What is an example of an event that ends the shelf life of a sterile package?

Manufacturers stamp the packaging with an expiry date. In most cases, international standards adopted by manufacturers ensure a shelf life of about five years. However, if stored under ideal conditions and if covered by an extra layer of sterile wrap, the product may have an enhanced shelf life. Conversely, if there are high levels of humidity and if the outer packaging material has cracks or develops defects while in storage, the stored product may have a shortened shelf life.

Shelf life of merdical products depends on a variety of factors. One is the process of manufacture and the manufacturing environment. Manufacturers with protocols adhering to EN ISO 13485, EN 868, EN ISO 11607 and CE standards can be expected to deliver products with an enhanced shelf life. The process in use, such as an absolutely sterile environment, class 8 clean room standards and rigorous quality checks at all stages ensure consistency and reliability. Trusted manufacturers not only have their own methods of quality checks but also get samples tested by independent third parties for higher levels of confidence. The process may vary according to material used and end purpose. Some of the common methods of sterilization in use are dry heat, unsaturated chemical vapor and steam autoclaving, each with its specific advantages. Additionally packaging may carry color indicators to ensure if the contents are sterile or if they have been contaminated. Chemical indicators may be used in conjunction with biological indicators to check for sterilization. The biological indicators may be chosen to be process-specific to assure higher reliability.

Raw materials used in the medical packaging also influence shelf life. Sourcing the best quality materials from top manufacturers and then sample checking before inducting into the process is one way to ensure medical products retain sterility for a longer duration. In such cases it is important to select UV and oxidation stabilized materials with high vapour barrier capabilities and ability to withstand rough handling in transit.

People are just as important to the shelf life of a product because it is they after all who handle the process and implement standards. Manufacturers with highly qualified, trained and professional staff can be expected to take the utmost precautions at each stage to guarantee extended shelf life of medical products packaging. Such packaging may be used in hospitals to temporarily store items while in transit from sterilization section to operation theatres or wards and, in such cases, sealing method of the packaging may determine protection level.

End users such as nurses, attendants and doctors may lack the time to carry out specific tests for each item to determine valdiity of their sterility. In such cases, it is the reliability of a manufacturer, his processes and his product that assures shelf life after sterilization of products. To sum it up, time is not as much an important factor as the events influencing the package.

References

Association for the Advancement of Medical Instrumentation, American National Standards Institute. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79-2010; A1:2010; A2:2011; A3:2012; and A4: 2013. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2010.

CDC. Guidelines for infection control in dental health-care settings – 2003. MMWR 2003; 52(No. RR-17):1–66. Available at: https://www.cdc.gov/mmwr/PDF/rr/rr5217.pdf pdf icon[PDF-1.2M]. Accessed March 18, 2016.

CDC. Summary of infection prevention practices in dental settings: basic expectations for safe care. Available at: https://www.cdc.gov/oralhealth/infectioncontrol/pdf/safe-care2.pdf pdf icon[PDF – 844 KB]. Accessed March 31, 2016.

Harte JA, Molinari JA. Instrument Processing and Recirculation. In: Molinari JA, Harte JA, eds. Cottone’s Practical Infection Control in Dentistry, 3rd ed. Baltimore: Lippincott Williams & Wilkins, 2010;221–231.

Harte JA, Molinari JA. Sterilization Procedures and Monitoring. In: Molinari JA, Harte JA eds. Cottone’s Practical Infection Control in Dentistry, 3rd ed. Baltimore: Lippincott Williams & Wilkins, 2010;148–170.

Miller CH, Palenik CJ. Instrument Processing. In: Miller CH, Palenik CJ, eds. Infection Control and Management of Hazardous Materials for the Dental Team, 4th ed. St. Louis: Mosby, 2010;135–169.

Event-related sterility assurance is a part of any operating room, sterile processing department or ancillary department that uses or distributes sterile packages for patient use. We all know that we must classify what an event is:
- Soiled packages
- Damaged packages/dropped packages
- Packages that have been sterile so long that the manufacturers recommended shelf life for the wrap (two years is standard), pouch (up to six months) or filter after sterilization has expired.
- Temperature or humidity variances that can negatively affect packaging.
- Moisture
- Rips/tears or holes
- Any other event that can adversely impact and render a package compromised

Event-related sterility assurance is something we in healthcare live and breathe every day.  We track packages from distribution to the patient and back (if re-usable) everyday while we make sure that any package we provide is safe for patient use. We track humidity/temperature, traffic flow, infections, process improvements, patient care directives that support positive patient-care outcomes, create policies that mirror manufacturer’s Instructions for use (IFU) and the AAMI/ANSI, AORN standards along with utilizing organizations like the CDC and IAHCSMM for support in our patient care directives. We seek out organizations like the Joint Commission and CMS for accreditations to make sure our processes are consistent with the current standards of practice thereby further protecting our patient populations from any potential harm.  We constantly train, re-train, perform competencies, provide education opportunities and updates on new policy, process or standard. We provide hands on, computer based training, internal/external educational opportunities through professional organizations/vendors along with pursuing certifications and licenses that say we know what to do and that we are the best line of defense/protection for our patients that trust us not only to know what to do but how, as well as, trust we have their best interest at the front, middle and end of their patient care experience.  We are constantly looking for ways to improve our patient care delivery systems and our services we provide to our communities for one reason, our patient.

Healthcare does all this and more for our patients every day to protect their safety and to insure the very best outcome for their sake but we have forgotten to do one very important thing. All our efforts are largely internal but what about the outside sources that touch our patients? Back to packaging we go.
AAMI/ANSI ST79, p. 89, 8.11;8.11.1,8.11.5 states:

8.11.1 General considerations
Sterile packaged items should be transported in a manner that will protect the items from puncture and from contamination by moisture, excessive humidity, condensation caused by exposure to temperature extremes, insects, vermin, dust and dirt, excessive air pressures, and microorganisms.
Rationale: Adequate protection during transport minimizes the potential for damage and helps prevent compromise of sterility. This rationale also holds for 8.11.2. through 8.11.6.

8.11.5 Off-site transportation
Vehicles used to transport sterile packages between health care facilities should provide for the complete
separation of clean and sterile items from contaminated items. Transport vehicles must be completely enclosed and should be checked periodically, at least annually and more frequently as needed, to ensure that they do not leak. Carts containing sterile packages should be secured within the vehicle to prevent damage or contamination. Transport vehicles and handling practices should allow for ease of loading and unloading.
NOTE: For the purposes of this paragraph, all external shipping cartons (corrugated or otherwise) are considered contaminated, even if they contain packaged sterile items.

When motor vehicles are used, environmental conditions should be assessed while the vehicle is in motion and when it is not in motion. Additionally, in geographical areas where high humidity is the norm, actual testing should be performed to determine the potential for absorbent items to become contaminated and for the contents of sterile packages to become wet from the condensate that can occur on metal or plastic surfaces that are moved from air-conditioned environments within the processing facility to the non-air-conditioned environment of transport vehicles to the air-conditioned storage area of the using facility.

The design and materials used in the construction of all transport vehicles (motorized or manual) should allow for appropriate decontamination processes, especially if the vehicles are to be used alternately for the transport of sterile/clean items and soiled items. Transport vehicles (motorized or manual) that are loaded and ready for transport should not be left unattended in unsecured areas.

Healthcare addresses this very well internally but what about those items that travel in personal vendor vehicles and live in the trunk where certainly temperature and humidity is not only inconsistent but definitely not measured. What about the practice of storing in garages on the floor or thrown on a shelf in a basic household tub? Maybe the implant bin (purchased at a local store or provided by the Vendor Company) is inside a home or apartment where the environment is certainly not controlled, regulated or recorded.

Bins full of implants travel all over vendor territories going in and out of healthcare facilities with no thought given to the real potential patient threat these tubs full of implants could pose to our patients.  Vendors often try to bring and sometimes do bring tubs of implants to the operating rooms without first cleaning the outside surface much less being able to provide a clear didactic of where the implants/bins have been, storage conditions, handling conditions not to mention how many operating rooms has this dirty bin been in? Cross-contamination from patient to patient (potentially via the traveling packaging), facility to facility should be a very real concern. We are opening a potentially dirty bin, reaching in with potentially contaminated hands, retrieving potentially and repeatedly contaminated packaging and opening up potentially contaminated devices to be used on what could now be a potentially compromised patient.    

Here is a scary scenario: What if an external vendor brings a tub of implants to our facility that has been contaminated by a potentially lethal strain or contaminant?  It takes so little to become a maiming or lethal agent. First, anyone coming in contact with this tub is now potentially contaminated or providing more contaminants to an already tenuous arena. The vendor and his vehicle, any passenger(s)/animals he/she may have had in the interim and anyone he/she may have come in contact with casually over a period of time as hand washing is not as strictly adhered to outside of a healthcare venue. He/she brings this tub of potential contaminates to your SPD or operating room for check in (maybe) with instruments that are often also cared for in a questionable manner. If the tub is not cleaned and the contents there in are not stringently handled and monitored for efficacy, everyone from sterile processing right to the patient(more importantly) is potentially at risk.

As healthcare professionals, we should insist upon a better external practice. We need answers to the same questions we ask ourselves in our own internal patient care pathways we use to protect our patients. The same conditions we insist upon in our facilities should be mirrored by our external vendors. Implants/instruments should be cared for with the same dedication and attention to details that can be lethal if ignored. As a sterile processing professional, I have been known to refuse implants because of questionable packaging integrity and the inability to verify the efficacy of the storage method/conditions. Yes, it is that important. Orthopedics seems to be one of the largest contributing culprit(s) as most of our orthopedic vendors keep an inventory of “sterile” implants for the systems they provide to us, on hand, without the storage controls that would be present if those same implants were shipped via a medical delivery system where environmentally controlled/modulated delivery vehicles are loaded from environmentally controlled warehouses or distribution sites. If that is not true we need to go back to the drawing board and make it so.  We must know the conditions of our packaging, especially those devices that go into our patients, at every juncture of their travel to us to include storage/handling.  Right now we don’t and that is what you would call a weak link in the infection control process where after all the effort and good we have done for our patients internally potentially comes falling down because we are not looking at what happens to our packages and devices before they arrive to us for use on/in our patients which can directly affect their life long health and wellness.

Fellow healthcare professionals, we need to take a serious look at this and make sure the control is where it should be for our patient’s sake. Who is liable if we don’t ask or if we know and we don’t act? Here is a thought -- temperature controlled packaging is already available in/to industry and readily available through numerous companies in every variation possible to fit the needs of nearly any device/packaging requirement/need. It is a search engine, phone call or e-mail away.

Becki Jenkins, CST, CRCST, CIS, CHL, FCS, PhD, is a 35-year healthcare veteran, supervisor, sterile processing expert, consultant, educator, speaker and expert witness for medical malpractice as that pertains to sterility/infection control.

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