Specific Considerations on the Safety of MED-EL Products in Light of the Coronavirus Pandemic

MED-EL has always been very committed to protect our users, patients, professional partners and employees and ensuring their occupational health and safety. Due to the ongoing Coronavirus pandemic, we have invested in additional measures for our employees in general, and in particular, for teams responsible for sterilization and packaging processes.

Special protocols are being used to minimize person to person interaction and maximize the distance between individuals at all times. Moreover, we have established enhanced cleaning protocols for all these areas and substantially increased sanitation stations for the entire MED-EL headquarters.

Our hearing implants and accessories have always been manufactured in certified clean rooms. Final sterilization provides a sterility assurance level that exceeds the power of any disinfection process by at least one million. Thus, MED-EL’s sterilization process is also effective in preventing any potential viral contamination, including SARS-CoV-2. The whole manufacturing process is approved, certified, and routinely inspected by regulatory bodies worldwide. MED-EL makes every effort to ensure that our hearing implants and accessories are safe to use.

Coronavirus Specific Q&A

Q: Is the sterilization process capable of inactivating any potential SARS-CoV-2 contamination of MED-EL hearing implants?

A: Yes, MED-EL’s sterilization process efficiently prevents any potential contamination of SARS-CoV-2. For active implantable hearing implants, MED-EL employs ethylene oxide (EO) as sterilant. EO gas molecules react with and destroy the microbial genetic material and thus, inactivates the DNA, RNA, and proteins of microorganisms (bacteria, fungi, viruses, and spores).¹ The new SARS-CoV-2 is a single-stranded RNA virus featuring an envelope made from phospholipids and proteins, similar to a traditional cell membrane.^2,3 This means that also SARS-CoV-2 is susceptible to ethylene oxide sterilization and thus, can be inactivated with a high assurance level. This applies to every MED-EL cochlear implant, as well as to the Vibrant SOUNDBRIDGE and the BONEBRIDGE including their packaged surgical accessories.

For sterile single use templates (which are shipped with every MED-EL cochlear implant) MED-EL employs gamma irradiation. Gamma irradiation breaks chemical bonds, including those of molecule constituting microorganisms, including viruses.⁴ This method is also highly effective against a potential SARS-CoV-2 contamination.

Q: Which virucidal agents are used in the production process?

A: MED-EL manufactures exclusively in certified clean room environments, followed by a final sterilization process that that exceeds the power of any disinfection process by at least one million in terms of sterility assurance. Therefore, it is not necessary to use virucidal agents to inactivate any potential contamination of SARS-CoV-2 prior to ethylene oxide sterilization.

Q: Are MED-EL hearing implants with a production date before e.g. March 1st, 2020 free of SARS-CoV-2 contamination?

A: Regardless of the production date, all packaged MED-EL hearing implants are free of any potential contamination of microorganisms including SARS-CoV-2.

Q: Do MED-EL audio processors and external accessories pose a risk to transmit SARS-CoV-2?

A: Shipped audio processors and external accessories do not pose a risk to transmit SARS-CoV-2 due to MED-EL’s clean production processes and packaging procedures. There are currently no cases which have shown any evidence of humans being infected with SARS-CoV-2 by contact with contaminated articles and dry surfaces. There are also no known reports for other coronaviruses about infections due to contact with dry surfaces because of the relatively low stability of coronaviruses in the environment.⁵

Q: How can I disinfect a cochlear implant audio processor used in daily life?

A: Further information on cleaning and disinfecting audio processors can be found here: Cleaning Your Audio Processor: Special Guidance Relating To COVID-19 (Coronavirus).

References

1. Dusseau, J. Y., Duroselle, P., & Freney, J. (2008). 12.3 Gaseous sterilization. Russell, Hugo & Ayliffe’s Principles and Practice of Disinfection, Preservation and Sterilization, 401.
2. Wrapp, D., Wang, N., Corbett, K. S., Goldsmith, J. A., Hsieh, C. L., Abiona, O., … & McLellan, J. S. (2020). Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science, 367(6483), 1260-1263.
3. Cascella, M., Rajnik, M., Cuomo, A., Dulebohn, S. C., & Di Napoli, R. (2020). Features, Evaluation and Treatment Coronavirus (COVID-19). In StatPearls [Internet]. StatPearls Publishing.
4. Feldmann, F., Shupert, W. L., Haddock, E., Twardoski, B., & Feldmann, H. (2019). Gamma irradiation as an effective method for inactivation of emerging viral pathogens. The American journal of tropical medicine and hygiene, 100(5), 1275-1277.
5. BfR – Bundesinstitut für Risikobewertung – Can the new type of coronavirus be transmitted via food and objects? (Online, updated 23 March 2020). Note: The content of this page is regularly updated and the latest version was reviewed before publication.

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