The Michigan legislature has approved a bill that prohibits reusing single-use medical devices. Senate Bill No. 528 was passed 37-0. The bill is now being prepared for presentation to Governor Jennifer Granholm.

The bill states that a health care provider shall not knowingly reuse, recycle, refurbish for reuse or provide for reuse a single-use device. Exceptions are provided for health care providers that use a single-use device that has been reprocessed by an entity registered as a reprocessor and regulated by the U.S. Food and Drug Administration, or uses an open but unused single-use device that has been re-sterilized. Violations of the law, if enacted, would incur up to 10 years imprisonment and a fine up to $50,000.

State Senator Bill Hardiman (R-Kentwood), sponsor of the bill, stated during the vote that the legislation will address "a vital issue," and bring peace of mind to Michigan residents. "As many of you know," Senator Hardiman said, "there was a doctor a few years ago who deliberately reused medical devices in complete disregard for his patients' safety. This has been deeply distressing to those patients and other residents. That doctor was convicted for billing fraud, but Michigan law still contains a gray area on the misuse of medical devices. This bill will clear that up."

Senator Hardiman was referring to former dermatologist Robert Stokes, who had been sentenced to 10 years in prison in 2007 for Health Care Fraud, in part for "up-coding" office surgical procedures, and fined $175,000. There was no federal criminal law for improperly reusing medical devices. The Michigan Department of Community Health had investigated unsafe sanitation practices allegations made against Stokes--including reusing scalpels, gloves, syringes and suture materials on multiple patients, and had sent letters to Stokes' patients recommending testing for hepatitis B, hepatitis C and HIV. Stokes' conviction is currently awaiting an appellate decision.

"No one should have to go through the experience that these patients had," Senator Hardiman commented. "They would all want us to prevent this from happening again. With Senate Bill No. 528, we will, hopefully, take that step."

The Legislative Journal: http://www.legislature.mi.gov/%28S%2842vk3d552arb4s55mtjori45%29%29/documents/2009-2010/Journal/Senate/htm/2010-SJ-03-11-022.htm

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