The U.S. Public Interest Research Group says that many manufacturers or respiratory ventilators do not provide access to repair documentation, limiting who can repair the equipment. The advocacy group claims this practice discourages third-party medical repair companies or in-house medical engineers from trying to fix things. In that regard, USPIRG, which also sponsors a Right to Repair Campaign, says it has delivered a petition to ventilator manufacturers calling on them to release service manuals, service keys, schematics and service keys for their products.However, an informal investigation shows the availability of repair manuals for ventilators might not be much of a problem. Several online sites host ventilator repair manuals for download. One, frankshospitalworkshop.com which runs out of Tanzania, lists manuals for 44 ventilator manufacturers. Of these only two, Dräger in Germany and Tecme in the U.S., are listed as unavailable because the manufacturer won’t provide them. (We contacted Tecme for a comment but the company had not responded as of this writing.)
However, manuals for five different Dräger machines could be found on a ventilator manual page of the iFixit.com site. In all, the ifixit site hosts manuals from 36 medical equipment manufacturers. Ifixit says it is building a central resource for maintenance and repair of hospital equipment and will host any manuals it receives.
The principal issue with manual availability seems to be with third-party repair services rather than with hospitals themselves. Technical personnel at UCSF Medical Center told us they generally have manuals for the equipment they own. And the usual practice is to require that manuals be provided as a condition of purchase, though they admit this point is not always enforced. They also point out that oneSOURCE Document Management Services maintains a service for the healthcare industry wherein subscribers can download equipment manuals.
In addition, UCSF further explains that some manufacturers will not provide manuals unless someone from the facility has attended the manufacturer’s official service training. Given the life-and-death nature of ventilator use, this may not be an unreasonable requirement. Says one biomedical engineer who once ran an independent medical maintenance firm, “Ventilators are relatively easy to repair, but I never liked working on them. Always in the back of your mind is the knowledge that if you screw up somehow, somebody’s life could be on the line.”
The Mayo Clinic says it has no difficulty getting ventilator service manuals, but other entities may not have the same experience. Says Mark Manning, Division Chair, Mayo Clinic Healthcare Technology Management, “A strong relationship with our vendors, as well as purchase contracts specifying training for our staff, parts discounts and service manuals help assure access to these materials. However, this is not always the case with other healthcare and third-party servicing organizations. Vendors can restrict who is allowed access to training and service materials, and often do. In addition, there is also a layered and increased challenge as older ventilators are being put into use after being in storage, where sourcing service materials can be even more challenging. Not all Healthcare organizations have a strong in-house support programs and contract management like Mayo.”
One thing seems certain when it comes to respiratory ventilator repairs during the crisis: There are likely to be a lot of them. One study of respiratory failures published in the European Respiratory Journal found indications that the number of ventilator failures is related to total hours of their use. Researchers found on average an 8% failure rate per manufacturer considering both old and very new ventilators in service. The commonest causes of ventilator malfunction they saw were motor blower or bellows failure and circuit boards ceasing to function. They also found a large number of the alarm problems identified by external service and maintenance companies turned out to be a consequence of water in a pressure line which could be resolved in some models by inserting a small filter.
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Filed Under: Hack the Crisis: Engineering through COVID-19