We proudly support the Dr. Lorna Breen “Hero’s” Foundation to help health professionals everywhere!

The Federal Agency “CMS” on UVC Disinfection in Healthcare

Dr. Helene Paxton

MS, MT(ASCP), PhD, CIC, Professor of Biosciences

Although UVC systems have contributed greatly to the reduction of infections, there are still Infection Preventionists concerned about its impact on CMS surveys and the JCAHO reviews.

Since UVC is a chemical-free disinfection solution the EPA has not taken a position on UVC devices, and while the FDA does not regulate UVC disinfection activities, they did recognize its importance and growing use by releasing Guidelines under Title 21, Chapter 1, Subchapter H, Section 880-6600.

For those health professionals concerned about CMS regulations for use and the impact on JCAHO certifications, the answer is clear.

I recently contacted CMS to find their stance on this issue. Their response as of 08/14/2022 is as follows:

“CMS does not have a specific rule that would preclude the use of UV disinfection of room or equipment. It is required that hospitals have policies for the appropriate disinfection of patient rooms and equipment in accordance with national standards of practice, manufacturer’s instructions, and be consistent with any state, federal, or local laws.”

Per [email protected]

This is great news as this allows the facility to perform its own assessment of risk (risk analysis) and determine the appropriate disinfection protocols for its facility.

While UVC Robots have been an acceptable adjunct to patient room disinfection for many years, the recent development of high-performance medical-grade cabinet systems provides the opportunity to expand the use and application of UVC technologies to an area of disinfection long identified by the health agencies as a major challenge needing improvement, non-compliance on the disinfection of health electronics, tools, and devices.

For disinfection wipes to be effective, users must know device composition, and the target pathogen, and observe appropriate wet contact times. A lack of standardized protocols and missed surfaces amplify the challenge. At any one time, up to 97% of common healthcare equipment may be contaminated with multiple organisms. How does one know the item is germ-free?

UVC systems complement current CDC guidelines in the removal of biological materials followed by UVC deactivation on health electronics, wearables, unopened packaged patient supplies, and all non-critical devices.

TMG Health Technologies offers a cabinet-style unit with well-defined performance properties, a 30-second cycle time, a disinfection efficacy up to 6 Log₁₀, a large capacity, a three-year warranty, and a software technology that confirms the proper germicidal dosage on every disinfection cycle.

In everyday practice, healthcare electronics, wearables, personals, packaged supplies, and non-critical patient tools can be wiped of any biomaterial with a simple alcohol wipe, then disinfected by UVC to ensure a high-level of disinfection. By combining hand hygiene and disinfection together, the whole process is standardized and reduced to a single 30-second process.

In selecting a UVC device, facilities need to understand the great difference between medical-grade systems designed for the rigors of a healthcare environment and consumer-grade systems designed for the home. The user should understand the lamp intensity or dosage, cycle time, and other technical considerations for effective use. The user should be familiar with the published data on the effectiveness of UVC on various surfaces including packaged supplies. Healthcare UVC systems get used up to 200 times daily. A longer-term factory warranty is a clear indication to the robustness and longer-term life cycle of the product.

The use of UVC cabinet systems is a game changer. It simplifies the hand-hygiene-equipment disinfection process to 30-seconds, is environmentally safe and requires no on-going supply expense. The technology is a real-time tool available to all personnel in the institution due to its simplicity of use and its mobile application. Consistent utilization of cabinet-style systems such as the “RDS-32a” reduces the chemical footprint, cuts supply cost and creates a safer work environment for both the patient and the healthcare worker.

The clarity of the CMS statement above makes it clear that Clinics or Hospitals may incorporate this disinfection technology without concern of a citation if established protocols are being followed.

Contact TMG Health Technologies for details. We have written Protocols to share on both Equipment and Supply savings to help. Technical specifications can be found on the Website: www.tmghealthtech.com

Dr. Paxton is a Doctor of Epidemiology with medical device and Infectious Disease consulting experience. She is a Member of SHEA and ASM. Dr. Paxton specializes in studies for 510k submission and regulatory submissions, FDA liaison, design control and GMP and FDA inspection readiness. She has 30 years as an infection preventionist for Acute Care and LTAC’s and is an expert in Bio-Safety. Dr. Paxton offers IP and CIC online consultations and training
at www.bioguidancecell.org

TMG Health Technologies is a biosafety company dedicated to the art and science of infection prevention, providing fast, convenient decontamination solutions that lead to improved patient outcomes, cost containment, and operational savings. Our current Rapid Decontamination Cabinet System, Model: RDS-32a, as an example, sets the industry benchmark for capacity, throughput, reliability, and performance in simplifying the infection prevention protocol to a one-step 30-second process by providing a certified, repeatable high-level standard of disinfection for Electronics, Wearables, Personal Effects, Non-Critical Patient Tools, and Unused, Unopened Patient Supplies Contact: www.tmghealthtech.com | 888-443-1528

 

Distributed with permission by TMG Health Technologies | www.tmghealthtech.com | 2022 All Rights Reserved