Ban Urged on Reusable Medical Devices

Amid an unfolding national debate over the safety of reprocessed, single-use medical devices, a Sacramento lawmaker announced that he will introduce a bill to temporarily ban the use of such devices in California.

Assemblyman Thomas Calderon (D-Montebello) says the bill--proposed in response to a Times story published Monday--would ban reprocessed, single-use devices until further studies can demonstrate whether they pose a risk to public health.

“I want to make sure that reprocessing is safe,” Calderon said. “Part of the health care process is to have confidence in the system. In the absence of data, it’s important to take a serious look” at reprocessing.

The Times article described how surgical devices labeled for a single use are reprocessed for use on other patients. It cited several reports of malfunctions, infections and adverse chemical reactions that were linked to reprocessed devices.

The article brought the issue of reprocessing to Calderon’s attention, according to a staff member.

The bill, which focuses on single-use devices that make contact with blood or other body fluids, comes as reprocessing is being heavily scrutinized in Washington. Under pressure from legislators and several associations, the U.S. Food and Drug Administration is expected to decide soon whether reprocessing is safe.

In addition to a temporary halt on the reuse of single-use devices, Calderon’s bill calls for an industry standard for reprocessing, should the practice be proved safe. Also, it would require companies that reprocess single-use devices in California to register with the California Department of Health Services.

Calderon’s bill is likely to encounter resistance from third-party reprocessors, companies that clean the used devices and resell them to hospitals at a price lower than that of a new device. Hospitals striving to cut rising health care costs are expected to oppose the legislation.

“To ban reprocessing is to overreact. It would be a very disruptive measure that would not be in the best interest of the patient,” said Rick Wade, senior vice president of the American Hospital Assn.

“The pressure should be on the FDA,” he said. “They have the authority to regulate the practice.”

Efforts should focus on obtaining more data about the safety of these devices, Wade and others say. The FDA has cited the lack of data on the subject.

A ban on reprocessing, even if temporary, would have disastrous consequences for many hospitals, Wade said. Buying new devices instead of reprocessed ones would present purchasing departments with unexpected items in their budget, prompting a search for other ways to cut costs.

Disposal of all one-time devices would trigger a new stream of medical waste, he said, leading to significant treatment costs in addition to environmental consequences.

Calderon said he is willing to listen to all sides--and possibly moderate the bill--as long as patient safety is not jeopardized in the process.

Sen. Martin Gallego (D-Irwindale), chairman of the Assembly’s health committee, believes that Calderon’s bill will get strong support from the Legislature. According to Gallego, the issue of reprocessing merits a public interim hearing--possibly to take place next fall--where all stakeholders will convene before the entire health committee.

This is not the first time a state bill would attempt to ban reprocessing. In 1997, state Sen. Evelyn Bowles introduced a similar bill in Illinois, aiming to forbid reprocessing of single-use devices. But by the time the bill took effect, she said, the final version had been heavily amended to make concessions for reprocessors.

“Let’s hope they don’t get battered around like I did,” said Bowles of the ongoing efforts in California. Reprocessing is still legal in Illinois.