilation in sterilizer rooms for odor control and worker comfort
Conduct at least annual audits of sterilizers
Safety officers and infection control preventionists should conduct either yearly or twice-yearly audits of employee and patient safety measures surrounding sterilizers, said Rose Seavey, president and CEO of Seavey Healthcare Consulting in Arvada, CO.
The goals of these audits are to:
Keep tabs on who is using sterilizers
Determine whether workers have received comprehensive training
Discover whether changes in patient load have increased the need for training and more sterilizers
“It’s too important to let fall by the wayside,” Seavey said.