EVENT NAME : Healthcare Technology Management Workshop
DESTINATION : Washington, DC
DATE : 27-29 March 2019
DELEGATE : Makeida James
Senior Drug Inspector(ag)
Government Analyst-Food & Drug Department
Ministry of Public Health
FINANCING : Pan American Health Organization / World Health Organization (PAHO / WHO)
OBJECTIVES OF THE EVENT
1.To create an awareness of the value of health technology management (HTM)
2.To improve the HTM systems by providing processes, tools and case study examples to empower participants
3.Promote discussion on key issues in the Caribbean (Example: leveraging acquisition and support services such
as maintenance)
4.To develop a plan and/or next actions to improve HTM
DESCRIPTION OF ACTIVITIES
Day 1 –Policy and Planning
Welcome and opening remarks were done by Mr. Alexandre Lemgruber where he discussed the concept of Health Technologies Integrated Approach. He presented on the Status of the Caribbean Region and stated that despite great progress on the Region of the Americas, implementation of Health Technology Assessment (HTA), guidelines and rational utilization in the Caribbean remains at low levels.
James O. Wear presented on the Policies and Regulations Supporting Healthcare Technology Management (HTM) which include: Acquisition, – to promote the proper and effective selection, procurement, donation acceptance, and commissioning of healthcare technologies, to develop institutional capacity and individual expertise in support of policy implementation, technology needs assessment, acquisition and use; Legislation & regulations-To consolidate existing legislation, regulations and incentives as well as formulate new instruments, where required, to ensure proper acquisition, adequate provision, appropriate distribution, and safe and effective use of healthcare technologies.
Mr. Tobey Clark presented on Health Technology Planning. He emphasized on the following: There is a need for Medical Devices to be manage to ensure Patient Safety; Post-market Surveillance: US Food & Drug Administration received Several hundred thousand medical device reports per year and the following was reported: Hospital Errors are the Third Leading Cause of Death in U.S –440,000/yr! (Journal of Patient Safety); Medical device failures account for 13% of all type of adverse events in medicine (Frost & Sullivan) –3-5% of all Sentinel events (Joint Commission 2015); The total national costs from preventable adverse events range between $20 billion to $75 billion annually. (IOM report); The annual number of medical device recalls increased by 97 percent from FY 2003 to FY 2012 (FDA Medical Device Recall Report); and Software failures were 24% of recalls (FDA 2011 annual report) –343 Recalls in the first quarter of 2018 was the highest on record (Stericycle Expert Solutions); Software issues constituted the No. 1 reason for U.S. medical device recalls for the eighth consecutive quarter. Cyber security is: the number one Health Technology Hazard (ECRI Institute 2018); Top five areas for the FDA (FDA Medical Device Safety Action Plan 2018); More than 1300 breaches reported to US HHS since 2010; Ransom ware, e.g. WannaCry shut down NHS in 2016; Patient data stolen, and Virus attacks on software.
Day 2 –Acquisition and deployment
Mr. Tobey Clark presented on Medical Device Acquisition and the following points were discussed:
Pre-purchase is time of maximum leverage; Acquisition must be a standardized process; A multi-disciplinary team is required including clinical engineering; Evidence-based review process required; and Deployment planning is critical for success.
Mr. Michael W Lane presented on Networked Medical Device Acquisition and Cyber security. The following was shared: Overview of networked medical device acquisition and cyber security issues; Best practices in the acquisition phase of networked medical devices; Cybersecurity best practices for networked medical devices. Equifax Breach -143 million Americans personal data exposed(September 2016); WannaCry-230 computers in 150 countries held for ransom(May 2017); –Shut down the UK National Health System –4 deaths; Anthem Health –78.8 million individuals –2016; Crypto wall affects more than 5 billion files (2016); Electrical power blackout in Kiev, Ukraine caused by cyber attack (2016).
Mr. James Wear presented on Medical Equipment Donations and Purchase of Refurbished Equipment where he discussed that donations are partnerships, not casual single-event relationships. Treat donated or refurbished equipment the same way as any acquisition of new equipment.
Jennifer C. Ott, presented on Project Planning Deployment of Medical Devices and Systems- The Business of Health Care should focus on improving the health and well being of people.
Day 3 –Maintenance and support of health technology
A presentation was done by Tobey Clark on Developing Health Technology Management Services, this is: 1. to make leaders aware of the value of healthcare technology management and 2. to determine ways to meet/overcome the challenges that you face.
James Wear presented on Quality Assurance and Maintenance Services, followed by presentation done by Michael W Lane on Computerized Medical Equipment Management Systems (CMMS) Healthcare Technology. The goal of this presentation is to provide a high level overview of CMMS capabilities; provide insight to practical routine reporting for day to day operations; and provide an opportunity to exchange thoughts and ideas around CMMS usage.
Jennifer C. Ott presented on Management of Service Contracts and Vendors. She discussed the importance of awarding contract to the most suitable vendor taking into consideration the after sale services provided such as, maintenance and servicing of equipment.
.
Managing Medical Devices on the Network was done by Michael W Lane where he discussed how technology and healthcare is changing rapidly where devices are now connected to the network, for example wearable, smart phone connected apps, diagnostics, imaging & laboratory equipment.
Recommendation and next step
• The Food and Drug Department should strengthen it’s capacity to Manage Medical Devices to ensure Patient Safety. At the end of January, 2020 the department will be utilizing similar measures used to register medicine to register Medical Devices as recommended by the presenters. The department will prepare the following documents:
1. Medical Devices Submission Application
2. Requirements For Registration of A Medical Device
3. Information to be carried on Label of a Medical Device
• To provide an integrated system for appropriate and effective data collection, storage and analysis as well as dissemination of information and knowledge in support of healthcare technology management
REPORT PREPARED BY
Makeida James