Pacemakers

- Yes! A pacemaker device is designed to last anywhere between 6 and 10 years. Though FDA regulations does not permit the recycling of pacemakers for humans in the United States, we have come to find many scientific journals that say recycling pacemakers is a safe practice. Here are a few excerpts from some of the scientific journals we have found that support recycling pacemakers

Many skeptics of pacemaker recycling cite potential problems with sterilizing the extracted pacemaker and guaranteeing its mechanical ability for a second recipient.http://wiki.answers.com/Q/Special:Wysiwyg?tid=wysiwyg#_ftn1 While these concerns may have been viable years ago technological developments and clinical research has proven them to be archaic.

The Cardiovascular Department at the University of Michigan Medical Center is now engaged in a pacemaker recycling study where they utilize the following procedure to adequately sterilize recycled pacemakers. According to their article published in the Journal of the American College of Cardiology, "Pipe cleaners and other instruments were employed to ensure that all debris was removed, specifically at the lead insertion sites. Devices were then bathed with isopropyl alcohol and soaked overnight in Asepti-zyme at a concentration of 1:128. Pacemakers were wiped with 70% ethanol, air dried, packed in gas permeable envelopes, and decontaminated via an 8-h ethylene oxide gas sterilization protocol." The U of M program has successfully re-implanted 12 pacemakers in the Philippines.http://wiki.answers.com/Q/Special:Wysiwyg?tid=wysiwyg#_ftn2

As far as the mechanical quality of potential recycled pacemakers, there seems to be no difference in quality except in battery life. The non-profit organization, Heart Too Heart and the University of Michigan both require that a pacemaker's battery has 70% or greater batter life remaining before it even becomes a candidate for reuse. Further, several longitudinal research studies have shown that there is no recognizable difference in mechanical quality between new and recycled pacemakers. In fact, some suggest that doctors can be more confident with a recycled pacemaker because of its proven track record. The following is another study that has shown pacemaker recycling to be a safe and life-saving opportunity for people in less privileged countries. Over 3,500 patients were studied in two groups from 1976 to 1981. One group received a new device and the other received a recycled pacemaker. The study concluded that "There were no statistically significant differences between the two groups, either in terms of indications for implantation or in terms of actuarial survival of patients. In addition, there was no significant change in survival of the pulse generator. The reutilization of pacemakers appeared to be in no way detrimental to patients."http://wiki.answers.com/Q/Special:Wysiwyg?tid=wysiwyg#_ftn3

- If you would like to read more scholarly work on the safety of pacemaker recycling the following articles all come from a scholarly background.

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- 1. Is there an afterlife for pacemakers and defibrillators?(2007). Harvard Heart Letter, 17(6), 7.

- [1] Food and Drug Administration. (June 18, 2009). CPG Sec. 310.100 Pacemaker Reuse (CPG 7124.12). Retrieved October 31, 2009, from http://www.fda.gov.er.lib.kstate.edu/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073891.htm

- 2Baman, T., Romero, A., Kirkpatrick, J., Romero, J., Lange, D., Sison, E., Tangco, R., Abelardo, N., Samson, G., Grezlik, R., Goldman, E., Oral, H., & Eagle, K. (2009). Safety and efficacy of pacemaker reuse in underdeveloped nations: a case series. Journal of the American College of Cardiology, 54(16), 1557.

- 3 Mugica, J., Duconge, R., & Henry, L. (1986). Survival and mortality in 3,701 pacemaker patients: arguments in favor of pacemaker reuse. Pacing and Clinical Electrophysiology, 9(6), 1282.

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2. Anilkumar, R., & Balachander, J. (2004).
Refurbishing Pacemakers: A Viable Approach. Indian Pacing and Electrophysiology Journal, 4(1), 1-2.

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3. Francis, J., Anilkumar, R., & Mond, H. (2007). Reuse of Expanted Pacemakers: An Options for Ecomomically Underprivileged Patients in Developing Countries. Indian Pacing and Electrophysiology Journal, 7(4), 192-194.

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4. Jackson, M. (1996). Issues affecting refurbishment and re-use of pacemakers. Australian Health Review, 19(1), 68.

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5. Linde, C. L., Bocray, A., Jonsson, H., Rosenqvist, M., Rdegran, K., & Rydn, L. (1998). Re-used pacemakers--as safe as new? A retrospective case-control study. European Heart Journal, 19(1), 154.

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6. Mitka, M. (2007). Death not necessarily end for heart devices. JAMA, 297(2), 144.

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7. Mugica, J., Duconge, R., & Henry, L. (1986). Survival and mortality in 3,701 pacemaker patients: arguments in favor of pacemaker reuse. Pacing and Clinical Electrophysiology, 9(6), 1282.

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8. Panja, M., Sarkar, C. N., Kumar, S., Kar, A. K., Mitra, S., Sinha, D. P., Chatterjee, A., Roy, S., Sarkar, N. C., & Majumder, B. (1996). Reuse of pacemaker. Indian Heart Journal, 48(6), 677.

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9. Romero, J., Romero, A., Kirkpatrick, J. N., Lange, D. C., Eagle, K. A., & Baman, T. S. (2009). Pacemaker Reuse in a 65-Year-Old Woman in the Philippines with Severe Medical Need. Pacing and Clinical Electrophysiology,

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10. Sethi, K. K., Bhargava, M., Pandit, N., Mohan, J. C., Arora, R., Khanna, S. K., & Khalilullah, M. (1992). Experience with recycled cardiac pacemakers. Indian Heart Journal, 44(2), 91.

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11. Tyers, G. F. (1992). Recycling and 'transplantation' of implantable electronic devices. The Canadian Journal of Cardiology, 8(7), 683.

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Though the FDA does not endorse or prohibit recycling outside of the United States, a few organizations that have taken on the task of recycling pacemakers. These pacemakers come from patients in the US who have recently passed and are shipped to third world countries to save the lives of their people. Most pacemakers sent to third world countries are used to help save the lives of children. Between the 7 organizations we have researched, we have found they have jointly saved over 14,524 lives! For more information on joining the effort to recycle pacemakers, or to find out how to donate one yourself contact one of the following organizations:

1. Heart Too Heart/World Heart Aid- 220 34th St. West Billings, MT 59102

2. Solidarity Bridge- •http://www.solidaritybridge.org/index.html

3. University of Michigan- Project My Heart Your Heart- www.med.umich.edu/cvc

4. World Medical Relief- www.worldmedicalrelief.com

5. Second Life Program- (what info did we have;I cant find any)

6. Heartbeat International- www.heartbeatintl.org

Animals have become a growing speicies in need of pacemakers. Though the FDA does not permit recycling pacemakers between humans, they do not prohibit the recycling of pacemakers in pets. Check out the following website for information on how to recycle a pacemaker to your pet.

http://vetmed.illinois.edu/petcolumns/showarticle.cfm?id=177

Special:WysiwygCPG Sec. 310.100 Pacemaker Reuse (CPG 7124.12). Retrieved October 31, 2009, from http://www.fda.gov.er.lib.k-state.edu/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073891.htm

Special:Wysiwyg

N., Samson, G., Grezlik, R., Goldman, E., Oral, H., & Eagle, K. (2009). Safety and efficacy of pacemaker reuse in underdeveloped nations: a case series. Journal of the American College of Cardiology, 54(16), 1557.

Special:Wysiwyg