by
Lisa Chamoff, Contributing Reporter | April 04, 2016
From the April 2016 issue of HealthCare Business News magazine
“Not all device manufacturers are following the AAMI recommended cycles,” says Jason Simon, product manager for infection prevention at Skytron. “Unfortunately, you need to create and document your departmental processes in preparation for a worst-case scenario: if a patient is infected and it goes to court,” Simon says. “You need to show that you followed the manufacturer’s instructions.”
Angela Jensen, certified sterile processing and distribution supervisor at Rush Foundation Hospital in Meridian, Miss., maintains a book of up-to-date IFUs in alphabetical order by manufacturer for SPD staff. When her facility upgraded to Skytron equipment at the end of 2014, after using nearly 40-yearold steam sterilizers from industry veteran STERIS, the department preprogrammed custom cycles based off of the hard copies of the instructions. Jensen takes a hard line when it comes to following the guidelines and advises hospitals not to purchase a device until getting and reviewing the instructions, to make sure the proper sterilization processes are in place at the facility. “It is the manufacturer’s responsibility to supply us with the IFUs,” Jensen says. “Over time, vendors tend to know when they bring stuff in, who’s going to require something and who isn’t. My rule is if I don’t have paperwork, I don’t process it, period.”
To go paperless, sterile processing departments can subscribe to OneSOURCE, a comprehensive database of manufacturers’ validated IFUs. Smith, of Belimed, says the company is looking to develop a user interface that would have the ability to connect to the IFU database and easily access the manufacturer parameters directly from the sterilizers. Sterile processing departments also need to document that they are following manufacturer IFUs, either through paper or electronic records, which manufacturers are starting to provide.
“The Joint Commission [says] show me all your records and evidence you’re using [IFUs] on these sets,” Smith says. “They are treating this as a requirement.” These regulations, and the drive to bring down the number of hospital-acquired infections, are also driving the use of instrument-tracking software. This includes the CS-iQ Sterile Processing Workflow Management software from STERIS. Belimed offers software that can download the cycle parameters into any instrument-tracking program.
Size and time matter
Manufacturers are also responding to surgical equipment that is becoming larger and heavier. Companies are making wider sterilizers for orthopedic surgical instrument trays, says Chobin. They’re also going back and revalidating sterilizers for heavier trays. “We are seeing a lot of changes where they’re listening to their customers,” Chobin says.
