Compliance and disposable devices

The use of disposable devices has become an increasingly common component of medical and dental patient care.

The use of disposable devices has become an increasingly common component of medical and dental patient care. Items classified as disposable are defined as single-use, and are intended to be used on one patient, then discarded. They are not to be processed for reuse on another patient. The advantage disposable products have as compared to reusable products is inherent in the reality that disposable devices reduce the potential for patient-to-patient cross-contamination and possible cross-infection. This advantage, along with their ease of use and time savings from reprocessing procedures, provides a rationale for including this approach in current health professional infection-control guidelines. Numerous examples are found in dental facilities. These include gloves, masks, prophylaxis cups, patient bibs, syringe needles, and environmental surface covers. There is also a class of products that are available as either disposable or reusable items. In recent years, the trend has shifted to the disposable side. This is demonstrated in the fact that most recent dental graduates do not realize that their teachers and mentors reused plastic saliva ejectors, high-volume evacuation tips, impression trays, and air-water syringe tips.

While an inspection of medical and dental dispensary areas would show a variety of single-use, disposable patient-care items, one question remains. Are they being used as mandated and directed by the manufacturer? As strange as this may sound, consider these two points:

The health professions aren’t too far removed from a time when “reuse” was more common than “disposable.”

Compliance with recommended procedures and precautions continues to present challenges to accepted infection-control goals.

Besides the examples for the first point, many dental clinicians recall using the same pair of latex gloves during treatment of multiple patients. Gloves were changed when they became sticky from washing with a liquid antiseptic, or when they developed visible defects. Reuse of plastic saliva ejectors and prophy cups, after washing and immersion in chemical disinfectants, was also common. Despite this trip down infection-control memory lane, another important question lingers. Were these practices the most dangerous documented misuses of disposable devices?

A recent Boston Globe article on hospital reuse of medical devices meant to be discarded after a single use stated patients were unaware of the practice. Evidence included improperly cleaned and sterilized surgical instruments and catheters, which subsequently were used on other patients. Regulatory agencies have dealt with this problem. A 1999 survey conducted by the National Center for Policy Analysis investigated hospital recycling of medical items. Nearly half of the 132 hospitals surveyed did reuse medical devices designed for single use. Plastic catheters were among items inappropriately reused.

Long term, clinical evidence is not available for the cross-infection potential presented by reuse of most disposable devices. There is, however, documented information to show how reuse of disposable needles and other sharp devices presents substantial risks for exposed patients. This was most recently demonstrated in a CDC report of four hepatitis outbreaks among patients from 2000 to 2002. One of these outbreaks involved routine reuse of syringes and needles by a nurse anesthetist during clinic sessions. By the time the investigation of cases was concluded, 69 hepatitis C virus and 31 hepatitis B virus infections were identified as likely being retraceable to this person’s practice. The nurse anesthetist ceased reusing needles after a complaint was filed by staff nurses. Since then, no evidence of HCV or HBV transmission associated with treatment has been detected.

Although a lack of compliance with basic infection-control practices for single-use disposable needles and syringes was apparent and serious in this instance, misuse of other disposable devices may not present with the same indirect infection risks. The most common outcome may be a lessening of the overlap and effectiveness of one’s total chain of infection control. The ripple effect caused by a seemingly minor infraction can reduce the margin of reinforcement and overlap each component of a prevention program provides to the other components. The FDA repeatedly has taken the position that it is not aware of any data that would establish conditions for the safe, effective cleaning and subsequent resterilization and/or reuse of any disposable medical devices. The FDA has urged those who reprocess devices to submit additional data to show their procedures are safe. Keep this in mind if you see someone misusing an item that was not manufactured to withstand deterioration or provide maximum effectiveness with repeated and prolonged use on more than one patient.

Dr. John A. Molinari is professor and chairman of the Department of Biomedical Sciences at the University of Detroit Mercy School of Dentistry. Contact him at (313) 494-6632, or molinaja@udmercy.edu.

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