Table 5.
Evidence inputs and factors considered in medical device procurement planning
| Factors/ Evidence input | Areas of concern in current procurement planning processes | Selected key references a | Recommended course of action to address areas of concerns / best practices: | Selected key references a |
|---|---|---|---|---|
| Medical device cost: costs considered for each product purchase | Installation, maintenance and safe disposal costs not captured; User training costs not included; |
SR143: WHO, 2011 SR122, 124–131: WHO, 2010 |
Include all expenses associated with medical device deployment to health facilities, in particular user training and maintenance; | SR241: Martin, 2005 SR247: Free, 1993 SR122, 124–131: WHO, 2010 |
| Specialist expertise: advice or opinion of biomedical engineers, health economists, clinical or procurement specialists considered when planning | Experts are rarely locally available; Where experts are available, expertise is likely financing/ pharmaceutical rather than device specific; |
SR79: Mullally, 2008 SR26: Mundy, 2012 SR34: Mundy, 2012 |
If possible, create national training programs/specialized procurement units staffed with biomedical engineers; Consult international biomedical engineers or health economists on specifications and value for money of products; |
SR63–69: Bloom, 1989 SR80: Mytton, 2010 |
| Regulations and standards: Equipment conformity to international regulatory approval (FDA approval, ISO certification, CE mark) | Products complying with international regulatory approvals may be costly and unavailable in local markets; Absence of national regulatory agencies impedes verification of certifications; |
SR163: WHO, 2012 SR133: WHO, 2011 |
As a minimum standard, ensure high-risk equipment is internationally certified for use so as to ensure patient safety; | SR35: Keller, 2010 |
| Health needs assessment: Identified population health priorities and/or technological needs | National level decision-makers may distrust needs-assessments conducted by health facility personnel due to exaggerations or mis-information; Needs assessment information may not be up to date; |
SR38: Aid-Khalet, 2001 SR56: Mavalankar, 2004 |
Create regional or national level participatory structures where health facility representatives may directly participate in procurement planning and tendering. | SR122, 124–131: WHO, 2010 SR176: WHO, 2000 |
| Clinical guidelines: Patient management guidelines for interventions/clinical areas | Clinical guidelines may not include information on products needed to carry out specific health interventions; | SR184: Anderson, 2008 | Incorporate indications on medical device necessities into clinical guidelines and where possible advise on LMIC friendly product specifications. | SR41: Briggs, 2008 SR44: Dyer, 2010 |
| Health technology assessment: Methods and reports on the procurement economic and health impact, and policy and regulatory approval | HTA difficult to undertake due to data paucity on health impacts, medical device coverage, equipment life span, true costs of equipment. | SR24: PAHO, 2012 SR249: Withanachchi, 2007 |
Within resource constraint, adopt transparent and evidence-based processes to evaluate different investment options; If possible, secure political support for HTA implementation. | SR106: Panerai, 1989 SR198: Teerawattananon, 2005 |
a Numbers with a prefix “SR” shown in the Table refer to identification numbers for documents included in the systematic review – please see Additional file 4 to identify the individual references