In April, the Certification Board for Sterile Processing and Distribution (CBSPD) issued a helpful news update regarding chemical indicators. One of the organization’s members was concerned that appropriate testing procedure were being set aside in favor of expediency. Nancy Chobin (RN) sent a communication to the FDA to clarify the current standards. In her message, Chobin revealed that several health facilities had been asked to use Class VI indicators to release all load types. This is in contrast to accepted practices of using spore strips to do equipment validation and implant sterility verification.
The manufacturer’s documentation listed the product (apparently the STERIS SixCess chemical indicator) as being appropriate for all these purposes. In addition, Chobin stated that a sales rep represented this product as being cleared by the FDA for use as an adequate replacement for biological indicators. She found this statement troubling and decided to reach out to FDA contact Dr. Sheila Murphy for answers.
Dr. Murphy sits on the AAMI Sterilization Committee with Nurse Chobin and is chief of the Infection Control Devices Branch. This makes her uniquely qualified to answer questions regarding the standard use of indicators. Her response was clear: The FDA has not approved any chemical indicator (CI) to be used in lieu of a biological indicator (BI).
It is a normal practice at many hospitals to use CIs to release standard loads containing instruments and other items. That is not considered a problem. However, these indicators measure only the physical cycle parameters (heat, length, etc). In the case of specialized loads that include implantable devices, best practices still dictate the use of both a BI and a CI. The CDC and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) agree on this point. As with implant sterilization, the longer wait time for receiving the results of a spore test is justified for equipment qualification as well.
More About CBSPD
This non-profit certification board handles examinations for technicians who perform sterilization and disinfection activities. CBSPD creates and administers these competency based certification programs to meet international standards. Since 1991, this New Jersey based company has issued credentials to almost 20,000 individuals around the world. The National Commission for Certifying Agencies (NCCA) has accredited the Technician, Supervisor and Manager programs.
Initial and ongoing education in the sterile processing field ensures that the public is protected from unnecessary exposure to pathogens. CBSPD certification offers a measurable standard of knowledge and experience. The registry is public, so healthcare clients can safeguard themselves by choosing to do business with facilities that employ qualified personnel. This accountability and transparency is good for everyone involved.
Accurate information is one of the most vital aspects of any sterilization process. This is one reason CBSPD has gone above and beyond to make its recent correspondence regarding CIs freely available. Accessing critical SPD facts online has never been easier. For information about what types of autoclaves and sterilizers are ideal for your department or facility, take a moment to read our free report.
