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Background: Disposable trocars with safety shields are widely used for laparoscopic access. The aim of this study was to analyze risk factors associated with injuries resulting from their use as reported to the Food and Drug Administration., Study Design: Manufacturers are required to report medical device-related incidents to the Food and Drug Administration. We analyzed the 629 trocar injuries reported from 1993 through 1996., Results: There were three types of injury: 408 injuries of major blood vessels, 182 other visceral injuries (mainly bowel injuries), and 30 abdominal wall hematomas. Of the 32 deaths, 26 (81%) resulted from vascular injuries and 6 (19%) resulted from bowel injuries. Eighty-seven percent of deaths from vascular injuries involved the use of disposable trocars with safety shields and 9% involved disposable trocars with a direct-viewing feature. The aorta (23%) and inferior vena cava (15%) were the vessels most commonly traumatized in the fatal vascular injuries. Ninety-one percent of bowel injuries involved trocars with safety shields and 7% involved direct-view trocars. The diagnosis of an enterotomy was delayed in 10% of cases, and the mortality rate in this group was 21%. In 41 cases (10%) the surgeon initially thought the trocar had malfunctioned, but in only 1 instance was malfunction subsequently found when the device was examined. The likelihood of injury was not related to any specific procedure or manufacturer., Conclusions: These data show that safety shields and direct-view trocars cannot prevent serious injuries. Retroperitoneal vascular injuries should be largely avoidable by following safe techniques. Bowel injuries often went unrecognized, in which case they were highly lethal. Device malfunction was rarely a cause of trocar injuries.

There is no doubt that the practice of reuse in hospitals is a reaction to the budgetary constraints under which hospitals are operating. However, the costs of appropriately monitoring and sterilizing reused equipment as well as the significant risk of patient harm and potential liability raise the unavoidable question of whether this practice is an advisable one. These costs and risk should be carefully examined before a decision about whether to reuse single-use devices is made.

This descriptive study aims at learning about the behavior of 113 people with diabetes mellitus assisted at a large hospital in relation to the utilization and re-utilization of disposable syringes for the administration of insulin at home. Semi-structured interviews were used for data collection. The obtained results showed that 98.2% used a disposable syringe for insulin application and only 5.3% actually disposed of it. Among these, 94.6% re-used the disposable syringe after application by means of various procedures. We believe that such practice is one of the facets in diabetes education and, in view of it, we point out the need for a scientifically-based review of DIMED's recommendation established by Decree no. 4/86.

The lack of regulation and procedures to monitor the reuse of single-use devices (SUDs) is allowing the use of medical devices that can pose a risk to patient health. Studies on reused SUDs show a range of defects. Despite this, uncontrolled reuse of SUDs continues. This article explores the extent of the problem, reports the findings of some of the studies and suggests what should be done.

Background: Insertion of the first trocar during the "closed" technique of creating a pneumoperitoneum remains one of the most hazardous maneuvres in laparoscopic surgery, with complications such as major vascular and bowel injuries. The ease with which trocars are inserted through the abdominal wall may have some bearing on these complications., Methods: A range of both disposable and reusable trocars, which were identical in point cross section and size, were compared in an abdominal wall model reconstructed with animal hide, using a hand-held pressure transducer. Multiple insertions were performed, and the results were expressed in pounds per square inch (PSI)., Results: The disposable trocar tested required the least effort to insert (mean pressure, 2.76 PSI), followed by the new reusable (mean pressure, 3.42 PSI), with the used reusable trocar requiring the greatest force for insertion (mean pressure, 4.80 PSI)., Conclusions: The effect of previous use on ease of insertion demonstrates an obvious disadvantage of reusable instruments. The excessive force required to insert some trocars may place the patient at greater risk of trocar injury.

Background: The reuse of disposable laparoscopic instruments carries a risk of transmitting infectious diseases such as hepatitis and HIV. We evaluated the safety of reusing disposable trocars by studying the chances of their harboring infectious viruses after resterilization in an in vitro setting., Methods: Disposable laparoscopic trocars were exposed to horse blood contaminated with high or low viral concentrations of herpes simplex virus type 1 (HSV1) and attenuated polio virus type 1 at room temperature for 2 h. HSV1 was chosen as the surrogate for lipid viruses that include hepatitis B and HIV virus; polio virus represented the nonlipid viruses that cause infections in immunocompromised patients and are more resistant to sterilization. The trocars were subsequently cleaned and resterilized by low-temperature steam and formaldehyde at 80 degrees C for 3 h. Viral cultures were then repeated after sterilization., Results: A cytopathic effect (CPE) was demonstrated at both concentrations for HSV1 in all trocars before but not after sterilization. For the polio virus, CPE was evident in 50% of the trocars (two of four) exposed to high viral concentration after sterilization., Conclusion: Disposable trocars are difficult to resterilize and may harbor infectious viruses after their initial use. Therefore, the reuse of disposable trocars in laparoscopic surgery cannot be recommended.

A multi-centre project has been run to identify laboratory tests capable of predicting the leakage performance of disposable incontinence bedpads. Each of 95 subjects tested each of six products for a week in turn and reported whether or not they and/or their carers found the leakage performance of each product acceptable. In addition, carers noted the severity with which individual used bedpads had leaked so that, when they had been weighed, their leakage performance could be determined as a function of urine weight. These clinical data were compared with results from the 16 different laboratory tests used routinely for bedpad evaluation in three hospital laboratories. Each test was evaluated by seeing how well the data it yielded correlated with the clinical test data. No individual test was very successful at predicting the performance of bedpads when used as sole protection but a combination of an absorption capacity test and an absorption time test predicted the percentage of users/carers finding leakage performance acceptable, accurate to within +/- eight percentage points for all six test products. A different absorption capacity test proved most successful for bedpads used as back-up to body-worn products. It predicted the percentage of users/carers finding leakage performance acceptable, accurate to +/- five percentage points for all six products.

Objectives: We sought to evaluate the performance of angioplasty catheters, restored under a strict manufacturing process, in patients with coronary artery disease., Background: Most countries outside the United States routinely reuse disposable medical equipment, resulting in significant cost savings. Because of quality and legal concerns, reuse in the United States has been limited. We investigated the reuse of percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, restored by a process strictly controlled for bioburden and sterility, in patients undergoing PTCA., Methods: Used PTCA balloon catheters were shipped to a central facility and were decontaminated, cleaned and tested for endotoxin using the limulus amebocyte lystate (LAL) gel clot method. Physical testing and quality assurance were performed. The products were packaged and sterilized with ethylene oxide. Catheter performance was assessed in a pilot study powered to detect a 5% difference in the angiographic failure rates of new and reused balloons (beta 0.8)., Results: The study enrolled 107 patients. The indication for PTCA was stable angina pectoris in 69 patients, unstable angina in 22 and acute myocardial infarction in 16. Of the 107 patients enrolled, 106 had a successful laboratory outcome, and 1 required coronary artery bypass graft surgery after failed rescue stenting. There were 122 lesions attempted (American College of Cardiology/American Heart Association classification A, n = 32; B1, n = 43; > or = B2, n = 35; C, n = 12). Of the 110 lesions initially approached with restored PTCA catheters, 108 were crossed and dilated. Sixty-four required no further procedures. Stenting was performed in 37 patients (29 planned, 8 rescue). Thus, the angiographic failure rate was 7% (10 of 108, 95% confidence interval 2% to 12%), comparable to the 10% rate seen with new balloons in other studies., Conclusions: Restoration of disposable coronary angioplasty catheters using a highly controlled process appears to be safe and effective, with success rates similar to those of new products and no detectable sacrifice in performance. Cost analysis suggests that implementation of reuse technology for expensive disposable equipment may offer cost savings for U.S. hospitals, without sacrifice of quality.

An international multi-centre project has been run to create an international standard for measuring the leakage performance of small, disposable incontinence pads for lightly incontinent women. One hundred and thirteen women tested batches of nine different incontinence pads of widely differing designs and noted the severity with which each individual used pad had leaked so that leakage performance could be determined as a function of urine weight. In addition, testers rated the overall leakage performance of each of the nine products on a five-point scale. These clinical data were compared with laboratory data from 153 different pad measurements, each of which was evaluated by seeing how well the data it yielded correlated with the clinical test data. A wetback test emerged as the clear winner. It usually predicted the clinical leakage performance of pads to an accuracy of +/- 10%. It involved applying 25 ml of 1% w/v saline to a pad and measuring how much escaped into a filter paper held against the wet pad for 1 min under a pressure of 1.5 kPa. Pads which released the least test fluid into the filter paper leaked least in the user tests. The method will be published as an ISO standard during 1997.

To determine trends in a number of hemodialysis associated diseases and practices, the Centers for Disease Control and Prevention, in collaboration with the Health Care Financing Administration, performed a mail survey of 2,304 chronic hemodialysis centers in the United States in 1993. By the end of 1993, at least three doses of hepatitis B vaccine were administered to 29% of patients and 76% of staff at responding centers. Hepatitis B surface antigen was present at low frequency in patients (incidence = 0.1%, prevalence = 1.2%) and staff members (incidence = 0.2%, prevalence = 0.3%). The 1993 incidence of hepatitis B virus infection among patients was higher at centers that accepted hepatitis B surface antigen positive patients but did not use a separate room and dialysis machine for treatment of these patients, government and profit (versus nonprofit) centers, and centers in four End Stage Renal Disease Networks. The prevalence of antibody to hepatitis C virus was 9.7% among patients and 1.6% among staff members. Pyrogenic reactions in the absence of septicemia were reported by 21% of centers and associated with use of high flux dialysis. Human immunodeficiency virus infection was known to be present in 1.5% of patients; 34% of centers reported providing hemodialysis to one or more human immunodeficiency virus infected patients.

Objective: To evaluate the cost benefits of reusing disposable laparoscopic instruments., Design: A cost-analysis study based on a review of laparoscopic and thoracoscopic procedures performed between August 1990 and January 1994, including analysis of disposable instrument use, purchase records, and reprocessing costs for each instrument., Setting: The general surgery department of a 461-bed teaching hospital where disposable laparoscopic instruments are routinely reused according to internally validated reprocessing protocols., Methods: Laparoscopic and thoracoscopic interventions performed between August 1990 and January 1994 for which the number and types of disposable laparoscopic instruments were standardized., Main Outcome Measures: Reprocessing cost per instrument, the savings realized by reusing disposable laparoscopic instruments and the cost-efficient number of reuses per instrument., Results: The cost of reprocessing instruments varied from $2.64 (Can) to $4.66 for each disposable laparoscopic instrument. Purchases of 10 commonly reused disposable laparoscopic instruments totalled $183,279, and the total reprocessing cost was estimated at $35,665 for the study period. Not reusing disposable instruments would have cost $527,575 in instrument purchases for the same period. Disposable laparoscopic instruments were reused 1.7 to 68 times each., Conclusions: Under carefully monitored conditions and strict guidelines, reuse of disposable laparoscopic and thoracoscopic instruments can be cost-effective.

Purpose: The objective of this study was to analyze prospectively the continuous use of disposable contact lenses., Methods: We conducted a clinical study of extended wear of disposable contact lenses for a period of 7 days and 6 nights by 25 patients during a 90-day period. Factors such as visual acuity, keratometry, complications, and contamination were analyzed., Results: Visual acuity and keratometry measurements did not present significant alterations during the study. Complications related to the use of disposable contact lenses were not observed. Analysis of cultures did not present any significant microbiological alterations due to contact lens use. All of the patients were satisfied with the wear schedule and considered the Acuvue lenses comfortable., Conclusions: Our results may be useful in increasing the level of acceptance of extended wear of disposable contact lenses in Brazil.

A new fiberoptic sigmoidoscopic system has been developed that utilizes a disposable sheath to cover and protect all working surfaces of the endoscope from contamination. The reusable part of the endoscope has no air, water, or suction/biopsy channels. These are incorporated in the disposable sheath, which is easily removed after use to provide each patient with a contamination-free endoscope. A prospective, randomized, controlled trial was performed to compare the disposable, sheathed, flexible sigmoidoscope with standard sigmoidoscopes. Clinical evaluations of the new sigmoidoscope system were performed at 15 facilities. Visual analog rating scales were used to record evaluations of endoscope performance and reprocessing by endoscopists and reprocessing personnel. The time to perform procedures, depth of insertion, and total instrument downtime were also recorded. One hundred forty-three procedures (70 standard, 73 sheathed) were performed. No significant difference was found for overall depth of insertion (50 versus 48 cm), although fewer sheathed endoscopes reached to 60 cm than did standard endoscopes (51% versus 30%). The sheathed system had a slightly longer mean procedure time than the standard (5.6 versus 6.7 minutes), but a significantly shortened overall downtime (32.8 vs 8.1 minutes). The standard system was preferred by the endoscopists. Reprocessing personnel preferred the disposable system. The disposable sigmoidoscope system has important advantages of decreased instrument turn-around time and potentially increased staff and patient safety, and future models should be improved to meet physicians' concerns.

Background: Arterial and venous pressure is commonly measured using fluid filled catheters. To avoid obstruction they are continuously spilled by a flush-device. The accuracy of the flowrate has not been investigated previously., Methods: The accuracy of 5 different flush-devices available in Switzerland was checked for flowrate when factory new, after a single sterilization with ethylen-oxide, in a long-term test over 96 hours, after repeated handling of the integrated bypass and under application of a pulsing counter-pressure., Results: Flow is linearly related to differential-pressure and is constant over time. The flow of each flush-device at 200 mmHg differential-pressure was below the indicated 3 ml per hour (1.69 - 2.49 ml/h). Sterilization in two types produced a significant but not relevant difference in flowrate. Longtime-use, bypass actuation and pulsing pressure did not alter the flowrate significantly (p <0.05). In two factory-new flush-devices and 4 re-used ones a plugged capillary induced cessation of flow., Conclusions: Flowrate in flush-devices is accurate under sterilization, longtime use, bypass-actuation and pulsing counter pressure. A plugged capillary occurred in a few new and reused flush-devices, which can be the explanation for clotted catheters in clinical use.

The lack of agreement on the use of over-shoes tends to perpetuate the ritual of their use in general operating theatres. However, the limited evidence which supports their use in such settings is not applicable in a Day Surgery Unit where their use is not recommended. In order to reduce overt contamination in the unit theatre, a local protocol should be drawn up specifying the use of designated day unit footwear for those that remain within the unit and for all persons entering the operating theatre.

At Munroe Regional Medical Center in Ocala, FL, an effective partnership between Materials Management and the Operating Room was begun by building consensus around a shared concern--minimizing the Operating Room's impact on the environment. To accurately evaluate cost-in-use issues, Materials Management and the OR needed a better understanding of each other's processes, procedures and decision-making criteria. Materials Management observed surgical procedures to understand product requirements, and OR personnel were given financial information on such matters as group purchasing and disposal costs. After considering all the data, the MM/OR team decided to continue using single-use polypropylene gowns rather than switch to reusable gowns. Success in this endeavor led the team to institute a disposable wrap recycling program. Lasting benefits of the collaboration include higher cost consciousness among clinicians, open communications, greater supplier accountability for cradle-to-grave cost estimates and team building.

Pediatric patients with insulin-dependent diabetes mellitus were surveyed over a 5-month period to determine disposal practices of insulin syringes. Eighty-nine (79.5%) of 112 patients surveyed responded. Thirty-three percent of the responders disposed of syringes in accordance with recommendations of the local health department and the American Diabetes Association, while the remaining patients did not. Fifty-two percent of the patients rendered the syringes useless before disposal. The study revealed a need to educate and inform patients on the proper procedures that should be followed when disposing of syringes in the home.

There are very few products that could be considered acceptable candidates for a reuse program when using this criteria for reuse. In addition, the cost of the resources necessary to implement and maintain an effective reuse program rarely equate to cost savings. In today's health care environment, the focus on employee safety adds another variable that may make reprocessing unacceptable.