Health Technology Inquiry Service

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Charity Farmer
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Health Technology Inquiry Service Title: Reprocessing of Single-Use Medical Devices: A National Survey of Canadian Acute-Care Hospitals (Additional Analyses) Date: February 28, 2008 Context and

1 Health Technology Inquiry Service Title: Reprocessing of Single-Use Medical Devices: A National Survey of Canadian Acute-Care Hospitals (Additional Analyses) Date: February 28, 2008 Context and Policy Issues: There are concerns that the use of reprocessed single-use medical devices (SUDs) might be associated with increased risk to patients of infection or other adverse events. Other issues include legal liability, ethical concerns, the safety of health care professionals, and the cost-effectiveness of SUD reprocessing. The Canadian Agency for Drugs and Technologies in Health conducted a national survey to obtain information on the current situation in Canadian institutions on the reprocessing and re-use of SUDs. The survey was sent to 572 acute-care hospitals (academic and community) in all Canadian jurisdictions, and data were collected from December 2006 to May The survey response rate was 72% (413/572). Of the 413 responses, 13 (2.2%) were from longterm care facilities with no acute-care beds and two (0.3%) were incomplete; these were excluded from the analysis. Three-hundred and ninety-eight responses, corresponding to 70% of the survey population, were used in our analysis. Data collected include hospital demographics, written policies and decision-making processes on SUD reprocessing, third-party reprocessors, types of SUDs reprocessed, and incident report mechanism. Subgroup analyses were performed by jurisdiction (province and territory), hospital type, and size. Complete survey results will be published in a Health Technology Assessment report in the autumn of A second report that includes a clinical review, economic analysis, and health services impact section will be published concurrently. Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness, particularly in the case of new and emerging health technologies for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 Preliminary results of both reports were presented at an F/P/T re-use of SUDs Working Group meetings on August 21 and October 2, 2007, spearheaded by Health Canada. Members from various jurisdictions were interested in having particular information related to the survey results on SUD reprocessing. Research Questions: 1. What SUDs are reprocessed by risk classification? 2. What is the number of device types reprocessed by hospitals by risk classification and by location of reprocessing (in-house and third-party reprocessor)? Methods: Based on the survey data, additional sub-analyses were conducted by risk classification and by jurisdiction in STATA 8.2. Their findings are presented in a table format. Summary of Findings: Results for the research questions are presented in Tables 1 to 3. The types of SUDs reprocessed by hospitals vary by jurisdiction, and the majority of device types reprocessed are critical in terms of risk, as seen in Tables 1 and 2. Based on Table 2, the greatest number of device types is reprocessed in the Departments of Anesthesiology and Gastroenterology. It is evident in Table 3 that an equal proportion of device types reprocessed in British Columbia, Ontario and Quebec are done so in-house and by a third-party reprocessor. SUD Reprocessing 2

3 Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction and Semi-critical SUDs Jurisdiction*, BC AB SK MB ON QC NB Total ANESTHESIOLOGY Ventilator circuit In-house Mouthpiece Airways (oral and 0 2 laryngeal) Anesthetic tube Lighted tube stat Mask Aerochamber Nose clip 3 3 Pep valve Tee adapter Bain Laryngeal airways CO 2 tubing Airways, intubation stylettes Gliceurs pour Lidoron endotracheal Bellow tube for recovery room Noncritical Heater blanket Torque steering device and lead hand Volume sensor cartridge Fittings Peak flow expiratory rate CARDIOLOGY Angiography catheter In-house Electrophysiology In-house 2 diagnostic catheter Pacing electrode In-house (temporary) Ultrasound catheter In-house 2 2 Goretex Vascular Grafts (leftover OBNU) 6 6 Arterial compression discs OPCAB Device Vacuum Tube Set, Octopus 4 GASTROENTEROLOGY Biopsy forceps In-house SUD Reprocessing 3

4 Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction and Semi-critical SUDs Jurisdiction*, ERCP- Cannulatomes/Catheter Esophageal balloon dilator BC AB SK MB ON QC NB Total In-house 9 9 In-house 9 0 In-house Hot biopsy forceps/gold probe electrohemostasis catheter Loop catheter Gastrointestinal sclerotherapy needle Gastrointestinal guidewires Gastrointestinal sphincterotome In-house In-house In-house In-house 9 0 Laser probes Tonsillectomy snare NEUROSURGERY Colorado needle In-house Electromyogram concentric needle Stereotactic brain biopsy needle & cavitron micro needle-tip In-house In-house Scissors OB/GYN (LAPAROSCOPY) Laparoscopic coagulator cutter In-house Trocar 2 2 Tubing for curettage Noncritical Cupping glass OPHTHALMOLOGY Bipolar hemostatic In-house 1 3 eraser Endo-ocular probe In-house 9 9 (curved) Laser probe (straight In-house 0 11 and curved) Phaco tip (straight and In-house curved) SUD Reprocessing 4

5 Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction and Semi-critical SUDs Jurisdiction*, BC AB SK MB ON QC NB Total Scleral plug In-house 7 7 Endo Illuminator In-house 0 11 Gauge diamond-dusted membrane scraper In-house 10 1 Round stainless steel cutting bar Phaco tubing Needle (straight and curved) Knife Cautery for ophthalmic application Iris retractor; knife Gas tubing ORTHOPEDICS Arthroscopic curette In-house Burrs In-house Arthroscopic tubing OTHER Blades and drill bits Rotating knife Sculpture knives, drills, cautery blade All saw blades, arthroscopic shavers UROLOGY Balloon dilator In-house 10 1 Electrode rollerball In-house Loop catheter In-house 2 2 Stone baskets In-house Urethral catheter In-house 2 2 Urodynamic catheter In-house Cutting loop Endoscopic shears TL Staplers SUD Reprocessing 5

6 breast implant Peak flow meter Esophageal 7 7 stethoscope Earplugs Sequential compression sleeves Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction and Semi-critical SUDs Jurisdiction*, BC AB SK MB ON QC NB Total Bite blocks Noncritical Cleaning brushes for one-day use only Urinary filters MISCELLANEOUS EEG Needle In-house Electrosurgery cautery In-house 13 4 pencil Harmonic scalpel In-house Oxygen nasal prongs In-house 3 3 Non- Breast pump kit In-house Scissors-handle staple 2 2 remover Cord clamp cutter Cord clamp remover 2 2 Harmonic shears Tungster needle Cautery cable Myringotomy kit Trial prosthesis for Noncritical Multiple respiratory therapies Adapter 7 7 End-tidal CO2 7 7 Portex nes var 3.35; flotteur EEG=electroencephalography; =third-party reprocessor * Prince Edward Island does not reprocess SUDs Newfoundland & Labrador, Nova Scotia, and the Territories did not indicate which SUDs are reprocessed Hospitals did not indicate the location of reprocessing (in-house or third-party reprocessor) of these devices, and these devices were not assigned a risk classification NOTE: The above SUDs were classified to the best of the authors abilities based on the Spaulding criteria, though some of the devices were too vague to be certain. SUD Reprocessing 6

7 Table 2: Number of device types reprocessed by risk classification and Semi-critical SUDs Jurisdiction*, BC AB SK MB ON QC NB ANESTHESIOLOGY 1 Semi-critical Non-critical 1 CARDIOLOGY Semi-critical Non-critical GASTROENTEROLOGY NEUROSURGERY 1 3 OB/GYN (LAPAROSCOPY) Non-critical 1 OPHTHALMOLOGY Semi-critical ORTHOPEDICS UROLOGY Semi-critical Non-critical 1 MISCELLANEOUS Semi-critical Non-critical * Prince Edward Island does not reprocess SUDs Newfoundland & Labrador, Nova Scotia, and the Territories did not indicate which SUDs are reprocessed SUD Reprocessing 7

8 Table 3: Number of device types reprocessed by risk classification and location of reprocessing and Semi-critical SUDs Jurisdiction*, ANESTHESIOLOGY Semi-critical CARDIOLOGY GASTROENTEROLOGY NEUROSURGERY OB/GYN (LAPAROSCOPY) OPHTHALMOLOGY Semi-critical ORTHOPEDICS UROLOGY MISCELLANEOUS Semi-critical Non- BC AB SK MB ON QC NB In-house In-house In-house In-house 3 In-house 1 In-house In-house In-house In-house In-house In-house 1 In-house =third-party reprocessor * Prince Edward Island does not reprocess SUDs Newfoundland & Labrador, Nova Scotia, and the Territories did not indicate which SUDs are reprocessed NOTE: Numerous hospitals did not indicate the location of reprocessing (in-house or third-party reprocessor) for devices in the Other category, and, therefore, are not included in this table. SUD Reprocessing 8

9 Conclusions and Implications for Decision or Policy Making: The results in Tables 1 to 3 provide further insight on the types of devices reprocessed by Canadian acute-care hospitals and location of reprocessing (in-house or third-party reprocessor) of these devices to assist policy-makers in making an informed decision. Prepared by: Julie Polisena, MSc, Research Officer, HTA SUD Reprocessing 9

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