The following article was written by Joseph Keane, director of ASC/GI sales for STERIS Corp.
In this era of increased safety vigilance in healthcare environments, it's surprising that risky conditions and activities still exist in ambulatory surgery centers in spite of the dangers they pose. In particular, the use of glutaraldehyde-based disinfectants has been documented to have serious health effects, yet this chemistry is still in frequent use in many ASCs and GI facilities.
The question is: Why?
Good, bad and ugly
Glutaraldehyde has been in use since the 1950s as a low-temperature liquid disinfectant, and continues to be used in many healthcare environments. Today it is commonly used to reprocess endoscopes in ASCs and GI suites. In the early days it was considered to be an efficacious high-level disinfectant that was also cost effective, and these perceived benefits increased its popularity.
Orthopthalaldehyde (OPA) was introduced in 1999 as an alternative to glutaraldehyde. While it was more costly, it was promoted as being cost effective due to its longer shelf life and faster action.
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Not surprisingly, the term "cost effective" can be interpreted in multiple ways. In order to be a credible claim, the cost of purchasing and using a product should be a comprehensive calculation. In this case, the full cost of using glutaraldehyde or OPA products must be calculated to include the real expenses beyond the purchase of the product. It must include the human side effects and related costs, the expected additional accessory costs, and the more subtle costs required because of mandates related to the use of these types of chemistries.
Human factor
Without proper protection and ventilation, glutaraldehyde can have long- and short-term effects on the human body. Besides being a potent skin irritant and sensitizer,1 the various health impacts of glutaraldehyde have been clearly documented and the following symptoms reported:
- Throat and lung irritation 2,4
- Asthma, asthma-like symptoms and breathing difficulty 2,4
- Nose bleeds, nose irritation, sneezing and wheezing 2,4
- Burning eyes and conjunctivitis 2,4
- Rash- contact and/or allergic dermatitis 2,4
- Hives 2,4
- Headaches 2,4
- Nausea2,4
- Chemical sensitization disorders2
- In rare instances glutaraldehyde-based products have been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies 6
As for OPA, there have been multiple reported cases of side effects from exposure to OPA — one example is anaphylaxis following cystoscopy with endoscopes sterilized with OPA.6 Exposure to OPA can also cause a variety of other physical conditions such as the following:
- Eye irritation 2
- Staining of the hands (brownish or tan) 2
- Skin irritation 2
- Potential sensitization 2
- If inhaled, symptoms including but not limited to discharge, coughing, wheezing tightness of chest and throat, difficulty breathing and stinging sensation in nose and throat, tingling of mouth and lips, headache, loss of smell and dry mouth. 2
In addition to the human risks and illnesses, the exposure of workers to glutaraldehyde and OPA has a cost to facilities in the forms of lost work time, loss of experienced personnel, increased medical claims and increased regulatory expenses.5 Even with OPA, although symptoms are temporary and reversible, workers can still miss time from work in order to recover, costing ASCs and GI clinics time and money. It's also important to note that there is potential for patients to be exposed to glutaraldehyde/OPA vapors when the chemistry is in use in a facility.
Mandated ancillary costs
The costs of using these products exceed even the price of the product, its accessories, and costs related to medical claims or lost time. Facilities must also invest in special ventilation in areas where glutaraldehyde is in use. These additional ventilation units must then be cleaned, maintained and replaced, which adds to the long-term costs of using glutaraldehyde and OPA.1,4,8
Additionally, related universal precaution recommendations and/or mandates may require that monies be budgeted for the cost of such things as training programs, neutralization chemicals, absorbent mats and spill team supplies. Area monitoring also must be conducted to ensure glutaraldehyde/OPA levels are within the specified regulated ranges, which adds ongoing costs for monitoring supplies.
The sticky wicket
Another major drawback to glutaraldehyde and OPA are their fixative properties.3,5 These chemistries tend to affix residues to the inner and outer surfaces of endoscopes processed with these products, which can contribute to biofilm formation. This can lead to cross-contamination of patients if the scopes are not thoroughly cleaned and rinsed after each case. In a 2010 article by Stryker Medical and ECRI,6 cross-contamination was reported to be the number one technology hazard in healthcare. In addition to the treatment costs for sickened patients, biofilm can also hide issues (leaks and damage) within the scopes that eventually lead to costly repairs.
No matter how you look at it, using glutaraldehyde or OPA is a costly and risky proposition. So, why are they still in use, since there is a less risky and less costly alternative?
Alternative
There is a proven low-temperature liquid disinfection option that minimizes costs, eliminates most of the risks described above, and is highly effective. Oxidative disinfectants and sterilants, which have been applied in various forms for decades, provide multiple benefits without the risks associated with glutaraldehyde and OPA. These formulations use oxidation to interrupt cellular functions within proteins, carbohydrates, lipids and nucleic acids.2,3 Once this occurs, the microorganism can no longer sustain life and is killed. The popularity of oxidative chemistries is increasing because of their many advantages, including the following:
- Excellent cleaning, disinfecting and sterilizing efficacy at low temperatures 7,9
- Compatible with a wide range of device surface materials 7,9
- Environmental benefits through reduced water usage (fewer rinses required) 7,9
- Safe for employees and patients 7,9
- Require no special ventilation 7,9
- Do not require area monitoring 7,9
In addition, they are not fixative in nature, so they don't pose the cross-contamination risks of glutaraldehyde and OPA products. Oxidative chemistries truly are also cost effective: they cost on average about the same as glutaraldehyde and OPA products, but do not incur the additional required expenses associated with glutaraldehyde- and OPA-based chemistries.
It is important to note that oxidative chemistries have not been validated for use with all endoscopic devices. Although device testing with oxidative disinfectants is ongoing and devices continue to be added to the validated list, users must check with the device manufacturer or the oxidative chemistry manufacturer to obtain documented testing results for the most current approved devices.
Due diligence will pay off
Change is a challenge for any organization, but is perhaps more so for fast-paced ASCs and GI departments. They are already dealing with a changing landscape of sterilization and disinfection accountability, guidelines and standards. In addition, they must stay as productive as possible while also focusing on delivering excellent patient care. It may be difficult to motivate a change of disinfection procedures and products when what is in place has been used for years and is a familiar routine.
In this case, the motivation to change may come from the awareness that there are significant and numerous patient, personnel and financial benefits the facility could experience. Investigating to determine whether oxidative chemistries are right for a facility and its current scope inventory could also yield process improvements that put the facility ahead of the compliance curve.9 By transitioning away from glutaraldehyde and OPA, managers can make the facility safe for patients and employees, increase productivity, lessen risk, enhance the facility's reputation and potentially save money in the process.
References
1. 10 Reasons to Eliminate Glutaraldehyde: Fact Sheet of the Sustainable Hospitals – http://www.sustainablehospitals.org
2. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 - http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf
3. Safe Use of Glutaraldehyde in Health Care - http://www.osha.gov/Publications/glutaraldehyde.pdf
4. Reducing Ethylene Oxide and Glutaraldehyde Use - http://www.epa.gov/region9/waste/p2/projects/hospital/glutareth.pdf
5. Choosing between Dialdehyde and Peracetic Acid Chemistries for Endoscope Reprocessing - http://www.endonurse.com/articles/2004/06/choosing-between-dialdehyde-and-peracetic-acid-ch.aspx
6. Cross Contamination Article – Stryker Medical/ECRI - https://www.stryker.com/stellent/groups/public/documents/web_content/141698.pd
7. Understanding oxidative chemistries (Healthcare Purchasing News\Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cystoscopy. - http://www.ncbi.nlm.nih.gov/pubmed/15316522
8. Best Practices for the Safe Use of Glutaraldehyde in Health Care- http://www.osha.gov/Publications/glutaraldehyde.pdf
9. Opting for an oxidizing chemistry - http://www.hpnonline.com/inside/2009-11/0911-Scopes-Steris.html
Joseph Keane is the director of ASC/GI sales, an internal sales team for STERIS Corp. that supports ASCs and GI facilities. He has more than 27 years of experience in the healthcare industry, and has held positions in healthcare service, sales, management, distribution and consulting. Mr. Keane holds a certification as a hospital equipment technician from Edinboro University of Pennsylvania and is a U.S. Navy veteran.
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