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Director - Standards and Global Business Development
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3M Center Bldg. 220-11W-02
Saint Paul, Minnesota,55144
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AAMI Board of Directors - Membership and Community - Association for the Advancement of Medical Instrumentation
Director Janet Prust, BS Director, Standards and Global Business Development 3M
Sterile processing migrates towards electronic record-keeping
Because once you test for it, it's no longer sterile and can't be used," said Janet Prust, marketing manager for biological indicators, 3M Sterilization Assurance.
To monitor the sterilization process, the SPD uses a variety of indicators, from chemical to biological to external, and relies on its workers to use these tools correctly and perform their jobs up to standard. "Sterility assurance is looking at all of those pieces of information, putting it together to have the best level of confidence that the item indeed is sterile," said Prust. AAMI first made a reference to electronic records in its ST46: 2002 standard, (Steam Sterilization and Sterility Assurance in Healthcare Settings), stating that both paper and electronic records meet their recommendations, explained Prust. "Electronic records are actually preferable to paper record systems," said Prust. "And that's for a variety of reasons: there's data integrity, security, legibility. Electronic records are designed in a way to require people to enter the information before they can complete the process," she explained. Now nearly all of them have computers in areas beyond just the manager's office," said Prust. "Sterile processing departments really recognize, as we all do in both our personal lives and professional lives, the benefits of using IT technology to make our jobs easier." According to Prust, IT support is key. Prust agreed. "The standards are heading toward the direction of a requirement to have all items that are sterilized be able to be directly traced to the patient," she noted. "Mandatory reporting simply means more scrutiny in all of the practices around reducing infection," said Prust. "Sterilization is considered a sentinel event around surgical site infections. So for a facility to be able to document and prove that they did all of those things the right way via an electronic record keeping system is a tremendous value for a facility." By the same token, if a hospital has a high level of reported infections, inadequate record keeping can "cast suspicion on that sterile processing area relative to the effectiveness of their sterilization practice," Prust added. "The level of interest in our record-keeping software has quadrupled this year compared to where it was last year," said Prust. "A lot of that is driven from this recognition that hospitals need to be in a continuous state of compliance versus, 'we know the Joint Commission is coming in next June so therefore we're going to start preparing for it in March'. They realize now, with the Joint Commission moving to unannounced audits in 2006, that they need to be compliant, and they need to be in a continuous state of compliance. "And for sterile processing, one of the key things an accrediting organization will look at is the records. Their records are what they have to prove that they've done things the right way - the only information that they have to prove that they've done things the right way. Their policies and procedures prove an intent to do it a certain way, but the records prove that it was actually done," said Prust. Prust explained. Similarly, "records directly reflect what is being performed in the department and so poor or incomplete records can maybe mask some performance issues or training needs within a department," said Prust. Prust believes that the 3M Record Keeping Software is well within reach for most facilities. It shouldn't be an afterthought at all," reiterated Prust.
Janet Prust, director of standards and global business development for 3M in St. Paul, MN. Prust has been an active committee member for 19 years, also serving on the AAMI Standards Board.
In addition, she participated in AAMI's meeting on humidity levels in the operating room as a stakeholder representative.
"These guidelines are directed for surgical and other environments in healthcare facilities and are designed to help ensure safe and effective use of reprocessed devices used for patient care," said Janet Prust, global marketing manager, 3M Sterilization, 3M Infection Prevention Division , St. Paul, MN.
While sterile processing managers and staff understand the value of recommended practices, it is difficult to stay up-to-date and modify policy and procedures and training programs to keep not only the policy, but the practice current - and to follow the best available recommendations for patient safety, according to Prust. To assist SPD professionals in this regard, 3M Sterilization developed a Standards Practice program that connects the standards to actual facility monitoring practice based on what is being monitored. "Hospitals are looking for easy-to-follow programs to meet guidelines, not only for patient safety, but to ensure they are compliant," she said, adding that the program will also help SPD staff prepare for Joint Commission survey requirements for monitoring practices. In regard to pack monitoring, best practice includes Class 5 Chemical Integrating indicators, as they provide more information than Class 3 or Class 4 indicators, explained Prust. Best practice includes use of a chemical indicator in the geometric center of each pack, peel pouch or unwrapped tray to be sterilized, noted Prust. New CIs used in the category are being introduced with easy-to-interpret, reliable color change with elimination of lead or other heavy metal components," Prust continued.
This has provided measurable benefits, even with the increased acquisition, operational and service costs with these systems," noted Janet M. Prust, business development manager for 3M Sterilization - Low Temperature Sterilization Systems and MSS products , St. Paul, MN.
The next advancement, she said, will be the combination ozone/hydrogen peroxide low-temperature sterilization system currently under review by the FDA (the 3M Optreoz Low Temperature Sterilization system is approved in Canada and a CE mark has been obtained). While reduction of risk to the healthcare worker and patient are key aspects of regulatory review for any new system, Prust pointed out that all low-temperature sterilants are nonetheless potentially hazardous materials and must be handled in a safe manner according to manufacturer's instructions. Although EO has not undergone any significant recent changes - aside from the realization by the market that it is likely impossible to go "EO free" - Prust said that EO continues to be the most effective low-temperature sterilant due to its ability to penetrate materials and provide efficacy even in devices of challenging design, including those with very long, narrow lumens. "It is still the best technology to provide a terminally sterilized multi-channel flexible endoscope," she explained. Prust acknowledged that the lengthy cycle time and regulatory requirements associated with EO are a concern for some facilities; however, "technological advances, including single-use cartridges, single chamber sterilization and aeration, and mechanical safety features have essentially eliminated occupational exposure risk, and many hospitals are beginning to understand this. FDA and AORN have both issued statements to this effect," said Prust.