PERISCOPE
Color-coded standard needed for H2
O2
arlier this year numerous healthcare facilities alerted the Food and Drug Administration (FDA) of the poten- tial for healthcare personnel to misinterpret colored hydrogen peroxide chemical indicator strips that are used to validate vapor sterilization of medical devices. Misinterpreta- tion creates the potential for patient harm because currently there is no standard indicator color to show if a device has been sterilized and safe for use. This concern led the FDA to issue a letter to healthcare providers on May 7, alerting them to this problem.
E
According to the FDA’s letter, during the COVID-19 pan- demic, “Reprocessing staff may be using sterilization systems for the fi rst time or concurrently using sterilization systems from different manufacturers. If staff assumes that all manu- facturers use the same color code to validate sterilization, they may mistakenly release contaminated devices for reuse.”1 The FDA’s letter also points out that they are currently working with the manufacturers of vapor sterilization indi- cator strips to improve the products’ labeling “and explore standardization for colors used to indicate sterilization.”2 Currently, manufacturers of indicator strips have been left to come up with their own color schemes to indicate steril- ity. What is even more confusing is that the manufacturers’ various colors have been validated for the same hydrogen peroxide sterilization cycle conditions and approved for use by the FDA. This lack of a standard color code puts healthcare personnel in the untenable position of not being able to tell immediately whether a device has been sterilized and is safe for use with patients. If a patient infection or fatality can be defi nitively linked to the incorrect interpretation of an indicator label color by healthcare personnel, the healthcare facility and the label manufacturer potentially will face litigation with a large damage claim.
To eliminate the current risk of patient harm caused by the
lack of a standard color-coding scheme, one of three solutions must be adopted and implemented immediately: 1. The FDA issues a requirement for manufacturers of indi- cator strips to adopt a single, industry-wide color-coding scheme.
2. If the FDA doesn’t issue a requirement, then the manu- facturers themselves must voluntarily agree to a single, industry-wide color-coding scheme.
3. Unless – and until – one of the fi rst two options are imple- mented, healthcare facilities can choose to stop using hydrogen peroxide as a sterilization media or, they must follow the recommendations in the FDA’s letter:
sterilization indicator strips
Either FDA or manufacturers must step up to the plate by James Schneiter
a. Review the manufacturer’s instructions for the particular indicator bar or card being used and know the signifi cance of the indicator colors. b. Enhance staff training on the indicators for all steriliza- tion systems employed in the facility and reinforce that training with prominently displayed visual reminders.3 Healthcare facilities need to understand that until either of the fi rst two solutions are adopted and implemented, the facility is assuming the legal responsibility for the use of these strips.
Orange is the new check
Over 40 years ago the medical industry solved a similar prob- lem by adopting an industry-wide, color-coding standard for all parenteral (IV) and enteral nutrition delivery devices. As part of that color-coding standardization, it was decided that all enteral nutrition connectors, nasogastric tubes, stomach tubes, P.E.G. tubes, Jejunostomy tubes, enteral feeding bags and pumps would be color-coded orange.
While creating patient discomfort, the infusion of a paren- teral drug into a patient’s gut through an enteral nutrition device is not a life-threatening event. The accidental infusion of enteral formula into a parenteral delivery device into a patient’s vascular system, however, is a life-threatening event. This was why the medical industry went to orange color-coding for all enteral products to protect patients more than 40 years ago.
The present lack of an industry standard for color-coding hydrogen peroxide vapor sterilization indicator strips is a clear, present and ongoing threat to patient safety. The best solution to the problem is the adoption of a standardized color-coding system for these indicator strips. HPN
References
1 FDA Letter to Health Care Providers “Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization” May 7, 2020 2 Op. cit. FDA 3 Op. cit. FDA
Prior to his retirement in December 2018, James Schneiter had been the founder, owner and president of America’s MedSource Inc., which designed, developed, licensed and marketed a variety of implantable vascular devices, laparoscopic devices and neurosurgi- cal instruments. Schneiter has nearly fi ve decades of experience in medical device design and production and is a recognized expert in the area of instructions for use (IFU) and independent laboratory IFU validation studies. Schneiter can be reached at
jas.schneiter@
talloaks2014.com.
60 November 2020 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66
