Although the definition of terms and scope of practice can vary by responder, healthcare organizations generally acknowledge that the concept of reprocessing single-use devices can be classified three ways: Resterilization involves unopened and unused device packages, reprocessing involves opened but unused packages and reuse involves opened and used devices, such as those that pierce the skin or enter the body or bloodstream.

Many hospitals argue that the practice is cost effective and safe, particularly if they use a reputable and validated third-party reprocessor. By and large, they contend that prior to the 1980s and the advent of minimally invasive surgery, many devices classified today as disposable or single-use only originally were reusable, and that the switch is nothing more than a profit-grab by manufacturers.

Not so, counterpunch the manufacturers who say that many of those devices today contain hard-to-access features that can be difficult, if not impossible, to clean properly and sterilize effectively, according to the Massachusetts Medical Device Industry Council (MassMEDIC), an organization of 335 manufacturers, suppliers, research institutions and academic health centers. In addition, many of these devices are made with different materials such that their structural integrity may be "seriously compromised or destroyed" by cleaning and sterilization procedures, effectively rendering them unsafe for subsequent patient use. The devices in question include surgical saw blades, angioplasty catheters and endotracheal tubes, originally designed and manufactured for one-time use, after which they technically become medical waste.

As providers and suppliers debated the practice, the Food and Drug Administration stepped into the fray about four years ago by implementing changes to the agency’s product review procedures, including new regulatory requirements on SUD reprocessing. The federal agency’s efforts satisfied some organizations but not others, such as MassMEDIC, who called this a "notable first attempt" that "does not go far enough to protect patients from potential contamination and injury from reprocessed SUDs."

MassMEDIC noted that the FDA’s regulatory reforms fail to require validation data for all classes of critical SUDs, organizations to establish a tracking system for reprocessed SUD and to disclose to patients the potential use of reprocessed SUDs.

"Under Massachusetts law, an individual must provide consent if an aftermarket part is used in their vehicle but they are not required to provide consent if a reused medical device is used in their body," said Thomas Sommer, MassMEDIC president. "While hospitals use reprocessed devices primarily in an effort to cut costs, this savings may come at the price of jeopardizing patient safety. We believe that patients should have the right to make informed decisions about the medical care that they receive to protect themselves from unnecessary risk."

As a result, MassMEDIC issued its support for a state legislative initiative that requires patients to provide consent before reprocessed SUDs are used on them, hospitals to develop reprocessed SUD tracking systems and reprocessors to "assume sole and complete liability for the safety and effectiveness of the reprocessed device."

Last fall Sommer, and representatives from Smith & Nephew, Boston Scientific Corp. and C.R. Bard Inc., testified before the Massachusetts State Legislature’s Joint Committee on Public Health in favor of Senate bill 1321 that stipulates patients agree to a reprocessed SUD being used on them during any medical procedure. MassMEDIC claims this is the first informed consent legislation in the nation for reprocessed SUDs.

Healthcare Purchasing News Senior Editor Rick Dana Barlow posed a series of thought-provoking questions to Sommer to gauge the ongoing momentum of his organization’s efforts and their effect on legislative and regulatory bodies, as well as healthcare providers and suppliers.

SOMMER: MassMEDIC believes that this is an important piece of patient safety legislation that is being considered by the Massachusetts State Legislature. MassMEDIC is not participating in a multi-state or national campaign to pass similar legislation.

We are aware that the AMDR is opposed to this patient safety and patient rights legislation and that they testified against the legislation at the State House hearing on October 19.

Again, MassMEDIC believes that this legislation addresses a patient safety issue and is not a question of healthcare economics. If OEMs believed that reprocessing single-use only medical devices did not impact patient safety, they would be in the business of reprocessing their own products. Their internal tests, along with independent testing show that this cannot be safely done.

Once such independent study, for which Smith & Nephew provided an unrestricted grant, was published in April 2003. ‘Assessment of Reprocessed Arthroscopic Shavers,’ by Jonathan S. King, M.D., et. Al., presented at the Arthroscopy Association of North America (AANA) annual conference, indicates that reprocessed shavers are frequently contaminated with DNA and protein. The study also indicated that the contamination represents a risk of iatrogenic infection from various microbes, especially those that are more resistant to ethylene oxide sterilization such as viruses and prions.

The study also cited significant wear both visibly and functionally in reprocessed devices, which may affect the outcome of certain surgeries.

It’s very clear from this study that arthroscopic shaver blades cannot be consistently and effectively cleaned and sterilized for use in additional surgeries.

As with any informed consent prior to a surgical procedure, patients retain their right to pursue malpractice and/or product liability claims. Under this legislation, the informed consent provision only grants patients the right to choose whether reprocessed single-use only medical devices may be used in their surgical procedure. We believe patients should have that right.

The bill covers any entity or facility that reprocesses single use only medical devices.

In the mid-1980s medical device OEMs responded to public health concerns over rapidly increasing rates of infections and developed and manufactured sterile single-use only medical devices that could be safely used one time only.

In responding to this call, OEMs designed single use devices that could not withstand repeated cleaning and sterilization. Many of these SUDs often have unique features such as narrow lumens, acute angles, crevices, coils and joints, reinforcing meshes and rough, porous or occluded surfaces that make access difficult, create barriers to cleaning and provide a surface on which blood, tissue and other organic matter can accumulate. Commonly used sterilization techniques used in reprocessing may be incapable of penetrating and removing this biological tissue residue, leaving potentially pathogenic bacteria, viruses, proteins and other microorganisms on the devices which may be transferred to another patient on reuse.

If MassMEDIC truly is focused on patient safety, why not expand this bill to cover and regulate the quality of hospital reprocessing procedures for even reusable medical devices? I’m sure you’ve seen the reports of improperly cleaned and sterilized scopes at various leading healthcare institutions that led to patient warnings. Why not hold hospitals liable for these medical errors/mistakes?