A Review of Selected Articles on the Safety of Reprocessing SUDs

Originally Published MDDI May 2002

SINGLE-USE DEVICES

A Review of Selected Articles on the Safety of Reprocessing SUDs

Of the literature cited by reprocessors to support SUD reuse, few documents, if any, provide indisputable evidence of the safety of reprocessing.

David N. Cowan, Stephen O. Cunnion, and Tina M. Swift

In defense of its position that the practice of reusing single-use medical devices is safe, the single-use device (SUD) reprocessing industry cites a number and variety of published documents. What follows is an evaluation of those articles, undertaken by scientists with expertise in medicine, epidemiology, biostatistics, infectious disease, and medical research methods, design, and analysis, to determine whether the data presented are adequate to support the reprocessors' claims that cleaning, sterilizing, distributing, and reusing SUDs is safe and appropriate.

The articles come from three types of sources: public news media, industry and trade publications, and medical journals. As appropriate, each article was reviewed for its content and for the following characteristics: study design, sample size, statistical analysis, biological plausibility, feasibility of generalizing the findings, apparent errors or omissions, inappropriate conclusions, and other factors that became apparent on review.

Sorting Through the Documents

The reviewed articles were categorized based on the information they provide: those that offer no data at all or no data relevant to the issue of safety, and those that offer data related to safety. Presented here are detailed comments on only those articles that provided data related to the safety of the practice of reprocessing SUDs.

Of the 52 documents cited by reprocessors to justify reprocessing, only 15 (31%) provide some data related to the safety of reprocessed SUDs. In some of these articles, the Methods or Results sections are not adequate to allow for interpretation. Several other articles find no statistically significant association between the use of reprocessed devices and the risk of device failure or of adverse events, while still others offer data that indicate there are at least potential risks associated with reprocessed SUDs.

Discussion of the Analyses

The question of risks related to the reprocessing of SUDs is complicated. Many variables must be considered, such as the original intended use or design of the device, its complexity and fragility, the ease of and methods for cleaning and sterilizing the product, and the number of times it is reprocessed. Safety problems resulting from reprocessed SUDs can include catastrophic failure, deterioration or alteration of the physical properties of the device, and patient infection from inadequate or improper cleaning and sterilization.

There are a number of ways that defects, contamination, or failure can occur. These depend on the specific type of device and how it is designed and manufactured; how it is cleaned, disinfected, sterilized and handled; and how many times it is reprocessed. There are few general conclusions that can be reached, since each device type is unique with its own potential problems. Furthermore, many types of devices are continually evolving, and improvements in original designs can lead to unexpected new problems upon reprocessing.

Limited information is available on the prevalence or incidence of problems in specific devices that are reprocessed. In order to measure the prevalence or incidence, denominator data must be evaluated in addition to the number of events.

The literature cited by reprocessors is not sufficient to establish the safety of reprocessed SUDs because of the narrow focus of most reports, the constantly changing technology of devices, the identification of emerging infectious agents, the relatively small numbers of devices or subjects included in specific studies, inadequate follow-up of study subjects, and vague presentation of methods or results, which all make interpretation difficult or impossible. Each of these topics is addressed below.

A Too-Narrow Focus. Most of the research reports reviewed address only one type or even one brand of a specific device, or a very narrow range of devices. It is not appropriate to extrapolate data from these specific devices to others.

Evolving Technology. The inherent delay in designing, executing, analyzing, reporting, and publishing scientific studies can lead to difficulties in interpreting those studies and in applying the findings to evolving technologies. It is not unusual for three or more years to pass between the conception and design of a study and its appearance in the medical literature. During this period there may be substantial change in the design of and the materials used in the devices being considered.

While products generally tend to become better through evolution, the changes can adversely affect reprocessability, and operating characteristics may change enough to render studies of previous generations of similar devices obsolete. For example, newer generations of balloon catheters operate at substantially higher pressures than older versions, and they can be manufactured with different materials that have different properties. The higher pressures might result in better performance in clearing coronary arteries, but the risk of failure for the new devices might be different and, should catastrophic failure occur, the higher pressures may increase the risk of severe injury.

The Risk of Unforeseen Infection. Most cleaning and sterilization methods are based on removing and killing well-recognized bacteria and viruses; however, in recent years a new form of pathogenic infectious agent, the prion, has been identified. Prions, which are thought to cause variant Creutzfeldt-Jakob Disease (vCJD), are not organisms and contain no genetic material. They are complex proteins that have assumed a form different from normally occurring proteins. When introduced into a new individual, they may have the capability of inducing the same structural change in the normal existing proteins in that person.

Although this disease is rare, it has been transmitted in the healthcare setting, and there is clearly a potential for transmission via the reuse of SUDs. Prions resist ordinary disinfection and sterilization techniques, as was reported last year by Brown et al. in Emerging Infectious Diseases (available on-line at http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm).

Too Few Test Devices and Subjects. The small numbers of devices, subjects, or both included in most of the studies reviewed are of major concern. Both the laboratory and the human studies are essentially uninterpretable because of their lack of information on the risks of adverse events occurring in both new and reused devices. If the likelihood of adverse events among both new and reprocessed devices is not known, then it is not possible to interpret the findings from any given study.

Another fact that goes unaddressed in the discussion of the safety of reprocessed SUDs in all of the studies is the understanding that risk cannot be reduced to zero for new or reprocessed devices. In addition, the level of risk that must be detected or that is not acceptable is not adequately defined. In order to design and execute any study, or to fully interpret the results of any existing study, some estimation of the underlying, expected, or acceptable level of risk is required.

When the sample sizes reported in the various studies are considered, it is apparent that many or most of these studies probably had little statistical power to detect important differences between new and used devices. Because these studies lack such statistical power, their reported lack of evidence of adverse events can not be interpreted as lack of evidence of risk.

These same concerns apply for failures or defects that are not dichotomous ("fail" versus "not fail"). For example, a catheter can increase in diameter with repeated use, causing difficulties with insertion, extraction, or passage through a blockage. In situations such as this, the distribution of the characteristic and how it differs between new and reprocessed devices, as well as how it varies with the number of reprocessing cycles and with age, must be understood before data from studies can be adequately interpreted.

Inadequate Follow-Up. Most of the studies that report any follow-up did so only for a short time, such as during the patients' hospitalization, and subjects were not followed for the amount of time required to detect signs or symptoms of diseases with longer incubation periods, such as hepatitis B or C. In addition, most of the studies do not report that any viral tests had been conducted. In some patient populations the prevalence of hepatitis is relatively high, and the potential for transmission in the event of a contaminated device exists. Even though nosocomial transmission of hepatitis B or C is rare, transmission in even small numbers of patients can be catastrophic because these infections can lead to chronic infection, cirrhosis of the liver, liver cancer, early death, and high medical-care expenses.

Ambiguous Test Methods. Several of the articles are written so unclearly that the studies they describe cannot be interpreted, or the validity of the findings and conclusions cannot be ascertained from the data provided. Furthermore, some studies fail to provide adequate information in their respective Methods and Results sections to allow for interpretation. In general, the quality of the research presented in many of the articles is poor, and it is certainly inadequate to establish the safety of reusing SUDs.

Critiques of the Individual Studies

The following are individual critical reviews of each of the 15 documents available that address safety issues in conjunction with reprocessing SUDs.

"Safety of Reusing Cardiac Electrophysiology Catheters." (American Journal of Cardiology, 1994.¹) The data presented in this article are not adequate to support the position that reprocessing SUDs is safe. This study of 12 reprocessed cardiac electrophysiology catheters assesses microbiologic contamination; mechanical integrity; and residual EtO, ethylene chlorohydrin, and ethylene glycol. One new catheter served as a control.

Although the three catheters tested for microbial contamination were deemed sterile, problems with particulate and chemical residuals were noted. All six catheters tested for residue contained levels of residual EtO exceeding federal standards. Moreover, based on their observations, the authors caution that "fluid entrainment around the distal pole may occur in catheters with tip electrodes." The small number of catheters studied precludes any meaningful interpretation of the results beyond what is reported.

"Repeated Use of Ablation Catheters: A Prospective Study." (Journal of the American College of Cardiology, 1993.²) The data presented in this article are not adequate to support a position that reprocessing is safe. This study focused on the electrical, physical, and mechanical integrity of a small number of reused cardiac catheters: 69 deflectable ablation catheters used in 336 procedures over a 1-year period were evaluated. Each device was inspected between uses, and 59% were eventually rejected. The authors note various failure modes, including tip-electrode glue separation, loss of deflection, and electrical discontinuity, after multiple reprocessing cycles. The authors also noted deep pitting of the catheter-tip electrode and small fractions of missing polyurethane glue, which could have been released into a patient's bloodstream. Blood that collected in the spaces where glue was missing could not be cleaned out.

The report notes that no major catheter failures or major adverse clinical complications occurred during procedures. The methods, however, failed to describe how, or whether, the subjects were evaluated for such complications. Rather, the article mentions only that charts of 140 of the 336 patients were evaluated for evidence of embolism or infection. One local infection was noted. Therefore, one cannot interpret the report by concluding that there were no serious adverse outcomes. Additionally, there was no mention of follow-up of subjects, and no mention of evaluations for viral diseases noted in the study.

"Reuse of Catheters for Invasive Electrophysiological Procedures." (European Heart Journal [supplement], 1999.³) This article does not present results of a new study conducted by the author. Instead, it reports on the reprocessing experience at the author's hospital and reviews other published studies.

This article does not provide data supportive of the safety of reprocessing SUDs; it does provide some evidence that the reprocessing and reuse of diagnostic electrode and ablation catheters might not be safe. Because reprocessed catheters used at the hospital were rejected because of their inaccurate temperature readings, breakage or a defect in the internal pulling wires, problems with electrogram readings, and insufficient deflection capability, the author concludes that "multiple uses and reprocessing may have adverse effects on the characteristics or quality of the catheter, leading to unsafe and ineffective patient treatment."

"Technical and Economic Feasibility of Reusing Disposable Perfusion Cannulae." (Biomedical Instrument Technology, 1997.⁴) This article provides evidence that the reprocessing and reuse of perfusion cannulae might not be safe. The report appears to be derived from a poster presentation and does not contain the level of detail typical of literature reports. In this laboratory-based study of single- and dual-stage cannulae from two manufacturers, the authors assess functional integrity, biocompatibility, and in vivo performance after one use and up to nine simulated reuses. Notably, the Methods section discusses biocompatibility and in vivo performance testing, but no results are given for these tests.

This study lacks statistical power to detect even substantial changes associated with reprocessing. For some comparisons only three examples were used in some groups, and no more than 10 cannulae were used in any group for any test. The authors did report a few statistically significant differences (four comparisons out of 21 made). Significant changes in bending and tensile stiffness, ranging from 5–15%, were noted with reprocessing. In other comparisons where no significant differences were reported, the changes in parameters were as high as 21%.

Finally, it is important to note that these data are not from independent academic study. Half of the authors are employed by a manufacturer of sterilization equipment, the sales volume of which is dependent in part on resterilization of medical devices.

"Initial Experience with Reuse of Coronary Angioplasty Catheters in the United States." (Journal of the American College of Cardiology, 1997.⁵) The data presented in this article are not adequate to support the position that reprocessing of balloon catheters is safe. This self-described "pilot study" purports to assess the safety of reprocessed coronary angioplasty catheters, but it is so poorly described and executed that it cannot be interpreted. The authors state that the study was powered to detect a 5% difference between comparison groups, but they fail to define that as a relative or absolute difference. In fact, no control patients—those treated with new catheters—were enrolled in the study. The authors compared failure rates in this study to historical controls.

Equally problematic is the Methods section, which provides no detail of the cleaning process or the process for removal of contrast agent. It states only that the processes are "proprietary." The study conditions are therefore impossible to reproduce.

As far as patient follow-up is concerned, the subjects were followed for 24 hours after their procedure for signs of infection and until discharge for cardiac or coronary complications. No postdischarge follow-up was reported, including testing for viral diseases.

Catheter quality measurements, such as fatigue, burst strength, material compatibility, and tip strength testing, were reportedly taken, but no results are given. Detailed results of balloon compliance tests are similarly not provided, but the authors do note that some balloons measured greater than 10% outside the published compliance curve of the new device.

"A Prospective Study of the Repeated Use of Sterilized Papillotomes and Retrieval Baskets for ERCP: Quality and Cost Analysis." (Gastrointestinal Endoscopy, 1997.⁶) The data presented in this article are not adequate to support the position that reprocessing papillotomes and retrieval baskets is safe. This study of 25 papillotomes and 15 retrieval baskets—used a combined total of 439 times—focuses primarily on cost analysis. Device quality was reportedly assessed by staff physicians, who used a 1–10 scale to rate the devices' "function." No objective measure of performance was used.

The article does provide data showing that both devices deteriorate with repeated use and reprocessing. In fact, some retrieval baskets were used in patients to "sweep ducts" even after the baskets' quality was deemed too low for stone retrieval.

Although the authors state that there were "no complications attributable to using reused equipment," no information on evaluation or follow-up of subjects is provided.

"Reuse of Disposable Laparoscopic Instruments: A Study of Related Surgical Complications." (Canadian Journal of Surgery, 1995.⁷) The data presented in this article are not adequate to support the position that reprocessing of laparoscopic devices is safe. This is a retrospective review of procedures conducted in the authors' facility rather than a prospectively designed study. The methods used are not clearly or adequately described, and the findings cannot be interpreted. Furthermore, details of the study design and analysis were inadequate for replication and substantive review; for instance, the study notes that "data sheets" were completed for each patient but fails to identify what data were collected.

The authors assess several different devices, including Veress needles, reducers, trocars, scissors, dissectors, graspers, clip appliers, intestinal gauges, mechanical linear staplers, and camera sleeves. The authors report an infection rate of 1.8%, but because the methods are not presented, this finding cannot be interpreted. In other words, it is unclear whether the information collected is sufficient for an accurate determination of infection rates.

This study provides no description of follow-up or testing for viral infections, nor does it present a concurrent control group. The authors compare their findings to rates reported by other researchers.

"Success of Re-Use of Cardiac Electrode Catheters." (American Journal of Cardiology, 1987.⁸) The information presented in this dated article is not adequate to support the position that reprocessing electrode catheters is safe. This is essentially a 5-year report on one hospital's quality control program for solid cardiac catheter reuse. The report is based on routinely collected data rather than research-quality information. Performance data are limited to inspection for surface defects and tests for stiffness and electrical continuity testing, all of which lasted fewer than 10 minutes per device.

Fever checks were conducted at 24 and 48 hours on patients who remained in the hospital, but there was no active follow-up of discharged patients, and no long-term follow-up whatsoever. Surveillance cultures were conducted only when catheters were discarded, and no information was provided to explain the rationale for this practice.

While the reported monitoring and controls may be sufficient for a quality control program, as research this log review fails to look beyond the obvious quality control data collection. The testing and data collection for sampling of the used catheters are inadequate, as is the follow-up of patients. The authors note that a number of catheters failed the testing procedure as a result of failure of the catheter casing or changes in the electrical impedance.

"Infection Risk of Cardiac Catheterization and Arterial Angiography with Single and Multiple Use Disposable Catheters." (Clinical Cardiology, 1988.⁹) The data presented in this article provide evidence that reprocessing disposable catheters might not be safe. In this report, 4.4% of patients receiving a new device developed a fever of more than 37.5°C, and 6.0% of those receiving a device reprocessed multiple times developed a fever, which indicates possible increased infection rates or pyrogenic reactions in patients treated with reprocessed devices. Similarly, hematoma rates were higher for patients exposed to reprocessed devices.

The reported 36% increase in fever risk for patients receiving reprocessed catheters was not statistically significant in this study, perhaps because the study was not statistically powered to show such a difference. The difference might have been statistically significant in a larger study.

The findings in this particular study are suggestive of increased safety risks associated with reprocessing, but because of the small sample size, they do not statistically demonstrate such a risk. The study does not mention any long-term follow-up of subjects.

"Reuse of Disposable Sphincterotomes for Diagnostic and Therapeutic ERCP: A One-Year Prospective Study." (Gastrointestinal Endoscopy, 1999.¹⁰) The data presented in this article are not adequate to support the position that reprocessing of disposable sphincterotomes is safe. This prospective study used 27 five-French and 127 six-French sphincterotomes for a maximum of 10 uses or until they failed. The devices failed after a mean of every 3.4 uses, typically as a result of a broken or stiff cutting wire. Other failure modes included inadequate bowing or faulty curvature of the cutting wire, or friction when passing it through an injection port. It appears that some of these failures occurred while the devices were being used in a patient.

The authors report no adverse events associated with reprocessed devices. The potential cost savings, not safety, is the primary outcome evaluated; no information was provided on short-term or long-term follow-up of patients.

"Absence of Increased In-Hospital Complications with Reused Balloon Catheters." (American Journal of Cardiology, 1996.¹¹) The data presented in this article are not adequate to support the position that reprocessing single-use balloon catheters is safe. This article provides no new data; it is a reanalysis of a study by Plante et al., published in 1994, in which 373 subjects were treated with new devices at a single-use center, and 320 with reprocessed ones at a reuse center. The original study found significant differences between new and reprocessed devices, but did not include controls for any underlying differences in the patient populations.

The multivariate analyses used in this new study controlled for the measured variables and found substantial and significant differences in the patients seen at the two centers, with those attending the reuse center generally sicker.

This study showed no significant differences between those receiving new and reused devices when other factors were controlled; in fact, the adverse-event odds ratio for reused devices was 0.59, although it was not statistically significant. The assumptions made in the reanalysis, however, do not all appear to be appropriate. The authors note that the number of catheters and volume of contrast media were higher at the reuse center, as was the average procedure time, and they assume that these findings indicate sicker patients at that center. In fact, they might indicate that reused catheters failed more often and recqired replacement and lengthened procedures.

This paper provides an interesting critique of the Plante study, pointing to methodological problems that make that study difficult to interpret. For the same reasons that these authors claim the Plante study cannot be used to demonstrate the risks of reuse (lack of randomization, for one), however, it also cannot be used to demonstrate the safety of reuse. The flawed study remains flawed after the reanalysis, and as such, it advances neither the argument for reuse nor the argument against it.

"Reuse of Pacing Catheters: A Survey of Safety and Efficacy." (Pacing and Clinical Electrophysiology, 1988.¹²) The data presented in this article are not adequate to support the position that reprocessing electrophysiology catheters is safe. This "study" is actually a retrospective survey of three centers at which pacing catheters were used only once, and of nine centers where they were used multiple times. Laboratory directors were asked to answer questions about the incidence of superficial skin infections and clinically apparent bacteremia within 48 hours of electrophysiology procedures in their laboratories. The authors report that no significant differences in risk were observed, but the methods of this study are so poorly presented that the study cannot be interpreted. In addition, 48 hours is insufficient to detect contamination with a longer incubation time, such as hepatitis. It appears that the primary method by which the laboratory directors assessed infection rate was unsolicited, patient-initiated telephone calls reporting infection.

The authors note that "catheters are generally reused until visible defects appear or until recordings are unsatisfactory." The authors also claim that there is "no evidence for any other type of complication related to catheter reuse." This result, however, is not surprising since the study apparently did not pursue such evidence.

"In Vitro Evaluation of Integrity and Sterilization of Single-Use Argon Beam Plasma Coagulation Probes." (American Journal of Gastroenterology, 1999.¹³) In this laboratory-based study of probes used in treating gastrointestinal bleeding, 10 probes were evaluated for cleanliness and sterility, physical integrity, electrical integrity, and cost-effectiveness, but the probes were not subjected to actual clinical use. After undergoing manual cleaning and EtO sterilization (the 10 probes were tested 10 times each), none had positive cultures for Bacillus subtilis var. niger. One probe developed a split on the proximal (non-patient-contact) end, reflecting a failure of structure or loss of material integrity. In addition, the tips of nine of the 10 probes showed discoloration after three reprocessings. None of the probes lost its electrical integrity.

The authors conclude that the "electrical integrity of all 10 probes remained intact without significant changes in depth of coagulation." The charted data, however, do demonstrate significant differences in depth of coagulation after reprocessing. While this study had negative findings, it lacked the statistical power to provide evidence of safety because only 10 probes were included. It can only identify the failures that were extremely common, and therefore cannot be used to extrapolate to failures that would be anticipated to occur less frequently.

"Adventures in Recycling: The Reuse of 'Disposable' Pulse Oximeter Probes." (Respiratory Care, 1993.¹⁴) This article is an editorial, not a peer-reviewed report. Nevertheless, because some data are included, it is reviewed here. The data presented in this article are not adequate to support the position that reprocessing pulse oximeter probes is safe.

The article describes a program of reusing oximeter probes. It presents limited data to indicate that when new and after being reprocessed one time, a sample of probes provided similar results for pulse and mean-oxyhemoglobin saturation. The authors also note that at their facility, "probes are reprocessed repeatedly until they (1) are visibly soiled, (2) are visibly damaged, or (3) cease to function."

"Reuse of Catheters for Percutaneous Transluminal Coronary Angioplasty: Effects on Procedure Time and Clinical Outcomes." (Catheterization and Cardiovascular Interventions, 1999.¹⁵) The data presented in this article are not adequate to support the position that reprocessing balloon catheters is safe. As part of this study, medical and patient characteristics were measured, and the outcomes observed included procedure and fluoroscopy time, number of devices used, postprocedure stenosis, and clinical outcomes. No measure of mechanical failure or infection was reported. The two study groups were generally similar, but the reuse group was 8 years younger overall and had a lower proportion of hypertension, angina, and diabetes.

No significant differences were observed except as noted. The all-new-stents group received, on the whole, more stents (25 versus 18), which the authors attribute to long-term temporal trends. Mean hospital stay was longer for this group (8.4 versus 5.6), which the authors attribute to the increased stent use. On multivariate analysis, the authors report that using new versus reprocessed devices had no effect on procedure duration.

As a result of provincial policy, Quebec terminated the use of reused catheters in July 1996 because of concerns about transmission of CJD. This study included 53 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) prior to July 21, 1996, and 54 consecutive patients who underwent PTCA after that date. Although it is safe to assume that all 54 patients treated after July 21 were treated with new catheters because the hospital had stopped reuse, the inverse is not true for the 53 patients treated before that date. In fact, because the hospital's policy was to reprocess balloon catheters four times, we must assume that only 42 (four out of five) of the patients treated before July 21 were treated with reused catheters and that the data from these patients were contaminated with data from approximately 11 patients treated with new devices.

Conclusion

For a number of reasons, the articles reviewed, both individually and overall, do not provide adequate evidence of the general purported safety of the reuse of SUDs; therefore, claims of safety based on this body of literature are inappropriate. Large-scale, long-term studies of different devices are needed to establish baseline risks for both new and reused devices, and the different types of risks need to be more carefully delineated. In addition, some consensus must be established to define acceptable levels of risk for both new and reused devices so that the existing studies can be better interpreted, and new studies can be designed.

References

1. EA Aton et al., "Safety of Reusing Cardiac Electrophysiology Catheters," American Journal of Cardiology 74 (1994): 1173–1175.

2. B Avitall et al., "Repeated Use of Ablation Catheters: A Prospective Study," American College of Cardiology 22 (1993): 1367–1372.

3. C Blomstrom-Lundqvist, "Reuse of Catheters for Invasive Electrophysiological Procedures," European Heart Journal Supplement 1 (1999): G15–G19.

4. DF Bloom et al., "Technical and Economic Feasibility of Reusing Disposable Perfusion Cannulae," Biomedical Instrument Technology 31 (1997): 248–249.

5. KF Browne et al., "Initial Experience with Reuse of Coronary Angioplasty Catheters in the United States," Journal of the American College of Cardiology 30 (1997): 1735–1740.

6. J Cohen et al., "A Prospective Study of the Repeated Use of Sterilized Papillotomes and Retrieval Baskets for ERCP: Quality and Cost Analysis," Gastrointestinal Endoscopy 45 (1997): 122–127.

7. JG DesCoteaux et al., "Reuse of Disposable Laparoscopic Instruments: A Study of Related Surgical Complications," Canadian Journal of Surgery 38 (1995): 497500.

8. A Dunnigan et al., "Success of Re-Use of Cardiac Electorde Catheters," American Journal of Cardiology 60 (1987): 807–810.

9. U Frank et al., "Infection Risk of Cardiac Catheterization and Arterial Angiography with Single and Multiple Use Disposable Catheters," Clinical Cardiology 11 (1988): 785–787.

10. RA Kozarek, et al., "Reuse of Disposable Sphincterotomes for Diagnostic and Therapeutic ERCP: A One-Year Prospective Study," Gastrointestinal Endoscopy 49 (1999): 39–42.

11. KH Mak et al., "Absence of Increased In-Hospital Complications with Reused Balloon Catheters," American Journal of Cardiology 78 (1996): 717–719.

12. S O'Donoghue and EV Platia, "Reuse of Pacing Catheters: A Survey of Safety and Efficacy," Pacing Clinical Electrophysiology 11 (1988): 1279–1280.

13. SK Roach et al., "In Vitro Evaluation of Integrity and Sterilization of Single-Use Argon Beam Plasma Coagulation Probes," American Journal of Gastroenterology 94 (1999): 139–143.

14. JW Salyer et al., "Adventures in Recycling: The Reuse of 'Disposable' Pulse Oximeter Probes," Respiratory Care 38 (1993): 1072–1076.

15. JP Shaw et al., "Reuse of Catheters for Percutaneous Transluminal Coronary Angioplasty: Effects on Procedure Time and Clinical Outcomes," Catherization and Cardiovascular Interventions 48 (1999): 54–60.

David Cowan is an epidemiology consultant in Silver Spring, MD; Stephen Cunnion has been a Navy Medical Corps captain for 21 years; Tina Swift is a consultant for T.M. Swift & Associates.

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