The above image is an example of a label that may be encountered with symbols included ( https :// www . fda . gov / medicaldevices / unique-device-identificationsystem-udi-system / udi-basics ).
Applying the Hierarchical Approach to Infection Prevention to Packaged Sterile Supplies and Devices :
The Joint Commission receives many questions about whether temperature and humidity monitoring are required for packaged sterile devices and instruments . It is important to follow the hierarchy when developing your practices around storage of these products .
Rules and Regulations
The first level of the hierarchy is that a healthcare organization ensures it is compliant with all building code requirements . Deemed organizations must fulfill Centers for Medicare and Medicaid Services ( CMS ) ventilation requirements which outline criteria for new or renovated existing facilities ( constructed or plans approved on or after July 5 , 2016 ). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1 . If a local authority has published building codes , then a healthcare organization must meet the most restrictive requirement .
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL
SUPPLY areas . If an organization is storing sterile items in a room designated as a Central Medical and Surgical Supply Area , the following will be required :
● Positive air pressure relationship to adjacent areas
● Minimum outdoor air exchange two per hour
● Minimum total air exchange four per hour
● Maximum relative humidity of 60 percent
● Temperature range 72 to 78 F or 22 to 26 C
CMS Requirements
The CMS Infection Control Worksheet for the Hospital ( HAP ) and Ambulatory Surgical Center ( ASC ) accreditation programs is one of CMS ’ requirements . Depending on the type of facility surveyed , these organizations must meet Conditions of Participation ( CoP ) or Conditions for Coverage ( CfC ). CMS requires that sterile packages are stored so that sterility is not compromised , and sterile items are inspected for integrity before use .
Manufacturer ’ s Instructions for Use
Organizations must be compliant with the manufacturer ’ s instructions for storage as indicated on the label . If , for example , the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage , an organization would need to demonstrate during survey that these requirements are being met . The Joint Commission does not specifically require that these parameters be documented , however a facility ’ s staff should be able to identify if any sterilized supply , has been potentially compromised ( as may occur if the integrity of the package is in question or has evidence of damage from humidity ) and should be able to determine whether that item would be appropriate for use .
Evidence-Based Guidelines and National Standards
Health care organizations may refer to evidence-based guidelines and national standards ( EBGs ) for guidance for how sterile supplies should be stored . Most EBGs agree that sterile supply areas must be clean , well ventilated and should protect supplies from contamination , moisture , dust , temperature extremes , and humidity extremes . Healthcare organizations must show evidence that , whether in a designated central surgical supply area or in a storage room with mixed clean and sterile supplies , storage techniques are protecting supplies from contamination and maintain the integrity of the packaging from damage . Failure to store medical and sterile supplies in a manner to protect from contamination will be scored according to Standard IC . 02.02.01 EP 4 .
For more information on how health care organizations can better manage commercially prepared sterile supplies , please contact The Joint Commission ’ s
Standards Interpretation FAQ Page to receive answers to specific questions .
Diane Cullen , MSN , MBA , RN , CIC , is assistant director of standards interpretation at The Joint Commission .
References :
https :// www . fda . gov / medical-devices / uniquedevice-identification-system-udi-system / udi-basics https :// www . fda . gov / medical-devices / devicelabeling / quality-system-regulation-labelingrequirements https :// www . fda . gov / regulatory-information / search-fda-guidance-documents / labeling-regulatoryrequirements-medical-devices-fda-89-4203 https :// www . fda . gov / news-events / fda-voices / using-symbols-convey-information-medical-devicelabeling https :// www . jointcommission . org / standards / standard-faqs / ambulatory / environment-of-careec / 000001275 /