On March 12 Becton Dickinson (BD) advised of the recall of a number of Dedicated and Non – dedicated infusion sets and accessories due to an issue with a third-party sterilization supplier.
23 March 2021
Auckland DHB has a supply chain issue with IV infusion consumables that is impacting clinical trials giving intravenous IPs. This is due to Becton Dickinson recalling products that did not have a valid certificate of sterility. We do not believe there is an issue with sterility however – and neither does any other jurisdiction globally.
The organisation is approving use of BD products but they will soon run out so we are introducing alternative products as supply chain allows. This is being coordinated by the MOH. Please check the HIPPO website where all information is stored.
1) should notify CRAs and sponsors if they use IV consumables
2) should advise that Auckland DHB is continuing to use the recalled products as supplies allow and approves research continuing with use of such products.
3) should advise that the Ministry of Health is coordinating alternative product supply chain and we are introducing those as they arrive with central stock arriving early next week.
Auckland DHB is committed to its programme of research and the viability of active studies. COVID-19 research guidelines will continue to be updated as information becomes available; make sure you are following the most up to date guide on the Hippo page. Play it safe, continue to do everything you can to reduce the risk of COVID-19 when conducting research.
This document is evolving and will not cover all possible scenarios.
Document control – Version 1
Author: Mary-Anne Woodnorth, Auckland DHB Research Office
Approval: Auckland DHB on _03/07/2020__
All research conducted during COVID-19 alert levels must be consistent with the national ethical standards, as at any other time (https://neac.health.govt.nz/publications-and-resources/neac-publications/national-ethical-standards-health-and-disability). For all research approved by a Health and Disability Ethics Committee (HDEC) or due to be reviewed by an HDEC, researchers should ensure they are aware of HDEC’s most up to date COVID-19 guidance and operating procedures.
Usually, to resume an HDEC-approved study after a temporary halt requires that an amendment is first submitted for review by the HDEC. For studies seeking to resume after lockdown, this is not necessary as long as those studies will be resuming according to the previously approved protocol.
Conducting research away from our facilities helps to minimise interpersonal contact as we continue to respond to COVID-19, and reduces the cost of travel for our patients. Our research teams have told us that mitigations put in place to obviate hospital research visits during lockdown were appreciated by participants as efforts to keep them safe.
When it's appropriate and clinically safe, we encourage research teams to carry out more patient appointments by phone or video conference, to courier investigational product to participant’s dwellings or dispense from community pharmacies, and use community laboratories for sample collection.
Researchers in the hospital and community are asked to reconsider or reduce the frequency of laboratory tests that are non-essential, discretionary, routine or could be delayed.
Auckland DHB research staff were not restricted from accessing hospital facilities during lockdown, but under low alert levels may more fully resume their research activities in compliance with clinical and organisational guidelines.
The risk of transmission of SARS-CoV-2 is low but researchers and staff may still become infected at low alert levels.
As responsibility to carry out study procedures may have to be assigned to another research team member if one is stood down due to SARS-CoV-2 infection it is recommended that all research teams review their delegation logs to ensure study continuity.
Researchers from other organisations (e.g. the University of Auckland) may access our DHB facilities for approved research projects during low alert levels.
Non-Auckland DHB (external) researchers must not access hospital facilities if unwell. Any external researcher who tests positive for SARS-CoV-2 or displays symptoms of possible COVID-19 may only resume accessing hospital facilities when negative for SARS-CoV-2 (at least 10 days post positive COVID test) AND symptom free for at least 48 hours.
Under alert level 2, non-Auckland DHB research personnel must access hospital buildings via the visitors’ pathway and undertake a health screening at the point of entry. A central register will be maintained, documenting researchers’ names and telephone numbers, and the ward or hospital service visited. The screening will be repeated each time a researcher presents at an Auckland DHB facility
During alert level 2 in-patients are only permitted one visitor per day. As non-Auckland DHB researchers count as visitors during alert level 2 they should liaise closely with their Auckland DHB research partners or clinical supervisors about research access to hospitalised patients, which should be limited only to patients not expecting a visitor on a given research day.
Monitors and sponsor representatives may access DHB facilities for research-related appointments but via the visitors’ pathway during alert level 2 (see above).
Monitors must not access hospital facilities if unwell. Any monitor who tests positive for SARS-CoV-2 or displays symptoms of possible COVID-19 may only resume accessing hospital facilities when negative for SARS-CoV-2 (at least 10 days post positive COVID test) AND symptom free for at least 48 hours.
Outpatient research clinic appointments can proceed at low alert levels with appropriate use of PPE. Patients coming to an Auckland DHB facility for an outpatient research appointment are able to bring a support person with them. Under alert level 2 support persons will be classed as visitors and must access hospital buildings via the visitors’ pathway (see above).
Research participants and their support persons presenting to an Auckland DHB facility should be screened for COVID-19 using the Auckland DHB-IMT COVID-19 Influenza like Illness Screening Tool
When a research visit will be conducted outside a routine clinical appointment the screening MUST be conducted by a member of the research team who is employed by Auckland DHB.
From time to time there may be COVID-19 patients in the community or in hospital, even at low alert levels. These patients may be enrolled in studies if appropriate precautions are taken.
COVID-19 does not release researchers from their obligation to obtain written informed consent when this is stipulated in the study protocol but the risk of transmission through close proximity of researchers must be managed. Any study which proposes to enrol in-patients with COVID-19 in a study which requires written consent should submit their consent plans to the Research Office, which will organise liaison with infection control regarding the appropriate balance of risks.
Alternatives to traditional written consent that give effect to the Code of Right’s requirement (Section 7.6) for “written informed consent for research” (e.g. photo of signed forms which remain in the room, e-signatures, recorded verbal statements etc.) may be used if researchers can defend their use as “reasonable in the circumstances” (as per Section 3 of the Code: “A provider is not in breach of this Code if the provider has taken reasonable actions in the circumstances to give effect to the rights, and comply with the duties, in this Code”).
Study participants who test positive for SARS-CoV-2 during the period of their enrolment may remain on study at the discretion of the local principal investigator but will not be permitted to access hospital facilities unless as in-patients. Therefore in addition to clinical decision-making about participant’s best interest the PI must also give full consideration as to whether it will be feasible to maintain the participant on study remotely. This may be achieved with telehealth visits, courier or community-dispensed investigational product, and other mitigations.
 All non-Auckland DHB research personnel are required to have engaged an Auckland DHB research partner or clinical supervisor (student projects). It is the research partner or clinical supervisor’s responsibility to ensure the researchers have been issued with ID cards and signed confidentiality agreements before accessing Auckland DHB facilities for research.
 The HDC Code of Health and Disability Services Consumers' Rights