Numerous questions to the Committee on Technology are individually and quickly answered each quarter by knowledgeable committee members. Many of those responses would be of value to the general readership, but are not suitable for the Dear SIRS column. Therefore, we have created this simple column to address the needs of our readership.
Older Machines—Maintain or Replace?
Our facility has several anesthesia machines that have been in use for over 15 years. We have a couple of Ohmeda Modulus IIs , several Dräger Narkomed 2Bs, and one Narkomed 2C. After 2008, Dräger will no longer provide preventive maintenance for the Narkomed 2Bs. We are studying the feasibility of replacing the older machines. Do you know of any legal ramifications we could face by having a third party provide service for these older machines since Dräger will no longer service them? Is there a recommended time for replacement of older anesthesia machines and are they considered to be “end of life” after so many years?
Scott Tumlin, CRNA
Dear Mr. Tumlin,
There are no laws limiting the use of an anesthesia delivery system after the manufacturer has declared the system to be obsolete and will not provide support, service, or parts. However, the American Society of Anesthesiologists has published GUIDELINES FOR DETERMINING ANESTHESIA MACHINE OBSOLESCENCE, located on the web at http://www.asahq.org/publicationsAndServices/machineobsolescense.pdf
There are 2 issues of concern regarding the use of an anesthesia machine that the original manufacturer has declared obsolete and will no longer support:
- Does the machine meet current safety standards? For example, does it have a hypoxic mixture guard to prevent the accidental delivery of a hypoxic gas mixture to the patient? Does it have an exhaled volume monitor? These are the issues addressed by the ASA document.
- Can you obtain quality service that supports the machine to the level of the manufacturer’s performance specifications? Can the service organization provide new original equipment manufactured (OEM) parts, or warranted remanufactured parts that meet OEM specifications, or are they using parts that they removed from other obsolete machine that may have serious reliability issues?
To expand on this service issue, be aware that proper service and support of an anesthesia system involves 3 main elements:
- Factory Service Training (knowledge of function and design)
- Factory Technical Support (troubleshooting knowledge and troubleshooting experience)
- Parts availability to restore performance specifications and reliability.
Without service and support from the manufacturer, all parties involved assume the following risks:
- Factory service training. Has the service technician been factory trained on the particular model of machine in question? Simply because the original manufacturer will no longer support a particular model of anesthesia machine does not mean that an independent service organization does not have the technical expertise to service an obsolete machine. It is important to confirm that your service technician has been factory trained on the machine in question.
- Factory technical support. Original manufacturers, once a model of machine has been declared obsolete, will no longer provide technical support on the telephone or otherwise. If the service technician is unable to effectively troubleshoot the machine you are counting on their honesty and integrity to tell you that they cannot resolve the issue or suffer the consequences of using a potentially defective machine. In this case you may be assuming a very high risk.
- Parts availability. The original manufacturer will not sell parts after they declare that they are no longer providing service for the machine. Some independent service providers may have new parts, access to new parts through original equipment manufacturers who may have sold the parts to the machine manufacturers, or they may have access to warranted remanufactured parts. Functioning parts removed from other obsolete machines are not usually acceptable due to reliability concerns. However, if a part to repair the unit is unavailable, then that unit must be removed from service until a replacement part can be obtained.
Real problems may exist with equipment purchased for office-based procedures. It is incumbent upon the anesthesia providers to inform those individuals who are responsible for anesthesia machine purchases, in office-based practices, that a machine may not be acceptable in terms of safety features. You may also question who is maintaining the equipment and how frequently it is serviced and what happens when the machine needs parts.
Unfortunately, remote areas of the hospital often get anesthesia machines that were retired from service in the operating room. This is a particularly bad practice because life support equipment that is used infrequently needs to have the highest reliability and latest safety features. These machines should be equipped with the same safety features as machines in the operating room; otherwise anesthesia providers could assume safety features are included and make assumptions that are not in the best interest of quality patient care. For example, a machine that has low flow and high flow oxygen flowmeters could easily be used to accidentally deliver a hypoxic mixture to the patient when this scenario could never happen in the main operating rooms.
In conclusion, the recommendation is to follow the ASA GUIDELINES FOR DETERMINING ANESTHESIA MACHINE OBSOLESCENCE and know the service provider. When in doubt, replace the anesthesia machines in question with newer units that meet all of the above criteria.
The APSF Committee on Technology
The information provided is for safety-related educational purposes only, and does not constitute medical or legal advice. Individual or group responses are only commentary, provided for purposes of education or discussion, and are neither statements of advice nor the opinions of APSF. It is not the intention of APSF to provide specific medical or legal advice or to endorse any specific views or recommendations in response to the inquiries posted. In no event shall APSF be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the reliance on any such information.