Some single-use devices can be reprocessed safely, GAO report says

Joint Commission surveyors are asking questions — Are you ready?

Here are two bits of surprising news that could affect your opinion on reprocessing of single-use devices (SUDs): First, the General Accounting Office (GAO) has released a report that says some SUDs can be reprocessed safely.1 Second, the report surprised same-day surgery managers by disclosing that surveyors with the Joint Commission on Accreditation of Healthcare Organizations will collect information on the practice.

The surveyors will collect data about in-house reprocessing of SUDs on behalf of the Food and Drug Administration (FDA). Beginning in July with the publication of the final FDA regulation, and for six months, Joint Commission surveyors will ask three types of questions:

1. Does the hospital reprocess and reuse devices labeled for single -use, and if so, which devices does it reprocess or reuse?

2. Is the hospital aware of the FDA’s requirement for registration and listing of the devices it chooses to reprocess and reuse?

3. Does the hospital intend to continue to reprocess and reuse such devices?

Although the Joint Commission won’t identify individual hospitals when it supplies this information to the FDA, the practice raises a number of red flags, says Mark Mayo, facility director at Valley Ambulatory Surgery Center in St. Charles, IL, and executive director of the Illinois Freestanding Surgery Center Association. Mayo is consulting editor for Same-Day Surgery.

"It’s fine if they just collect that data," Mayo says. "But now it opens the hospital to a more thorough in-house inspection by the Joint Commission about the efficacy of their reprocessing process."

The Joint Commission is making a good-faith effort to help the FDA, he says. "But I can see surveyors saying, Oh, you reprocess? We want to take a look at that,’" Mayo says.

Anthony Tirone, director of federal relations for the Joint Commission in Washington, DC, says reprocessing already is addressed in the current standards, such as infection control, and the survey process won’t change based on responses to the surveyor’s questions. But he doesn’t go as far as to say that the surveyors won’t look at reprocessing SUDs.

"If there are indications that the facility is having problems with infection following surgery, we would look at that," Tirone says. "If it leads to the reuse of single-use devices, we would look at that."

A government stamp of approval

For its part, the GAO has examined the data and given reprocessing SUDs a qualified stamp of approval. (For caveats regarding safety of reprocessing, see story, p. 100.)

"The results of clinical studies show that selected devices can be reprocessed safely if appropriate procedures are followed and closely monitored, a view shared by many professional organizations and infection control experts," said Janet Heinrich, associate director of health financing and public health issues for the GAO, in June 27 testimony summarizing the report before the Senate Committee on Health, Edu-cation, Labor, and Pensions.2 (Both the report and the testimony can be accessed on the GAO’s Web site: www.gao.gov.)

The GAO bases this finding on four types of information it gathered:

• Well-developed clinical studies have established the safety of reprocessing some types of devices, the report said. Some evaluations of reprocessing single-use endoscopic instruments published in peer-reviewed scientific journals found that those SUDs could be reused at least several times without increasing patient risk, according to the report.3, 4

No health risk with proper care, experts said

• Hospital infection control practitioners, risk management executives, and patient safety experts at the Centers for Disease Control and Prevention (CDC) all said that careful reprocessing of the types of SUDs that can be properly cleaned and sterilized does not pose a health risk.

"The head epidemiologist of CDC’s Hospital Infection Program told us that although the CDC does not specifically monitor SUD reuse, he was confident hospital infection surveillance systems would have uncovered infections resulting from SUD reuse if they had occurred," the report said.

• Only a very small percentage of reports to the FDA’s Medical Device Reporting program concerned adverse outcomes involving reused SUDs.

• Several of the reports of patient adverse events allegedly related to SUD reprocessing were inaccurate, not relevant to the debate, or difficult to interpret, the report said.

"Everybody seems to say it’s safe, except for manufacturers," Mayo says.

About 20% to 30% of American hospitals reuse at least one type of single-use device, according to the GAO report. Health care personnel "distrust" the single-use label for three reasons, according to the report:

• The FDA cannot require manufacturers to support the designation of a device as single-use.

• The FDA’s approval requirements for SUDs are less extensive than those for reusable devices.

• Health care personnel perceive that manufacturers have an economic incentive to market devices as single-use that could be sold as reusable.

Going beyond the label

"I think the GAO report highlighted the fact that the single-use label doesn’t necessarily mean single use. They reported instances of manufacturers saying a device was single use and then providing instructions on how to reprocess," says Pamela J. Furman, Esq., executive director of the Association of Medical Device Reprocessors in Washington, DC.

The single-use label may sometimes be for marketing purposes as opposed to being a legitimate safety warning, she claims.

The GAO was unable to verify two claims that officials repeatedly heard, according to the report.

"Health care personnel told us that they believed that some SUDs were identical to reusable devices," the report said. "Similarly FDA officials and health care personnel told us that they recalled that the labels of some devices were changed from reusable to single-use in years past without significant design changes."

Although Same-Day Surgery readers might expect that manufacturers and reprocessors would find little to agree on about the report, both sides agree that FDA oversight is needed.

"FDA oversight is an important part of ensuring patient safety," says Furman, who represents the reprocessors.

On the manufacturing side, Louis Mazzarese, consultant in regulatory and clinical affairs and co-founder of the Association of Disposable Device Manufacturers (ADDM) in Washington, DC, says, "The report I believe confirms ADDM’s position: The FDA’s approach to regulating these devices has been inadequate, and further oversight is need to ensure patients exposed to these types of devices don’t experience safety or efficacy problems."

At press time, the FDA’s final regulation on reuse was scheduled to be published in July, and implementation was scheduled to take place in 2001. Ambulatory surgery centers were exempt in the proposed regulation. (For more on the proposed regulation, see SDS, January 2000, p. 1, and February 2000, p. 23. For legislative action, see story, p. 100.)

Mazzarese disagrees that a new regulation is necessary. "Existing laws and the existing [FDA] classification system work just fine," he says. "We just need to apply them."

Mazzarese isn’t the only one expressing concern about a new FDA regulation. In her testimony, Heinrich said, "The new framework is cumbersome and will be difficult to implement."

The GAO report says the FDA faces barriers such as the additional work of reviewing applications for SUD reprocessing, which will be required under the new regulation.

References

1. General Accounting Office. Single-Use Medical Devices — Little Available Evidence of Harm from Reuse, but Oversight Warranted. Washington, DC; 2000.

2. General Accounting Office. Medical devices: Reprocessing and reuse of devices labeled for single use. Statement of Janet Heinrich, associate director, health financing and public health issues; Health, Education, and Human Services Division; before the Committee on Health, Education, Labor, and Pensions, U.S. Senate. Washington, DC; June 27, 2000.

3. Cohen J, Haber GB, Kortan P. A prospective study of the repeated use of sterilized papillotomes and retrieval baskets for ERCP: Quality and cost analysis. Gastrointest Endosc 1997; 45:122-127.

4. Kozarek RA, Raltz SL, Ball TJ. Reuse of disposable sphincterotomes for diagnostic and therapeutic ERCP: A one-year prospective study. Gastrointest Endosc 1999; 49:39-42.

For more information on reprocessing single-use devices, contact:

Pamela J. Furman, Esq., Executive Director, Association of Medical Device Reprocessors, 1400 16th St. N.W., Suite 400, Washington, DC 20036. Telephone: (202) 518-6796. Fax: (202) 234-0399. E-mail: pfurman@amdr.org.

Louis Mazzarese, Co-founder, Association for Disposable Device Manufacturers, Washington, DC. Telephone: (203) 254-3565. E-mail: loum @snet.net.

Mark Mayo, Facility Director, Valley Ambulatory Surgery Center, 2210 Dean St., St. Charles, IL 61075. Telephone: (630) 584-9801. Fax: (630) 584-9805. E-mail: Mayconsultant@msn.com.

Anthony Tirone, Director of Federal Relations, Joint Commission on Accreditation of Healthcare Organizations, 601 13th St. N.W., Suite 1150 N., Washington, DC 20005. Telephone: (202) 783-6655. Fax: 202-783-6888. E-mail: Atirone@ jcaho.org.