7-5-2011:  Dr. Phillip Moen Testimony on House Bill H1048,
"Sterilization of Musical Instruments"

Musical Instrument Sterilization: Key points.

1)  Evidence for public health threat from passing musical instruments (wind instruments) from one player to the next.

I searched several online databases for publications/reports relating to "wind instruments" and "respiratory", "infectious", "public health", and other related terms. Databases searched were: The National Institutes of Health, National Library of Medicine Pub Med online database of scientific and medical publications, US FDA, and the US Department of Health and Human Services (DHHS), including the CDC (US Centers for Disease Control and Prevention).

In the database of medical literature, only three reports, dating back to 1958 were found. The most recent article was published in the journal Chest in 2010 and reported a case of hypersensitivity respiratory infection in a saxophone player due to mold inside of his own instrument. Routine cleaning of the instrument with isopropyl alcohol completely resolved the problem. A survey of 15 additional saxophone players revealed no evidence of prior or current infection. Another Chest article, from 1998, reported a similar respiratory infection due to poor mouthpiece hygiene. The third scientific publication was from 1958. The conclusion of the article was the recommendation to clean instrument mouthpieces with detergent and brushing; recommendations no different from the current articles.

The US FDA search returned no documents. The US DHHS (and CDC) search returned one related report, stating categorically that no evidence exists for transmission of hepatitis through contamination of musical instruments. Of interest, a publication investigating the risk of acquiring infection during CPR (mouth to mouth resuscitation) training, certainly analogous to sharing mouthpieces, found no reports of infection. From a Google search, I did find a very interesting report on Mouthpiece Hygiene: (www.shwoodwind.co.uk/HandyHints/mouthpiece_hygiene.htm ).  His somewhat irreverent, but cogent conclusion is that if this were a serious issue, there would be dead musicians in the streets. The Communicable Disease Control Directorate of Western Australia considers wind instrument sharing to present a "low risk" for transmission of meningococcal disease. Note that there is no question that bacterial and molds/fungi are found on mouthpieces and within instruments. What is important is that this presents an extremely low risk of illness.

2)  Justification for regulating musical instruments to the same extent as dental instruments

A key argument presented by Encore Etc. Inc. (EEI) is that wind instruments should be classified the same as dental instruments in terms of disease transmission due to the potential of "mucous tissue to mucous tissue" transfer of pathogens. According to CDC guidelines for infection control in dental settings, surfaces/instruments that only contact mucous membranes only require disinfection with hydrogen peroxide or bleach. It must be noted that routine dental procedures typically cause minor bleeding to gums; hence recommendations for dental instrument sterilization have the need to address blood-borne pathogens, which obviously are not an issue with wind instruments. Based on this assessment, EEI presents an unrealistic level of threat of harm.

3)  In the medical device industry, it is routine practice to perform a risk-benefit analysis to determine which types of risk exist, and to what level if any risk they need to be controlled. Key aspects of risk management are the frequency of the risk and level of harm posed by the risk. From extensive searching of public health and medical journal databases, only three reports of respiratory infection due to instrument contamination were found over the last 53 years. In all cases, the instrument belonged to the individual, and symptoms typically spontaneously resolved by not playing the instrument until it had been cleaned. By common medical device risk analysis standards, they only risk control measure warranted is a regular cleaning of the instrument. Performing costly instrument sterilization will not provide any additional benefit over routine cleaning.

4)  Effectiveness/danger of Ethylene Oxide (ETO) sterilization

ETO sterilization involves placing the instrument in an airtight chamber, evacuating the air (vacuum), adding ETO gas, and heating the chamber to 130 degrees F.  ETO is considered by the US EPA to be mutagenic/carcinogenic (capable of causing genetic mutation/implicated as a cancer causing agent). EEI states that the instrument can be sterilized inside of its carrying case. Based on review of documents supplied by EEI on ETO sterilization, as well as US EPA (Environmental Protection Agency) documents pertaining to EEI's application for use of ETO for musical instrument sterilization, I find no data to support that ETO sterilization is effective for musical instruments. In fact, US EPA has requested documentation from EEI on effectiveness of sterilization, and hazard of disease transmission, which to date has not been provided, based on absence of additional documentation provided on the US EPA website. Furthermore, no data on residual ETO threat to the student is provided, other than a study on two cases where rubber mouthpieces sterilized by ETO were not considered hazardous based on a single exposure. This study does not replicate the following conditions: a) student use of the sterilized instrument over a long period of time, b) presence of residual ETO on/within the music instrument casing, especially the lined foam padding.

There is ample evidence of financial motive for EEI's desire to have musical instrument sterilization legally required. By the company's own admission, several years and several hundreds of thousands of dollars have been expended in an attempt to create a market for their services. One can propose that a theoretical risk of disease transmission exists from sharing wind instruments. However, evidence to support this risk to date is non-existent. In fact, the very few documented cases involve the musicians own instrument. Students have been playing in school bands, using instruments shared year to year, for numerous decades. If an actual public health threat existed, it surely would have been apparent by now. Prudent practice that each player uses only his/her own mouthpiece/reed (which is not shared) and that instruments be routinely cleaned at the end of the school year should continue. By all evidence, these practices are more than sufficient. There is no demonstrable need for expensive instrument sterilization.

Sincerely,

Phillip T. Moen, Jr. Ph.D.

114 Granite Street

Foxboro, MA 02035

phil.moen@verizon.net