Canadian medical device reprocessing in all health care settings

1.1 Standard addresses

This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including

a) establishing a QMS for the MDRA, including

i) key performance indicators;

ii) policies and procedures;

iii) documentation;

iv) roles and responsibilities;

v) management review;

vi) planning, resources, and operations;

vii) environmental conditions and infrastructure; and

viii) recalls and alerts;

b) personnel requirements, including

i) qualifications;

ii) occupational health and safety; and

iii) infection prevention and control;

c) manufacturer’s instructions for use (MIFUs);

d) evaluation and purchase of reprocessing equipment and reusable medical devices;

e) loaned, reusable medical devices;

f) work areas and design;

g) environmental conditions;

h) utilities (e.g., power supply, water, and steam quality);

i) the reprocessing workflow, including

i) decontamination;

ii) preparation of medical devices for reprocessing;

iii) sterile barrier systems;

iv) sterilization methods;

v) storage, transportation, and distribution; and

vi) equipment maintenance and quality assurance;

j) sterile storage;

k) selection and use of gowns and drapes; and

l) laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers.

1.2 Health care settings standard applies to

This Standard applies to health care settings or providers where medical device reprocessing (MDR) occurs including, but not limited to,

a)all acute care hospitals;

b)trauma centres;

c)emergency care facilities;

d)medical clinics with or without overnight stay or observation;

e)endoscopy centres;

f)laser eye clinics;

g)outpatient surgical services;

h)cosmetic surgical offices;

i)dental general and surgical facilities;

j)other office surgical facilities;

k)general physician offices (with and without treatment spaces);

l)stand-alone laboratory facilities;

m)diagnostic imaging centres;

n)nursing homes;

o)long-term care facilities;

p)assisted-living facilities;

q)mental health facilities;

r)forensic facilities;

s)rehabilitation facilities;

t)health care professional offices (e.g., occupational therapy, physiotherapy, ostomy);

u)chronic care facilities;

v)group homes;

w)hospice care facilities;

x)stand-alone dialysis clinics;

y)ambulatory clinics;

z)walk-in health clinics and independent doctor’s offices;

aa)pediatric clinics;

bb)public health clinics;

cc)adult daycare centres;

dd)third-party reprocessors;

ee)educational settings;

ff)community health centres;

gg)private practices for health care professionals (e.g., foot care or any home based reprocessing); and

hh)additional health care settings as applicable.

1.3 Standard does not apply

This Standard does not address

a) reprocessing of single-use/disposable medical devices;

Notes:

1) Information concerning safety, technology, cost/benefit, and legal issues involving the reuse of such medical devices is found in such publications as CADTH (2015).

2) See also Health Canada Update: Notice to Stakeholders — Health Canada’s Regulatory Approach to Commercial Reprocessing of Medical Devices Originally Labelled for Single Use, available at

b) sterilization by injecting ethylene oxide (EO) or mixtures containing EO directly into packages or a flexible chamber; and

c) medical devices that have been used with patients (clients) who are known or suspected to have Creutzfeldt–Jakob Disease (CJD) or prion-related diseases.

Note: See PHAC’s Infection Control Guidelines: Classic Creutzfeldt — Jakob disease in Canada. Quick Reference Guide.

1.4 Terminology

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.