Anti-reprocessing STate Legislation

The Threat

To all U.S. hospitals, surgery centers, surgeons, nurses, infection control, materials management, central sterile professionals, and all other health care personnel with any responsibility over medical devices:

Hospital and surgical center access to safe, effective, FDA-regulated, and low-cost reprocessed medical devices is at risk. Original equipment manufacturers of "single use" medical devices (“OEMs”) are pressuring state legislatures to impose restrictions and burdens on the use of reprocessed medical devices.  We need your support to help fight these economically-motivated efforts. (see, How to Get Involved below).

Under the guise of promoting a patient's “right to know,” OEMs are attempting to do at the state level what they could not accomplish federally: to put the reprocessing industry out of business in order to bolster their own bottom lines. OEMs have engaged in a misinformation campaign, scaring legislators with misleading, unsubstantiated photos or stories, in the hopes of convincing law makers that reprocessed devices are unsafe or unclean. We need your help in showing lawmakers the truth about reprocessed medical devices.  (see, How to Get Involved below).

What Would the Proposed Legislation Do?

The typical legislation being promoted at the state level has three components: 

• First, it would require health care providers to obtain “informed consent” from a patient before using a reprocessed device during a procedure. AMDR would support informed consent requirements for all medical devices that informs patients of real, and not fabricated risks.
• Second, these state bills would require hospitals and reprocessors to submit a report to the state's Department of Health whenever a reprocessed device has, or could, cause or contribute to a death or serious injury.  AMDR believes this requirement is duplicative of the federal requirement and therefore unnecessary and burdensome.

• Third, the bills would immunize OEMs from all liability associated with their devices whenever the device happens to have been reprocessed, even for liability attributable to the manufacturer’s own acts or omissions. AMDR's view is that reprocessors are already liable for all injuries due to reprocessing making this requirement unncessary.  

What is Wrong with These Bills?

This OEM-Sponsored Legislation is Bad for Hospitals, Patients and the Environment:

:

• The provisions of the proposed legislation are designed to burden users of reprocessing services to such an extent that hospitals will cease to use reprocessed devices.  

• Enacting this legislation would cost hospitals, and state governments, millions. Hospitals face enormous cost-containment pressures but currently save nearly 100 million dollars a year by using safe and effective reprocessed devices. 
• Savings from reprocessing benefit patients by enabling hospitals to hire additional nurses, to upgrade medical technology, to enhance indigent care, and to make other patient care improvements.
• Reprocessing of “single use” medical devices is a form of recycling, and helped hospitals keep over 900 tons of medical waste from the waste steam in 2004 alone.

• The “informed consent” provisions of these bills are unnecessary because reprocessed devices are just as safe and effective as original equipment. 

• Seeking the patient’s “informed consent” will imply to the patient that there is a risk associated with reprocessed devices that does not, in fact, exist. 
• The “informed consent” provision is bad for patients because it will lengthen informed consent documents by adding irrelevant information, and will obscure the importance of other facts being presented prior to a procedure that may, in fact, carry real risk. 
• There is no legal, medical or ethical basis for requiring the patient’s consent. The OEMs seek to impose an “informed consent” requirement because they know it will frighten patients and encourage them to refuse to permit hospitals to use these devices.

• The adverse event reporting provisions are unnecessary because they are redundant of existing federal requirements -- manufacturers, including reprocessors, are already required to meet FDA's reporting requirements.  The requirement would only add to the paperwork burdens of hospitals without producing a corresponding benefit to patients.

• Finally, the liability provisions are unnecessary because existing tort law fully protects patients and fairly allocates liability. 

• Liability should follow fault. If a reprocessed device injures a patient because it was reprocessed, the reprocessor must be liable. 
• However, if a reprocessed devices injures a patient because of a design flaw in the original device, the fault lies with the original manufacturer and liability should remain with that manufacturer. 
• The proposed liability provisions would radically alter traditional tort law by transferring liability to reprocessors for acts or omissions of the original manufacturer. 
• The provisions will cause insurance costs to escalate for third-party reprocessors serving hospitals, likely making it prohibitive for them to do business. Thus, the legislation threatens to eliminate hospitals’ access to safe, effective, low-cost reprocessed devices.  

What We're Doing

AMDR is working hard with state legislators, regulatory authorities and hospitals to show reprocessing's true safety and regulatory record. We are convinced that, when guided by facts and science and not unsubstantiated scare tactics, legislators will realize what hospitals have known all along -- that reprocessing has a crucial role to play in America's health care system.

How to Get Involved

We need your help in getting our message to your state legislators and other elected officials. Please call or e-mail your state representatives, Governor's office, and the state department of health, and tell them to support the safe, cost-effective and environmentally responsible practice of reprocessing and to oppose efforts sponsored by manufacturers to limit or needlessly regulate the practice.

1. To locate your state legislators, please use the following links:

• Massachusetts
• New Jersey
• Rhode Island
• Utah
• Virginia

For all other states, please contact the Association of Medical Device Reprocessors (AMDR) at info@AMDR.org.  Please provide your name, hospital or surgical center affiliation (if applicable) and a phone number. We'll be in touch to discuss ways you can get involved.

2.  Call, write, or send an e-mail to your legislator. For talking points, please see above, or, see our sample letter:

• In Massachusetts, reference S.B. 2433 and in Rhode Island, reference bill S. 2607.
• Use the sample letter below as a template for your own letter, or
• Talk about your own experience with reprocessed medical devices.