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 2007.

The survey response rate was 72% (413/572). Of the 413 responses, 13 (2.2%) were from long- term 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 2007. 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.

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

Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction Critical and Semi-critical SUDs Jurisdiction *,† BC AB SK MB ON QC NB Total ANESTHESIOLOGY Semi- Ventilator circuit In-house 9 3 9 11 32 critical TPR OTHER ‡ Critical Mouthpiece 1 1 Semi- Airways (oral and 1 10 1 12 critical laryngeal) Anesthetic tube 1 1 Lighted tube stat 1 1 Mask 1 2 1 4 8 16 Aerochamber 1 2 1 4 Nose clip 3 3 Pep valve 1 1 Tee adapter 1 1 Bain 1 1 Laryngeal airways 10 10 CO 2 tubing 1 1 Airways, intubation 1 1 stylettes Gliceurs pour Lidoron 1 1 endotracheal Bellow tube for recovery 1 1 room Non- Heater blanket 1 1 critical Risk classification unknown Torque steering device 1 1 and lead hand Volume sensor cartridge 1 1 Fittings 1 1 Peak flow expiratory rate 1 1 CARDIOLOGY Critical Angiography In-house TPR 1 1 Electrophysiology In-house 1 1 2 diagnostic catheter TPR 4 1 5 Pacing electrode In-house 1 1 (temporary) TPR Ultrasound catheter In-house 2 2 TPR 1 1 OTHER ‡ Critical Goretex Vascular Grafts 6 6 (leftover OBNU) Risk classification unknown Arterial compression 1 1 discs OPCAB Device Vacuum 1 1 Tube Set, Octopus 4 GASTROENTEROLOGY Critical Biopsy In-house 10 3 13

SUD Reprocessing 3

Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction Critical and Semi-critical SUDs Jurisdiction *,† BC AB SK MB ON QC NB Total TPR 1 1 ERCP- In-house 9 9 Cannulatomes/Catheter TPR Esophageal balloon In-house 9 1 10 TPR Hot biopsy forceps/Gold In-house 10 2 12 probe electrohemostasis catheter TPR 1 1 Loop catheter In-house 10 10 TPR Gastrointestinal In-house 10 10 sclerotherapy needle TPR Gastrointestinal In-house 1 10 2 13 guidewires TPR Gastrointestinal In-house 9 1 10 sphincterotome TPR OTHER ‡ Critical Laser probes 1 1 Tonsillectomy snare 1 1 NEUROSURGERY Critical Colorado needle In-house 1 1 TPR Electromyogram In-house 1 1 concentric needle TPR Stereotactic brain biopsy In-house 1 1 needle & cavitron micro needle-tip TPR OTHER ‡ Critical Scissors 1 1 OB/GYN (LAPAROSCOPY) Critical Laparoscopic In-house 1 1 coagulator cutter TPR 2 1 3 OTHER ‡ Critical 2 2 Tubing for curettage 1 1 Non- Cupping glass 1 1 critical OPHTHALMOLOGY Critical Bipolar hemostatic In-house 1 1 1 3 eraser TPR Endo-ocular probe In-house 9 9 (curved) TPR Laser probe (straight In-house 1 10 11 and curved) TPR Phaco tip (straight and In-house 10 4 14 curved) TPR 1 1

SUD Reprocessing 4

Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction Critical and Semi-critical SUDs Jurisdiction *,† BC AB SK MB ON QC NB Total Scleral plug In-house 7 7 TPR Semi- Endo Illuminator In-house 1 10 11 critical TPR

Gauge diamond-dusted In-house 10 1 11 membrane scraper TPR

OTHER ‡ Critical Round stainless steel 10 10 cutting bar Phaco tubing 1 1 Needle (straight and 1 1 curved) Knife 1 1 Cautery for ophthalmic 1 1 application Iris retractor; knife 1 1 Risk classification unknown Gas tubing 1 1 ORTHOPEDICS Critical Arthroscopic In-house 1 1 2 TPR 1 2 3 Burrs In-house 2 10 2 4 18 TPR 1 4 1 6 OTHER † Critical Arthroscopic tubing 1 1 Blades and bits 8 2 3 13 Rotating knife 1 1 Sculpture knives, , 10 10 cautery blade All saw blades, 1 1 arthroscopic shavers UROLOGY Critical Balloon dilator In-house 10 1 11 TPR 1 1 Electrode rollerball In-house 1 10 1 1 13 TPR 3 1 4 Loop catheter In-house 1 1 TPR 2 2 Stone baskets In-house 10 1 3 14 TPR 2 2 Urethral catheter In-house 2 2 TPR Urodynamic catheter In-house TPR 1 1 OTHER ‡ Critical Cutting loop 1 1 Endoscopic shears 1 1 TL Staplers 1 1

SUD Reprocessing 5

Table 1 : SUDs reprocessed in-house and by third-party reprocessor by jurisdiction Critical and Semi-critical SUDs Jurisdiction *,† BC AB SK MB ON QC NB Total Semi- Bite blocks 10 6 16 critical Non- Cleaning brushes for 1 1 critical one-day use only

Risk classification unknown Urinary filters 1 1 MISCELLANEOUS Critical EEG Needle In-house 1 1 TPR Electrosurgery cautery In-house 13 1 14 pencil TPR 1 1 Harmonic In-house 1 1 1 1 6 10 TPR 1 1 2 Semi- Oxygen nasal prongs In-house 3 3 critical TPR Non- Breast pump kit In-house 1 12 8 3 5 6 35 Critical TPR OTHER ‡ Critical Scissors-handle staple 2 2 remover Cord cutter 1 1 Cord clamp remover 2 2 Harmonic shears 1 1 Tungster needle 1 1 Cautery cable 1 1 Myringotomy kit 1 1 Trial prosthesis for 1 1 breast implant Semi- Peak flow meter 1 1 critical Esophageal 7 7 stethoscope Earplugs 1 1 Non- Sequential compression 5 1 2 8 critical sleeves Risk classification unknown Multiple respiratory 10 10 therapies Adapter 7 7 End-tidal CO2 7 7 Portex nes var 3.35; 1 1 flotteur EEG=electroencephalography; TPR=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

Table 2: Number of device types reprocessed by risk classification Critical and Semi-critical SUDs Jurisdiction *,† BC AB SK MB ON QC NB ANESTHESIOLOGY Critical 1 Semi-critical 4 3 1 1 5 5 7 Non-critical 1 CARDIOLOGY Critical 3 5 1 Semi-critical Non-critical GASTROENTEROLOGY Critical 2 8 2 6 NEUROSURGERY Critical 1 3 OB/GYN (LAPAROSCOPY) Critical 1 3 1 Non-critical 1 OPHTHALMOLOGY Critical 3 6 2 5 Semi-critical 1 2 1 ORTHOPEDICS Critical 3 2 1 5 7 UROLOGY Critical 1 3 8 8 Semi-critical 1 1 Non-critical 1 MISCELLANEOUS Critical 3 4 1 5 5 1 Semi-critical 1 1 1 1 Non-critical 2 1 1 2 2 1

* Prince Edward Island does not reprocess SUDs † Newfoundland & Labrador, Nova Scotia, and the Territories did not indicate which SUDs are reprocessed

SUD Reprocessing 7

Table 3: Number of device types reprocessed by risk classification and location of reprocessing Critical and Semi-critical SUDs Jurisdiction *,†

BC AB SK MB ON QC NB ANESTHESIOLOGY Semi-critical In-house 1 1 1 1 TPR CARDIOLOGY Critical In-house 1 2 1 TPR 1 3 GASTROENTEROLOGY Critical In-house 1 8 5 TPR 2 NEUROSURGERY Critical In-house 3 TPR OB/GYN (LAPAROSCOPY) Critical In-house 1 TPR 1 1 OPHTHALMOLOGY Critical In-house 3 4 1 1 TPR 1 Semi-critical In-house 1 2 1 TPR ORTHOPEDICS Critical In-house 1 1 1 1 2 TPR 1 2 2 UROLOGY Critical In-house 1 3 3 4 TPR 3 3 MISCELLANEOUS Critical In-house 1 3 1 2 1 TPR 1 2 Semi-critical In-house 1 TPR Non-Critical In-house 1 1 1 1 1 1 TPR TPR=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

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