Medical safety: Patients have a right to know about re-used devices

Here's a surprise for anyone who has been a patient in a hospital: Some medical devices used in treatment have been used before. The practice of reprocessing and re-using medical devices - including those that were designed for one use only - goes on in Massachusetts and throughout the country.

What's even more surprising to patients and most people is the practice is undertaken without the knowledge and consent of patients, and in many cases, without the knowledge of health care providers. Massachusetts state legislators are now considering a bill that would require hospitals and health care facilities to obtain a patient's consent before using these reprocessed, single-use devices.

Although reprocessing medical devices can be a cost-saving approach, it is not a safe practice for all medical devices. Single-use devices are manufactured and designed for one use, on one patient - after which they are considered medical waste.

Many of these devices, particularly those that pierce the skin or enter the body or bloodstream, have unique features such as narrow lumens and acute angles that make cleaning difficult, if not impossible. They come in contact with blood, bone, and other body fluids, and provide a surface on which blood and other organic matter can accumulate, which may be transferred to another patient on reuse. Reprocessed devices may be a possible source of unexplained hospital infections.

Furthermore, the structural integrity of these single-use medical devices may be seriously compromised, or destroyed by the reprocessing procedure that includes cleaning, refurbishing, and sterilization, among other activities. Yet, patients have no way of knowing if these types of devices are being used in their procedures.

A survey of health care providers, conducted on behalf of Smith & Nephew, a manufacturer of minimally invasive endoscopic surgical instruments, has shown:

<ul>

<li>65% of patients surveyed were unaware that medical devices used in a procedure may have been previously used;</li>

<li>74% of surgeons do not believe that single-use medical devices should be reprocessed;</li>

<li>79% of nurses believe that the use of reprocessed single-use medical devices should be discontinued;</li>

<li>and 82% of all nurses and 71% of all doctors surveyed say they would be uncomfortable if a reprocessed single-use medical device were used on themselves or a member of their family.</li>

</ul>

Medical device manufacturers have been accused of having only profit in mind, when they seek to simply allow patients to be informed of the practice now occurring without their knowledge. Profit is not the issue; safety is.

Medical device companies are concerned that patient safety is being compromised. And, if they believed that single-use devices could withstand cleaning and multiple use, they would reprocess them themselves or purchase a reprocessing company.

The federal Medical Device User Fee and Modernization Act of 2002 introduced a series of reforms to the FDA's product review procedures, including new regulatory requirements governing the reprocessing of single-use medical devices. The federal act mandates that all reprocessed single-use medical devices be clearly labeled as such by the company reprocessing these devices.

In addition, the statute orders reprocessors to supply validation data on cleaning, sterilization and functional performance of some of these devices to the FDA and requires reprocessors to file "pre-market reports" that include validation data for all Class III devices. If, in the FDA's determination, the validation data does not support the safety and efficacy of a reprocessed single-use medical device, it may not be marketed.

While the reprocessing provisions contained in federal law represent a notable first attempt at better regulating reprocessed single-use devices, we believe that it does not go far enough to protect patients from potential contamination and injury from them. Specifically, the law does not require disclosure to patients on potential use of a reprocessed single-use medical device; validation data for all classes of single-use medical devices that enter the body; or that institutions establish a tracking system for

reprocessed single-use medical devices.

Consumers are afforded more significant rights for repairs to automobiles. In 27 states across the nation, car owners have the right to visually inspect replaced parts and must be informed if replacement parts used in the repair were manufactured by the vehicle maker or made by another company. Shouldn't patients be provided similar rights when reprocessed single-use devices are going to be used in their medical procedures?

Patient safety is at stake. All we ask is that patients have the information to make an informed choice prior to surgery.

Thomas J. Sommer is the president of the Massachusetts Medical Device Industry Council (MassMEDIC). He lives in Scituate, Mass.