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ASHCSP Re-use Alert Friday, August 06, 1999
August 6, 1999 MEMBER ALERT SENATE ADOPTS AMENDMENT IMPACTING REUSEDear ASHCSP Members:
This week, the Senate adopted an amendment to the Agriculture Appropriations Bill, advanced by Sen. Richard Durbin (D-Ill), appropriating $1,000,000 for the Food and Drug Administration to enforce and oversee reprocessed medical devices. Although work is still needed on the final language of the amendment, the American Society for Healthcare Central Service Professionals supports the regulation of reuse of single-use medical devices through the FDA.
You may have heard about Sen. Durbin’s original proposal containing provisions that would have severely restricted, if not discontinued, the reprocessing of single-use devices in hospitals and third party reprocessing facilities. Due to procedural barriers, the Senator wasn’t able to offer this proposal. Instead, the $1,000,000 FDA funding amendment passed. However, the Senator has stated he intends to introduce legislation of the more prohibitive nature sometime this year. Consideration of that bill is likely next year.
Reuse is a complex issue and cannot be solved with a broad-brush approach. Here are the basic tenets of ASHCSP’s position on reuse: (Please refer to the ASHCSP web site www.ashcsp.org to review the complete document.)
ASHCSP believes hospitals should have the prerogative to determine whether or not the reprocessing of disposable devices is appropriate for their facility. However, the decision to reuse internally should be made only if the facility has the capabilities of ensuring the necessary steps are taken to preserve patient safety and device integrity. If a hospital or third party reprocessor cannot demonstrate and document these steps, reuse is not recommended.
ASHCSP supports a regulatory approach that considers the classification of, complexity of and ability to clean a medical device and treats reuse, reprocessing and resterilization separately.
Here’s why we’ve taken this position:
There is no scientific evidence that suggests the proper reuse of single-use devices is a threat to patient safety. Tens of millions devices have been reprocessed over the years safely and effectively.
Many products that were once sold as multi-use devices are now labeled single-use. Examples include transducers, bulb syringes, cautery pencils, stopcocks, burrs, bits, blades, and EP guide wires. The single-use label on a medical device may merely indicate the manufacturer has chosen not to conduct the pre-market 510(k) testing as a multi-use device. It does not explicitly imply that the device is unsafe for reuse. For some products, the manufacturer even provides guidance for reuse.
While disposable devices are a convenient option in the delivery of patient care, manufacturers are the driving force behind the continued shift from reusables to disposables as a strategy to protect a growing market share.
Disposing of single-use devices that can be safely and effectively reused contributes significantly and unnecessarily to hospital waste in an age when healthcare professionals are striving to be better stewards of the environment.
While many devices can be safely and effectively reused, some cannot and should not. ASHCSP does not support reusing all disposable devices. Regulations which include clear standards for label requirements and guidelines based on the category of product and whether or not a device can be cleaned are needed. Examples of devices that should not be reused include EP catheters, perfusion lines, oxygenators, endo-surgical instruments less than 2mm in diameter and with a length greater than 15/17 in.
In continuing our effort to gain credibility and visibility for Central Service professionals on the reuse issue, ASHCSP and AHA have been working over the last several months with key stakeholders in the legislative and regulatory arenas. ASHCSP has provided guidance to the AHA on the development of statements, letters and talking points and will continue to do so.
In addition, we’ll be working to gain consensus from the health care community on this issue. A one-day conference is planned for October. The FDA has agreed to participate. Additionally, representatives from IAHCSMM, AORN, APIC, the Association of Healthcare Resource and Materials Management, and American Society for Healthcare Risk Management have been invited to participate.
ASHCSP welcomes members’ comments on this issue.Please reference Chronology of events listed below
Chronology of Events Reuse of Single-Use Devices
1998
The ASHCSP Regulatory Advocacy Committee identifies reuse as its number one regulatory issue. ASHCSP surveys members on the prevalence of reuse and other activity associated with the practice. Results are communicated to members through the ASHCSP newsletter and presented during a session at the October Conference.
February, 1999
ASHCSP is invited to speak at the AAMI/FDA Reuse of Single-Use Devices meeting to present the general findings and ASHCSP’s position on the issue.
April, 1999
ASHCSP develops a position on reuse which defines terminology and provides guidelines should a facility choose to reuse, resterilize or reprocess. ASHCSP contacts IAHCSMM regarding its position and to understand if both organizations are thinking along the same lines on this issue. Both do, but have differing guidelines around who should do the reprocessing if the facility opts to reuse, resterilize or reprocess disposables. ASHCSP believes hospitals should be given the choice to reuse, resterilize or reprocess, if they have the capability of taking the necessary steps to preserve the quality of patient care and device integrity. IAHCSMM discourages in-house reprocessing altogether regardless of a facility’s ability to manage it internally. May, 1999
ASHCSP position appears on its web site and in its newsletter. ASHCSP attends the AAMI/FDA Conference, The Reuse of Single-Use Devices: Practice, Patient Safety and Regulation. FDA concludes that more scientific data is needed and reports it will have an official position on reprocessing of single-use devices by October. FDA stresses that incidents reporting device malfunction and/or impact on patient health are isolated considering that tens of millions of devices have been reprocessed over the years.
June, 1999
ASHCSP learns of Sen. Durbin’s (D-Ill) reuse amendment with burdensome provisions that could result in the discontinuation of reuse in hospitals and at third party reprocessing facilities.
ASHCSP works with AHA lobbyists to educate Senators on the real issues surrounding reuse and asks that the amendment not be considered on the Agriculture Appropriations bill when it comes to the Senate floor. Instead, ASHCSP/AHA recommends the regulation of reuse of single-use medical devices through the FDA.
August, 1999
The American Hospital Association and the Medical Device Manufacturers Association are interviewed on Good Morning America regarding reuse. The program concludes with both sides agreeing that reform is needed and should be placed appropriately in the hands of the Food and Drug Administration. Sen. Durbin redrafts the Appropriations amendment. The new amendment appropriates $1,000,000 for the Food and Drug Administration to enforce and oversee reprocessed medical devices. Contact: Kathy Svedman Via e-mail at: ksvedma1@aha.org or call 312-422-3861 Reposted by permission 3/13/00. |