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

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Cleaning, Disinfection and Sterilization of
Medical Devices Some Legal Implicationsby
Tanya M. Goldberg
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What are legal implications when cleaning,
disinfection and/or sterilization of medical
devices is inadequate?
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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

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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

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How do we Determine the Standard of Care for
Cleaning, Disinfection and Sterilization of
Medical Devices?

• a function of many factors/sources
• Health Canadas 1998 Guidelines on Handwashing,
  Cleaning, Disinfection and Sterilization in
  Health Care based on Spauldings classifications
• CSA standards
• manufacturers recommendations
• Hospitals policies, protocols and procedures
• professional Colleges may have issued
  guidelines/policies
• not an exhaustive list
• Court will be assisted by expert testimony

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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

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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

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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

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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

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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

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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

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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?

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Decision to Notify Patients(continued)

• no Court decisions on these issues yet in context
  of voluntary hospital disclosure
• Andersen v. Wilson Rose v. Pettle

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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 manufacturers
  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

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Case Study the Acetabular Reamer(continued)

• general consensus that risk of transmission of
  disease was low (Health Canadas April 21, 2004
  Notice to Hospitals) but could not be ruled out
• Sunnybrook and Womens 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

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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. 106 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

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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

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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

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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

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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

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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 105 to 106 cfu/channel

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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

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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

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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

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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

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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

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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

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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 manufacturers
  recommendations, dedicated staff members with no
  competing patient responsibilities, tracking of
  instruments from patient to patient

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Future Directions (continued)

• third party reprocessing facility established
  with the assistance of the MOHLTC?
• may require substantial increase in inventory