Number

047-EN

Section

General Section

Use

Abstract

In a hospital in the Capital Region of Denmark cleaning of flexible endoscopes with enzymes was substituted by a product based on triethanolamine hereby reducing the risk of allergy. The substitution can only be performed if the succeeding machine wash is not based on aldehydes.

Substituted substances

Alternative Substances

Reason substitution

skin/respiratory sensitizing
physical hazards

Hazard Assessment

Substances to be substituted: Lipase and α-Amylase are not listed in the SUBSPORTplus Database and has no harmonised classification according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) Propan-2-ol is not listed in the SUBSPORTplus Database. Subtilisin may cause allergy or asthma symptoms or breathing difficulties if inhaled, according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). It fulfils the criteria to be listed in the Substance Database according to SUBSPORTplus Screening Criteria (SDSC). Alternative substances: The alternatives are not included in the database of hazardous substances according to SUBSPORTplus screening criteria (SDSC) and have no harmonised classification according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). » Check the Substance Database according to SUBSPORTplus Screening Criteria (SDSC)

Description of Substitution

Cleaning of flexible endoscopes in hospitals is a very sensitive process. Endoscopes represent a risk of contamination from patient to patient and from patient to personnel. Furthermore, endoscopes are very sensitive to oxidng agents and physical manipulation. Endoscopes are first cleaned manually and hereafter in a machine. The ingredients in the manual cleaning depend on the succeeding machine wash. If the cleaning agent used in the machine is based on aldehydes, it may be necessary to use an enzyme-based product in the manual cleaning, because the aldehyde makes the proteins coagulate. At Herlev Hospital in the Capital Region of Denmark, the product 3E-Zyme was used for the manual cleaning. This product contains three enzymes for the enzymatic breakdown of proteins, saccharides and lipids: subtilisins, alpha-amylase and lipase. None of these enzymes have an official classification but subtilisins have a very low threshold limit in occupational health because of the skin allergy risk. The personnel knew other products existed, and asked the occupational health department at the hospital to assist in an assessment of different products. A product based on triethanolamine (Cleantop-21) was recommended. The efficiency of the product was tested in a phase 3 test performed at the Clinical Microbiologic Department at Hvidovre Hospital, The Capital Region of Denmark. The conclusion of this test was that manual cleaning of flexible endoscopes with Cleantop-21 was a statistical stable process and the procedure could be recommended. The procedure removes blood and other human secretions from the endoscopes and by this the risk of Hepatitis B and Hepatitis C.

Case/substitution evaluation

The new product contains no enzymes or other known sensitisation agent, thereby reducing the risk of allergic reactions. It can only be used if aldehydes are not used in the succeeding machine wash. By substituting the enzymes, the allergy risk is reduced. The alternatives do not hold an official classification.

State of implementation

In use

Date and place of implementation

2011 in Denmark

Enterprise using the alternative

https://www.herlevhospital.dk/

Availability ofAlternative

Alternative is available on the market.

Producer/Provider

https://www.cbc-europe.com/

Type of information supplier

User

Contact

https://www.herlevhospital.dk/

Other solutions

Ultrasan from Brenntag Sekusept from Ecolab Both products contain enzymes

Further information

Cleantop-21_MSDS_DK

Date, reviewed

December 11, 2020