1. 1 Cleaning, Disinfection and Sterilization of Medical Devices: Some Legal Implications by Tanya M. Goldberg

2. 2 What are legal implications when cleaning, disinfection and/or sterilization of medical devices is inadequate?

3. 3 Some Basic Concepts of Legal Negligence “ negligence” arises when a person fails to take reasonable care in order to avoid a risk of foreseeable injury to another we use the legal concept of “standard of care” to limit liability for negligence “standard of care” is what a reasonable person of ordinary intelligence and training would do in the same circumstances “standard of care” is a legal concept and not equivalent to general practice (i.e. what everybody else is doing) although this may be one factor the court considers

4. 4 Some Basic Concepts of Legal Negligence (continued) Anderson v. Chasney where allegedly negligent act is so “fraught with obvious risks” that anyone is capable of finding it negligent on the basis of common sense (without need for professional expertise) then judge/jury can exercise own judgment whether the “standard of care” is met is always a question of fact dependent on the particular circumstances

5. 5 How do we Determine the Standard of Care for Cleaning, Disinfection and Sterilization of Medical Devices? a function of many factors/sources Health Canada’s 1998 Guidelines on Handwashing, Cleaning, Disinfection and Sterilization in Health Care based on Spaulding’s classifications CSA standards manufacturer’s recommendations Hospital’s policies, protocols and procedures professional Colleges may have issued guidelines/policies not an exhaustive list Court will be assisted by expert testimony

6. 6 Ontario Audit of Infection Prevention and Control in Hospitals a comprehensive audit requested by the Ontario MOHLTC in November 2003 of all reprocessing areas throughout the hospital focus on the appropriate disinfection and sterilization of semi-critical and critical devices respectively initiated in response to two independent “lookback and notification” processes undertaken by Toronto area hospitals which received media attention

7. 7 “Lookback” and “Notification” “lookback” – process whereby hospital identifies all patient who may be affected by an occurrence “notification” – process whereby hospital advises those identified patients of the occurrence and any recommended follow-up generally undertaken when the occurrence has generated a risk to patient health

8. 8 Assessment of Risk under what circumstances ought a risk to be disclosed, i.e. is there a threshold? the general rule is that the more significant the potential consequences of the risk, the lower the threshold to trigger a duty to disclose for example, where the potential consequences may include serious injury/illness or even death, the threshold is very low analogy with informed consent cases and regulation of industrial/environmental hazards

9. 9 Assessment of Risk (continued) the threshold question has not been determined by a Canadian court in this context how do you assess risk? i.e. the possibility of infection particular circumstances of case, look at all aspects of reprocessing including manual cleaning as well as disinfection/sterilization, design and components of device, part of body that component enters into contact with, prevalence of disease in patient population, possibility of laboratory testing, in house and independent expert assistance, review of scientific literature

10. 10 Assessment of Risk (continued) risk must be assessed in a timely manner because patient health may have been compromised and patient may be unaware of infection and ability to transmit to others assume the “worst case scenario” importance of accurate and complete (time permitting) information to underlie analysis be aware of the potential impact of any assumptions made and make them conservatively

11. 11 Decision to Notify Patients always a question of judgment in the “grey areas” overriding concern is patient health and safety, possibility of transmission to others, recommended blood testing and follow-up, possibility of prophylactic medication if you decide to notify, must do it appropriately, otherwise expose hospital to claim of “negligent notification” Pittman v. Bain; A.B. v. Tameside & Glossop Health Authorities disclose accurate information, facilitate resources available to patients (blood testing, family physician, MRP, counselling), information line

12. 12 Decision to Notify Patients (continued) decision to notify may result in legal proceedings against the hospital class action lawsuits: large number of potential claimants, relatively small amounts of individual claims absent actual cases of infection claims for mental distress/nervous shock should we deny/limit these claims on grounds of public policy? where a remote risk is at issue, should hospital balance the potential mental distress caused to uninfected patients by the notification with the potential that a patient may have been infected?

13. 13 Decision to Notify Patients (continued) no Court decisions on these issues yet in context of voluntary hospital disclosure Andersen v. Wilson; Rose v. Pettle

14. 14 Case Study: the Acetabular Reamer instrument used to prepare site for hip replacement/revision surgery concern raised because shaft of particular model not disassembled for cleaning and sterilization “loaner” device; lack of manufacturer’s documentation initially discovered in Montreal; Health Canada notice to all hospitals in April 2004 potential to affect not only particular acetabular reamer model but a number of other instruments of similar design

15. 15 Case Study: the Acetabular Reamer (continued) general consensus that risk of transmission of disease was “low” (Health Canada’s April 21, 2004 Notice to Hospitals) but could not be ruled out Sunnybrook and Women’s College Health Sciences Centre, with the assistance of HIROC, retained Dr. William Rutala, a microbiologist and internationally recognized authority on the cleaning, disinfection and sterilization of medical devices, to provide an opinion. Dr. Rutala prepared an experimental protocol and carried out a series of laboratory tests to try and quantify the risk to which patients may have been exposed

16. 16 Case Study: the Acetabular Reamer (continued) tested the “worst-case scenario” by inoculating an inaccessible portion of the reamer shaft (i.e. hidden when shaft assembled) with a high concentration of spores (i.e. 10 6 geobacillus stearothermophilus) and performing no cleaning subjected shaft to pre-vacuum steam sterilization at 132° C for 4 minutes ran 7 trials using 80% fetal calf serum (averaging at least 1,000,000 spores) and found no growth of spores concluded that less than 1 in 1,000,000 spores survived the sterilization process

17. 17 Case Study: the Acetabular Reamer (continued) then performed risk assessment, applying reductions to account for prevalence of disease in population, increased susceptibility of viruses as compared to spores (at least 100 times less resistant), effectiveness of cleaning and infectivity (i.e. likelihood that dose necessary to cause infection is present) concluded that risk of Hepatitis B was 1 in 500 billion, risk of Hepatitis C was 1 in 10 trillion and risk of HIV was 1 in 200 trillion population of world in 2004 is 6.4 billion according to U.S. Census Bureau

18. 18 Case Study: the Acetabular Reamer (continued) these findings and reports were circulated to Ontario hospitals under cover of a joint memorandum by the OHA and MOHLTC

19. 19 Case Study: Defective Component of Endoscope Washer “problem” identified when technician noticed that two “identical” parts on the same machine did not look the same transpired that one of the parts had been incorrectly installed by the manufacturer prior to purchase and was “backwards” this part was a port adapter (suction barb) that formed part of a “quick connect” kit for attaching scope to sterilizing machine

20. 20 Case Study: Defective Component of Endoscope Washer (continued) key issue was how well the liquid sterilant (peracetic acid) perfused all lumens of the scope to ensure adequate high- level disinfection was achieved hospital retained a leading independent expert to advise and also engaged in discussions with the manufacturer to see if any testing could be done to quantify the risk ultimately the manufacturer conducted testing at its GLP compliant lab in consultation with the expert retained by the hospital

21. 21 Case Study: Defective Component of Endoscope Washer (continued) first tested “flow” and found outlet of adapter was severely occluded (more than 85% reduced); this resulted in increased flow to other aspects of channel including distal tip, channel selector port and suction valve port outlet channel still received 14.6 mL/min for a total of 175.2 mLs over the 12 minute disinfection cycle then inoculated scope (on separate trials) with both Gram negative and Gram positive vegetative organisms (more resistant to disinfectant killing) with a load of 10 5 to 10 6 cfu/channel

22. 22 Case Study: Defective Component of Endoscope Washer (continued) found no viable micro-organisms following disinfectant procedure despite defective suction barb adapter testing conclusively demonstrated that, despite the improper assembly, perfusion was achieved through all lumens of the scope, and hence high-level disinfection was adequate

23. 23 Advisability of Laboratory Testing laboratory testing not always possible depending on the type of organism we are concerned about (must be able to grow in cultured medium, cannot be highly dangerous to work with) and the type of “problem” that has been identified importance of devising an appropriate scientific methodology, following standard laboratory practices, keeping thorough notes, being aware of any possible variances between the factual situation under investigation and the testing situation, accounting for any assumptions made and their potential impact on the conclusions reached

24. 24 Advisability of Laboratory Testing (continued) importance of testing “worst case scenario” within reason when should you do testing “in house” and when should you have an independent expert participate? understanding of “problem” level of expertise required time constraints ability to create and execute a scientific protocol occupational health and safety considerations potential for litigation disclosure of information

25. 25 Advisability of Laboratory Testing (continued) only engage in testing if you are confident you have the requisite knowledge and expertise to conduct appropriate testing and only make conclusions that are amply supported by the evidence a powerful tool to eliminate reliance on assumption

26. 26 Current State of the Law since the MOHLTC audit a heightened awareness in Ontario of cleaning, disinfection and sterilization practices of medical instruments in a hospital setting the bar has likely been raised in terms of standard of care no decisions to date in Canada on the substantive legal issues where uninfected patients proactively notified of remote health risk by hospital issues re duty of care, duty to notify, appropriateness of notification, balancing of potential for infection with potential for mental distress, public policy aspect of encouraging disclosure of a remote health risk, damages (i.e. compensation), implications of finding hospitals liable to uninfected patients and their family members

27. 27 Current State of the Law (continued) claims to date have involved actual cases of infection or “needle stick” type cases raises interesting issues about how we, as a society, regard risk and whether liability will be found for exposure to risk where that risk does not materialize

28. 28 Future Directions increased reliance on central processing departments with staff, expertise, equipment and focus on cleaning, disinfection and sterilization establishing separate areas for different reprocessing tasks, appropriate training and education including continuing development, heightened awareness of potential problems, importance of immediate reaction, proper quality control and monitoring, regular maintenance of machines, record keeping, familiarity with the machines/instruments, knowledge of manufacturer’s recommendations, dedicated staff members with no competing patient responsibilities, tracking of instruments from patient to patient

29. 29 Future Directions (continued) third party reprocessing facility established with the assistance of the MOHLTC? may require substantial increase in inventory