Reuse of SingleUse Medical Devices

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Reuse of Single-Use Medical Devices

• Dodie Marcil C.I.M.
• Manager Projects, Surgical Services
  Calgary Health Region

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(No Transcript)
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The Canadian Healthcare System

• Canada Health Act-1984
• Establishes the national standard-the criteria
  and conditions related to insured healthcare
  services
• The Canadian Provinces are constitutionally
  responsible for administration and delivery of
  Healthcare services
• They decide
• where hospitals will be located
• how many physicians they need
• how much money will be spent on their healthcare
  systems

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Canadian Healthcare System

• provincial insurance system
• Covering all medically necessary hospital,
  physician, surgical-dental services
• standard public ward accommodation
• nursing services
• diagnostic procedures
• drugs administered in hospital
• use of operating rooms, case rooms and anesthesia
  facilities
• medically required physician services
• long-term residential care
• ambulatory care services

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REUSE OF SINGLE-USE MEDICAL DEVICES
The Development of Single-Use Labels

• Prior to the late 1970s most medical devices
  were considered reusable

• Why were devices such as catheters
  reclassified for single-use only when the
  product remained unchanged?

USCI Cardiology Radiology Products letter Our
manufacturing process of woven Dacron
Intracardiac Electrodes have not changed. These
electrodes are made with the same materials and
in the same manner as they have been in the
past24
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The Development of Single Use Labels

• 1998 USA District Court Case
• The judge found that the manufacturers only
  purpose in labeling a device single-use were to
  comply with the FDAs requirements and to limit
  its own liability from reuse NOT prevent a
  hospital from using the device more than once.25
• The increase in the number of lawsuits in
  medicine in Canada and the USA undoubtedly is a
  major reason for this change
• If the manufacturer does not label the device
  for single-use only the manufacturer must
  provide information indicating the number of
  possible (safe) reuses and provide cleaning,
  packaging, sterilization and quality assurance
  procedures

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The Development of Single-Use Labels

• The discretion to label a device single-use lies
  solely with the manufacturer
• There is a general mistrust over the single-use
  label because
• Neither Canadian or US regulations require
  manufacturers to prove the designation of
  single- use
• The perception is that financial incentives
  influence the single-use designation
• Some manufacturers re-manufacture and
  others provide reprocessing guidelines.

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Classification of Medical Devices

• (CDC)Center for Disease Control and Prevention,
  US Department of Health.
• based on infection risk to the patient and
  reflects the historical concern over reuse
  focusing on the potential for cross contamination
  between patients
• has implications on the degree of
  disinfection/sterility recommended.

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Classification of Medical Devices

• Critical - devices that penetrate skin or mucous
  membranes and enter a normally sterile part of
  the body. It is critical that objects that enter
  sterile tissue or the vascular system be sterile.
• - implants, surgical instruments, cardiac
  and urinary catheters and needles.
• Semi-Critical - devices that contact but do not
  penetrate mucous membranes during use.
  Respiratory and anesthetic equipment and
  Endoscopes such as Gastroscopes Sigmoidoscopes.
  Semi-critical items require high level
  disinfection.
• Non-Critical - devices contact the patients
  intact skin or do not normally make contact with
  the patient. Intact skin acts as an effective
  barrier to most micro organisms.
• Blood pressure cuffs, infusion pumps
• Non-Critical items require low level disinfection

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• Classic Reuse
• Device contacts patient, is cleaned,
  decontaminated, reconditioned/refurbished,
  disinfected or sterilized
• Device is reused on the same or another patient
• the process may be carried out by the hospital, a
  second hospital, or a manufacturing facility

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• Re-sterilization
• further reprocessing of a SUD that was sterile
  when received by the hospital
• - passing of the devices expiry date
• - inclusion in a larger sterile pack
• Reprocessing
• SUD is opened in preparation for surgery or a
  procedure and not used
• SUD is opened in error

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Position on Reuse in Other Countries

• European Union Countries
• The Medical Devices Directive (MDD) governs the
  regulations for all Medical Devices placed on the
  European Common Market (EC)
• This is mandatory effective June 1998
• If the user wishes to reuse a SUD, the MDD states
  such reuse would render the re-processor a new
  manufacturer.
• Subject to the same requirements of the MDD as
  the original manufacturer.

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• France
• Reuse of SUDs was banned in 1994
• In June 1999-the French Court stated that reuse
  of SUDs was A deception to the patient6

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• United Kingdom
• Reuse of SUDs is not prohibited by law
• The Medical Devices Agency (MDA) an Executive
  Agency of the Department of Health
• August 2000 bulletin states
• Devices designated for single-use must not be
  reused under any circumstances7

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• In 1999 Belgium proposed a bill to the European
  Commission on the reuse of SUDs.
• INTENT to force manufacturers of SUDs to
  prove that their product could only be
  used once.
• The European Commission rejected this approach
  because it required the manufacturers to prove a
  negative - would be impossible and uneconomical
  to implement
• EC threatened to legally challenge Belgium in the
  European Union Court of Justice on grounds that
  the bill was a wrong interpretation of the
  Medical Devices Directive.6

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• United States
• Reuse of SUDs is not prohibited by law
• New FDA requirements subject hospitals and
  third-party re-processors to the same regulations
  as the manufacturers
• Including
• Registration of SUD with the FDA, medical
  device tracking, corrective action and removals,
  quality system regulations, labelling, and
  pre-market notification and approval submissions8

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• Australia
• Reuse is not prohibited by law
• National Health and Medical Research Council (NH
  MRC), subject to the Direction of the Minister
• An expert panel on the Reuse of SUDs stated
  the current practice of reuse cannot be
  condoned
• Recommended
• The Australian Health Ministers make a decision
  that reuse of SUDs should not occur or
• the continuation of reuse must be subject to
  more stringent regulations9

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Canadian Regulations

• Canadian Federal regulations have little to say
  about reuse
• Manitoba Provincial Government banned reuse of
  all Critical SUDs
• Quebec Provincial Government banned reuse of
  Angioplasty Catheters
• The application of Canadian Federal Law to the
  reuse of SUDs has not been tested in the
  Canadian Courts.
• Heath Canadas authority to regulate medical
  devices is based on the Food and Drugs Act and
  the Medical Devices Regulations
• These regulations apply to Manufacturers and
  require manufacturers to provide adequate
  instructions and warnings for the safe use of
  their products

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A manufacturer is defined as a person,
partnership, etc, that manufactures and sells a
device

• The Food and Drugs Act and the Medical Devices
  Regulations set no requirements on the user of
  the device.
• Off-label use (the use of a device contrary to a
  manufacturers instructions) is not in itself a
  violation of the Act or Regulations.
• A hospital might reprocess and repackage a SUD,
  but unless the hospital distributes the device
  under its own name or trademark, it would not be
  considered a manufacturer of the device.

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Canadian Regulations

• Off Label-Use of devices is not prohibited by law
• Reprocessing devices does not make a hospital a
  manufacturer
• The Act and Regulations control the sale of
  medical devices - Reuse is not sale

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Organizational Positions on Reuse

• Formal positions on reuse are rare and are found
  more often in the USA.
• MEDEC, a Canadian medical device industry trade
  association has issued a formal statement against
  reuse.
• The Canadian Council on Health Services (CCHSA) -
  accredits Canadian Hospitals
• ask about reuse and look for policies/procedures
  and quality control activities. Reuse practices
  do not impact on accreditation awards.

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Insurers take a risk management approach to reuse
of SUDs

• Healthcare Insurance Reciprocal of Canada
  (HIROC) provides liability insurance to
  healthcare facilities.
• Encourages hospitals considering reuse to
  develop a reuse policy to ensure consistent
  application of each reuse issue.
• Canadian Medical Protective Association (CMPA)
  provides liability insurance to physicians.states
• it does not advise physicians how to practice
  or what standards to use

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Reuse in CanadaCanadian Survey Results

• 1986 - 86 response rate
• 41 - regularly reused SUDs
• 29 - performed cost analysis
• 38 had written procedures
• 68 had no way of determining
  the number of times an item was reused
• 1991 - survey hospitals with Cardiovascular
  Labs
• 39 reused Angiogram, Angioplasty,
  Catheters

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Reuse in CanadaCanadian Survey Results

• 2001 - 57 response rate - This survey focused on
  reuse of Critical devices
• 40 - regularly reused SUDs
• 73 - performed cost analysis
• 51 - had written procedures
• 61 - had no way of determining the number of
  times an item was reused
• 25 - had formal Reuse Committees
• (63 were aware of the 1996 CHA-Guidelines
  for Reuse)
• 21 - of hospitals with Cardiovascular Labs
  reused Electrophysiology Catheters but none
  reused Angiogram and Angioplasty catheters.

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The Reuse of Single-Use Medical Devices1996

• Published by
• The Canadian Healthcare Association
• Under contract to
• Medical Devices Bureau, Health Protection
  Branch,Health Canada

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Guidelines for Healthcare Facilities

• Canadian Healthcare Association
• Disclaimers
• The opinions expressed are those of the authors
  and not of Health Canada
• Guidelines not to be construed as a statement of
  regulatory policy
• Guidelines - intended for information purposes
  only
• Legal opinion regarding potential liability
  intended to provide an overview of legal issues
  not specific legal advice

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Canadian Healthcare Association

• A federation of the Canadian provincial
  hospital/health associations

• Acute care
• home and community care
• long-term care
• public health
• mental health

• Palliative care
• children, youth and family services
• addiction services
• professional licensing bodies

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THE REUSE OF SINGLE-USE MEDICAL DEVICES - 1996

• Part I The Reuse of Single-Use Medical Devices
  A discussion of the Issues.
• - A summary of research and reviews to
  date that have been published in the field
  of reuse of SUDs
• Part II Guidelines for the Reuse of Single -
  Use Medical Devices
• - A comprehensive set of guidelines
  developed for healthcare providers to
  follow when considering reuse or when
  evaluating the comprehensiveness of their
  reuse program

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CHAThe Reuse of Single-Use Medical
DevicesGuidelines for Healthcare Facilities -
1996

• Issues in Reuse
• 1. Patient Risk of Infection
• 2. Ethical Concerns
• 3. Integrity of Function
• 4. Cost Effectiveness
• 5. Legal and Liability Issues
• 6. Safety of Healthcare Professionals

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CHA-The Reuse of Single-Use Medical Devices

• 1. Patient Risk of Infection
• Adverse incidents relating to malfunction of
  reused SUDs which have been documented in the
  literature are primarily related to
• lack of quality control
• breakdown of procedures
• 1977-infection traced to a minute leak in a
  pressure monitoring dome16
• 1991-infections in an ICU related to reuse of
  disposable nebulizers17

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CHA-The Reuse of Single-Use Medical Devices

• Patient to patient transmission of disease is
  not just related to reuse of SUDs
• It is not always the device that is being
  reprocessed that is important but how it is being
  reprocessed
• 1997- Hepatitis C Virus transmitted
  patient-to-patient during colonoscopy-traced to
  inadequate cleaning protocol26
• 1992 - Septicemias in a dialysis unit traced to
  improper mixing of disinfectant18

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Key Points

• Disease and infection transmission from patient
  to patient will occur as a result of
• - inadequate cleaning/sterilization of
  medical devices - both reusable and SUDs
• - the device design must permit the cleaning of
  all contaminated serrations, joints, crevices
  lumens.
• -if reuse is occurring and cleaning/sterilization
  is inadequate, any infection or disease is at
  risk of being transmitted and any patient is high
  risk.

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Issues in Reuse

• 2. Ethical Issues
• The Ethical scope of reuse centers on
• The Management of Risk
• regarding reuse, this discussion has not reached
  beyond the Canadian healthcare professionals
  directly involved in the decision of reuse.

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• The Calgary Health Regions Reuse Policy takes
  the position that there are some single-use
  medical devices that can potentially be reused
  without
• exposing patients to any significant risk of harm
  other than those risks normally associated with a
  particular procedure or treatment
• compromising the quality and safety of patient
  care
• The risks and benefits of reusing any SUD must
  be carefully considered before reuse is approved

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• 3.Integrity of Function
• Retention of functionality is a most important
  issue to be addressed in the decision to reuse
• the physical/characteristics/quality must not be
  adversely affected by
• - cleaning, disinfection or re-sterilization
• the device remains safe and effective for its
  intended use without toxic residue or change in
  consistency, which may be harmful to the patient.

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• Calgary Health Regions reuse policy takes the
  position that the responsibility for determining
  the items suitability for reuse remains with the
  clinicians in the department using the device.
• After consultation with
• Sterile Processing - to verify the device can be
  appropriately cleaned and sterilized
• Clinical Engineering - to verify the structural
  and functional integrity of the device

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4. Cost Effectiveness
Direct Costs of labor material related to

• Indirect Costs
• research about the device
• attending Reuse Committee meeting
• development/implementation of monitoring
  processes
• training staff
• periodic quality reviews

• cleaning
• routine inspection
• marking
• packaging
• sterilization

• Potential Costs - Risks to Patients
• increased procedure time

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• 5. Legal and Liability Issues
• There is no existing case law in Canada and
  limited USA case law on reuse of single-use
  medical devices
• Legal Issues
• a. Liability of the hospital and healthcare
  professionals
• b. informed consent by patients
• c. liability of the manufacturers

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• a. Liability of the hospital and healthcare
  professionals
• In 1995 the Canadian Healthcare Association
  commissioned a legal opinion on the potential
  legal liability of Canadian healthcare facilities
  in the event of a claim of patient injury
  resulting from reuse of a SUD.
• Conclusion
• Under negligence principles a hospital must
  ensure a reasonable standard of care was adhered
  to in the reuse of SUDs. This involves written
  policies, testing of reprocessing protocols and
  strict adherence to quality assurance systems.

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Issues in Reuse

• If there is no established patterns of reuse of
  the SUD in other institutions, hospitals are
  advised to exercise extreme caution.
• Any protocol in common use must be such as to
  reasonably insure patients safety.
• If the established pattern of reuse, even those
  in widespread use, are judged to be below the
  level necessary to adequately insure patients
  safety, then following widespread practices will
  not shield an institution from liability

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• b. Informed consent
• Healthcare providers are under a duty to obtain
  an informed consent from patients for medical
  procedures
• Primary Question
• Has the patient been sufficiently informed of
  all the risks of the procedure that would
  influence his decision whether to have the
  procedure
• Regarding reuse of SUDs- the hospital must take
  appropriate steps to ensure reuse of the device
  is safe and presents no increased risk.

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• C. Liability of the Manufacturer
• Under United States law, the doctrine of Strict
  Liability in Tort and implied warranties
• - attaches liability regardless of whether the
  provider was negligent or whether the defect was
  known or foreseeable.
• This doctrine is not recognized in Canadian Law
• for the strict liability in Tort rule to apply
  the health care provider must be fully informed
  on all risks associated with the use of the
  product such that the providers knowledge equals
  that of the manufacturer.
• In the courts opinion this was not reasonable.

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• 6. Safety of Healthcare Professionals
• Reuse creates additional opportunities for
  healthcare workers to be exposed to
• -blood and body fluids
• -chemicals used in disinfection and
  sterilization
• These risks must be addressed in good reuse
  protocols and appropriate work environments.
• e.g. adequate ventilation for gluteraldehyde
  disinfection

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Calgary Health RegionsReuse of Single-Use Items
Committee

• Co- Chairs- Medical Director Infection
  Prevention Control
• Regional Manager Processing/Case
  Carts Department.
• Clinical Engineering
• Infection Prevention Control Practitioner
• Risk Management/Clinical Evaluation Services
• User Department Representatives/Clinicians
• Ad hoc representatives
• Legal Affairs

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Calgary Health Regions Reuse Policy

• The Reuse Committee reports to an Executive
  Director designated to represent Administration.
• Final authority for approving or rejecting a
  reuse application
• Department Directors are responsible for
  accuracy and validity of the information supplied
  on the Application for Reuse of Single-Use Items.
• Any changes in design, material, manufacturer or
  intended use must be communicated in writing to
  the Reuse Committee.

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Calgary Health Regions Reuse Policy

• Process for renewal of reuse approval
• Examine original assumptions-that the device can
  be decontaminated /sterilized appropriately.
• Compare with current conditions
• have standards of care changed?
• Have procedures changed?
• Is there more manipulation of body tissue?
• Are additional devices used?
• Are changes required in the existing
  decontamination protocol to respond to procedural
  changes?

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Calgary Health Regions Reuse Policy

• - Has the external environment changed?
• Are clinical interventions more time sensitive,
  more intense?
• Where are procedures occurring?
• Is it a controlled environment?
• Are there issues re MRSA and travel accelerated
  global transmission of disease
• Prepare a new cost benefit analysis- will cost
  savings still result?

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Summary

• The only benefit to reuse of SUDs is cost
  savings - everything else is RISK
• The clear message from data on this subject
  Reuse must not be treated casually
• Establish a hospital specific policy for reuse of
  SUDs
• Provide clear guidelines to insure patient,
  healthcare worker, and hospital safety
• Itemize information needed and the approval
  process

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A Reuse Program Should Include

• Cost Analysis- provide guidelines and direction
  so that the analysis is comprehensive.
• Development and validation of reprocessing
  procedures using tools available in hospital.
• Assurance of quality with regular reviews
• Development of an employee training program with
  verification of competency.