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03.11.2016
CLOSING THE GAP
Medical device manufacturers and healthcare facilities must work together
Anja Heidmann, Peter Drechsler
1 qtec group qtec consult | qtec services | qtec academy
03.11.2016
DRUGWATCH
https://www.drugwatch.com/ercp/superbug/
2 qtec group qtec consult | qtec services | qtec academy
Common problems of inadequate reprocessing, that were reported, are among
others:
• Inadequate reprocessing instructions that are hard to understand
• Complex devices hard to maintain
• Health care personnel not well trained
• Lack of validated reprocessing processes and properly addressed agents
• Missing resources or not state-of-the-art of the equipment
• Occupational high risk for hospital employees
CAUSES
03.11.2016 3 qtec group qtec consult | qtec services | qtec academy
Objective
Provision of cooperation of Healthcare facilities and
medical device manufacturers
Alignment of efforts for reprocessing by means of a
quality management system
Regulatory requirements incl. Post Market Surveillance
03.11.2016 4 qtec group qtec consult | qtec services | qtec academy
Assumptions
• QMS for medical devices manufacturers based on ISO
13485:2016 and 21 CRF 820 (covers the most used QM-
Systems in industry)
• QMS for Healthcare facilities is based on ISO 9001:2008
or ISO 9001:2015
• Only intentional reusable medical devices covered
• Single use devices that are reprocessed are out of scope
03.11.2016 5 qtec group qtec consult | qtec services | qtec academy
INTERFACES
Between two quality management systems
03.11.2016 6 qtec group qtec consult | qtec services | qtec academy
QMS
Medical Device Mfg.
ISO 13485
21 CFR 820
(Risk Management
ISO 14971)
QMS
Healthcare Facility
ISO 9001:2008
ISO 9001:2015
(Risk Management
EN 15224)
Manufacturer
ISO 13485-7.1 Planning of product realization
and 21 CFR 820.5
The manufacturers shall implement
risk management according to ISO
14971.
Healthcare Facilities
ISO 9001:2008-7.1 Planning of product realization,
ISO 9001:2015-8.1 Operational planning and
control
The hospitals shall/should implement a
clinical risk management according to EN
15224.
RISK MANAGEMENT
03.11.2016 7
It might be wise to align the risk management.
qtec group qtec consult | qtec services | qtec academy
03.11.2016
NOTE?
8 qtec group qtec consult | qtec services | qtec academy
Hazard Mitigation New risks/resp.
IFU not complete or not
understandable (missing
language)
Reprocessing validation
Use of established standard
reprocessing method
Impact on the device:
• Incompatibility
• Short term damage
• Long term damage
• Patient, users and
financial risks
Reprocessing method not
• applicable,
• allowed or
• available
in your country
CSSD not familiar with the
device
RISK MANAGEMENT
Healthcare Facilties -- Reprocessing
03.11.2016 9
RISK MANAGEMENT
From a reprocessing manual
03.11.2016 10
RISK MANAGEMENT
From a reprocessing manual
03.11.2016 11
*1 The endoscope is only compatible with ultrasonic cleaning as performed in an
Companyname-recommended endoscope reprocessor such as OER-AW, OER-Pro (OER-AW and
OER-Pro are not available in some areas). When using an AER that is recommended by Company
other than listed above, contact ….
*3 ACECIDE are not available in some areas.
Use a high-level disinfectant cleared by your national regulatory agency for use in reprocessing
flexible endoscopes. Follow the disinfectant manufacturer’s instructions regarding activation (if
required), concentration, temperature, contact time, and expiration date. For further
information regarding the compatibility of glutaraldehyde-based or non glutaraldehyde-based
disinfectant solutions, contact ...
Manufacturer
ISO 13485-7.2 Customer related processes
The manufacturer must be aware on
how its devices are used in the
hospitals and if there are special
statutory and regulatory requirements
requested by national authorities.
Healthcare Facilities
ISO 9001:2008-7.4.2 Purchasing information, ISO
9001:2015-8.4.3 Information for external providers
Clear description of the expectation of the
products.
Delivering input into the design.
Pass valuable information to the
manufacturer, since users are familiar with
devices in their daily use and the
circumstances of reprocessing.
PURCHASING PROCESS
03.11.2016 12 qtec group qtec consult | qtec services | qtec academy
Manufacturer
ISO 13485-7.2 Customer related processes
The manufacturer must determine
customer requirements that were not
explicitly stated by the Healthcare
facility.
Provision of actual IFU and
reprocessing instructions to clients.
Healthcare Facilities
ISO 9001:2008-7.4.1 Purchasing process, ISO
9001:2015-8.4 Control of externally provided
processes, products and services
Establish a process to be up-to-date
regarding reprocessing instructions.
Evaluate device manufacturers.
PURCHASING PROCESS
03.11.2016 13
Document Control
qtec group qtec consult | qtec services | qtec academy
Manufacturer
ISO 13485-7.3.6 and 21 CFR 820.30 (g)
Design validation:
Design validation with healthcare
personnel:
• cleaning
• disinfection
• sterilization
• maintenance
• usability
Healthcare Facilities
ISO 9001:2008-7.5.2 Validation of processes,
ISO 9001:2015-8.5.1 Control of production and
service provision
Validation of processes regarding
cleaning, disinfection, packaging and
sterilization in order to prevent
inadequate decontamination.
Invitation of manufacturers for design
validation activities of the device and to
gain experience in validation activities.
DEVICE DESIGN
03.11.2016 14 qtec group qtec consult | qtec services | qtec academy
Manufacturer
ISO 13485-7.3.2 and 21 CFR 820.30 (c)
Design Input:
Determination of all product
requirements.
Invitation of doctors, nurses or CSSD
staff to determine possible deficits of
the medical devices.
Follow standards for cleaning,
disinfection and sterilization.
Healthcare Facilities
See above.
ISO 9001:2008-7.5.2 Validation of processes,
ISO 9001:2015-8.5.1 Control of production and
service provision
Follow instructions provided by the
manufacturers of the device.
Train your personnel.
DEVICE DESIGN
03.11.2016 15 qtec group qtec consult | qtec services | qtec academy
Manufacturer
ISO 13485-7.2.3 Customer communication
The manufacturer shall establish a
substantial communication with their
customers and evaluate their
feedback.
Healthcare Facilities
ISO 9001:2008-7.4.3 Verification of the
purchased product, ISO 9001:2015-8.6 Release
of products and services
Verify that all purchased products
satisfy your needs.
Report problems with the device like
inadequate reprocessing instructions,
bad maintainability etc. to the
manufacturer.
PRODUCT SPECIFICATION
03.11.2016 16 qtec group qtec consult | qtec services | qtec academy
Manufacturer
ISO 13485-7.2 Customer related processes
The manufacturer must determine
customer requirements that were not
explicitly stated by the healthcare
facility.
Provide device specific training of the
healthcare staff.
Healthcare Facilities
ISO 9001:2008-6.2.2 Competence, awareness,
training, ISO 9001:2015-7.2 Competence
Train the staff in the hospital.
Ask for device specific training by the
manufacturer.
USER TRAINING
03.11.2016 17 qtec group qtec consult | qtec services | qtec academy
Manufacturer
Post Market Surveillance/Vigilance by national
regulations
The manufacturer must report
incidents etc. to competent authorities.
Do proper Post Market Surveillance.
Evaluate customer feedback.
Healthcare Facilities
Obligation for reporting by national regulations or
laws
Report to authorities about malfunctions,
problems etc.
Report to the manufacturer.
REPORTING
Reporting and Vigilance
03.11.2016 18 qtec group qtec consult | qtec services | qtec academy
January 2013 through December 2014, the FDA received 75 MDRs encompassing
approximately 135 patients in the United States relating to possible microbial transmission
from reprocessed duodenoscopes.
FDA started investigations.
In 2015 FDA issued a warning letter to the manufacturer concerning insufficient
reprocessing instructions and missing adequate PMS.
Furthermore, failure to meticulously following the manufacturers instructions by
reprocessers.
THE REAL LIFE
Flexible duodenoscope case
03.11.2016 19 qtec group qtec consult | qtec services | qtec academy
The manufacturer validated the revised reprocessing instructions in April 2015.
FDA approved the instructions in October 2015.
FDA issued recommendation to facilities that reprocess flexible endoscopes to take
certain precautions:
• Strictly follow the manufacturers instructions,
• Train appropriate staff on the revised reprocessing instructions,
• Contact the sales representative if questions or concerns regarding the updated
endoscope reprocessing instructions,
• Invite Clinical Sales Specialists (CSS) for an in-service training regarding these
updated reprocessing instructions.
THE REAL LIFE
Flexible duodenoscope case
03.11.2016 20 qtec group qtec consult | qtec services | qtec academy
LIFE CYCLE
03.11.2016 21
D&D Mfg. Distribution Usage Disposal
Medical Device Manufacturer: ISO 13485
Healthcare Facility: ISO 9001:2008
Device
7.3
7.5.2
7.4
7.2
7.5.2
8.5
PMS
7.2
PMS
7.2
6.3
7.1
6.2.2
qtec group qtec consult | qtec services | qtec academy
LIFE CYCLE
03.11.2016 22
D&D Mfg. Distribution Usage Disposal
Medical Device Manufacturer: ISO 13485
Healthcare Facility: ISO 9001:2015
Device
7.3
8.5.1
8.4
7.2
8.5.1
10
PMS
7.2
PMS
7.2
7.1.3
7.1
7.2
qtec group qtec consult | qtec services | qtec academy
Manufacturer
Listen to hospital staff.
Invite CSSD personnel during design
phase.
Supply training.
Do proper post market surveillance.
Healthcare Facilities
Specify your requirements.
Train the staff in the hospital.
Ask for device specific training by the
manufacturer.
Fulfill your reporting obligations.
SUMMARY
03.11.2016 23 qtec group qtec consult | qtec services | qtec academy
INTERFACES
We need that intersection!
03.11.2016 24 qtec group qtec consult | qtec services | qtec academy
QMS
Medical Device Mfg.
ISO 13485
21 CFR 820
(Risk Management
ISO 14971)
QMS
Healthcare Facility
ISO 9001:2008
ISO 9001:2015
(Risk Management
EN 15224)
CLOSING THE GAP
03.11.2016 25 qtec group qtec consult | qtec services | qtec academy
To Close The Gap a substantial communication process between
healthcare facilities and medical device manufacturers must be
implemented, established and documented.
Thank you for your attention.
Authors:
Dr. Peter Drechsler*, Anja Heidmann
Qtec services GmbH
* Contact corresponding author:
Humboldtstrasse 30
70771 Leinfelden-Echterdingen, Germany
Phone: +49 1732462720
Email.: peter.drechsler@qtec-group.com
03.11.2016 26 qtec group qtec consult | qtec services | qtec academy

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Closing the Gap

  • 1. 03.11.2016 CLOSING THE GAP Medical device manufacturers and healthcare facilities must work together Anja Heidmann, Peter Drechsler 1 qtec group qtec consult | qtec services | qtec academy
  • 3. Common problems of inadequate reprocessing, that were reported, are among others: • Inadequate reprocessing instructions that are hard to understand • Complex devices hard to maintain • Health care personnel not well trained • Lack of validated reprocessing processes and properly addressed agents • Missing resources or not state-of-the-art of the equipment • Occupational high risk for hospital employees CAUSES 03.11.2016 3 qtec group qtec consult | qtec services | qtec academy
  • 4. Objective Provision of cooperation of Healthcare facilities and medical device manufacturers Alignment of efforts for reprocessing by means of a quality management system Regulatory requirements incl. Post Market Surveillance 03.11.2016 4 qtec group qtec consult | qtec services | qtec academy
  • 5. Assumptions • QMS for medical devices manufacturers based on ISO 13485:2016 and 21 CRF 820 (covers the most used QM- Systems in industry) • QMS for Healthcare facilities is based on ISO 9001:2008 or ISO 9001:2015 • Only intentional reusable medical devices covered • Single use devices that are reprocessed are out of scope 03.11.2016 5 qtec group qtec consult | qtec services | qtec academy
  • 6. INTERFACES Between two quality management systems 03.11.2016 6 qtec group qtec consult | qtec services | qtec academy QMS Medical Device Mfg. ISO 13485 21 CFR 820 (Risk Management ISO 14971) QMS Healthcare Facility ISO 9001:2008 ISO 9001:2015 (Risk Management EN 15224)
  • 7. Manufacturer ISO 13485-7.1 Planning of product realization and 21 CFR 820.5 The manufacturers shall implement risk management according to ISO 14971. Healthcare Facilities ISO 9001:2008-7.1 Planning of product realization, ISO 9001:2015-8.1 Operational planning and control The hospitals shall/should implement a clinical risk management according to EN 15224. RISK MANAGEMENT 03.11.2016 7 It might be wise to align the risk management. qtec group qtec consult | qtec services | qtec academy
  • 8. 03.11.2016 NOTE? 8 qtec group qtec consult | qtec services | qtec academy
  • 9. Hazard Mitigation New risks/resp. IFU not complete or not understandable (missing language) Reprocessing validation Use of established standard reprocessing method Impact on the device: • Incompatibility • Short term damage • Long term damage • Patient, users and financial risks Reprocessing method not • applicable, • allowed or • available in your country CSSD not familiar with the device RISK MANAGEMENT Healthcare Facilties -- Reprocessing 03.11.2016 9
  • 10. RISK MANAGEMENT From a reprocessing manual 03.11.2016 10
  • 11. RISK MANAGEMENT From a reprocessing manual 03.11.2016 11 *1 The endoscope is only compatible with ultrasonic cleaning as performed in an Companyname-recommended endoscope reprocessor such as OER-AW, OER-Pro (OER-AW and OER-Pro are not available in some areas). When using an AER that is recommended by Company other than listed above, contact …. *3 ACECIDE are not available in some areas. Use a high-level disinfectant cleared by your national regulatory agency for use in reprocessing flexible endoscopes. Follow the disinfectant manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time, and expiration date. For further information regarding the compatibility of glutaraldehyde-based or non glutaraldehyde-based disinfectant solutions, contact ...
  • 12. Manufacturer ISO 13485-7.2 Customer related processes The manufacturer must be aware on how its devices are used in the hospitals and if there are special statutory and regulatory requirements requested by national authorities. Healthcare Facilities ISO 9001:2008-7.4.2 Purchasing information, ISO 9001:2015-8.4.3 Information for external providers Clear description of the expectation of the products. Delivering input into the design. Pass valuable information to the manufacturer, since users are familiar with devices in their daily use and the circumstances of reprocessing. PURCHASING PROCESS 03.11.2016 12 qtec group qtec consult | qtec services | qtec academy
  • 13. Manufacturer ISO 13485-7.2 Customer related processes The manufacturer must determine customer requirements that were not explicitly stated by the Healthcare facility. Provision of actual IFU and reprocessing instructions to clients. Healthcare Facilities ISO 9001:2008-7.4.1 Purchasing process, ISO 9001:2015-8.4 Control of externally provided processes, products and services Establish a process to be up-to-date regarding reprocessing instructions. Evaluate device manufacturers. PURCHASING PROCESS 03.11.2016 13 Document Control qtec group qtec consult | qtec services | qtec academy
  • 14. Manufacturer ISO 13485-7.3.6 and 21 CFR 820.30 (g) Design validation: Design validation with healthcare personnel: • cleaning • disinfection • sterilization • maintenance • usability Healthcare Facilities ISO 9001:2008-7.5.2 Validation of processes, ISO 9001:2015-8.5.1 Control of production and service provision Validation of processes regarding cleaning, disinfection, packaging and sterilization in order to prevent inadequate decontamination. Invitation of manufacturers for design validation activities of the device and to gain experience in validation activities. DEVICE DESIGN 03.11.2016 14 qtec group qtec consult | qtec services | qtec academy
  • 15. Manufacturer ISO 13485-7.3.2 and 21 CFR 820.30 (c) Design Input: Determination of all product requirements. Invitation of doctors, nurses or CSSD staff to determine possible deficits of the medical devices. Follow standards for cleaning, disinfection and sterilization. Healthcare Facilities See above. ISO 9001:2008-7.5.2 Validation of processes, ISO 9001:2015-8.5.1 Control of production and service provision Follow instructions provided by the manufacturers of the device. Train your personnel. DEVICE DESIGN 03.11.2016 15 qtec group qtec consult | qtec services | qtec academy
  • 16. Manufacturer ISO 13485-7.2.3 Customer communication The manufacturer shall establish a substantial communication with their customers and evaluate their feedback. Healthcare Facilities ISO 9001:2008-7.4.3 Verification of the purchased product, ISO 9001:2015-8.6 Release of products and services Verify that all purchased products satisfy your needs. Report problems with the device like inadequate reprocessing instructions, bad maintainability etc. to the manufacturer. PRODUCT SPECIFICATION 03.11.2016 16 qtec group qtec consult | qtec services | qtec academy
  • 17. Manufacturer ISO 13485-7.2 Customer related processes The manufacturer must determine customer requirements that were not explicitly stated by the healthcare facility. Provide device specific training of the healthcare staff. Healthcare Facilities ISO 9001:2008-6.2.2 Competence, awareness, training, ISO 9001:2015-7.2 Competence Train the staff in the hospital. Ask for device specific training by the manufacturer. USER TRAINING 03.11.2016 17 qtec group qtec consult | qtec services | qtec academy
  • 18. Manufacturer Post Market Surveillance/Vigilance by national regulations The manufacturer must report incidents etc. to competent authorities. Do proper Post Market Surveillance. Evaluate customer feedback. Healthcare Facilities Obligation for reporting by national regulations or laws Report to authorities about malfunctions, problems etc. Report to the manufacturer. REPORTING Reporting and Vigilance 03.11.2016 18 qtec group qtec consult | qtec services | qtec academy
  • 19. January 2013 through December 2014, the FDA received 75 MDRs encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes. FDA started investigations. In 2015 FDA issued a warning letter to the manufacturer concerning insufficient reprocessing instructions and missing adequate PMS. Furthermore, failure to meticulously following the manufacturers instructions by reprocessers. THE REAL LIFE Flexible duodenoscope case 03.11.2016 19 qtec group qtec consult | qtec services | qtec academy
  • 20. The manufacturer validated the revised reprocessing instructions in April 2015. FDA approved the instructions in October 2015. FDA issued recommendation to facilities that reprocess flexible endoscopes to take certain precautions: • Strictly follow the manufacturers instructions, • Train appropriate staff on the revised reprocessing instructions, • Contact the sales representative if questions or concerns regarding the updated endoscope reprocessing instructions, • Invite Clinical Sales Specialists (CSS) for an in-service training regarding these updated reprocessing instructions. THE REAL LIFE Flexible duodenoscope case 03.11.2016 20 qtec group qtec consult | qtec services | qtec academy
  • 21. LIFE CYCLE 03.11.2016 21 D&D Mfg. Distribution Usage Disposal Medical Device Manufacturer: ISO 13485 Healthcare Facility: ISO 9001:2008 Device 7.3 7.5.2 7.4 7.2 7.5.2 8.5 PMS 7.2 PMS 7.2 6.3 7.1 6.2.2 qtec group qtec consult | qtec services | qtec academy
  • 22. LIFE CYCLE 03.11.2016 22 D&D Mfg. Distribution Usage Disposal Medical Device Manufacturer: ISO 13485 Healthcare Facility: ISO 9001:2015 Device 7.3 8.5.1 8.4 7.2 8.5.1 10 PMS 7.2 PMS 7.2 7.1.3 7.1 7.2 qtec group qtec consult | qtec services | qtec academy
  • 23. Manufacturer Listen to hospital staff. Invite CSSD personnel during design phase. Supply training. Do proper post market surveillance. Healthcare Facilities Specify your requirements. Train the staff in the hospital. Ask for device specific training by the manufacturer. Fulfill your reporting obligations. SUMMARY 03.11.2016 23 qtec group qtec consult | qtec services | qtec academy
  • 24. INTERFACES We need that intersection! 03.11.2016 24 qtec group qtec consult | qtec services | qtec academy QMS Medical Device Mfg. ISO 13485 21 CFR 820 (Risk Management ISO 14971) QMS Healthcare Facility ISO 9001:2008 ISO 9001:2015 (Risk Management EN 15224)
  • 25. CLOSING THE GAP 03.11.2016 25 qtec group qtec consult | qtec services | qtec academy To Close The Gap a substantial communication process between healthcare facilities and medical device manufacturers must be implemented, established and documented.
  • 26. Thank you for your attention. Authors: Dr. Peter Drechsler*, Anja Heidmann Qtec services GmbH * Contact corresponding author: Humboldtstrasse 30 70771 Leinfelden-Echterdingen, Germany Phone: +49 1732462720 Email.: peter.drechsler@qtec-group.com 03.11.2016 26 qtec group qtec consult | qtec services | qtec academy